When recalls or serious warnings are issued for medical devices, drugs, or other health care products, medical professionals must take specific steps to manage risk and maintain patient care. These notices can come from the FDA, manufacturers, or other agencies and may affect a range of health care providers including physicians, pharmacists, and advanced practice providers.
Medical practices are advised to begin by consulting the most recent information from relevant agencies or manufacturers. Such recall notices typically outline risks, benefits, and recommended actions. Providers should pay attention to guidance regarding treatment modifications, device corrections or removals, necessary patient monitoring, and available alternatives.
It is essential for providers to follow the manufacturer’s recommended action steps precisely and document each step taken. If any step cannot be completed as instructed, the reason should be documented as well. For individual patients affected by a recall or warning, all actions must be recorded in their medical records. In cases where patients decline recommendations, their informed refusal should also be documented.
Manufacturers often assign responsibility for notifying and counseling patients to licensed health care providers rather than contacting patients directly. A typical statement in such notices might read: “[Manufacturer’s name] will not communicate with patients directly about this issue. If patients have been impacted as part of this issue, health care providers have the responsibility to inform patients and/or update a patient’s care pathway.”
To identify affected individuals, providers should use patient lists and electronic health records (EHRs), especially if they prescribed the product or performed related procedures. For over-the-counter medications not prescribed by the provider, obligations may be less extensive.
If attempts to reach affected patients are unsuccessful after at least two tries using different communication methods such as phone calls or emails, more formal efforts like sending a “return receipt requested” letter may be necessary in serious cases.
High volumes of patient inquiries can result from major recalls. Practices are encouraged to direct these calls to an informed staff member who can provide guidance and knows when it is appropriate to schedule appointments with clinicians. Having a prepared script for responses is suggested. Documentation of every call with patients is important.
Financial responsibilities following recalls can vary; sometimes insurers or manufacturers cover follow-up visits and treatments while in other cases patients must seek reimbursement themselves. Manufacturers may provide instructions on how they will help reduce costs for those affected.
In legal matters arising from harm caused by recalled products, facilities and licensed professionals should ensure they have followed all required steps to avoid being named in lawsuits alongside manufacturers. Typically legal action targets manufacturers rather than individual practitioners or facilities but each case depends on its facts.
Providers interested in receiving timely alerts about FDA safety notifications can subscribe at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/subscribe-medwatch-safety-alerts.
“Follow the manufacturer’s recommended action steps exactly, document those steps, and in the event that you cannot, document why you can’t,” said Copic Insurance Company Chairman & CEO.
“In general, the legal actions are against the manufacturer and not the health care professionals and facilities; however, each case (individual or class action) is very fact-based,” he added.
