Hospitals are bestowed with a lot of power to heal the masses – all while being held to high-duty-of-care standards. But, what a lot of people and even many hospitals may not be aware of is that hospitals are charged by the U.S. Food and Drug Administration (FDA) to report any adverse situation where a medical device was used and could have possibly caused patient injury.
The FDA performed a large-scale investigation for an entire year looking into claims that hospitals were not reporting incidences where patients were injured and the causes may have been by a medical device. The investigation’s findings are very troubling and even involve some of the nation’s top research hospitals.
FDA’s Defective Device Investigation Details and Allegations
The following details and investigation allegations were captured in recent media reports:1
- The FDA inspected and investigated 17 hospitals across the United States.
- UMass Memorial Medical Center was among those that was found to fail to report any patient infections related to medical devices. UMass failed to report 14 separate infections allegedly caused by duodenscopes.
- The duodenoscope is put into a patient’s mouths and travels through the colon to look at the intestine. These scopes have known design flaws that make it impossible to completely sterilize between uses.
- Three of the UMass patients that were allegedly infected by duodenoscopes eventually died due to complications, while two suffered additional health issues.
- The hospital claims it didn’t report the incidences because it was unsure if the deaths were positively related to the defective medical device or not.
- Under the law, however, all hospitals are required to report any cases that reasonably suggest a defective medical device caused injury or death.
- The investigation also found that many hospital staff members weren’t even aware of the FDA’s reporting requirements involving medical devices.
Endoscopes and the Superbug Infection Facts and Allegations
The following endoscope medical device and superbug infection details and accusations have come from the watchdog group Drugwatch.
- Since manufacturer Olympus put out is TJF-Q180V duodenoscope in 2010, there have been two confirmed deaths and allegedly 200 more infections linked to an antibiotic resistant superbug allegedly caused by the device not being sterilized enough to rid it of all bacteria.
- Olympus didn’t receive proper clearance from the FDA before releasing its endoscope on the market.
- A revamped designed has also caused concern, because it’s now believed to be difficult to properly disinfect completely.
- UCLA Ronald Reagan Medical Center officials say they believe the Olympus duodenoscope is largely to blame for the superbug outbreak at its facilities between October 2014 and January 2015.
- In January 2016, the FDA announced that Olympus was recalling thousands of its scopes.
- Olympus is planning another redesign of its scope to see about preventing any further superbug infections.
Contact a New Jersey Defective Medical Product Attorney with Mayo Law
Have you or a loved one been injured or subsequently died as a result of a defective medical device? If so, contact a New Jersey Defective Medical Product Attorney with Mayo Law to arm yourself with a fierce advocate that will fight for your justice, rights, and any compensation that may be owed to you.
Since 1994, Mayo Law founder Todd Mayo and his highly-skilled legal team have established a winning record of assisting families and those injured by dangerous and defective medical products, and recovering compensation for their grief, pain, loss of enjoyment, and much more.
To find out more how our New Jersey defective medical product attorney can best help you and the services we can provide you, call (732) 613-3100 or (800) MAYOLAW or email us with the contact form on this page to set up a free case evaluation. Also, we don’t charge you any legal fees until or unless you obtain a settlement or an award in your case.
1“Do Hospitals Know the Defective Medical Device Reporting Requirements?” published in Consumer Advocacy News, November 2016.