​A Healthcare Risk Control (HRC) member recently wrote seeking guidance on developing a policy for explanted medical devices, especially regarding how long devices must be retained if they are not involved in litigation and how to handle manufacturer or patient requests for the devices (e.g., orthopedic implants).

HRC notes that a host of risk management issues surround the explantation, handling, and ultimate disposition of medical devices. As a "final distributor" that implants medical devices, the hospital has varied obligations upon explantation, including the following:

• Internally, to manage all related risks in a manner that protects the organization from potential litigation, whether anticipated or unanticipated
• To the patient, who has an ownership interest in the device
• To the U.S. Food and Drug Administration (FDA), which requires hospitals that distribute medi­cal devices to collect information about certain medical devices used in patient care so that the device can be promptly identified and recalled if it presents a seri­ous risk to patients' health

When developing a policy for explanted medical devices, organizations must balance all of these obligations. The following resources provide guidance regarding strategies for achieving that balance.

The discussion "A Risk Management Perspective on Explants" in the guidance article Implants and Explants details concepts that a policy should address, including but not limited to cleaning and sterilization, chain of custody, and third-party analysis. This discussion also addresses the patient's right to determine the explant's disposition, and issues to consider before any release to the manufacturer.

Additionally, this HRC response to a similar member inquiry contains a sample release and waiver-of-liability form addressing the release of an explanted device to a patient.

Organizations should consult their legal counsel for guidance on how long to keep the implant in various situations. Their answer will likely address the following factors:

• All applicable local, state, and federal regulations
• Any legal precedent regarding the application of a statute of limitation or repose in your jurisdiction that could influence policy development
• The generally unpredictable nature of whether or when litigation regarding a device may occur

The guidance article Medical Device Tracking and accompanying List of Tracked Devices contain additional information about FDA requirements. For example, if the tracked device is a medical device implant, the facility collects information at three times: at receipt, at implantation, and at explantation or other permanent disposal of the device (e.g., patient death, permanent discard).

Members may also find helpful the Frequently Asked Questionss "How should explanted medical device specimens be handled?" and "How should explanted orthopedic hardware being returned to the patient be handled?" from the Association of periOperative Registered Nurses.

The recommendations contained in Ask HRC do not constitute legal advice. Facilities should consult legal counsel for specific guidance and develop clinical guidance in consultation with their clinical staff.