FDA Ends Summary Medical Device Reporting
WASHINGTON, D.C. — The United States Food and Drug Administration (FDA) finally put an end to summary medical device reporting. According to U.S. Recall News, FDA rules allowed medical device manufacturers to summarily report medical device malfunctions and defects that caused injuries or deaths to patients. The practice known as … [Read more...]
New Medtronic Endeavor Stent Faces Doubts
Medtronic’s new drug coated stent, Endeavor, still faces some serious questions about its effectiveness, after a long-anticipated study showed that the device had only mixed success in meeting some performance goals. The new data was released just days before Endeavor undergoes a regulatory review, the outcome of which could help … [Read more...]
Essure Lawsuits Continue to Be Filed
Bayer Faces Thousands of Essure Injury Lawsuits Product liability lawsuits continue to be filed against Bayer alleging injuries from Essure, the female sterilization device. In the United States, roughly 3,700 lawsuits have been filed. Litigation has also begun in Canada. The U.S. Food and Drug Administration (FDA) reports over … [Read more...]
New Medical Device Guidance Finalized
FDA New Medical Device Guidance Medical device guidance is meant to provide the healthcare community and patients with prompt information on changes to medical devices. Consumers will see more rapid notifications regarding medical device risks and potential risks following guidance recently finalized by the U.S. Food and Drug … [Read more...]
MassTorts in the Spotlight
Medical Device Associated Injuries, Deaths And Malfunction. Each year, the FDA receives an excess amount of medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device reportage is one among the postmarket tools the bureau uses to watch device performance, discover … [Read more...]
Improved Reporting on Medical Device Injuries Deaths
Medical Device Improved Reporting. The U.S. Food and Drug Administration (FDA) is seeking to improve hospital reporting of medical device injuries after inspections last year at 17 hospitals exposed numerous device safety issues. During last December's FDA inspections, it was revealed there was a limited or no reporting … [Read more...]
Better Reporting for Medical Device Injuries
Medical Device Better Reporting Urged. In light of medical devices that have raised concerns in recent years, regulators and lawmakers are both looking to improve the way medical device injuries and deaths are reported. Specifically, there has been criticism over the delayed awareness of power morcellators, devices that can … [Read more...]
Two Bills Aimed at Better Medical Device Regulation
Hearings On Updating Laws Governing Medical Devices Eyed. Congress Introduces Two Bills that Aimed Better Medical Device Regulation. U.S. Representative Mike Fitzpatrick, long a crusader for better regulation of medical devices, is taking his concerns to his peers in Congress. Rep. Fitzpatrick has asked the Committee on Energy and … [Read more...]
Power Morcellator Use in Hysterectomy Procedures
Legal Actions Against Power Morcellator for The Spread of Cancer. A number of women are coming forward seeking legal action after they have been diagnosed with uterine cancer, blaming the power morcellator for the spread of their disease. The women hold the manufacturers of the devices responsible for being negligent in warning … [Read more...]
Medtronic Uses Preemption in Medtronic Infuse Case, Again
The denial of review by the United States Supreme Court today in the case of Caplinger v. Medtronic, Inc., Docket No. 15-321, though it might appear to be a victory for medical device manufacturer, Medtronic, Inc., it was not. While a shallow analysis of the Supreme Court’s action in denying certiorari made it seem as if Medtronic … [Read more...]
New Legislation Outsources Medical Device Safety Reviews
Consumer groups and health advocates are concerned about legislation just passed by the House of Representatives that would make it easier for medical devices to reach the market and would put safety determinations in the hands of subcontractors paid by device manufacturers. Documents just released by the Food and Drug … [Read more...]
FDA Warns of Possible Patient Injury if Coating Separates from Intravascular Medical Device
The Food and Drug Administration (FDA) has issued a safety communication warning of the possibility of patient injury if the hydrophilic and/or hydrophobic coatings on medical devices separate—peel, flake, shed, delaminate, slough off—during use. A number of factors can cause coating separation, including the difficulty of the … [Read more...]
European Medicines Agency Seeks Market Suspension of Medtronic InductOs
The European Union's medical device regulator has recommended suspension of the marketing authorization for Medtronic's InductOs bone growth device until issues at a U.S. plant that makes a component of the device are resolved. The European Medicines Agency (EMA) launched a review of InductOs—the device is sold in the U.S. as … [Read more...]
Device Used During Surgery Linked to 8 Infections, 4 Deaths at PA Hospital
A device used to heat and cool a patient's blood during heart surgery has been linked to infections in 8 patients at a Pennsylvania hospital. The New York Times reports that four of those patients have died, but it is unknown whether their deaths were a direct result of the infections. On Monday, WellSpan York Hospital said it was … [Read more...]
FDA Launches Medical Device Tracking System
Medical Device Tracking System Now Being Made. Nearly three years ago, Congress called for medical devices to be marked and tracked with unique identifiers and data on the tracked devices is now being made available to the public. Recently, the Food and Drug Administration (FDA) launched the online Global Unique Device … [Read more...]
Newly Launched FDA Website Tracks Medical Devices
The U.S. Food and Drug Administration (FDA) has announced the launch of its online Global Unique Device Identification Database, AccessGUDID, which allows the public to track medical devices through unique identifiers. Through this site, company-submitted information can now be looked up by consumers. Modern Healthcare reports that … [Read more...]
Justice Department Fines Medical Device Makers over $110 Million
The U.S. Department of Justice and U.S. Department of Health and Human Services released their joint annual report on health care fraud and abuse control on March 19th. According to the report, the federal government won or negotiated roughly $3.3 billion in judgments and settlements. Fines against medical device makers totaled over … [Read more...]
Justice Department Settles False Claims Case with Medtronic for $4.4 Million
In an announcement last week, the U.S. Department of Justice said it had reached an agreement with medical device maker Medtronic for violations of the False Claims Act. The announced settlement is $4.4 million. The Justice Department brought action against Medtronic for false statements about medical equipment to sold to the … [Read more...]
Stryker Hip Implant Settlement Expected to Cost $1B
Stryker Hip Implant Lawsuit Settlement. On Monday, medical device manufacturer Stryker announced that it had reached a settlement in thousands of lawsuits involving now-recalled all-metal hip replacement devices. The company’s settlement expenses could top $1 billion. The Stryker settlement is one of the highest amounts paid in … [Read more...]
FDA Plan for more Efficient Medical Device Recalls, Removal and Reporting Moves Forward
Efficient Recalls For Defective Medical Device. The U.S. Food and Drug Administration (FDA) is moving forward with their plan to make the reporting of medical device removals and corrections easier, Regulatory Focus reports. In June 2013, the agency said that they wanted to make submissions of “806 reports” easier; these … [Read more...]
Sham Medical Device Surgery Costly, Dangerous, Controversial
Some medical device testing appears to be using human beings as placebos. Some medical device testing appears to be using human beings as placebos in which people undergo bogus surgeries to determine a potential device’s efficacy. In drug trials, some participants are given placebo drugs, while others are given a real drug so that … [Read more...]
Cardiologist Reports on Medical Device Payments
Unreported Medical Device Payments. 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 … [Read more...]
Witnesses Voice Support for Medical Device Safety Act
Medical Device Safety Act. 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 … [Read more...]
Company that Approved Fake Medical Trial Sanctioned by FDA
Fake Medical Trial Sanctioned By FDA. U.S. regulators have acted against Coast IRB, a human medical study review firm that approved a clinical trial for a fake medical device that was part of a federal investigation. According to the Food & Drug Administration (FDA), the Colorado Springs, Colo., firm agreed to stop reviewing … [Read more...]
FDA Faulted Again on Medical Device Oversight
Safety Of Medical Device Scrutiny. Labs that develop medical devices haven't been receiving adequate scrutiny from the Food & Drug Administration (FDA), a new report says. According to the Project on Government Oversight (POGO), the FDA's Center for Devices and Radiological Health (CDRH) allows manufacturers and testing … [Read more...]
FDA Told to Toughen Medical Device Reviews
Agency told to impose tougher measures. The Food & Drug Administration (FDA) neglected to conduct appropriate medical device reviews, a new report by the Government Accountability Office (GAO) says. According to Dow Jones, the GAO report involves some high-risk medical devices. This shocking news follows the revelation earlier … [Read more...]
Top Hospital Medical Device Hazards For 2008 Revealed
List of Top 10 Hospital Medical Device Hazards Released. The ECRI Institute just released its annual list of top ten hospital medical device hazards for this year. The Institute is a nonprofit organization that “researches the best approaches to improving patient care” and is a designated Collaborating Center of the World Health … [Read more...]
Charges of Corruption in FDA Medical Device Approvals
Probe on FDA medical device approval gets tough. A letter from scientists and physicians at the Food & Drug Administration (FDA) has charged that the agency has corrupted the process by which new medical devices are approved, Bloomberg.com reports. The letter was sent to Democratic Representative John Dingell, Chairman … [Read more...]
Rushed Medical Device Approvals Endangering Patients
Rushed Medical Device Approval. Thousands of medical devices are approved every year in the U.S. without proof of their effectiveness. The Food & Drug Administration (FDA) defends this process - known as 501(k) approvals - by claiming that it promotes innovation. But a recent article in The New York Times raises serious concerns … [Read more...]
Senators Probe Industry Ties to Medical Device Conference Organizers
Medical Device Conference Organizers. Two lawmakers have written to the organizers of the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C. about the financial support they receive from five medical device companies, including Johnson & Johnson, Medtronic Inc. and Abbott Laboratories. Senator … [Read more...]
Lawsuit Alleges Medical Device Makers Paid Illegal Kickbacks to Doctors
Medical Device Makers Paid Kickbacks To Doctors. A Pennsylvania medical supply company is suing six joint implant manufacturers over alleged illegal kickbacks to doctors. The lawsuit, filed in U.S. District Court in Pittsburgh on Monday, alleges that the defendants blocked Intermedics-McCullough out of the market despite selling … [Read more...]
Sage Products Recalls Medical Device for Bacterial Contamination
Medical Device Could be Contaminated With Burkholderia cepacia. Sage Products Inc. has issued a recall of some lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation because it could be contaminated with the bacteria Burkholderia cepacia (B. cepacia). Customers who have these products should stop … [Read more...]
Medical Device Safety Act Would Restore Consumer Rights
Medical Device Safety Act Overturn A Court Ruling. A bill to overturn a Supreme Court ruling that protects the makers of defective medical devices from product liability lawsuits was introduced in the House of Representatives yesterday. One of the bills sponsors, Rep. Frank Pallone, D-N.J, said in a statement that the … [Read more...]
Medical Device, Drug Makers Seek to Head Off Regulation by Disclosing CME Grants
Drug Makers Facing Scrutiny From Congress. Medical device makers and drug companies, facing increasing scrutiny from Congress, have decided to come clean about donations and grants they provide to fund medical education programs, patient advocacy organizations and other groups. Drug maker Eli Lilly already has such a … [Read more...]
Group Pushes FDA to Announce Medical Device Tracking Program
FDA Medical Device Tracking Program. The Food & Drug Administration (FDA) is taking too long to announce and implement a program to track medical devices, a coalition of health care advocacy groups said. Implementation of an identification system that assigns a medical device unique number will mean quicker and more reliable … [Read more...]
Probe into Medical Device Kickbacks Now Targets Doctors
Medical Device Kickbacks Investigated. Federal investigators looking into kickbacks in the orthopedic device industry have apparently set their sites on another target - doctors who received these illegal incentives. The physician investigation is just the latest chapter in the government's ongoing probe of the financial … [Read more...]
China to Crack Down on Medical Device Makers
China Warns to Revoke The Licenses of Medical Device Makers. China will revoke the licenses of those manufacturers producing unqualified medical devices that cause disastrous results, according to a draft on the administration of medical device recalls. The Chinese government will assign compulsory recalls and levy … [Read more...]
Despite Tainted Heparin, US Drug, Medical Device Companies Still Like China
Adverse Reaction Linked To Tainted Heparin. Pharmaceutical companies and medical device makers are in no mood to break their China habit, as several life sciences companies are planning on expanding manufacturing operations in that country. That, despite 21 deaths and a staggering number—over 700—of reported adverse … [Read more...]
Medical Device Makers Get Lawsuit Protection from US Supreme Court
Supreme Court ruling will nullify some medical device product liability lawsuits.Medtronic Inc. and other medical device makers got a gift from the US Supreme Court yesterday, after it ruled that Food & Drug Administration (FDA) pre-market approval of a medical device shields companies from state product liability lawsuits. While … [Read more...]
FDA to Go After Dangerous Fake Medical Device
FDA To Go After Fake Medical Device. Fake medical devices have finally gotten the attention of federal regulators. In a collaborative move with foreign governments, the Food and Drug Administration (FDA) is taking steps to stop manufacturers who import fraudulent, and often, dangerous medical devices into the United States, … [Read more...]
Welch Allyn AED 20″ Defibrillators Recall
Automated External Defibrillators Are Being Recalled. Product: Welch Allyn AED 20™ Automated External Defibrillators manufactured from April through October 2003, serial numbers 205199 through 205786. Use: These devices are intended for use by emergency or medical personnel to treat adult and pediatric patients in … [Read more...]
Replacing Heart Device Found Risky
High rate of serious complications, including death. Surgery to replace potentially defective heart defibrillators carries an unexpectedly high rate of serious complications, including death, according to a study published today. The research in the Journal of the American Medical Assn. showed that one in 50 patients needed to … [Read more...]
Medical Firm’s Dangerous Secret
Medical Firm Failed To Report Malfunctions Of Medical Device. When a Guidant Corp. subsidiary pleaded guilty in June to 10 federal felonies, it acknowledged failing to report thousands of malfunctions of a medical device used to repair bulges in the body's main artery. Twelve of the unreported cases ended in deaths. But the … [Read more...]
Bronchoscopes Likely Weren’t Clean
Medical device suspected of spreading potentially life-threatening bacteria. The Japanese manufacturer of a medical device suspected of spreading potentially life-threatening bacteria at a U.S. hospital said Wednesday that faulty cleansing of the equipment was likely to blame for any infections. Tokyo-based Olympus Optical Co. … [Read more...]
Medical Device Faulted for Infection
Medical Device May Have Given Lung Infection. Johns Hopkins Hospital is alerting 415 patients and their families that a defective medical instrument may have given them a potentially life-threatening lung infection, a newspaper reported. Some patients who were examined by one of three contaminated bronchoscopes have died, but … [Read more...]
Texas Medical-Device Co. Faces Suit
Medical-device maker Sulzer Orthopedics, facing 700 lawsuits over a hip-replacement part it recalled last year. Medical-device maker Sulzer Orthopedics, facing 700 lawsuits over a hip-replacement part it recalled last year, has been sued by a man who says his knee implant had the same defect. Leroy Harp of Tulsa, Okla., sued … [Read more...]
