Medical Device Safety Warnings To Be Subject of FDA Virtual Public Meeting

The FDA has scheduled a “virtual” public hearing for November, to review how federal health regulators should release medical device safety warnings, and the best ways to quickly and reliably spread information about recalled products.

The Medical Device Virtual Public Meeting will take place on November 17, according to an FDA announcement issued on Thursday. The agency says the meeting will be held virtually due to the ongoing pandemic, and will focus on how the FDA relays information on medical device warnings and recalls.

Faulty medical devices frequently endanger patients, accounting for an estimated 83,000 patient deaths over the last decade, according to recent research. The number of medical device recalls has ticked upward over the last several years, with many defects related to complicated software failures, mislabeling, and quality issues, which if left in use could increase the risk of serious injury or death to patients.

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Two major topics of discussion outlined in the meeting’s agenda are how patients, caregivers, healthcare providers, regulated industry and media receive the safety communication information from the FDA, and what information is most important for healthcare professionals to make the best decisions for patients.

The virtual meeting will allow public access, and the agency encourages stakeholders, including patients, caregivers, healthcare providers, regulated industry, and media to join to relay what challenges they face due to the current way the FDA issues medical device safety communications.

The event will be webcast on November 17, 2020 from 1:00 p.m. to 3:30 p.m. EST. Those who wish to participate may register on the FDA web page, and will receive a link in their email with a confirmation.

The current practices for medical device safety communications will be posted on the hearing’s web page no later than October 12, for participants to review prior to the November webcast, the agency notes.

The FDA is tasked with not only approving medical devices for market use, but is also responsible for overseeing the recall and customer notification processes.

In 2016 the FDA issued guidance on when the public should be notified about health risks associated with a medical device. The guidance called for an early public notification to reduce or limit the number of patients exposed to the potential risk while the issue is being further evaluated, and to promote enhanced vigilance on the part of clinicians, risk managers, patients and consumers.

Currently, the agency categorizes each recall with a status that is either a “Class I” indicating there is a reasonable chance of serious health problems or death, “Class II” which indicated the product may cause temporary or reversible health problems or cause death, or “Class III” indicating it is not likely for the products defect to cause any health problem ort injury.

Most concerning to the medical community has been the upward trend in life-threatening Class I recalls, which were found to have increased from roughly 310,000 units per quarter in 2016, to 511,000 in 2017.


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