FDA Hearing To Discuss When And How It Issues Medical Device Safety Communications

Federal health officials plan to hold a public meeting in April to discuss when and how regulators should issue safety communications or medical device recalls, after problems are identified with products already on the market.

The FDA issued an announcement on January 28, indicating it will hold a public hearing on April 1, 2020, calling on healthcare providers, patients and medical industry stakeholders to join and present methods to improve safety communications regarding medical devices.

According to the agency, the goal of the meeting is to collect and discuss ideas to improve safety communications to assure hospital and healthcare facilities using these impacted medical devices receive critical safety information in a timely, clear and consistent manner.

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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 hearing will also allow attendees to tell the agency what challenges they face due to the current way the FDA issues medical device safety communications.

The FDA has faced criticism over its approval of medical devices before risks are known, and its ability to quickly inform the public about emerging risks once they are discovered.

Adverse events are generally first reported by either a medical professional who witnesses a problem occurring with a patient, or by the patients themselves. Often, these are reported to the manufacturers, who then are legally obligated to pass along that information to the FDA in a timely manner. However, a number of recalls and medical device adverse events have revealed that manufacturers do not always meet their reporting requirements.

When manufacturers do report problems, there are often many unknowns until an investigation by the manufacturer determines the problem, its frequency of occurrence, and whether a recall is necessary. This process can take weeks, if not months, often resulting in additional adverse health events which may have been avoided if the process was faster.

In 2016 the FDA issued guidance on when the public should be notified about health risks associated with a medical device in 2016. 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.

The agency indicated the guidance could save lives and prevent injuries by alerting the public quickly to devices that have been linked to serious adverse events or associated with detrimental health conditions and outcomes.

This latest public hearing will be held at the FDA White Oak Campus in Silver Spring, Maryland. It will also be webcast live. The link will be provided in an email to registering participants.


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