Healthcare News & Insights

FDA: Hospitals must improve reporting of medical device issues

As a result of several issues with medical devices causing the spread of illnesses and infections in hospitals, the Food and Drug Administration (FDA) is calling attention to facilities’ obligations for reporting harmful incidents involving devices. 

467135639Specifically, the FDA is responding to big problems caused by two different devices that made headlines for causing illness in patients: duodenoscopes and morcellators.

Last year, several people died after undergoing gastrointestinal procedures with contaminated duodenoscopes, which are used to treat problems in the bile ducts and pancreas, according to an article in Reuters. The reusable scopes have small parts that are hard to clean safely using traditional methods, so tainted scopes ended up transmitting infections to multiple people.

The purpose of morcellators is to remove uterine fibroids from patients. They cut tissue into smaller pieces so it can be removed through smaller openings in the body. However, these devices are known to have an undesirable side effect: They can spread undetected uterine cancer.

The FDA has released official warnings about the dangers of both devices, calling upon manufacturers to issue warnings of their own and correct the worst problems. And it’s required facilities to report any problems they’ve encountered due to their use.

However, hospitals have fallen short, which means these events didn’t come to light right away.

Areas to work on

In a recent blog post, the agency lays out the areas where hospitals missed the mark with their reporting requirements for adverse events involving medical devices:

  • Hospitals didn’t submit reports about deaths or serious injuries related to these devices. In fact, some hospitals didn’t even have the correct procedures in place to report incidents to the FDA or to device manufacturers. The FDA believes this is all too common for hospitals across the country.
  • Hospital staff weren’t aware of the FDA’s medical device reporting requirements. They weren’t trained on the correct protocol for compliance, and they didn’t know what details they had to submit. So events went unreported and underreported.
  • Information sharing isn’t seamless for reporting. Hospitals usually have to submit these reports to the FDA manually, which can cause delays. The agency wants to work with facilities to take advantage of the information that’s being stored by devices and hardware electronically, so reporting any adverse events is less of a burden for hospitals.

To solve these problems, the FDA is working closely with facilities to close any knowledge gaps about the reporting process and to streamline it for future events. In addition, it’ll clarify hospitals’ role in making sure medical devices are safe for patients – and their responsibilities if the devices are found to contribute to the spread of disease.

The FDA will also host a public workshop next month where it’s inviting healthcare professionals to give their input on how to improve the reporting process, including boosting surveillance to pinpoint issues quickly.

Although the FDA hasn’t announced any enforcement actions for hospitals that failed to comply with existing reporting requirements for the issues with duodenoscopes and morcellators, it’s working closely with those who had “significant violations of the regulation” to prevent similar problems down the line.

But just because the agency is taking a more cooperative approach right now doesn’t mean that it won’t be harsher on hospitals that don’t comply in the future, especially once it finalizes any changes to make reporting easier on facilities.

So this serves as an excellent reminder for your facility to make sure it has a system in place to keep track of adverse events caused by medical devices. That way, you can report any issues promptly to the FDA. Plus, it also helps you pinpoint any problems associated with them immediately, which means you can address them before they harm more patients.

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