Yourlawyer.com (Defective Medical Devices News)

Medtronic Cardiac Rhythm Disease Management Site Gets FDA Warning Letter

Thu, 19 Nov 2009 00:00:00 -0800

Device maker giant, Medtronic, Inc., just announced that it received a warning letter from the U.S. Food & Drug Administration (FDA).

According to the Twin Cities Business Journal, the letter came after an inspection of Medtronic’s Mounds View Cardiac Rhythm Disease Management site and concerned: “Corrective and preventative action and field-action timeliness, review and documentation of field action recommendations, supplier qualification and controls, and medical-device reporting timeliness,” said the Business Journal. Medtronic has 15 days to respond to the warning letter.

Medtronic said it will respond to the letter within the mandated timeframe and stated that it is in the process of implementing revised processes in response to the letter, said the Business Journal. Medtronic also said that, according to the FDA’s letter, the agency wrote that the firm’s proposal “appear to be adequate to address the concerns raised in the letter and will be confirmed upon re-inspection,” quoted the Business Journal.

In a statement, Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic said, quoted the Business Journal, “Medtronic remains committed to providing the highest quality products to our customers and is working with FDA to resolve all remaining issues as quickly as possible.”

This is not the first warning letter Medtronic has received in recent months. In June we wrote that Medtronic received a warning letter regarding its SynchroMed II Drug Pumps and MiniMed Paradigm Insulin Pump. In the letter, the FDA cited Medtronic for taking too long to recall the SynchroMed pumps. The letter also said that an inspection conducted last year at the Puerto Rican plant where both pumps were made found that Medtronic failed to establish and maintain quality controls in manufacturing. SynchroMed II pumps are implantable devices used to deliver medicine to the spine. The devices have been recalled on several occasions.

According the FDA warning letter, some SynchroMed pumps were released for distribution and implanted in patients even though they were not filled with a needed propellant. The problem was not discovered during the manufacturing process even though the pumps went through a propellant weight check, the letter said.

The pumps were recalled for this problem in May 2008, after Medtronic received two reports of SynchroMed pumps being removed from patients because of a lack of propellant. “FDA is concerned with your failure to initiate a recall for devices affected by the propellant problem in a timely manner,” the warning letter, dated June 1, states. “It took almost two years from when the missing propellant was initially identified to conduct a recall.”

The FDA letter also criticized Medtronic for failing to notify the agency within 30 days of at least two reports of potentially serious patient issues with MiniMed Paradigm Insulin Pumps, and for failing to have a person qualified to make a medical judgment determine if reported problems had anything to do with a patient’s death or serious injury. According to the letter, training records indicated that the employee who evaluated MiniMed pump reports only had a high school diploma with some additional in-house training.

CSI Says ViperSheath Sheath Introducer Could Break, Recall Issued

Wed, 18 Nov 2009 00:00:00 -0800

Cardiovascular Systems Inc (CSI) has initiated a recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical. According to the recall notice, Thomas Medical has received reports of fracturing or stretching occurring when the ViperSheath Sheath Introducer is in use.

The ViperSheath Sheath Introducer is a long-coil reinforced, kink-resistant catheter sheath that facilitates percutaneous, or through the skin, entry of an intravascular device. The device was developed and manufactured by Thomas Medical Products, Inc., and distributed by CSI.

It In the event of a device fracture, separated segments of the ViperSheath Sheath Introducer may require unplanned open surgery to remove the retained segments or control bleeding. Since this device is coil reinforced, any separation of the cannula (a flexible tube inserted into the body) has the potential to expose portions of the coil, creating the potential for vessel dissection or perforation.

To date, CSI is aware of three instances where a ViperSheath Sheath Introducer encountered the issues related to this recall. No permanent patient injuries have been reported. In these instances, successful surgical interventions were performed to retrieve a portion of the sheath

The recall encompasses products distributed from March 25, 2009 to October 21, 2009, and includes the following lot ranges and catalog numbers:

Lot range: S28117 through S29174
Catalog numbers: VPR-ISH 5 X 85, VPR-ISH 6 X 85, VPR-ISH 7 X 85, VPR-ISH 5 X 45, VPR-ISH 6 X 45, VPR-ISH 7 X 45

CSI has notified all customers by FedEx about the recall and is arranging for the return of all products. Customers with questions may contact CSI at 1-877-274-0360.

The ViperSheath Sheath Introducer recall was first announced on November 2, and CSI's recall notice was posted on the Food & Drug Administration's Web site yesterday.

Negative Pressure Wound Therapy Warning From FDA Following Death, Injury Reports

Tue, 17 Nov 2009 00:00:00 -0800

The use of Negative Pressure Wound Therapy systems have been associated with deaths and serious complications, the U.S. Food & Drug Administration (FDA) warned yesterday. In a health alert posted on its Web site, the FDA said it will continue to monitor adverse events associated with Negative Pressure Wound Therapy systems, and will make available any new information that might affect their use.

Negative Pressure Wound Therapy helps various types of open wounds heal by creating a negative pressure (vacuum) at a well-sealed wound site. The vacuum helps remove fluids and infectious materials and draw wound edges together. Negative Pressure Wound Therapy is most commonly used with burns, flaps, ulcers and grafts, but it is contraindicated for several types of injuries, including wounds where there are exposed nerves, organs and vasculature.

In the last two years, the FDA has received six death and 77 injury reports associated with Negative Pressure Wound Therapy systems. Most of the deaths reported to the FDA occurred at home or in a long-term care facility.

Bleeding was the most serious complication and was reported in six death and 17 injury reports. Extensive bleeding occurred in patients with vascular grafts (such as femoral and femoral-popliteal grafts), in sternal and groin wounds, in patients receiving anti-coagulant therapy, and during removal of dressings that adhered to or were imbedded in the tissues. Patients with bleeding required emergency room visits and/or hospitalization and were treated with surgical procedures and blood transfusions.

According to the FDA, 27 reports indicated infection from original open infected wounds or from retention of dressing pieces in the wound. Retention of foam dressing pieces and foam adhering to tissues or imbedded in the wound were noted in 32 injury reports. The majority of these patients required surgical procedures for removal of the retained pieces, wound debridement, and treatment of wound dehiscence, as well as additional hospitalization and antibiotic therapy.

The FDA has advised healthcare professionals to carefully consider patient risk factors before employing Negative Pressure Wound Therapy. They should assure that the patient is monitored frequently in an appropriate care setting by a trained practitioner. In determining the frequency of monitoring, the patient’s condition, including the wound status, wound location and co-morbidities, should be considered.

If a patient is considered a candidate for in-home Negative Pressure Wound Therapy, healthcare providers should:

Instruct the patient and/or caregiver about how to use the system, potential complications and their signs/symptoms, and what to do if complications occur.
Request that the patient and/or caregiver demonstrate use of the system, and document his/her proficiency.
Assure that the patient and/or caregiver understands the warnings associated with NPWT system use.
Provide the patient with a written copy of the patient labeling from the NPWT system manufacturer, if available. Encourage the patient to keep these materials and instructions for use readily accessible.

Zinc in Fixodent, Super PoliGrip Linked to Nerve Damage By Another Study

Mon, 16 Nov 2009 00:00:00 -0800

Super PoliGrip, Fixodent and other denture creams have been associated with nerve damage and the development of neurological problems, according to a study published earlier this fall in the journal "NeuroToxicology." The study, conducted by researchers at Vanderbilt University and the University of Michigan, involved 11 patients, all of whom had a history of ill-fitting dentures, and used large amounts of products like Super PoliGrip and Fixodent, resulting in significant zinc exposure.

Super PoliGrip, Fixodent and other denture creams are made with zinc. A small amount of zinc is necessary for a balanced diet. However, being exposed to an excessive amount of zinc can result in copper depletion and serious negative adverse neurological effects.

The11 patients detailed in the "NeuroToxicology" article all had suffered from significant injuries and neurological disorders for a period of years. The study authors discovered that all 11 patients had used a zinc-containing denture cream, such as Fixodent or Super PoliGrip, to keep their dentures in place. Blood test confirmed that each suffered from zinc poisoning and copper deficiency.

After the 11 patients stopped using denture creams, their zinc and copper levels normalized. This led the study authors to conclude that: "Inappropriate use of denture cream appears to be the sole source of excessive zinc in these patient." Sadly, even after they stopped using denture cream, the neurological condition of the 11 patients did not improve, and was seemingly irreversible.

This "NeuroToxicology" study is not the first to point to a link between products like Super PoliGrip and Fixodent, and neurological disorders. In August 2008, the peer reviewed journal “Neurology” reported on four patients suffering from neuropathy and other neurological symptoms typical of zinc poisoning and copper depletion. All of the patients had been using excessive amounts of denture cream for many years. It was determined that excess use of denture cream could have been responsible for their symptoms.

Over the past year or so, hundreds of victims of zinc-containing denture creams have filed suit against the makers of Super PoliGrip and Fixodent. These lawsuits allege that the manufacturers of these products failed to warn about their risks and failed to provide adequate warnings about the zinc in their products, or adequate instructions to prevent deviation from accepted use. Earlier this year, Super PoliGrip and Fixodent lawsuits were consolidated for centralized and coordinated pre-trial proceedings in the Denture Cream Products Liability Litigation in the United States District Court for the Southern District of Florida, Miami Division, before the Honorable Judge Cecilia Altonaga (MDL No. 2051).

Synthes USA Issues Class I Recall for Vertebrae Replacement Implants

Fri, 13 Nov 2009 00:00:00 -0800

Synthes USA is recalling all lots of the Ti Synex II Vertebral Body Replacement device.   The U.S. Food & Drug Administration (FDA) has deemed the Synthes USA Ti Synex II Vertebral Body Replacement recall a Class I recall.

The Ti Synex II Vertebral Body Replacement is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. The recall is being issued because of reports of moderate to severe loss of vertebral body replacement height (caused by failure of the central body component) in situ occurring at six to fifteen months post implantation.

Loss of device height may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for a reoperation or an operation to modify the implanted device.

The FDA has directed that surgeons and hospitals in possession of the recalled devices stop implanting them immediately. Patients who have this recalled device and have increased pain, other symptoms, or questions should contact their surgeon.

The recall applies to devices manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009. The devices included are:

•   Part No. 04.808.001; Description: Ti Synex (TM) II Central Body 14 mm - 19 mm
•   Part No. 04.808.002; Description: Ti Synex (TM) II Central Body 17 mm - 25 mm
•   Part No. 04.808.003; Description: Ti Synex (TM) II Central Body 21 mm - 29 mm
•   Part. No.04.808.004; Description: Ti Synex (TM) II Central Body 25 mm - 33 mm
•   Part No. 04.808.005; Description: Ti Synex (TM) II Central Body 29 mm - 44 mm
•   Part No. 04.808.006; Description: Ti Synex (TM) II Central Body 37 mm - 52 mm
•   Part No. 04.808.007; Description: Ti Synex (TM) II Central Body 45 mm - 71 mm
•   Part No. 04.808.008; Description: Ti Synex (TM) II Central Body 58 mm - 84 mm
•   Part No. 04.808.009; Description: Ti Synex (TM) II Central Body 71 mm - 97 mm
•   Part No. 04.808.010; Description: Ti Synex (TM) II Central Body 84 mm -110 mm
•   Part No. 04.808.011; Description: Ti Synex (TM) II Central Body 97 mm -123 mm

Class 1 recalls are the FDA's most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

FDA Investigating Problems With External Biphasic Defibrillators

Wed, 11 Nov 2009 00:00:00 -0800

The U.S. Food and Drug Administration (FDA) is investigating energy levels in external biphasic defibrillators with shocks ≤ 200 J. The agency indicated that it has received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion.

The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia, as well. FDA is seeking additional information in order to interpret the significance of these events, and to determine if agency activities are advised.

The FDA addresses this advisory to the clinical community and specific health care professionals including Electrophysiology Labs, code teams, Cardiac Catheterization Labs, Operating Rooms, Intensive Care Units, Emergency Rooms, Risk Managers, Quality Managers, Patient Safety Coordinators, Directors of Nursing, Medical Directors, Biomedical/Clinical engineers, and Emergency Medical Services Professional Organizations, including the American Heart Association, American College of Cardiology, Heart Rhythm Society, American Hospital Association, American Nurses Association, American Medical Association, and Electrophysiology physicians

The cardiac devices include external biphasic defibrillators that deliver energy levels ≤ 200 Joules (J), including monitor/defibrillators and automated external defibrillators (AEDs).

To date, the FDA analysis of the 14 cases does not suggest the need for any change to current clinical practice. As FDA continues its evaluation, it encourages compliance with American Heart Association’s guidelines/algorithms for treatment of cardiac arrhythmias, and compliance with manufacturers’ instructions for defibrillator use.

The FDA stated that it has reviewed its adverse event report database and explored the literature on defibrillation effectiveness and said it recognizes that there can exist multiple contributors to defibrillation and cardioversion success. Patient attributes, such as the size and shape of a person’s body, presenting rhythm; defibrillator attributes, such as energy level and waveform, and treatment conditions such as drug therapy and oxygenation, all affect defibrillation and cardioversion outcomes, said the FDA.

The FDA advises that if an event is experienced similar to those reported above, to report the incident to the FDA by filing a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program at www.fda.gov/MedWatch/report.htm. Healthcare personnel employed by facilities subject to FDA’s user facility FDA's user facility reporting requirements at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/default.htm and should follow the reporting procedures established by their facilities.

The FDA asks that the following information be included in adverse event reports regarding external biphasic defibrillators: Energy level/intensity, waveform (biphasic truncated exponential or biphasic rectilinear), acute vs. chronic cardiac rhythms, drug therapy, oxygenation, paddles vs. pads, delay in therapy, device make and model, and time from collapse to shock.

Edwards Lifesciences Recalls Aortic Catheters

Tue, 10 Nov 2009 00:00:00 -0800

Edwards Lifesciences Corporation has issued a recall of CardioVations EndoClamp Aortic Catheter. The Food & Drug Administration (FDA) has deemed this a Class I recall, its most serious type of recall.

The CardioVations EndoClamp Aortic Catheter locks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures. According to the recall notice, the balloon catheters may spontaneously rupture during surgery.

The CardioVations EndoClamp Aortic Catheters subject to this recall include Model Numbers EC1001 and EC65. This product was manufactured from August, 2008 through August, 2009 and distributed from November, 2008 through September, 2009.

On October 29 , 2009, Edwards Lifesciences sent a letter to their customers instructing them to:

Check their inventory and identify any unused product
Return unused products to the company

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Centurion Premie and Meconium Packs Recalled

Thu, 05 Nov 2009 00:00:00 -0800

Centurion Medical Products Premie Pack and Meconium Pack Pediatric Tracheal Tubes have been recalled, the U.S. Food and Drug Administration (FDA) just announced. The tubes were manufactured with an internal diameter smaller than that indicated on label.

The recall has been directed to anesthesiology healthcare professionals and hospital risk managers and both Centurion Medical Products and the FDA have notified healthcare professionals about the Class I recall that involves Premie Pack, Kit Code LM 110 and Full-Term Meconium Pack, Kit Code LM115. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

The pediatric tracheal tubes used in these kits, which were manufactured with an internal diameter smaller than indicated on the label, could result in an inability to remove secretions and cause partial or complete blockage of the airway and the inability to ventilate the patient. The recalled products were distributed from January 1, 2007 through September 22, 2009.

A tracheal tube is inserted through the nose or mouth into a patient’s windpipe in order to ensure that the airway is not obstructed and that oxygen or anesthesia reaches the lungs. These tubes are used in both adults and pediatric patients, but not newborns or infants.
The FDA indicated that the following models and lots are involved in the recall:

Model/Product Code: These are the Portex uncuffed pediatric sized tracheal tubes which were subject to a prior Class I recall with Smiths Medical:
•   2.5 mm product code 100/105/025
•   3.0 mm product code 100/105/030
•   3.5 mm product code 100/105/035
•   2.5 mm product code 100/111/025
•   3.0 mm product code 100/111/030
•   3.5 mm product code 100/111/035
•   2.5 mm product code 100/126/025
•   3.0 mm product code 100/126/030
•   3.5 mm product code 100/126/035
•   2.5 mm product code 100/141/025
•   3.0 mm product code 100/141/030
•   3.5 mm product code 100/141/035.

Lot/Serial Numbers: These kits contain Portex uncuffed pediatric sized tracheal tubes which were subject to a prior Class I recall with Smiths Medical:
•   Premie Pack: 901087,903267,907307,910297,901218,908258,2009020990,2009022390
•   Full Term Meconium Pack: 01297,07097,09107,12037,06028,2008091501,2008120801,2009033001,2009062201

Centurion Medical Products of Howell, Michigan can be reached toll-free at 1-800-248-4058 (Eastern Time).

More Claims Filed over Medtronic Sprint Fidelis Leads

Thu, 05 Nov 2009 00:00:00 -0800

Three more lawsuits have been filed against Medtronic, Medtronic USA, Medtronic International Technology, and Medtronic Puerto Rico Operations, reports the Madison Record. The three individuals, residents of Illinois, allege in their 60-count suit, that they suffer sudden shocks after being implanted with defective defibrillators made by the device maker, according to the Madison Record.

The complaints state that Lillian Tengstrand, Effie Thomas, and Marcus Williams received the implantable cardiac defibrillators (ICDs), which are surgically placed under the skin of the chest wall to decrease and increase heart rates, explained the Madison Record. Lead wires are placed into a major vein and attached to interior heart muscle. "Electrodes that sense the heart's rhythm are built into the lead wires and positioned in the heart, where they monitor the heartbeat and can transmit an electric shock to abort a dangerous 'overdrive pace,' a very rapid rhythm, or pace the heart at a normal rhythm if an irregularity is detected," the suit states, quoted the Madison Record.

If a lead breaks, the ICD can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent an ICD from sending a necessary, lifesaving shock to the heart. The Sprint Fidelis lead was removed from the market in October 2007 following reports of five deaths due to lead fractures. Medtronic sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients.

Replacing a lead is dangerous and the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture. A choice with which many patients are uncomfortable. According to a report in The New York Times, because of the risks involved, patients implanted with a Sprint Fidelis lead and their doctors often face difficult choices.

"Any failure that compromises the ability of the lead to conduct electrical signals will result in a failure of the ICD to perform properly," the suit states. "Lead failures may include fractured wires, bending, insulation loss, loss of ability to capture changes in electrical characteristics in the ventricle chamber, abnormal lead impedance, sensing failure, and changes in tissue conductor interface," it added, quoted the Madison Record.

The plaintiffs were implanted with the Sprint Fidelis Lead Model Number 6949, allegedly defective due to “spot welding” to connect ICD cables to electrodes placed on the heart, say the three, reported the Madison Record. "The welding required to affix the Sprint Fidelis Lead cables can damage the fine, small wires in the cables," the complaint says. "The welding techniques used were inadequate and resulted in damage to the cables in many Sprint Fidelis Leads," reported the Madison Record, citing the complaint.

Although physicians did tell the device maker about the problems, Medtronic apparently disregarded the complaints and initiated a massive, $100 million ad campaign for its ICD products, said the plaintiffs. Medtronic claimed surgical technique, not faulty device leads, were to blame. Defective devices continued to be implanted until Medtronic finally issued a recall following what the plaintiffs described as ICDs failing at “an alarming rate” worldwide, according to the Madison Record.

Cordis Recalls Crossover Sheath Introducer

Mon, 02 Nov 2009 00:00:00 -0800

Cordis Corporation is recalling all lots of the Crossover Sheath Introducer due to complaints about stretching or fracture of the sheath during use.

To date, Cordis has received six complaints about the Crossover Sheath Introducer. No permanent patient injuries have been reported. In two instances, successful surgical intervention was performed to retrieve a portion of the sheath.

According to a Cordis press release, the Crossover Sheath Introducer is a product developed and manufactured by Thomas Medical Products, Inc., and distributed by Cordis. It is a long-coil reinforced, kink-resistant catheter sheath intended for use in arterial and venous procedures requiring the percutaneous, or through the skin, introduction of therapeutic or diagnostic intravascular devices or fluids.

In the event of a device fracture, separated segments of the device can embolize downstream in the bloodstream and impede blood flow distal to the point where it lodges, resulting in ischemia or infarct to the distal extremity. Since this device is coil reinforced, any separation of the cannula has the potential to expose portions of the coil creating the potential for vessel dissection or perforation. The physician may be required to perform unplanned open surgery to remove the retained segments or control bleeding. If a procedure has been completed successfully using the product, there is no concern.

The recall encompasses products distributed from August 14, 2009 to September 23, 2009 and includes the following lot ranges and catalog numbers:

Lot range: U0000025 through U0000059
Catalog numbers: 403545S, 403585S, 403645S, 403685S, 403745S, 403785S

Cordis has notified all customers by FedEx about the recall and is arranging for the return of all products. Customers with questions may contact Cordis at 1-800-327-7714, 24 hours a day, seven days a week.

Cordis has apprised the U.S. Food and Drug Administration (FDA) of this action.

Stryker Biotech, Execs Indicted for Alleged Illegal Promotion of Bone Growth Product

Fri, 30 Oct 2009 00:00:00 -0700

Stryker Biotech LLC has been indicted on federal charges of illegally marketing bone growth products called the OP-1 Implant and OP-1 Putty. According to a press release issued by the Acting U.S. Attorney in Boston, Mass., the company's former president, Mark Philip, and its current sales managers, William Heppner, David Ard, and Jeff Whitaker were also indicted.

According to the press release, OP-1 Implant and OP-1 Putty, which were used to stimulate bone growth in long bones and the spine, were approved by the Food & Drug Administration (FDA) under a highly restrictive Humanitarian Device Exemption. One of the restrictions was that the device could only treat a condition that affected fewer than 4,000 patients in the United States, and could not be sold for a profit.

The federal indictment alleges the defendants encouraged doctors to use the OP-1 Implant and OP-1 Putty more broadly in combination with a bone void filler, called Calstrux. It further alleges that the defendants knew that such a combination had never been studied in a clinical trial and had never been presented to or approved by the FDA.

According to prosecutors, the defendants promoted the OP-1 products in a mixture with Calstrux because without a mixing agent, the OP-1 products were at a competitive disadvantage with other legal products. The Indictment also alleges that serious medical problems arose in a number of patients from this untested mix of products.

Stryker is facing charges of wire fraud, conspiracy, misbranding, and making false statements to the FDA. If convicted on all eight counts, the company could face fines of $4 million, double the damages caused by the misconduct, or double the company’s gross profits stemming from the misconduct - whichever is greatest.

Mark Philip, William Heppner, David Ard and Jeff Whitaker were charged in with five counts of wire fraud and one count of conspiracy. Ard and Whitaker were also charged with misbranding. Philip was also charged with making false statements to the FDA.

As we've reported previously, four other Stryker employees have already pleaded guilty to charges related to the case.

Qualitest Pharmaceuticals Issues Recall For All Accusure Insulin Syringes

Wed, 28 Oct 2009 00:00:00 -0700

A voluntary nationwide recall was issued yesterday for all Accusure® Insulin Syringes manufactured by Qualitest Pharmaceuticals of Huntsville, Alabama.

The recalled syringes may have needles which detach from the syringe. According to the recall notice, if the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection.

The distributed syringes are of the following descriptions and NDC numbers:

28G 1/2cc, NDC 0603-6995-21
28G 1cc, NDC 0603-6996-21
29G 1/2cc NDC 0603-6997-21
29G 1cc, NDC 0603-6998-21
30G 1/2cc, NDC 0603-999-21
30G 1cc, NDC 0603-7000-21
31G 1/2cc, NDC 0603-7001-21
31G 1cc, NDC 0603-7002-21

All Accusure® Insulin Syringes regardless of lot number are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico).

Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. Qualitest is notifying all customers who received these syringes and arranging for the return of any affected product.

FDA Investigating Faulty Power Cords on Medical Devices

Tue, 20 Oct 2009 00:00:00 -0700

Medical device manufacturers Hospira Inc. and Abbott Nutrition have submitted 122 reports of sparking, charring, and fires from faulty power cords used with their devices to the Food & Drug Administration (FDA). Those reports have prompted the agency to launch an investigation to determine if certain types of power cords used with medical devices may be defective.

The FDA's investigation follows a recall of defective AC power cords manufactured by Electri-Cord Manufacturing Corporation issued by Hospira in August. Items included in this recall include several LifeCare and Plum products, along with the Oximetrix 3 SO2/CO Cardiac Output Computer, Nutrimix Micro Compounder and the GemStar Docking Station. Hospira began working with its customers the week of August 16 to replace all affected power cords regardless of their condition.

According to a notice posted on the FDA Web site, all the reports received so far from Hospira and Abbott have involved AC power cords with a black plastic bridge manufactured by the Electri-cord Manufacturing Company. The companies' investigations of these reports determined that the power cord's prongs may crack and fail at/or inside the plug.

The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Depending on the device and therapy, these failures may potentially lead to serious adverse health consequences, including, death

According to the FDA, Electri-cord has supplied the affected power cords to other medical device manufacturers. The agency is now attempting to determine which devices may be equipped with these cords.

The FDA is advising that all users of medical devices, either in healthcare facilities or in the home, closely monitor the wear and tear on the electric cords used to power these devices. This vigilance is especially important in oxygen rich environments, in which electrical sparking and arcing may trigger a fire, the agency said.

Spine Devices Must Undergo Safety Studies, FDA Says

Tue, 13 Oct 2009 00:00:00 -0700

The manufacturers of certain types of pedicle screw systems, called dynamic-stabilization systems, have been ordered by the U.S. Food & Drug Administration (FDA) to conduct post-marketing studies on a number of potential safety issues. Sixteen companies, including Johnson & Johnson and Zimmer Holdings Inc., currently market these devices.

The FDA cleared the first dynamic stabilization system component in 1997. Dynamic stabilization systems are used in spinal surgery and some are intended to provide stabilizing support to the spinal column during bone fusion. Dynamic stabilization systems have different design features that allow bending or rotation while still facilitating fusion.

Components used to achieve this flexibility include polymer cords, moveable screw heads, and springs. According to the FDA, there is not enough clinical data to determine whether these dynamic stabilization systems provide enough spinal stability to allow for complete spinal fusion, as the system components may loosen, bend, or break over time. If fusion does not occur, a patient’s condition could worsen and possibly require additional surgical procedures.

Dynamic stabilization systems differ from traditional, rigid stabilization systems that have been on the market for decades, and provide stability via screws inserted into segments of the spine. These systems are not intended to allow motion.

When intended as stabilizers during bone fusion, dynamic-stabilization systems are considered class II devices, and are subject to the FDA’s premarket notification requirement (also known as 510(k)). Devices subject to this requirement are cleared for marketing in the United States if the FDA finds them to be substantially equivalent to legally marketed predicate devices.

The FDA is now requiring postmarket studies to address these potential risks for systems already on the market. In addition, the FDA is requesting manufacturers with new dynamic stabilization systems or components to submit clinical information for agency review prior to marketing.

The postmarket surveillance studies must address the following:

the fusion rate for dynamic stabilization systems compared to traditional stabilization systems;
the incidence rate, severity, and time course of adverse events for dynamic stabilization systems compared to traditional stabilization systems;
the type, incidence rate, and time course of subsequent surgical procedures for dynamic stabilization systems compared to traditional stabilization systems; and
the cause of failure for dynamic stabilization systems based on analysis of all reasonable available systems that have been removed from patients, along with any association between the patient’s demographic and clinical data and the device failure.

In reviewing the clinical data gathered from the postmarket surveillance studies, the FDA will consider whether labeling changes or additional preclinical and clinical testing requirements are necessary for these devices.

Orthopedic Docs Withheld Info About Industry Pay When Presenting Research

Thu, 08 Oct 2009 00:00:00 -0700

A new study has found that doctors who presented research last year at the annual meeting of the American Academy of Orthopaedic Surgeons weren't always as forthcoming as they should have been about their financial relationships with the manufacturers of artificial joints. The study appears this week in The New England Journal of Medicine.

The financial relationships between the medical industry and doctors have caused controversy in recent years. In 2007, a U.S. attorney in New Jersey filed criminal complaints alleging that some of the largest artificial-joint makers conspired to violate a federal anti-kickback statute by making payments to surgeons in an attempt to keep their business. As we reported the time, four of the companies, Biomet Inc., DePuy Orthopaedics, Smith & Nephew, and Zimmer Holdings Inc. – paid a total of $310 million, without admitting wrongdoing. A fifth manufacturer, Stryker Corp., cooperated with the probe and was not charged.

According to The Wall Street Journal, the New England Journal of Medicine study measured the accuracy of disclosures by orthopedic surgeons who presented research at the 2008 meeting. The authors of the study compared the doctors' disclosures against a similar list published by the five firms involved in the 2007 settlement. They found that the orthopedists did not disclose more than 20% of the payments they received from the artificial joint manufacturers when they were presenting research involving a the firms' products.

According to the article, of 344 payments disclosed by the companies, only 245 were disclosed by the recipients The study also found that only 165 of 208 payments "directly related" to the doctor's presentation were disclosed.

Critics of industry payments to doctors have long held that such relationships create conflicts-of-interest, and could unduly influence everything from research findings to prescribing practices. According to The Wall Street Journal, several states, including Massachusetts and Vermont, have enacted laws requiring medical companies to disclose the payments they make to doctors. On the federal level, the Physician Payment Sunshine Act would require similar disclosure. The legislation is currently part of the health reform being considered in the U.S. Senate, the Journal said.

Unomedical Recalls Manual Pulmonary Resuscitators

Thu, 08 Oct 2009 00:00:00 -0700

Certain units of the single-patient use Manual Pulmonary Resuscitator (MPR) have been recalled by Unomedical Inc. This recall is being conducted because of a potential malfunction of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. The occurrence of such a malfunction may create a situation in which the use of the product could potentially cause serious adverse health consequences or death.

Pulmonary resuscitators are used to administer artificial respiration to a patient while also giving an external cardiac massage. They are used during CPR to resuscitate patients suffering from cardiac arrest, and resuscitators use positive pressure to inflate the lungs of the patient while they are not breathing, in order to keep them oxygenated.

The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the Unomedical web site. This recall does not impact any MPRs manufactured after March 2008.

In order to distinguish between the recalled product and unaffected product, customers may examine the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned to Unomedical as instructed. MPR units with a clearly visible blue retention ring are not affected and do not need to be returned.

Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers. In addition, the company has set up a web page with a list of affected lot numbers, guidance (diagram and photos) to allow customers to identify products subject to the recall in the event that the customer has already removed the primary product packaging, and instructions on what actions to take.

System Needed to Track Recalled Medical Devices

Wed, 07 Oct 2009 00:00:00 -0700

Even though medical device recalls have increased in recent years, the Food & Drug Administration (FDA) has not devised an effective process for notifying the public about dangerous devices. According to an Associated Press report, lack of such a process has put patients in danger.

In 2008, 2,500 defective medical devices were recalled. More than 1,000 recall notices were sent out in the first seven months of 2009 involving medical devices, and of those recalls, 100 were deemed Class I. A Class I recall is the FDA's most serious recall, and is issued when there is a "reasonable probability of adverse health consequences or death." But finding these recalled devices is no easy task, particularly after they have been implanted into someone's body.

According to the Associated Press, medical device manufacturers generally only track their products as far as the distributor. Hospitals usually track the model and lot numbers of devices implanted at a facility, but that information can be difficult for patients to find. Even doctors aren't always aware that a device has been recalled.

The current situation can have disastrous results for people implanted with defective medical devices. For instance, last October, a New York man who had donated a kidney to his wife died 12 hours after surgery because a surgical clip called the Hem-o-Lok popped off his renal artery. According to the Associated Press, the Hem-o-Lok had been the subject of a recall three years ago, and doctors were warned stop using the fasteners on living kidney donors. It's not clear why, but SUNY Downstate Medical Center and the surgeon who performed the operation were still using the clip.

According to the Associated Press, groups like the Biomedical Research and Education Foundation in Philadelphia have been pushing for patient registries to better track medical devices. Such systems are already in use in Sweden, England and Australia to track artificial joints.

Health reform legislation currently being considered in Congress does include a proposal to set up a comprehensive medical device registry, the Associated Press said. The FDA is also working on a registry for patients with artificial joints and other implants, and is considering assigning each medical device a unique ID number to make them easier to track. The agency has been in talks with the medical device industry regarding these proposals for over a year, the Associated Press said.

Some medical organizations aren't waiting for the federal government to act. According to the Associated Press, Kaiser Permanente health system in California has a registry tracking 75,000 artificial joints. The American Academy of Orthopaedic Surgeons established a nonprofit organization in June with the goal of building a national joint implant registry similar to the Kaiser Permanente system. And the Biomedical Research and Education Foundation has set up a registry that any person can sign up for to automatically get e-mails about potential safety issues with their implant.

Philips Healthcare Recalls Defibrillators

Mon, 05 Oct 2009 00:00:00 -0700

Approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs) are being recalled by Philips Healthcare. According to the recall notice, a potential memory chip failure may render the device inoperable.

The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy.

The recall involves only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May 2007 and January 2008. The AEDs affected by this recall have been distributed globally to fire departments, emergency medical services, hospitals, and other organizations.

Philips said it has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated. These reported failures were detected during routine self tests, and Philips has received no reports of injury associated with this problem.

Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs by sending notification letters to distributors and users. In addition, the company has set up a page on the Philips Web site with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is.

Philips has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Customers who have questions about the recall or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.

Penumbra Recalls Original Version of Neuron 6F 070 Delivery Catheter

Thu, 01 Oct 2009 00:00:00 -0700

Penumbra is initiating a voluntary Field Removal of the original version of its Neuron 6F 070 Delivery Catheter, the U.S. Food and Drug Administration (FDA) just announced. Penumbra has received feedback from some users that these recalled catheters could kink or ovalize in certain anatomical situations.

This kinking and/or ovalization of the catheter lumen can lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued use of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury, or death. To date, there have been four injury reports, which may be potentially associated with this defect.

Consumers with the older version of 6F Neuron 070 Delivery Catheter, which is being recalled, should stop using and return the device. If your facility is in possession of units with lot numbers F14630 or higher, you may continue to use these units; units with lot numbers F14630 or higher are not affected by this Field Removal Action. The following product catalog numbers and lot numbers are affected by this Field Removal:

Neuron Delivery Catheter 070 catalog number: PND6F0701058, PND6F0701058M, PND6F070956, and PND6F070956M.

Affected lot numbers include: F13733, F13751, F13773, F13799, F13817, F13826, F13856, F13865, F13880, F13899, F13934, F13960, F13970, F13971, F13980, F13997, F14007, F14028, F14045, F14046, F14047, F14048, F14102, F14103, F14150, F14182, F14183, F14427, F14482, F14560, and F14629.

Penumbra voluntarily conducted a field removal of the devices after learning about the devices potential to kink or ovalize; the FDA has been apprised of this action. Penumbra is also notifying affected hospitals through detailed Field Removal notification letters requesting that the affected product be returned to Penumbra. A replacement product will be available for all affected customers. Consumers with questions may contact Penumbra at 1-888-272-4606 or 1-510-748-3200.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax at: www.fda.gov/medwatch/report.htm; by fax at 1-800-FDA-0178; or by regular mail—using postage-paid FDA form 3500 (available at www.fda.gov/MedWatch/getforms.htm)—to MedWatch, 5600 Fishers Lane, Rockville, Maryland, 20852-9787.

Menaflex Approval Influenced by Political Pressure, FDA Report Says

Fri, 25 Sep 2009 00:00:00 -0700

A report from the Food & Drug Administration (FDA) says the agency caved to political pressure when it approved ReGen Biologics Inc.'s Menaflex knee device. According to The Wall Street Journal, the FDA is now reconsidering its approval of Menaflex.

Menaflex is meant to repair a torn meniscus, which basically acts as a shock absorber for the knee. Menaflex was approved through a process known as 510(K), which doesn’t require human clinical trials, and is meant for devices that are substantially similar to products already on the market.

As we've reported previously, ReGen's 510(K) application for Menaflex was rejected by FDA scientists on three occasions, with the agency’s staff asserting it wasn’t eligible for the process. But several New Jersey Democrats - Sens. Frank Lautenberg and Robert Menendez, and Reps. Steve Rothman and Frank Pallone Jr. - contacted the FDA in 2007 and 2008 to encourage it to speed its review of the ReGen device, The Wall Street Journal said. Agency managers ultimately overruled the scientists and approved Menaflex in December.

The report issued yesterday said the FDA officials repeatedly deviated from procedures in approving Menaflex, the Journal said. According to the report, the FDA's Congressional Liaison said the pressure put on the agency was "the most extreme he had seen, and the agency's acquiescence to the company's demands for access to the commissioner and other officials in the commissioner's office as unprecedented." The document also criticized former FDA Commissioner Andrew von Eschenbach for pressuring other FDA officials to act quickly.

In a conference call yesterday, FDA Deputy Commissioner Dr. Joshua Sharfstein said the FDA will be reviewing the approval of Menaflex, and that it could take the agency a few months to decide if the device should stay on the market. He also said that the Menaflex approval was one of the reasons the FDA had decided to review the 510(K) process. As we reported, the FDA has commissioned the Institute of Medicine to conduct that review.

FDA Commissions Outside Review Of Device Approval Process

Thu, 24 Sep 2009 00:00:00 -0700

The U.S. Food and Drug Administration (FDA) just announced it commissioned the Institute of Medicine (IOM) to study the pre-market notification program used to review and clear certain medical devices marketed in the United States.

The study will examine the program, also called the 510(k) process, for medical devices, which can be accessed here. The 510(k) process was established under the Medical Device Amendments of 1976 to ensure safe and effective devices are made available to consumers and to promote innovation in the medical device industry.

The FDA announced that while the study is underway, its Center for Devices and Radiological Health (CDRH) will convene an internal working group to evaluate and improve the consistency of FDA decision-making in the 510(k) process. Established by the National Academy of Sciences, the IOM provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. As part of its study, the IOM will convene a committee to answer:

Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?

The $1.3 million IOM review is scheduled for completion in 2011, and is one of six priorities outlined for CDRH as well as to:

Create an internal task force on the use of science in regulatory decision-making
Develop an effective compliance strategy
Optimally integrate pre- and post-market information
Increase transparency in decision-making
Establish clear procedures to resolve differences of opinion
Ensure the IOM will hold two public workshops during the next nine months as part of its review and publish a final report in March 2011 containing its conclusions and recommendations

The FDA classifies medical devices into three categories according to their risk level. Class III devices represent the highest risk level and generally require pre-market approval to support their safety and efficacy prior to marketing. Class III devices include heart valves and intraocular lenses. Class I and II devices pose lower risks and include adhesive bandages and wheelchairs. Most Class II and some Class I devices can be marketed after submission of pre-market notifications (510(k) applications) that support their substantial equivalence to legally marketed devices that do not require pre-market approval. Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require pre-market approval.

Grassley Putting More Heat on Spine Surgeon with Medtronic Ties

Wed, 23 Sep 2009 00:00:00 -0700

Senator Charles Grassley (R-Iowa) has expanded his investigation of Dr. David Polly. As we've reported previously, the relationship between Dr. Polly, head of spine surgery at the University of Minnesota, and Medtronic Inc. has been under scrutiny.

Grassley's probe of Dr. Polly has already revealed that he had been paid $1.2 million by Medtronic between 2003 and 2007 for consulting work. Dr. Polly had come under fire in July for not disclosing his relationship with Medtronic when he testified before a Senate committee in 2006 urging more funding for research into combat-related injuries. According to Minneapolis-St. Paul Business Journal, Dr. Polly never told the panel that he was a Medtronic consultant, and was billing the company $6,000 for his appearance.

In July, Grassley sent Medtronic a letter, asking if its payments to Dr. Polly represent a conflict of interest. Grassley also charged in the letter that Dr. Polly gave Medtronic updates on government-sponsored research in violation of an agreement with the university and may have provided inaccurate information to a university ethics committee. Medtronic has said it was not aware that Dr. Polly had failed to tell the Senate committee about his financial ties to the company when he testified. Both the University of Minnesota and Medtronic have launched investigations of the allegations in Grassley’s letter.

Following his May 2006 testimony, Dr. Polly and his colleagues at the University of Minnesota received a $466,644 Department of Defense grant for a two-year study involving Infuse Bone Graft, a Medtronic product. At the time, because of his relationship with Medtronic, the University asked Dr. Polly if an alternate non-Medtronic product could be used in the research. According to the Pioneer Press, documents obtained by Grassley indicated that Dr. Polly told the University that Infuse "the only commercially available off shelf growth factor to date,"

Now the Pioneer Press is reporting that Grassley has written to the University of Minnesota raising issues of possible conflict of interest regarding Dr. Polly's Infuse research. He is questioning Dr. Polly's earlier assertion that Infuse was the only product suitable for his research. The letter says Michigan-based Stryker Corp. has provided information that appears to contradict Dr. Polly's claims, and that Stryker was selling a similar product in 2006.

Recently, Dr. Polly has defended his choice of Infuse by stating that the Stryker product as approved under a special "humanitarian device exemption," which limits sales to 4,000 devices per year, the Pioneer Press said. But Grassley is not buying that argument, writing in his letter that the Stryker product "never exceeded sales of 4,000 units in 2006, so that point appears to be irrelevant."

According to the Minneapolis Star-Tribune, Grassley has also sent a separate letter to University President Robert Bruininks, asking him to turn over any communications between the school and Dr. Polly. But the school, citing privacy laws, said it will only do so if Dr. Polly consents.

In addition, the Star-Tribune is reporting that Grassley also sent letters to Mark Eustis, chief executive of Minnesota's Fairview Health Services, and Timothy Healy, head of Team Spine-Minnesota Inc, a distributor of spine surgery products, requesting information regarding their relationship.

Choking Hazard Warning for Philips Lifeline Personal Help Buttons

Wed, 23 Sep 2009 00:00:00 -0700

U.S. Health Regulators warned today that Philips Lifeline Personal Help Buttons can pose a choking hazard. According to a notice posted on the Food & Drug Administration (FDA) website, there have been at least six reports between 1998 and 2009 of serious injury or death, including three deaths in the United States and one in Canada, from choking after the cord on the Philips Lifeline Personal Help Button became entangled on other objects worn around the neck.

According to Philips Lifeline, the device is used primarily by seniors living independently, who feel they are at risk for falls or other medical emergencies. By pushing the “help” button on the device when in distress, users can call for emergency assistance to their home.

The Lifeline pendant button is intentionally designed to not break away when tugged, which prevents the button from accidentally falling off. However, because it does not break away, there is a risk of choking, including the possibility of serious injury or death. Risks are greater for those with mobility limitations or for those who use wheelchairs, walkers, beds with guard rails, or other objects that could entangle with a neck cord.

According to the FDA, there are more than 750,000 users of these devices in the United States and Canada. While the number of adverse events reported is small compared to the number of people who use the Philips Lifeline Personal Help Button, the severity of these events is of concern. It remains important that users, along with their health care providers, assess the options provided by each style of button, and choose the option that best fits their condition.

Philips Lifeline is currently sending letters to its 750,000 customers and has changed the labeling of this product to include a warning against the potential choking hazard. The FDA recommends that users consult their health care providers to determine which style of emergency button, including those that are worn on the wrist, is most beneficial for them.

Senators Say Cardiologist May Not Have Reported All Medical Device Payments

Tue, 22 Sep 2009 00:00:00 -0700

A prominent cardiologist with ties to Columbia University is facing questions regarding his ties to medical devices makers, the New York Times is reporting. According to the Times report, two U.S. Senators are concerned that Dr. Martin B. Leon may not have reported all payments he received from companies like Boston Scientific, Johnson & Johnson, Medtronic and the Volcano Corporation to Columbia.

According to the Times, Sens. Charles Grassley (R-Iowa) and Sen. Herbert Kohl (D-Wisc.) have been investigating Dr. Leon's financial relationship with the medical device industry since last year. Last October, they sent letters to the Cardiovascular Research Foundation (CRF) and Columbia University regarding Dr. Leon and several other physicians. According to the Times, CRF sponsors an annual conference - the Transcatheter Cardiovascular conference - that has highlighted products developed by companies in which Dr. Leon and other CRF-affiliated doctors have financial stakes.

The letter to CRF was seeking information about its support for a medical device conference promoting cardiac devices and techniques. The letters to both Columbia and CRF asked for a detailed breakdown of information on all outside income earned by 21 physicians affiliated with the university and CRF. The 21 included Dr. Leon, who formerly headed the group. The Columbia letter also requested information on funding the university received from Abbott, Medtronic, Medinol, Boston Scientific, Johnson & Johnson, and CRF.

In their latest letter, which was sent to Columbia on Friday, Sens. Kohl and Grassley said a review of the information they requested last year indicated Dr. Leon failed to report "significant" amounts in consulting fees, speaking fees and other payments to Columbia, the Times said. The letter asserted the undisclosed payments totaled millions of dollars.

According to the Times, Dr. Leon did file amended disclosure forms with Columbia last December, after Kohl and Grassley began their probe. However, the Senators' letter said that their review indicated that Dr. Leon did not disclose all payments, even in those amended reports.

Medtronic Division Recalls Defibrillators

Thu, 17 Sep 2009 00:00:00 -0700

Physio-Control, Inc., a division of Medtronic, Inc., is recalling LifePak CR Plus Automated External Defibrillators (AED). The Food & Drug Administration (FDA) has deemed this a Class I recall.

This recalled device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an unconscious patient’s heart rhythm and instructs the user to press a button that delivers an electrical shock to the heart to restore a normal heart rhythm.

According to the recall notice, an extremely humid environment may cause the LifePak CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.

The recalled LifePak CR Plus AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008. Devices with the following serial numbers are affected by this recall:

37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211,37038365, 37135986, 37154526, 37154638

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Medtronic Issues Class I Recall for Sutureless Connector Intrathecal Catheters

Wed, 16 Sep 2009 00:00:00 -0700

Medtronic Inc. is recalling Sutureless Connector (SC) intrathecal catheters. In letters sent to physicians, Medtronic said that that the current SC catheter labeling incorrectly states that SC catheters are compatible with the IsoMed infusion pump.

According to a Medtronic press release, the Food & Drug Administration (FDA) has deemed this a Class I recall. Class I recalls are the FDA's most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

A physical interference between the SC catheter connector and the IsoMed pump prevents the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be connected and feel secure. This incompatibility is design related and is not a result of implant technique. This incompatibility may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death.

The clinical manifestations of an incomplete connection of an SC catheter to an IsoMed pump may include, but are not limited to, drug or cerebrospinal fluid (CSF) leakage into surrounding tissue, resulting in tissue damage, loss of or change in therapy, a return of underlying symptoms, drug withdrawal symptoms, a severe ("spinal") headache, and/or a clinically significant or fatal drug underdose. Patients receiving intrathecal baclofen therapy are at higher risk for adverse events as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively. The IsoMed pump is not FDA approved in the United States for the administration of baclofen.

To date, Medtronic has received 10 reports related to improper connection of these catheters to an IsoMed pump. In all of these incidents, medical intervention was required to correct the condition. According to the Medtronic press release, one of these patient died two days following a surgery to fix the catheter’s faulty connection to the pump, However, the company said it cannot be determined whether the cause of death is or is not related to the device.

Products affected by this recall include the following models: SC Catheter and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the IsoMed Pump Model 8472, which is no longer manufactured and marketed. Medtronic stopped producing IsoMed infusion pumps in September 2008 as part of a planned product phase-out. Other types of intrathecal catheters and intravascular catheters for delivery of chemotherapy are not affected by this issue.

Evenflo Didn't Investigate Breast Pump Complaints, Warning Letter Says

Wed, 16 Sep 2009 00:00:00 -0700

The Evenflo Co. did not properly investigate reports that its "Comfort Select" breast pumps caused some women to suffer electric shocks. In a warning letter dated August 25, the Food & Drug Administration (FDA) also said that during inspections earlier this year, several manufacturing violations were found at two Ohio plants that make the pumps.

According to the warning letter, the FDA said Evenflo received thirty-seven complaints involving breast pumps, but did not investigate 18 of them. Three complaints highlighted by the letter involved electric shocks. The FDA noted that Evenflo's response to this and several other violations had been "adequate."

An Evenflo official told The Wall Street Journal that the company does investigate its consumer complaints but said the problem was a "documentation issue."

Another violation noted in the letter included the failure to verify or validate corrective and preventive actions to ensure that such actions were effective and would not adversely affect the finished device. The letter says that Evenflo's response to this finding was only "partially adequate" because corrective actions did not extend to the Comfort Select pumps it sold prior to December 2008.

The FDA also says the company still needs to develop medical device reporting procedures for its breast pumps that identify, evaluate and report complaints that might be subject to federal reporting requirements.

Evenflo had 15 working days from the date of the warning letter to notify the FDA of the specific steps the company has taken to correct the noted violations. Failure to do so could result in regulatory action being initiated by the FDA against Evenflo. Such actions include, but are not limited to, seizure, injunction, and/or civil money penalties.

Medtronic Advisory Says Some Concerto, Virtuoso Defibrillator Batteries May Deplete Prematurely

Fri, 11 Sep 2009 00:00:00 -0700

Medtronic Inc. has issued an advisory for 6,300 Concerto CRT-D and Virtuoso implantable defibrillators. According to the advisory, the batteries on these devices may be depleted sooner than normal

According to a letter sent to physicians, the devices affected by this advisory will give a 90-day advanced warning if the batteries are nearing depletion. Medtronic maintains that the battery issue does not compromise device functionality or affect therapy delivery. The company said it has received no reports of death or injury attributed to this issue.

The Concerto and Virtuoso devices in the affected subset were manufactured primarily in 2006 and can be traced to a specific subset of low voltage capacitors, Medtronic said. So far, there have been no related confirmed failures in Concerto and Virtuoso devices outside of this subset, including devices that were manufactured during the same time, the letter said.

Medtronic is offering the following recommendations for patients with Virtuoso and Concerto CRT-D devices in the affected subset:

Physicians should continue routine follow-up sessions at least every three months in accordance with product labeling.
Physicians should verify that the Low Battery Voltage Recommended Replacement Time (RRT) alert is programmed to “On-High.” This provides an audible, alternating tone when the device reaches RRT. These devices are shipped with this alert programmed nominally to “On-High.”
Physicians may consider monitoring patients through CareLink. The CareLink home monitor can be used to automatically notify the clinician when the device reaches RRT.

Patients can determine if their device is included in this advisory by visiting http://CVSNList.medtronic.com. Patients will need the serial number of their device, which is available on their Medtronic patient identification card.

Covidien Issues Class I Recall for Pedi-Cap End-Tidal CO2 Detectors

Fri, 11 Sep 2009 00:00:00 -0700

A Class I recall has been issued for Pedi-Cap End-Tidal CO2 Detectors (Pedi-Cap and Pedi-Cap 6). Class I recalls are the Food & Drug Administration's most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

This Pedi-Cap End-Tidal CO2 Detector is used in pediatric patients, weighing 2.2-33 pounds, during the process of exchanging oxygen for carbon dioxide (ventilation) in healthcare settings.

According to Covidien's recall notice, the device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation and the inability to verify the correct placement of a breathing tube when inserting it into the windpipe. This problem may mimic the signs and symptoms of other medical conditions such as the presence of air or gas in the cavity of the membranes surrounding the lungs. There is a reasonable probability that use of the recalled PediCap will cause serious adverse health consequences or death.

The recalled devices were manufactured November 1, 2008 through July 24, 2009 and distributed from November 1, 2008 through July 31, 2009. Only Pedi-Cap End-Tidal CO2 Detectors (Pedi-Cap and Pedi-Cap 6) from the lot numbers listed here are included in this recall.

On August 14, 2009, Covidien sent a letter to their distributors/customers informing them to stop selling/using the affected devices and to return them to the company. The company has taken steps to resolve this problem and expects to have modified devices available by the end of September, 2009.

Penumbra 5F Select Catheters Named in Class I Recall

Thu, 10 Sep 2009 00:00:00 -0700

A Class I recall has been issued for Neuron 5F Select Catheters made by Penumbra Inc. According to the recall notice, the catheters may contain pin holes and exposed wire braids. Such a defect could result in a brain clot or a blood vessel puncture, and this may lead to possible death.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

The Neuron 5F Select Catheter is used to remove blood clots or foreign objects from blood vessels. The device was manufactured on or about May 26, 2009 and distributed from May 5, 2009 through June 12, 2009.

According to the recall notice, on May 29, 2009, Penumbra notified their customers by telephone and email. They informed their customers about the problem and instructed them to return the product. All nine defective devices involved in this recall were returned to the firm and have been destroyed, the notice said.

Medtronic-Paid Spine Surgeon Resigns From Medical Group Board Amid Probe

Wed, 26 Aug 2009 00:00:00 -0700

Dr. David Polly, a prominent spine surgeon whose financial relationship with Medtronic Inc. had recently come under scrutiny, has resigned from the board of the American Academy of Orthopaedic Surgeons.

As we've reported previously, Polly had come under fire for not disclosing his relationship with Medtronic when he testified before a Senate committee in 2006 urging more funding for research into combat-related injuries. According to Minneapolis-St. Paul Business Journal, Polly never told the panel that he was a Medtronic consultant, and was billing the company $6,000 for his appearance.

Following his May 2006 testimony, Polly and his colleagues at the University of Minnesota received a $466,644 Department of Defense grant for a two-year study involving Infuse Bone Graft, a Medtronic product. When the University of Minnesota approved Polly’s government-funded Infuse study, it said at the time that his “consulting duties for Medtronic appear sufficiently separate from the research he is performing.” Right after the study was approved by the University, Polly billed Medtronic for writing up a different Infuse study.

A probe conducted by Sen. Charles Grassley (R-Iowa) revealed that Polly had been paid $1.2 million by Medtronic between 2003 and 2007 for consulting work. As we reported previously, Polly’s billing records revealed that he billed Medtronic $50,000 for lobbying-related costs. According to The Wall Street Journal, Polly traveled to Washington, D.C. and met with members of Congress several times in 2005 and 2006. The Journal also reported that Polly’s “billing rate was $4,750 for an eight-hour day in 2007, and he billed as many as 13,000 minutes a quarter — or 216 hours over three months. In some months, he conducted at least some Medtronic business "nearly every day.”

Late last month, Grassley sent Medtronic a letter, asking if its payments to Polly represent a conflict of interest Grassley also charged in the letter that Polly gave Medtronic updates on government-sponsored research in violation of an agreement with the university and may have provided inaccurate information to a university ethics committee.

Medtronic has said it was not aware that Polly had failed to tell the Senate committee about his financial ties to the company when he testified. Both the University of Minnesota and Medtronic have launched investigations of the allegations in Grassley's letter.

Dr. Joseph Zuckerman, president of the American Academy of Orthopaedic Surgeons said Polly resigned from his board position because he did not want to be a distraction. "The (academy) believes that relationships between industry and physicians can be very productive, innovative exchanges that occur for the good of patients and medical advancements," Zuckerman said in the statement. "However, when those relationships come under scrutiny, as Dr. Polly's have, we believe this creates an unnecessary distraction from (the academy's) mission."

Accusure Insulin Syringes Recalled

Mon, 24 Aug 2009 00:00:00 -0700

Qualitest Pharmaceuticals, Inc. has issued a voluntary nationwide recall for two lots of Accusure Insulin Syringes.

According to the firm's recall notice, needles on the Accusure Insulin Syringes may detach from the devices. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection.

This recall involves Accusure Insulin Syringes (1/2 cc – 31 G – Short Needle) with lot number 6JCB1 (Expiration 10/2011) – NDC 0603-7001-2. This lot was distributed between January 2007 and June 2007 to wholesalers and retail pharmacies nationwide (including Puerto Rico). The recall also includes Accusure Insulin Syringes (1 cc – 31 G –Short Needle) with lot number 7CPT1 (Expiration 03/2012) – NDC 0603-7002-21 This lot was distributed between May 2007 and June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico). The lot number can be found on the white paper backing of each individual syringe.

Consumers who have any Accusure Insulin Syringes (1/2 cc – 31 G –Short Needle) with lot number 6JCB1 or Accusure Insulin Syringes (1 cc – 31 G –Short Needle) with lot number 7CPT1 should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. You can find the lot number on the white paper backing of each individual syringe.

Qualitest is notifying all customers who received the product and arranging for return of any affected product. Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

FDA Proposes Mandatory Electronic Reporting of Adverse Events

Fri, 21 Aug 2009 00:00:00 -0700

The Food & Drug Administration (FDA) has proposed two new regulations aimed at improving access to and analysis of safety information provided by the medical product industry. The two proposed rules will apply to the FDA's Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

Currently, the Centers receive most adverse event reports on paper. Medical device adverse event reports are manually entered into the Manufacturer and User Facility Device Experience (MAUDE) database. Likewise, drug and biologic side effects reported to CDER and CBER are manually entered into the FDA's Adverse Event Reporting System (AERS). The FDA says this step is costly and hinders the Centers' ability to review safety data quickly to uncover potential public health problems.

The proposed regulations for medical devices, drugs and biologics would require manufacturers and others in the supply chain to submit adverse event reports to the FDA in electronic format, which will be loaded into the MAUDE and AERS databases. This will eliminate manual processing of paper forms by both manufacturers and the FDA.

“Both proposed rules will improve the agency’s ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems,” said David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the CDRH, said in a statement on the agency's Web site. “Information obtained from these reports may be critical to future action that improves patient safety.”

“Electronic reporting of serious and unexpected adverse experiences will reduce industry costs and encourage better communication with the FDA and other regulators,” said Gerald J. Dal Pan, M.D., director of CDER’s Office of Surveillance and Epidemiology.

Both new rules would apply to medical products already approved for use. According to a statement posted on the FDA Web site, neither proposed rule changes what types of incidents are required to be reported.

Surgeon in Medtronic Infuse Study Scandal Resigns

Wed, 19 Aug 2009 00:00:00 -0700

Timothy R. Kuklo, the former Army surgeon who has been accused of falsifying data in a study of Medtronic Inc.'s Infuse Bone Graft, has resigned from his post at Washington University Medical School, according to The New York Times.

As we’ve reported previously, the study, which Kuklo conducted during his tenure at Walter Reed Army Hospital , claimed to show that wounded soldiers’ leg injuries healed better when Infuse was used. But an Army investigation found several problems with it. For one thing, the study cited higher numbers of patients and injuries than Walter Reed officials could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study. Kuklo's study was published in the Journal of Bone & Joint Surgery last August, but retracted it in March.

In June, Medtronic disclosed that over a ten year period, it had paid Kuklo roughly $850,000 in direct and direct payments. Between 2000 and 2006, he was paid to train other physicians in how to implant Medtronic products. In 2006, he signed on as a consultant for the company, a relationship which ended earlier this year. However, Medtronic has maintained that it had nothing to do with Kuklo’s Infuse study.

After leaving Walter Reed, Kuklo joined the faculty at Washington University Medical School in St. Louis in 2006. Last month, the school revealed that Kuklo failed to properly disclose his financial relationship with Medtronic. When he failed to make that disclosure, Kuklo was working on two studies that involved Medtronic products, the Journal said. The University said it stopped Kuklo’s Medtronic-related research in February of 2008, and learned of his relationship with the company in May 2007.

The school also said that Kuklo had discovered “extensive personal health information” for soldiers treated at the Walter Reed Army Medical Center from 2006 and before on computers used by Kuklo. The privacy of medical records is strictly regulated by the Health Insurance Portability and Accountability Act (HIPAA).

Kuklo had been on a voluntary paid leave while Washington University investigated the allegations against him. According to a New York Times report, Kuklo proffered his resignation on July 30. It will be effective Sept. 30, and between now and then will have no clinical, research, or educational duties for the University between now and that date.

Hospira Recalls Devices Over Defective Power Cords

Mon, 17 Aug 2009 00:00:00 -0700

Hospira Inc. is issuing an urgent recall for some medical delivery equipment because the devices include defective AC power cords manufactured by Electri-Cord Manufacturing Corporation.

According to UPI, the items included in this recall include several LifeCare and Plum products, along with the Oximetrix 3 SO2/CO Cardiac Output Computer, Nutrimix Micro Compounder and the GemStar Docking Station. A full list of the recalled items is available on the FDA Web site.

This recall is being issued in response to customer reports of sparking, charring and fires on the plug of the power cord. Hospira's investigation of these reports determined that the power cord's prongs may crack and fail at or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires which may also occur in an oxygen-rich environment. Depending on the device and therapy, these failures may lead to potential serious injury or death.

Hospira is working with its customers to replace all affected power cords regardless of their condition. Hospira will begin service activity the week of Aug. 16, 2009, and will continue until all replacement activity is complete.

This recall is limited to device power cords with a prong and ground-pin insert design, which can be identified by a black plastic bridge connecting the terminal prongs on the plug. Hospira will instruct users of these products to inspect and identify affected power cords on their devices to determine whether a product contains an affected Electri-Cord AC power cord.

Users with affected power cords that have bent or cracked prongs, burnt plastic or excessive wear and tear should discontinue use immediately and contact their Hospira sales representative or Hospira Technical Support Operations at 1-800-241-4002 (available from 6 a.m. to 4 p.m., Pacific time) for instructions on receiving replacement parts or devices. Users with affected power cords that are not exhibiting any of these characteristics should monitor the power cords regularly and be mindful of excessive wear and tear, misuse or abuse until all affected cords can be replaced.

FDA Says Certain Glucose Test Strips May Produce False Results

Fri, 14 Aug 2009 00:00:00 -0700

Federal health regulators are warning that GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) glucose meters or test strips should never be used by anyone who is being treated with drug products or therapies that contain certain sugars other than glucose. According to the Food & Drug Administration (FDA), doing so could produce a falsely high (elevated) result.

GDH-PQQ test strips are sold by a number of medical firms. A complete list of currently available GDH-PQQ strips is available here.

According to the FDA, diabetic patients who receive drug products or therapies containing certain sugars other than glucose could experience serious, although rare, injuries if they use blood glucose meters with GDH-PQQ test-trip technology. Such strips will react with certain non-glucose sugars, including maltose, galactose and xylose, and produce a falsely high result. If a diabetic patient then takes too much insulin because of this falsely high result, it could lead to abnormally low blood sugar (hypoglycemia), coma, or even death. In addition, if blood glucose is actually low, it could go unrecognized and untreated. Low blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.

From 1997 - 2009, the FDA received 13 reports of death associated with GDH-PQQ glucose test strips in which there was interference from maltose or other non-glucose sugars. The deaths occurred in healthcare facilities. Some reports indicated that serious patient injury, such as low blood glucose (hypoglycemia), confusion, neurologic deterioration, too little oxygen in the tissues (severe hypoxia), brain damage and coma, occurred prior to death.

Drugs and therapies that contain non-glucose sugars include:

Extraneal (icodextrin) peritoneal dialysis solution
Some immunoglobulins: Octagam 5%, Gamimune N 5% **, WinRho SDF Liquid, Vaccinia Immune Globulin Intravenous (Human) and HepaGamB
Orencia (abatacept)
Adept adhesion reduction solution (4% icodextrin)
BEXXAR radioimmunotherapy agent
Any product that contains, or the body breaks down into, the sugars maltose, galactose or xylose
Certain patients may be more likely to be using drug products or therapies that contain other sugars, including those who:
are on peritoneal dialysis
have recently had surgery

The FDA said it is working with manufacturers to address patient safety problems with GDH-PQQ glucose test strips and will continue to monitor adverse events associated with these products.

Witnesses Voice Support for Medical Device Safety Act

Fri, 07 Aug 2009 00:00:00 -0700

Earlier this week, a Senate hearing was convened to discuss the Medical Device Safety Act of 2009. If it becomes law, the Medical Device Safety Act would restore important legal rights to victims of a defective medical device.

Patients lost many of those rights in 2008, when the U.S. Supreme Court issued a ruling in a case known as Reigel v. Medtronic. In an 8-1 vote, the Court bestowed legal immunity to the makers of defective devices. The justices held that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempt product liability lawsuits in state courts. Since then, scores of medical device product liability lawsuits have been dismissed by lower courts.

The Medical Device Safety Act would nullify Reigel v. Medtronic. On Tuesday during a hearing before the Senate Health, Education, Labor and Pensions Committee, several witnesses expressed support for the bill. According to Medpage Today, one such witness was Dr. William Maisel, director of the Medical Device Safety Institute and a cardiologist at Beth Israel Deaconess Medical Center in Boston. Dr. Maisel also chairs the FDA's Circulatory Advisory Committee.

According to Medpage Today, Dr. Maisel told lawmakers that FDA approval of a medical device does not guarantee its safety. He said it is "simply impossible" for the FDA to continue to monitor the safety of every medical device it has approved. Maisel also told the committee that under current law, if a patient it is injured by a faulty device, they often have to cover the costs of their resulting medical treatment, Medpage Today said. For patients on Medicare or Medicaid, the government gets stuck with the bill.

Another witness to testify at the hearing was Michael Mulvihill, who two years ago suffered 22 electric shocks within a span of 53 minutes when the lead on his Medtronic defibrillator fractured. That lead, called the Sprint Fidelis, was recalled in October 2007 because of a high fracture rate. According to Talk Radio News Service, Mulvihill said he hoped Medtronic would one day be held responsible for the injuries the defective leads caused thousands of patients to suffer.

Right now, people like Mulvihill have no legal recourse. As we reported previously, in January, Judge Richard Kyle dismissed over 1,400 product liability cases involving the Sprint Fidelis that were pending in the U.S. District Court in Minnesota, citing Reigel v. Medtronic. In his ruling, Judge Kyle wrote that, "The Court recognizes that at least some Plaintiffs have suffered injuries from using Sprint Fidelis leads, and the Court is not unsympathetic to their plight. . . . Plaintiffs' remedy, therefore, lies with Congress, and not with this Court."

Alaris Pump Recall Update

Tue, 04 Aug 2009 00:00:00 -0700

CareFusion Corporation, which is expected to become a public company following its planned spin-off from Cardinal Health, just issued an update to its previously disclosed recall of the Alaris System, said the U.S. Food and Drug Administration (FDA).

On June 12, 2009, the company sent an urgent Medical Device Recall Notification to customers of its Alaris® System addressing potential risks identified with the Alaris System. The affected devices have one or more failures associated with the Occlusion Warning Message, Syringe Volume Warning Message, Electrostatic Discharge protection circuitry, and Fluid Ingress into the device's pumping mechanism. This recall also updates the labeling for the Inter Unit Interface (IUI) connectors on the Alaris® System. According the FDA, the potential risks may lead to improper infusion therapy, which could cause serious adverse health consequences or death.

Serial numbers of affected devices, CareFusion's short-term instructions to customers, and the firm's strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/. Also, following the FDA's 510(k) clearance of the firm's software correction in July 2009, CareFusion is now implementing corrections for units in the field.

CareFusion also began sending customers using the Alaris Patient Controlled Analgesia (PCA) module an update to the June 12, 2009, Medical Device Recall Notification. That update contains an additional required action to mitigate potential risk before completion of the field corrective action related to the Syringe Volume Warning Message that may appear while using the Alaris PC unit with the Alaris PCA module. The additional step involves removing the patient-controlled dose request handset from the patient prior to reprogramming the infusion pump.

In the interim, the FDA said customers should follow steps outlined in the June 12 Medical Device Recall Notification and the updated Notification for customers using the Alaris PCA module to minimize potential risk before implementation of the software and hardware updates. CareFusion notified customers by registered letter on June 12, 2009, posted the customer letter on the company's Web site, and set up a dedicated call center for customer support, said the FDA. The June 12 letter can be accessed (in PDF format) at: http://www.legacycarefusion.com/alaris/brochure/Customer%20Letter%20-%20Signed.pdf

The FDA is also asking that any adverse reactions experienced with the use of this product, and/or any quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by Fax at 1-800-FDA-0178; by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; or online at www.fda.gov/medwatch.

Customer inquiries should be addressed to the CareFusion recall center, tool-free, at 1-888-562-6018.

Abbott Issues Class I Recall of Powersail Coronary Dilatation Catheters

Thu, 30 Jul 2009 00:00:00 -0700

A Class I recall has been issued for four lots of Powersail Coronary Dilatation Catheters made by Abbott Vascular. A Class I recall is the Food & Drug Administration's (FDA) most serious type of recall, and is issued when a medical device could predictably cause serious health problems or death.

The recall involves three lots of Powersail Coronary Dilatation Catheters from United States distribution and one lot from international distribution. According to a notice posted on the FDA Website, Abbott has received four complaints (one from each lot) that the distal shaft of the catheter exhibited damage.

While the issue could be detected and avoided during the preparation for use of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and heart attack, which has the potential to lead to death.

According to a press release issued by Abbott Vascular, three out of the four complaints of distal shaft damage resulted in no adverse patient effects. One complaint reported that the patient had evidence of a post-procedural heart attack. According to the release, the patient was reported to be doing well.

Abbott Vascular's sales representatives contacted all customers affected by this action and instructed them to cease use of any units from the part numbers and lot numbers listed below:

Powersail 3.25x18mm (U.S.), Product# 1005524-18, Lot# 7101051,Exp. Date 09-2009
Powersail 4.0x8mm (CE), Product# 1005726-08, Lot# 7112051, Exp. Date 10-2009
Powersail 2.75x18mm (U.S.), Product# 1005522-18, Lot# 8012151, Exp. Date 12-2009
Powersail 3.25x8mm (U.S.), Product# 1005524-08, Lot# 8053061, Exp. Date 04-2010

According to the press release, all outstanding units are in the company's possession or are in transit. Patients who have already been treated are not affected by this action.

Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902.

Infuse Bone Graft Researcher Failed to Tell Senate Committee He was Paid by Medtronic During 2006 Testimony

Wed, 29 Jul 2009 00:00:00 -0700

A spine surgeon who had a financial relationship with Medtronic Inc. did not disclose that relationship when he testified before a Senate committee urging more funding for research into combat-related injuries, The Wall Street Journal is reporting. One of Medtronic's products, Infuse Bone Graft, has been used to treat wounded soldiers.

Following his May 2006 testimony, Dr. David Polly and his colleagues at the University of Minnesota received a $466,644 Department of Defense grant for a two-year study involving Infuse, the Journal said.

According to the Journal, Polly was paid more than $1 million by Medtronic from 2004 to 2007. When the University of Minnesota approved Polly's government-funded Infuse study, it said at the time that his "consulting duties for Medtronic appear sufficiently separate from the research he is performing." Right after the study was approved by the University, Polly billed Medtronic for writing up a different Infuse study.

Polly's billing records revealed that he billed Medtronic $50,000 for lobbying-related costs. According to The Wall Street Journal, Polly traveled to Washington, D.C. and met with members of Congress several times in 2005 and 2006. The Journal also reported that Polly's "billing rate was $4,750 for an eight-hour day in 2007, and he billed as many as 13,000 minutes a quarter -- or 216 hours over three months. In some months, he conducted at least some Medtronic business on nearly every day."

Senator Charles Grassley, R-IA, who has been investigating the financial relationships between medical companies and researchers, has sent Medtronic a letter, asking if its payments to Polly represent a conflict of interest. According to a report in the Minneapolis-St. Paul Business Journal, Grassley also charged in the letter that Polly gave Medtronic updates on government-sponsored research in violation of an agreement with the university and may have provided inaccurate information to a university ethics committee.

According to The Wall Street Journal, Medtronic said it was not aware that Polly had failed to tell the Senate committee about his financial ties to the company when he testified in May 2006. However, this is not the first time that Medtronic's relationship with an Infuse researcher has raised questions.

Earlier this month, we reported that another spine surgeon, Dr. Timothy Kuklo had failed to report his financial relationship with Medtronic to Washington University medical school in St. Louis. When he failed to make that disclosure, Kuklo was working on two studies that involved Medtronic products, the Journal said. The University said it stopped Kuklo’s Medtronic-related research in February of 2008, and learned of his relationship with the company in May 2007. Dr. Kuklo is currently on a paid personal leave at the request of the university.

Dr. Kuklo is the former Army surgeon who has been accused of falsifying data in a study involving Medtronic’s Infuse Bone Graft product - which he conducted during the time he received payments from Medtronic- while on the staff of Walter Reed Army Hospital.

UCLA Spine Surgeon Faces Probe for Allegedly Failing to Disclose Industry Payments

Wed, 22 Jul 2009 00:00:00 -0700

Another top spine surgeon is in trouble because of his financial ties to the medical device industry. According to The Wall Street Journal, Dr. Jeffrey Wang has left his position as executive director of the spine center at the University of California, Los Angeles (UCLA). The school is investigating the doctor's research after he allegedly failed to disclose payments from medical device makers.

According to the Journal, Dr. Wang conducted research on products made by the following companies while at the University:

Medtronic Inc., which paid Dr. Wang $275,000 in royalty and consulting payments from 2003 through 2008;
DePuy Spine Inc., a unit of Johnson & Johnson, paid Dr. Wang $125,900 in royalty and consulting payments from 2002 through 2008;
Facet Solutions Inc., a company in which Dr. Wang acquired options for 18,000 shares of stock;
Paradigm Spine LLC, an entity related to another company in which Dr. Wang received options for 20,000 shares of stock;
FzioMed Inc., which paid Dr. Wang $144,000 from 2002 through 2008.

Dr. Wang violated the University's guidelines between 2002 and 2008 by allegedly failing to disclose these financial relationships, the Journal said. Only in the case of Medtronic did Dr. Wang report some - but not all - of the payments.

According to the Journal, UCLA has appointed a committee to investigate Dr. Wang's work and determine whether the payments affected his research and "if there are any mitigating actions needed to ensure the integrity of the research results."

While most medical schools require that researchers disclose any payments or financial relationships they have with the medical industry, such rules are often violated. Just last week, we reported that another spine surgeon, Dr. Timothy Kuklo had failed to report his financial relationship with Medtronic to Washington University medical school in St. Louis. When he failed to make that disclosure, Kuklo was working on two studies that involved Medtronic products, the Journal said. The University said it stopped Kuklo’s Medtronic-related research in February of 2008, and learned of his relationship with the company in May 2007. Dr. Kuklo is currently on a paid personal leave at the request of the university.

Dr. Kuklo is the former Army surgeon who has been accused of falsifying data in a study involving Medtronic's Infuse Bone Graft product that he conducted while on the staff of Walter Reed Army Hospital.

No Justice for Plaintiffs in Little Noticed Supreme Court Decision

Tue, 21 Jul 2009 00:00:00 -0700

A Supreme Court decision issued in May is proving to have dangerous implications for plaintiffs in civil lawsuits. According to a New York Times article, the decision in Ashcroft vs. Iqbal has made it far easier - in fact, too easy - for federal judges to dismiss civil lawsuits long before plaintiffs even have a chance to be heard.

In Ashcroft vs. Iqbal, a Muslim plaintiff had claimed that he suffered abuse while imprisoned on immigration charges in New York after the September 11, 2001 terrorist attacks. In a 5 to 4 decision, the high court overturned a ruling that the plaintiff, who was imprisoned more than a year after the attacks, could proceed with his lawsuit against former Attorney General John Ashcroft and FBI Director Robert Mueller.

According to The New York Times, what was little-noticed about Ashcroft vs Iqbal is that it establishes a difficult new standard plaintiffs filing civil lawsuits must meet before they can even get past the courthouse door. In his majority opinion, Justice Anthony M. Kennedy wrote that: "Determining whether a complaint states a plausible claim for relief requires the reviewing court to draw on its judicial experience and common sense.”

According to The New York Times, Justice Kennedy's words mean a civil lawsuit must now "satisfy a skeptical judicial gatekeeper." Prior to this ruling, plaintiffs only had to file a basic complaint. To dismiss a suit - established in a 1957 Supreme Court decision - a federal judge had to determine "beyond doubt" that a plaintiff had no case.

The old standards served plaintiffs well, because in most cases, the facts surrounding an act of wrongdoing - whether it involves employment discrimination, defective products or fraud - are closely guarded by defendants. Even with a bare-bones complaint, plaintiffs were entitled to examine a defendant's records, and question key individuals. Through this discovery process, the outrageous, deliberate and unlawful conduct of many a defendant saw the light of day.

But under Iqbal, that process has been undermined. According to The New York Times, the decision instructs lower court judges to dismiss lawsuits that "strike them as implausible." That's a pretty loose - and dangerous - standard for judges to follow. Stephen B. Burbank of the University of Pennsylvania Law School told the Times that the Iqbal decision is "a blank check for federal judges to get rid of cases they disfavor.”

Justice Ruth Bader Ginsburg, who dissented from the majority opinion, has characterized Iqbal as important and dangerous, The New York Times said. Speaking to a group of federal judges last month, Justice Ginsburg said Iqbal "messed up the federal rules” governing civil litigation.

Already, Iqbal is having a huge impact on lawsuits in this country. According to The New York Times, lower courts have cited it 500 times since the decision was published in May by the Supreme Court. Lawsuit involving everything from employment discrimination to securities fraud have been dismissed before they even got off the ground. Sadly, under Iqbal, it seems clear that many plaintiffs with legitimate grievances will never have their day in court.

Synthes Execs Plead Guilty in Norian XR Illegal Testing Case

Tue, 21 Jul 2009 00:00:00 -0700

Two Synthes Inc. executives have pleaded guilty to participating in illegal clinical trials of the company's Norian XR bone cement, according to a New York Times report.

Norian XR bone cement was approved by the Food & Drug Administration (FDA) in 2002 for use in the arm, but not the spine. As we reported earlier, the FDA-cleared label for Norian XR warned against such use. Studies have shown that the use of Norian XR in the spine can cause blood clots that could become lodged in the lungs, leading to death. Synthes received a warning letter from the FDA in November 2004 regarding improper marketing of the product for vertebral compression fractures. Norian XR was finally pulled from the market after the warning letter.

Last month, Synthes Inc. and its Norian subsidiary were indicted on charges of illegally testing Norian XR bone cement on humans. Federal prosecutors allege that Synthes conducted clinical trials in which Norian XR was injected during spinal surgery on about 200 patients, the Associated Press said. The surgeries took place between 2002 and 2004, and many involved elderly people with compression fractures. The illegal trials ended after the third patient death, prosecutors claim.

The indictment charged Norian with a total of 52 felony counts, including conspiracy to impede the functions of the FDA, making false statements in connection with an FDA inspection, and shipping adulterated and misbranded Norian XR bone cement in interstate commerce. Synthes faced 44 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce between 2002 and 2004.

In addition, four Synthes executives were charged with a single count each of shipping misbranded Norian XR in interstate commerce. According to The New York Times, two of those executives - Michael D. Huggins, 51, of West Chester, Pa., and John J. Walsh, 46, of Coatesville, Pa. - have entered guilty pleas to those charges. They face up to a year in prison and a $100,000 fine, the Times said.

According to the Philadelphia Business Journal, Huggins served as president and COO of Synthes’ spine division from 1994 to January 2008; Walsh is director of regulatory and clinical affairs for the spine division, a post he has held since 2003.

Accuracy of Home Glucose Meters Questioned, FDA Seeking New Standards

Mon, 20 Jul 2009 00:00:00 -0700

U.S. health regulators are considering tougher standards for the home glucose monitors that millions of diabetics rely on. The Food & Drug Administration's (FDA) decision to reconsider the standards was prompted by a request from a prominent doctors' group.

Home glucose monitors are used by diabetics, as well as people with hypoglycemia to keep tabs on the level of glucose in the blood. According to a report in The New York Times, the use of home glucose meters is on the rise, even in hospitals. Current international standards for the devices - which the FDA follows - allow them to be inaccurate by as much as 20 percent, the Times said. This can lead to serious health problems, including seizure and coma.

According to The New York Times, a government study comparing tests from five different popular home glucose monitors found results varied by as much as 32 percent. What's more, the accuracy of the devices can be affected if people are taking drugs like Tylenol, the Times said.

In a May letter to the FDA, the American Association of Clinical Endocrinologists wrote that home glucose monitor technology is not up to par. One concern is that hospitals are switching to home meters in an effort to cut cost, UPI said. A former president of the group told The New York Times that no one knows how many hospital deaths may be related to the accuracy of home glucose meters, but said such deaths probably are not rare.

"Because of the highly variable quality of the meters and the glucose testing strips in widespread use, the safety of our patients who depend upon those meters is threatened," the Associations' letter said.

In a letter to the Association, the FDA acknowledged that it receives reports of several deaths and thousands of device-related failures associated with home glucose monitors every year. The agency said it had contacted the International Standards Organization, which sets the parameters for home glucose monitors, asking that the accuracy standards for the devices be revised.

According to UPI, the FDA may set its own standards if the international group does not. However, according to The New York Times, change would come more quickly if the international group changed the standards.

Lawsuits Allege Medtronic, Other Firms Illegally Marketed Surgical Ablation Products

Thu, 16 Jul 2009 00:00:00 -0700

Medtronic Inc., St. Jude Medical Inc., AtriCure Inc. and Boston Scientific Corp. all allegedly paid kickbacks to doctors in order to convince them to use their surgical ablation products to treat the heart-rhythm defect called atrial fibrillation, according to lawsuits recently unsealed in Texas. According to The Wall Street Journal, the lawsuits were filed by former employees of the companies.

Allegations of kickbacks by medical device makers are nothing new. For example, in 2007 a New Jersey based federal probe found that some orthopedic device makers made lucrative payments to U.S. physicians between 2002 and 2006 as a way to encourage doctors to favor their products. Stryker Orthopedics cooperated with prosecutors and escaped a fine, but agreed to federal monitoring for 18 months. The other companies, Zimmer Holdings Inc., Depuy Orthopaedics Inc., Biomet Inc. and Smith & Nephew Inc. agreed to a $311 million settlement with the Justice Department and the U.S. Department of Health and Human Services.

The lawsuits detailed by The Wall Street Journal, which were filed in federal court in Houston, are related to an inquiry in Texas by the U.S. Justice Department that was previously disclosed by several of the companies in filings with the Securities and Exchange Commission. They were originally filed in 2007, the Journal said.

According to the Journal, the lawsuits allege that a "fraudulent marketing and inducement campaign" involving kickbacks to doctors and hospitals resulted in excessive charges to the Medicare insurance program. For example, several of the suits allege that Boston Scientific, Medtronic and AtriCure marketed surgical ablation equipment as a treatment for atrial fibrillation even though it was not approved by the Food and Drug Administration to treat that condition.

Those charges were made by a former Boston Scientific salesperson, who the Journal says, claimed to have been fired after complaining about the company's allegedly illegal practices.

All of the companies involved in the lawsuits told The Wall Street Journal that they were cooperating with the probe. Boston Scientific is no longer in the ablation business, the Journal said.

Infuse Bone Graft Study Doc Didn't Tell School He Was Paid by Medtronic

Wed, 15 Jul 2009 00:00:00 -0700

The former Army surgeon at the center of a scandal involving falsified data in an Infuse Bone Graft study apparently did not tell his current employer that he had been a paid consultant to Medtonic Inc., The Wall Street Journal is reporting.

Infuse Bone Graft, which is manufactured by Medtronic., contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.

Last July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

As we’ve reported previously, a study conducted by Dr. Timothy Kuklo during his tenure at Walter Reed Army Hospital claimed to show that wounded soldiers’ leg injuries healed better when Infuse was used, was published in the Journal of Bone & Joint Surgery last August, but retracted in March. An Army investigation found several problems with it. For one thing, the study cited higher numbers of patients and injuries than Walter Reed officials could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study.

Kuklo is now retired from the Army. According to The Wall Street Journal, he joined the faculty of Washington University medical school in St. Louis in 2006. In a letter to Sen. Charles Grassley (R-Iowa) dated June 23, Washington University's medical-school Dean Larry J. Shapiro said Kuklo failed to properly disclose his financial relationship with Medtronic.

When he failed to make that disclosure, Kuklo was working on two studies that involved Medtronic products, the Journal said. The University said it stopped Kuklo's Medtronic-related research in February of 2008, and learned of his relationship with the company in May 2007.

The letter also said that the university discovered "extensive personal health information" for soldiers treated at the Walter Reed Army Medical Center from 2006 and before on computers used by Kuklo. According to the Journal, the privacy of medical records is strictly regulated by the Health Insurance Portability and Accountability Act (HIPAA).

According to The Wall Street Journal, Kuklo is on a paid personal leave at the request of the university.

Respironics' Recall of BiPAP Ventilator Systems Deemed Class I

Fri, 10 Jul 2009 00:00:00 -0700

A recall of BiPAP Focus Non-Invasive Ventilator Systems issued by Respironics California last September has been deemed a Class I recall by the Food & Drug Administration (FDA). Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

The recall involves BiPAP Focus Non-Invasive Ventilator System, model number PCM120PS18-2315P. This product was manufactured prior to March, 2008 and distributed from August, 2006 through April 11, 2008. The devices were distributed in the United States, Canada, Europe, Latin America, Africa and Asia Pacific.

The BiPAP Focus Non-Invasive Ventilator System is used by healthcare professionals to treat adult patients who have advanced lung disease and/or have difficulty breathing. According to the recall notice, power supply failures have occurred on some ventilators. A power surge may exceed the power supply capacity, causing the power supply to lose power. If there is a failure of power during operation, the BiPAP Focus will switch to back up battery power, which can provide up to 50 minutes of operation on a fully charged battery at default settings. Audible and visual alarms will alert clinicians to the loss of power, so that appropriate corrective actions can be taken.

In the unlikely event that alarms do not prompt the clinical team to provide alternative respiratory support before the battery is exhausted, patients may be at risk for serious injury or death due to low levels of oxygen or high levels of carbon dioxide in the blood. These risks apply primarily to patients who cannot breathe on their own, although it should be noted that the labeling for the BiPAP Focus Ventilator specifically states it is not intended for use on such patients.

Respironics has received several reports of device failure; however, there have been no reports of injury.

Respironics is providing replacement power cords to customers. On September 22, 2008, the company sent a letter to their U.S. customers and distributors with the affected devices informing them of the potential problem. The letter included instructions for device removal and replacement, and return of the company’s response form.

Medtronic Recalls Insulin Infusion Sets

Fri, 10 Jul 2009 00:00:00 -0700

Medtronic Inc. is recalling some of its Quick-set insulin infusion sets that are used with MiniMed Paradigm insulin pumps. According to a Medtronic statement released today, the Quick-set insulin infusion sets may not vent air pressure properly, causing delivery of improper amounts of insulin and the potential for serious injury or death.

An insulin infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. Medtronic said it recently discovered that approximately two percent of “Lot 8” Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million infusion sets currently with customers) may not work properly.

The Quick-set infusion sets involved in this recall bear reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting with the number “8.” Patients should discontinue using “Lot 8” Quick-set infusion sets. The lot number (for example 8XXXXXX) is clearly marked on both the product box label, and on each individual infusion set package.

“Lot 8” Quick-set infusion sets were distributed in the United States, and in limited quantities in a small number of countries outside of the United States. The list of countries affected by this recall is available at www.medtronicdiabetes.com/lot8 or by contacting any Medtronic country office. No other Medtronic devices or infusion sets are involved in this recall.

Customers are being asked to return any affected infusion sets to the company. Medtronic is providing customers with replacement Quick-set infusion sets at no additional charge. According a report in The Wall Street Journal, Medtronic has mailed out notification letters to customers, as well as one million replacement sets, which represent a 30-day supply.

Infuse Bone Graft Study Info Sought by Senate Armed Services Committee

Thu, 09 Jul 2009 00:00:00 -0700

A Senate investigation into a bogus Infuse Bone Graft study is heating up. According to The Wall Street Journal, the Senate Committee on Armed Services has asked the U.S. Army to provide it with the results of an investigation into the Infuse Bone Graft study, which was conducted at Walter Reed Army Hospital by former Army surgeon Timothy Kuklo.

Infuse Bone Graft, which is manufactured by Medtronic Inc., contains recombinant human Bone Morphogenetic Protein (rhBMP-2), a protein released naturally by the body. It is approved to treat a spinal condition called Degenerative Disc Disease, as well as open fractures of the tibia. It is also approved for use in two dental bone grafting procedures: sinus augmentation and localized alveolar ridge augmentation.

Last July, the Food & Drug Administration (FDA) warned that the use of Infuse Bone Graft and similar products had caused serious problems when they were used off-label in cervical spine (neck) surgeries. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

As we’ve reported previously, Kuklo's study, which claimed to show that wounded soldiers’ leg injuries healed better when Infuse was used, was published in the Journal of Bone & Joint Surgery last August, but retracted in March. An Army investigation found several problems with it. For one thing, the study cited higher numbers of patients and injuries than Walter Reed officials could account for. Kuklo also did not obtain the Army’s required permission to conduct the study, and investigators at Walter Reed have also concluded that Kuklo forged his co-authors signatures on the study.

Kuklo retired from the Army in 2007. Last month, Medtronic disclosed that over a ten year period, it had paid Kuklo roughly $850,000 in direct and direct payments to Kuklo. Between 2000 and 2006, he was paid to train other physicians in how to implant Medtronic products. In 2006, he signed on as a consultant for the company, a relationship which ended earlier this year. However, Medtronic has maintained that it had nothing to do with Kuklo's Infuse study.

According to The Wall Street Journal, in a letter to Army Secretary Pete Geren, Sens. Lindsey Graham (R.- S.C.) and Ben Nelson (D.- Neb.) asked for the results of the Army's investigation. The Senators are just the latest to express an interest in the Kuklo debacle.

Late last Month, Medtronic revealed that it had received a subpoena from the U.S. Attorney’s office in Boston, MA. In addition to information on Kuklo’s Infuse study, the subpoena also sought information about “contracts, research grants, speaking and education programs, and payments for certain named physicians.”

Sen. Charles Grassley (R.- Iowa) has also been investigating the Kuklo Infuse study as part of his investigation into the financial relationships between medical firms and doctors and researchers.

Arthroscopic Shavers Subject of FDA Safety Alert

Wed, 08 Jul 2009 00:00:00 -0700

Arthroscopic shavers, devices that are used in some orthopedic surgical procedures, are being subjected to a Food & Drug Administration (FDA) safety review. According to the agency, there have been reports of instances in which pieces of tissue have remained within certain arthroscopic shavers, even after the cleaning process was believed to have been completed according to the manufacturer’s instructions.

According to an agency statement, reports have suggested that the tissue retained in arthroscopic devices was not evident to the naked eye. The FDA said it is concerned about this because retained tissue in these devices can compromise the entire sterilization process.

The agency is actively working with the manufacturers of arthroscopic shavers to gather more data about this situation and to understand its potential public health impact. The FDA said that as it obtains more information that better defines the situation and determines whether there are specific risks, it will provide that information to facilities, health care providers and the public.

According to the FDA, multiple manufacturers of arthroscopic shavers recently informed their customers of this situation and reiterated the importance of proper cleaning procedures. The FDA is encouraging facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures. Hospitals should consider taking the following steps to minimize any potential risk to patients:

Be sure that all personnel responsible for device cleaning and sterilization at your facility are aware of and comply with all steps in the manufacturer’s instructions for thoroughly cleaning these devices prior to sterilization. Please refer to the specific instructions provided in the labeling or user manual for each brand and/or model of shaver your facility uses.
Consider inspecting the inside of the devices following cleaning to ensure that they have been cleared of any tissue or fluids. There may be multiple ways to accomplish this. As one example, the facility that brought this situation to our attention uses a 3mm video scope to inspect the channels of the shaver handpiece.

Finally, the agency is asking health care professionals to file a voluntary report with MedWatch, the FDA Safety Information and Adverse Event Reporting program if retained tissue is discovered in an arthroscopic shaver.

Defective Medical Device Recall Injury Lawyer

Wed, 08 Jul 2009 00:00:00 -0700

Parker Waichman Alonso LLP is a leader in a defective medical device litigation. We are currently evaluating cases involving the medical devices listed below. Please click on a specific medical device or fill out the form at the right for a free case evaluation by a qualified attorney.