Cardiac Devices Due to Battery Issues
UNITED STATES – The medical device manufacturer Maquet is recalling thousands of cardiac devices called intra-aortic balloon pumps (IABPs) due to battery issues that could be life-threatening to patients. The U.S. Food and Drug Administration announced the recall in May 2019 because of concerns that the devices could lose charge and … [Read more...]
FDA Releases Draft Guidance on Medical Device Recalls
FDA Releases Draft Guidance on Voluntary Medical Device Recalls, Raising Concerns About Inconsistencies Between the Guidance and Current Regulations UNITED STATES – According to an online article published by www.raps.org, the FDA has released a draft guidance regarding the process for initiating voluntary recalls of medical … [Read more...]
FDA Acknowledges Medical Device Underreported Malfunctions
WASHINGTON, D.C. — The United States Food and Drug Administration acknowledged that problems with medical devices are underreported. This is a dangerous situation, which, according to some, the FDA is making worse. Kaiser Health News said that many reports, including those filed regarding the Sprint Fidelis defibrillator manufactured … [Read more...]
Doctor Exposes an FDA Policy that Endangers Patients
WASHINGTON, D.C. — A renown physician notice he had an irregular heartbeat and in 2006, he had a Sprint Fidelis defibrillator made by Medtronic implanted into his chest. The device was designed to shock the heart back into its correct rhythm if it skipped a beat. However, the device did not work as advertised. Instead, the device … [Read more...]
Power Morcellators Allegedly Spread Cancerous Tissue
Power Morcellators Designed To Remove Tissue. Power morcellators were designed to facilitate the removal of tissue during laparoscopic procedures. The morcellator works by breaking tissue into smaller chunks for easier removal. Power morcellators has been used as a replacement for traditional surgery as the smaller incision puts … [Read more...]
Radiation Overexposure Medical Devices Side Effects May Result In Radiation Overdose Lawsuits
Radiation Overdose Injury Lawsuits. Have you been the victim of excess radiation from a CAT scan or other medical imaging? According to recent studies, Americans are exposed to more radiation as a result of procedures like CAT scans than people elsewhere. Patients have even been injured by a radiation overdose from a single CAT scan. … [Read more...]
FDA Investigation Finds Underreporting of Medical Device Problems
Under federal law, hospitals must report adverse events related to medical devices to the U.S. Food and Drug Administration (FDA), but an FDA investigation has revealed that many hospitals are likely underreporting these events. This reporting helps the FDA identify potentially defective medical devices and prevent additional … [Read more...]
Senate Report Critical of Medical Device Makers’ Failure to Report Infections
A Senate report released on January 13, 2016 finds that superbug infections linked to poorly cleaned medical devices have been more widespread than previously known. The reports places blame on hospitals, device makers, and the Food and Drug Administration (FDA). Senator Patty Murray of Washington state began the yearlong … [Read more...]
Reusable Menstrual Pads Classified As Medical Devices
Retailers are being required to pay a “premarket notification fee” to continue the sale of Reusable Menstrual Pads. Because the Food and Drug Administration (FDA) classifies menstrual cups and reusable menstrual pads as “medical devices,” retailers are being required to pay a “premarket notification fee” to continue the sale of … [Read more...]
Additional Monitoring Needed for Medical Devices
In an article published by the Lexington Herald-Leader, a Kentucky physician calls for greater regulation of medical devices. Dr. Kevin Kavanagh of Somerset, Kentucky, who is also board chairman of Health Watch USA, writes that patients will continue to be harmed by medical devices unless more monitoring is implemented. “...we are … [Read more...]
Congress Would Weaken Testing and Regulation of Medical Devices
Approval process usually requires one clinical trial to demonstrate safety and effectiveness. In an op-ed piece this week in the New York Times, two prominent cardiologists warn that legislation currently before Congress could dangerously weaken the standards the Food and Drug Administration (FDA) uses to determine the safety and … [Read more...]
Legislation Before Congress Would Weaken Testing and Regulation of Medical Devices
In a time when ever-increasing numbers of Americans rely on medical devices, legislation currently before Congress could weaken the standards the Food and Drug Administration (FDA) uses to determine a device’s safety and efficacy. The 21st Century Cures Act would allow devices to reach the market using case-study evidence rather … [Read more...]
Patient Experiences to Become Part of Medical Device Reviews
The Food and Drug Administration (FDA) is developing guidelines that will incorporate patients’ experiences with medical devices into the regulatory review process. Working together, the Medical Device Innovation Consortium, a collaboration of the device industry, the FDA, and the National Institutes of Health, released a draft … [Read more...]
Case over Stryker Bone Medical Devices
Case Over Stryker Bone Medical Devices Now On The Way. For the most part, a lawsuit alleging that Stryker Corp. promoted the off-label combining of two medical devices can move forward, a Louisiana federal judge ruled. According to Law360, the plaintiff alleged that Stryker promoted the off-label combination despite being aware of … [Read more...]
PW Attorney Named to Biomet M2a Magnum MDL
Parker Waichman Tapped To protect patients harmed by Biomet M2a Magnum hip implant. The national law firm of Parker Waichman LLP has again been tapped for a leading role in protecting the rights of people injured by defective medical devices, this time those harmed by the Biomet M2a Magnum™ hip implant. Attorney Daniel C. Burke … [Read more...]
NMD Lawyers Warn About Metal Hip Implants Risks
Safety Concerns of Metal-On-Metal Hip Implants. Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, is notifying the public about the safety concerns surrounding metal-on-metal hip implants. Following a major recall by Johnson & Johnson, the devices have … [Read more...]
70,000 Children Per Year Injured by Medical Devices
Injured by Medical Devices. Medical devices send tens of thousands of children and teens to the ER every year, according to researchers at the U.S. Food & Drug Administration (FDA). Their study appears online in the journal Pediatrics. To reach their conclusions, researchers from the FDA’s Center for Devices and Radiological … [Read more...]
FDA Investigating Faulty Power Cords on Medical Devices
Faulty Power Cords on Medical Devices. 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 … [Read more...]
System Needed to Track Recalled Medical Devices
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 … [Read more...]
Older Medical Devices To Get Safety Reviews
U.S. regulators are finally going to review 25 types of medical devices that were marketed prior to 1976. U.S. regulators are finally going to review 25 types of medical devices that were marketed prior to 1976. According to a statement from the Food & Drug Administration (FDA), all of the medical devices slated for review were … [Read more...]
Risks of BPA in Medical Devices to Be Investigated
Risks of BPA Awaits Probe. Medical Devices To Be Investigated. The Food & Drug Administration (FDA) has launched two studies to determine if bisphenol-A (BPA) in some medical devices is exposing patients to health risks. According to the Website medpagetoday.com, the two medical device studies will focus on whether BPA in … [Read more...]
Unapproved Medical Devices Subject to Class I Recall
There is a reasonable probability that the use of a device will cause adverse health consequences or death. Federal regulators have announced a Class I recall of two unapproved unapproved medical devices. The recall involves Vibrational Integrated Bio-photonic Energizer (VIBE device) sold by VIBE Technologies of Greeley, CO and the … [Read more...]
FDA Looking At Medical Devices, Drugs Containing BPA
FDA To Probe Drugs Containing BPA. Yesterday, the US Food and Drug Administration (FDA) announced that it is seeking assistance identifying medical devices, drugs, and other products it regulates that contain Bisphenol A (BPA). The FDA is also reviewing a financial conflict of interest issue concerning a prominent toxicologist … [Read more...]
Senate Panel Looking at Medical Devices Consumer Ads
Medical Devices Misleading Ads. Some lawmakers, medical groups, and others are seeking restrictions on some direct-to-consumer advertisements for medical devices such as artificial knees and heart stents, claiming such ads mislead patients. The amount of medical device advertising directed to consumers on television or over the … [Read more...]
Defibrillator Shock Linked to Early Death
Shock from an implanted heart defibrillator may also be linked to future problems. While a defibrillator shock may provide a lifesaving nudge, the Associated Press reports that such a shock from an implanted heart defibrillator may also be linked to future problems and early death. The government-funded study revealed that heart … [Read more...]
BPA in Medical Devices Concerns Lawmaker
Rep Rosa DeLauro urges the US FDA Science Board follow Health Canada’s lead and expand its inquiry. Representative Rosa DeLauro (Democrat-Conneticut) is urging the US Food and Drug Administration’s (FDA) Science Board follow Health Canada’s lead and expand its inquiry of bisphenol A (BPA) by identifying all medical devices containing … [Read more...]
Medical Devices Malfunction Due to Wireless Tracking Systems
Medical Devices Potentially Deadly Breakdowns. The wireless systems which are used by many hospitals to track equipment may be creating potentially deadly breakdowns in lifesaving medical devices such as respirators, dialysis machines, and external pacemakers. Apparently, some microchip-based "smart" systems, hyped for their … [Read more...]
Lawmakers Want Oversight of Imported Medical Devices and Cosmetics
Imported Medical Devices More Oversight. Democratic lawmakers say the US Food and Drug Administration (FDA) has insufficient funding and power to maintain appropriate oversight and regulation of products, especially medical devices and cosmetics. "While the market for these products becomes increasingly global, the FDA has no … [Read more...]
Medical Devices Made with Tainted Heparin Recalled by Medtronic
Medical devices may be coated with tainted heparin, a drug linked to 81 deaths in the US. Medtronic Inc. is recalling some medical devices because they may be coated with tainted heparin, a drug linked to 81 deaths in the US. The disposable medical devices, used during cardiac bypass surgery, are made with Medtronic's Carmeda … [Read more...]
More Kid-Sized Medical Devices Needed
Children should not be fitted for adult-sized medical devices. More and more, physicians are realizing that children should not be fitted for adult-sized medical devices. According to Dr. David Staffenberg, a metal plate improperly lodged in a young boy's skull showed him how very dangerous traditional devices—generally made to fit … [Read more...]
Controversy Swirls Around Recycled Medical Devices
Recycled Medical Devices Cause Of heated Arguments. Recycled medical devices are the subject of a heated debate between healthcare providers and the industry. Hospitals - and the reprocessing companies they pay to recycle single use medical devices - say that the practice saves million in healthcare costs and waste. But medical … [Read more...]
Germany Recalls Heparin
Germany Recalls Heparin. Heparin has been recalled in Germany, for the same reason that Baxter Heparin was recalled in the US. Germany's drug regulator, the Federal Institute for Drugs and Medical Devices, confirmed Friday it issued a recall for supplies of the blood thinner heparin after severe allergic reactions to the drug were … [Read more...]
Medtronic Asks Supreme Court to Ban Personal Injury Lawsuits
Medtronic Defective Medical Devices. Medtronic, Inc., the maker of the faulty Sprint Fidelis Defibrillator Lead and several other defective medical devices, will try to convince the US Supreme Court that people injured by dangerous medical devices and drugs should not be allowed to sue manufacturers if those products have been … [Read more...]
Ex-J&J officer files lawsuit as whistle-blower
The Former J&J Officer Filed A Lawsuit. The former chief medical officer for a unit of Johnson & Johnson has filed a whistle-blower lawsuit against the company, claiming he was fired for seeking product recalls of several faulty medical devices. Joel Lippman said he was terminated from his post at Ethicon in May, after working … [Read more...]
Analysis: Panel urges warning on stents
FDA New Warning On Stents. A Food and Drug Administration advisory panel recommended new warnings Friday for popular medical devices used in millions of patients with cardiovascular disease. Experts said the two brands of drug-coated stents available in the U.S. should carry new warnings that the devices may increase the risk of … [Read more...]
Boston Scientific Shares Dip on Letter News
Regulatory Problems In Medical Devices Shipped From Quincy, Mass. Federal regulators sent Boston Scientific Corp. a warning letter identifying "serious regulatory problems" in medical devices shipped from a Quincy, Mass., distribution plant, including heart stents sent to hospitals despite a quality control problem. The U.S.Food … [Read more...]
FDA: 22% of Follow-Up Studies On Medical Devices Go Undone
FDA-Required Medical Devices Study Failed. Nearly a quarter of follow-up studies required by the Food and Drug Administration for medical devices in recent years were never completed, according to a senior regulator who has launched a campaign to improve the ratio. "It's not a pretty picture," Daniel G. Schultz, director of the … [Read more...]
Medtronic Announces Voluntary Recall of of Older ICD Models
Two older models of implantable cardioverter defibrillator recalled.Medtronic, Inc. announced that it is voluntarily recalling two older models of implantable cardioverter defibrillator due to a defect. The Class I recall involves a small subset of Micro Jewel® II Model 7223Cx and GEM® DR Model 7271 ICDs. this two devices may … [Read more...]
Faster Recall of Medical Devices Urged
Doctors at Johns Hopkins Hospital traced a bacterial outbreak to a defective medical device . Doctors at the Johns Hopkins Hospital who traced a bacterial outbreak to a defective medical device say the problem might have been averted by a faster and broader product recall. Writing this week in The New England Journal of Medicine, … [Read more...]
FDA Warns Of Chemical In Plastic
Baby Boys Are At Risk From Chemical In Plastic. Sick baby boys may be at highest risk from a chemical used to soften such plastic medical devices as blood bags and IV tubes, the government says in advising various hospitals. The chemical, called DEHP, can leach from the plastic into certain liquids, especially fat-containing ones … [Read more...]
