It was a busy summer for the staff at the U.S. Food and Drug Administration that oversees medical device recalls:

When products are recalled, the hospital looks to the manufacturer for assistance and information. While the Guidant Web site provides patient safety information for patients and physicians in relation to recalled products, information is scarce for the customer who actually purchases the products – the hospital. One hospital materials manager at a very large and prominent heart program in the Mid-Atlantic was told by the hospital’s Guidant representative that information would not be forthcoming to the materials manager because "the hospital is not the customer."

So, the hospital may be on its own to manage recalls internally and externally. In the event of a recall, what should you do?

Form a multi-disciplinary team to create policies and an action plan
Every materials management department needs an up-to-date recall policy and procedure. Chances are you already have this type of document on hand from preparation for JCAHO surveys or implementing other internal controls standards. Make sure you have a policy in place that provides steps to take in the event of a product recall. The hospital also should consider forming a multi-disciplinary team to determine the proper response to the recall and assure compliance to the recall policy. You need to pull together representatives from nursing, public relations, risk management, and the medical executive team to assess risk from all angles. This group needs to determine to what extent and how your organization will react to a recall, including whether a certain product should be pulled off the shelf.

Confirm how your facility will gain access to the latest product news
First, you will need to decide how your organization will scan the healthcare horizon for important product news. Ensure that your process for being notified is fail-safe. Notifications may be sent by mail or other express delivery service. Check your mailing address on record with key suppliers. If your address on record is the hospital loading dock, your facility may be at risk for missing the notification entirely or failing to take quick and appropriate action if the notification is delayed in making it to your desk. You may also want to subscribe to a service that will notify you in the event of recalls or other important product news. (Emergency Care Research Institute (ECRI) and Mitretek Systems’ Risk and Safety Management Alert System are two examples; visit www.ecri.org or www.rasmas.com to learn more.)

Keep your house (internal documentation) in order
In the case of physician preference item implants and devices, patient lawsuits are highly likely. You must make every effort to keep and maintain documentation of product utilization and assure that it is reliable and easily accessible. Revisit the processes of how product information is recorded to ensure that your operative records and implant logs in the O.R. and EP Lab are complete, accurate and up-to-date. You must know that your processes and documentation can withstand JCAHO Environment of Care standards as well as any possible legal scrutiny. Proper documentation saves time and minimizes risk.

Create a communication plan
Your multi-disciplinary group will also need to create an internal and external communication plan. Your hospital staff, physicians, and the community should immediately be made aware of product recalls or other new product safety information. Assuming that your staff and patients will hear about a recall from another source could put you at risk, even though you, as a materials manager, are not considered by the manufacturer as part of the clinical transaction. You will want to discuss posting information on your Web site when a recall is for a widely-used product or in an area that is somewhat sensational, such as cardiac rhythm management products. Some hospitals are holding patient forums at their facility during which patients can question manufacturer’s representatives directly. You must work with your physicians on such an event; don’t pre-empt them on clinical matters. Be sure they are at the head of any contacts with their patients.

Consider the financial impact of a recall on your facility
Although your hospital may not be privy to manufacturer guidance in the event of a recall, you may be held financially responsible in some patient cases. You need to explore the possible scenarios for device replacement and not be the financial scapegoat just because you didn’t pay attention. For example, most manufacturers will provide a replacement device free of charge. But what happens if the patient or physician has lost confidence in that particular manufacturer’s product? Will the manufacturer provide information on how to get a comparable product? All aspects, clinical and financial, of every replacement case that passes through your hospital should be closely tracked in order to ensure that no unnecessary expenses fall on the hospital’s tab. HPN