More than 10 million medical devices were recalled in 2020, according to the Food and Drug Administration1. All medical devices carry some risks, and sometimes either the FDA or the device manufacturer determines that those risks outweigh benefits and issues a recall notice.
When recalling a device, the manufacturer is responsible only for notifying its customers -- most often, physicians and hospitals. The FDA doesn’t provide guidance on how physicians should respond to a medical device recall and doesn’t require physicians to notify patients of one.
Even so, to preserve relationships and avoid potential liability, physicians should establish procedures to inform and work with patients in the event of a recall. Here are six steps MagMutual suggests that physicians can follow to prepare for, communicate and provide treatment after a medical device recall.
- Create a system for responding before receiving a recall letter.
Don’t wait until you have a recall notice in hand to develop guidelines for a response. In the event of a recall, you’ll already be prepared to notify affected patients, answer questions and schedule follow-ups. Your preparation should include the creation of a user-friendly tracking system to identify patients who use a recalled device.
- Schedule a meeting with the device manufacturer.
A medical device manufacturer should inform you about a recall and provide all the information necessary for you to effectively treat your patients and answer their questions. However, if the manufacturer doesn’t contact you, or you need further information, reach out to them to make sure you understand:
- The product, size, lot number(s), serial number(s) and any other pertinent descriptive information
- The reason for the recall
- Possible hazards or implications involved
- The date range of the product’s manufacture and distribution
- The availability of replacement products
- The manufacturer’s recommended actions to take
- A ready means for collection of the medical device.
If you need further information, you can contact the FDA and/or other physicians in your specialty, since they’re likely to also be affected by the recall.
- Follow the manufacturer’s recommended action steps.
In the recall letter, the manufacturer will describe actions for safe handling of the recalled product. The following information also should be included in the recall letter:
- Recommended treatment or actions to take to minimize the risk or impact of the affected product
- Actions to taken pending correction or removal of the device
- Alternative products.
- Reach out to patients in a timely manner to communicate with them about a recall and provide follow-up care.
Physicians have an ethical obligation to notify patients if they believe a medical device could put them at risk. You should attempt to contact patients via phone or email at least twice and document each contact.
- Pursue a course of shared decision-making with patients.
It’s important to conduct open and honest communications with patients about the nature of a recall, possible symptoms, the risks and benefits of actions to take and financial considerations. After an initial conversation, give the patient time to think about the course of action they want to take. Assure the patient that you are monitoring the situation and will keep them up to date.
- Stay current with information and findings.
Accurate information should remain a physician’s top priority. It will help you develop the best possible treatment plans for patients and keep them informed. In addition to staying in touch with the manufacturer, you can visit the FDA’s medical device recall database2 for information.
Patient Safety Comes First
For follow-up visits, procedures and therapy, patients or insurers, not physicians, are financially responsible for services performed by the physician. Patients may have to sue a manufacturer for reimbursement of out-of-pocket costs. Sometimes the manufacturer will cooperate with payers to reduce the financial burden on patients.
Generally, in medical device recalls the manufacturer will be sued and not the patients’ physician. However, physicians open themselves up to liability by:
- Failing to obtain informed consent from a patient
- Negligently installing an implant or medical device
- Failing to take appropriate action when receiving a recall notice when that failure results in injury to a patient
- Failing to adequately maintain records that results in a delay in a patient receiving care.
In the end, physicians should always put patient safety first and take all steps necessary to communicate with patients about recalls, treat them as recommended and follow up as needed. Communication, timely outreach and shared decision-making demonstrate respect and can soothe patient concerns about a medical device recall, helping you maintain positive patient relationships.
MagMutual’s Learning Center offers many additional resources concerning the business, practice and regulation of medicine.
1 https://www.fda.gov/medical-devices/medical-device-recalls/2020-medical-device-recalls
2 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm
Disclaimer: The information provided in this article does not constitute legal, medical or any other professional advice. No attorney-client relationship is created and you should not act or refrain from acting on the basis of any content included in this article without seeking legal or other professional advice.