GAO: FDA Oversight of Medical Devices Inadequate
A Government Accountability Office (GAO) review of FDA’s oversight of medical devices has found a number of deficiencies that could expose the public to potentially dangerous and defective medical devices. The report was submitted as testimony today at a congressional hearing regarding legislation that would restore patients’ ability to file product liability lawsuits against the manufacturers of medical devices.
The House Energy and Commerce Committee’s health subcommittee is holding hearings today about the Medical Device Safety Act of 2009, which seeks to overturn a 2008 Supreme Court decision in Riegel vs. Medtronic. In that case, the Supreme Court held that medical device lawsuits against manufacturers for injuries caused by defective products may be barred if the device was approved by the FDA.
The GAO report identifies gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Proponents of the new legislation point to the report as evidence that the FDA is not capable of ensuring medical device safety, and that manufacturers need to bear ultimate responsibility for the safety and effectiveness of their products.
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Health subcommittee chairman Frank Pallone, Jr. said that there is already evidence that the medical device approval system is “broken” and cannot be the only defense between the public and defective medical devices.
The GAO report found that the FDA does not put all of the high risk category Class III medical devices, such as pacemakers, through its premarket approval process (PMA), which is its most stringent form of premarket review. Some Class III devices are approved through the less strict premarket notification process instead, which only looks to see if a new device is substantially equivalent to an already legally approved device out on the market.
The GAO report points out that Congress intended all Class III devices to be PMA approved since 1976, but that has yet to occur. Between 2003 to 2007, the FDA cleared 228 submissions, covering 24 types of Class III devices, for approval through the less stringent premarket notification process.
According to Dr. William Maisel, director of the Medical Device Safety Institute at Harvard Medical School, one type of device still cleared by FDA through the less stringent notification process is the automated external defibrillator (AED). More than 20% of AEDs have been recalled by FDA, and 370 fatalities have been attributed to defective AEDs between 1996 to 2005.
The report also found fault with FDA’s postmarket surveillance of medical devices, a problem area the FDA has itself noted. According to the GAO report, in 2006 the FDA noted that it was overwhelmed by the volume of submitted reports on medical device-related risks and does not review those reports in a timely or routine manner. FDA indicated that it has so far been unsuccessful in alleviating the backlog.
The GAO also noted that FDA has not kept up on inspections of manufacturing establishments, including a statutory requirement that the agency inspect certain domestic facilities every two years. FDA officials estimate that they inspect Class III facilities every three years and Class II facilities every five years. Foreign manufacturing facilities of Class III devices have only been inspected every six years.
“Taken together, these shortcomings in both premarket and postmarket activities raise serious concerns about FDA’s regulation of medical devices,” Crosse said in her testimony. “In January 2009, we added FDA’s oversight of medical products, including devices, to GAO’s list of high-risk areas warranting attention by Congress and the executive branch.”
The FDA’s own reviews have blamed both a lack of resources and increasing technical complexity of medical devices as causes for the agency’s inability to keep up with medical device safety standards.
Recent lawsuits over the Medtronic Sprint Fidelis defibrillator lead, which was recalled in October 2007, have been used as an example of the need for legislation to restore individuals ability to pursue lawsuits against medical device manufacturers. The Medtronic defibrillator lead recall was issued after they were implanted in more than 250,000 patients, when they were found to be defective and prone to fracture or break.
Although evidence suggests that Medtronic was aware of the reported lead problems for months before the recall was issued, an order was issued in January by a federal judge dismissing all of the Medtronic lead lawsuits based on the Supreme Court ruling in Riegel.
While those cases are on appeal and other medical device product liability lawsuits are in limbo, consumer advocates are pushing for the Medical Device Safety Act of 2009 to be enacted, which could be retroactive to any case still pending in the court system at the time the bill is signed into law.
robertJanuary 22, 2015 at 4:09 pm
Well, ya. Duh! Not only is the fda not doing there jobs but, their investigators lie, get paid to side with doctors and they don't even look at your file when the device the doctor put in you and you file an adverse event for it . Then your told that the doctor did nothing wrong by implanting a spinal implant in me that has never had a study or approved by fda and it don't have to be,and the docto[Show More]Well, ya. Duh! Not only is the fda not doing there jobs but, their investigators lie, get paid to side with doctors and they don't even look at your file when the device the doctor put in you and you file an adverse event for it . Then your told that the doctor did nothing wrong by implanting a spinal implant in me that has never had a study or approved by fda and it don't have to be,and the doctor does have to tell me what he put in me. Ya investigator, called me for a statement but seen doctor in person and decided it medical research he can do what he wants, if investigator would have looked at my records, it shows no anchoring rings at each end of cage and doc cut all serial numbers off cages and never installed rings or screws but lists them in surgery and billing notes and bone graft stuff should have had a lot number, manufacturer, serial #'s and failed to all of that, so I don't even know really who where cages are from what lot. The fda is there to protect the public from harm and because of this quack doctor that wasn't even on depits approved im plant doctors at time of my surgery &wasn't suppose to be able to buy or order any of there implants. Because of the fda's gross negligence, I will be filing a suit against the investigation dept, adverse event dept. And as well as the oregon medical board and the doctor and the bone graft maker, depuy spinal titanium cages, because they were not ever approved for spinal implants in usa or anyplace for sPinal use. I thinks it's high time the fda,doctors and companies pay the patient for lieing to patients they have screwed up for life and should loose there lic's to practice medicine, the pay hush money to medical boards and fda to look other way and say its ok to screw people up or they die from implant. I urge any person that has lost a loved one from cage surgeries lumbar areas or have been severely screwed up and in agonizing pain the rest of your life to write on this page and we all together can change how we the patients get screwed both ways and pay the rest of our lives while the doctor that don't know what he is doing, is sitting nice and pretty because fda and state medical board say it is OK because it's medical research, that like saying, I built a gun for the military and since it is made to kill alot of people at one time, I walk downtown and ask a bunch of people to stand on a corner and I don't have to tell why, I asked then to stand there and then I come from behind and shoot the gun and either they are now dead or will be messed up for life hey that's OK because it's military research, same as medical research, a bunch of liars and bull of deception. If any of you had a surgery by Scott h kitchell in eugene oregon and have issues with pain and nerve damage we need to get together and make it hurt right back. Our fda and medical boards are corrupt and are paid to expedite things that will hurt people and they don'tt care.
christineFebruary 9, 2014 at 12:27 pm
I been in pain. Suffering .since ,2006 ,I had a spine fusion now in 2013 ,,after a sycope and MIR I found out I have a broken screws ,and. morphineThat only answer I got from the surgeon is to install a morphine pump im a single mom I Im in pain 24/7 ,can't work please I need help
richardJanuary 21, 2013 at 5:27 am
I belive. if your sold produce break . under work "/ Your produce cant be sold at all. and if you beside to go forward with this produce. and Lie to the Govtnment with this produce. and your produce KiLL or harm other', the very first thing is to take away your Licence(s) should be take-IN from you and by this New LAW cant never sale need thing in the United State for LIFE. .. and because of the.[Show More]I belive. if your sold produce break . under work "/ Your produce cant be sold at all. and if you beside to go forward with this produce. and Lie to the Govtnment with this produce. and your produce KiLL or harm other', the very first thing is to take away your Licence(s) should be take-IN from you and by this New LAW cant never sale need thing in the United State for LIFE. .. and because of the. that takein the lives of others. do to this Product you recived the automatic. FEDARAL JAIL TIME 35YEARS PER PRODUCT SOLD PER STATE SOLD. THEIRFOR ITS VERY IMPORTANT NOT TO LIE WHEN THE SAFETY. OF PRODUCT. IS FOR LIFE SAVEING. JUST LIKE THE 25 TON AIRCRAFT(S) THAT NOT LIE. AND ITS NOT A BAD PRODUCT. AND IF IT GOWRONG. THE MAN WILL GET 25 YEARS IN FEDERAL JAIL. BECAUSE SOME ONE UNDERSTAND WHEN TO STOP WORK. AN IF FORGO WILL TAKE THE LIFE OF MANYS OTHERS . ALSO : THERE SHOULD NEVER BE A LAW. CLAIMS THAT ARE FINNALS WITHOUT THE COURT. AND JURY OR 12. JUDGNMENT WHEN THE LIFE OTHERS ARE TAKEIN WITH ALL PRODUCT SOLD IN THE UNITED STATES OF AMERICAN. THIS IS FAIR FOR THE DEAD WHOM DONT HAVE A SAY. AND PAYMENT OF MONEY TO THE LIVEING IS NOT. THE WAY YOU WILL STOP UNCAREING BUSSINESS OF UNSAFE MEDICAL product sold. and the selling therof.
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