FDA Relaxes Rules on Reporting Medical Device Problems

Medical Device

Under a new pact between the Food & Drug Administration and the medical device industry, the device makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices will have to hurriedly report in case of any injuries or death in relation to their product, although they would have more time to file their reports if the sold devices are not working properly.

The deal between FDA and billion dollars device industry is renegotiated every five years which includes a fee that the device makers are ought to pay for the agency to review their products. However, according to the current ongoing deal, the device makers should notify the regulator of malfunctions within 30 days, whereas the new 5-year deal would oblige them for disclosure on a quarterly basis on an issue occurring.

On the other hand, critics are opposing the move claiming that underreporting of faulty devices is already extensive and any further underreporting can seriously put the life of patient’s at risk.

The regulators depend on the manufacturers of the device and hospitals to report them of possible injuries, infections and other adversarial events linked to faulty medical devices in addition to glitches. The course of action states a call for alerting the FDA no longer than 30 days in the event of an incident. When the reports are received by the authorities, they go through them usually in the order of importance, beginning with deaths than injuries and lastly malfunctions. The next day, they go through the same process once again start with new deaths and injuries and malfunctions.

Meanwhile, administrators of the medical device industry doubt on the claims of extensive underreporting, saying that the change in regulation will not affect their obligation to intimate the FDA about cases where consumers are affected by the devices. A report suggests that neither the FDA nor the Government Accountability Office (GAO) may possibly detect the ratio of unreported medical device issues.

Although it will take several years to be fully operational, it is believed that in the near future, these reports issues will turn out to be less significant as a new electronic system will soon be implemented that would source electronic health records to detect troubling patterns much faster.

About Anurag Sharma 4 Articles
Delivering high-quality research and consulting projects at tight deadlines remains Anurag Sharma's forte. An experienced market research professional, he has helped business of varied scales make key strategic decisions. Anurag is a specialist in the medical devices market research domain, and has accurately predicted the trends in the market. Anurag is an avid traveller and music aficionado; in his free time, he loves to introspect and plan ahead.

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