Consumers may not realize it, but the U.S. Food and Drug Administration (FDA) currently has no way to track problems with medical devices and drugs that go wrong other than voluntary reporting. Unlike other countries that have drug and device registries, the FDA has an absolute head-in-the sand approach to keeping abreast of metal hip injures or a drug that causes birth defects.
Why is post-approval monitoring important?
A head in the sand approach to drug and device safety.
In Australia, the country’s National Joint Replacement Registry keeps track of medical devices after they are implanted. As a result, back in 2007, it was the first to report that the DePuy ASR hip had a high revision rate which was a red flag that the hips were failing prematurely, according to a report in the British Medical Journal.
DePuy, the orthopedics division of U.S.- based Johnson & Johnson, received 17 warning from the Australian registry between 2007 and 2009. After receiving the reports, in 2010 DePuy recalled 93,000 ASR hips from the worldwide market.
The FDA is now attempting to step up its post-approval monitoring by making it easier for consumers, doctors and health facilities to report complications.
On this 20-year anniversary of the FDA’s MedWatch program, the agency along with AARP, Consumers Union and the National Women’s Health Network has improved the reporting experience to MedWatch by creating a more user-friendly form that most people can read and understand.
Consumers who experience problems with any product the FDA regulates – from cosmetics to energy drinks, from drugs to permanent medical implants – should report the problem to the MedWatch program. This is an obvious improvement from the FDA’s MAUDE data base.
The Manufacturer and User Facility Device Experience (MAUDE) database was intended to become the place where manufacturers, health care providers and facilities and consumers reported “adverse events” or bad outcomes. But one visit to MAUDE would be your last. That’s because it is so difficult and cumbersome to maneuver. The consumer must understand technical regulatory jargon, the category of the implant, lot number etc. – information most consumers do not have.
The truth is MAUDE was so ineffective that years ago the GAO predicted about 1 percent of actual complications were ever reported.
Sort of like a black hole, the MAUDE database has been a less than satisfactory way to track how products perform in real-life situations. It appears the FDA is finally listening, and with some input from consumer groups, will get a better handle on what happens after medical devices are let loose on an unsuspecting public.
Once again thank you for the update. You are more than polite by your comment FDA having it’s head in the sand.
If I haven’t persisted as best as I can for a lay person there is no way folks would file a complaint with a medical device given the questions asked or even finding where or how to file a complaint. Human nature is more apt to say forget it, allowing the manufacturer of these devices to get away with hurting people again.
The FDA failed to follow up on their request for manufacturers to provide studies on metal particles ( metal on metal hips) entering the bloodstream of patients.
How are they planning on correcting any proposal they make when the basic foundation of the current FDA is cracked beyond repair. Are the drug and device manufacturers ever going to be held accountable and placed under control as all others are including the Church, Penn State, Oil and Auto industries etc.
The Fda should be split into one segment for devices, one for drugs etc.
The manufacturers should foot the bill for the registry, it is a cost of doing business, more importantly providing safety for patients instead of using patients as their test subjects. We patients aren’t even made aware of the fact we are the lab rats.
Respectfully
Howard Sadwin
I spent 30 plus minutes filing out Online Voluntary Submission Form 3500.
In section 2 Outcomes attributed to adverse event (check and reply)
Check all that apply:
Death
Life-threatening Congenital Anomaly/Birth Defect
Hospitalization-initial or prolonged Required intervention to Prevent Disability or Permanent Damage Permanent Impairment/damage
(Devices)
Other Serious (Important Medical Events)
I didn’t answer death–Congenial Anomaly I hit submit as directed, response was I had to check both questions in order to continue. I tried entering all zero’s for death that didn’t work – enough maybe I’ll try later.
What is so easy ???