Managing a tissue recall in a large academic hospital

In October 2005, a recall of human tissue for implantation was initiated because one recovery center obtained tissues from donors who were not screened properly for infectious diseases. The Food and Drug Administration (FDA) and Centers for Disease Control (CDC) recommended notifying affected patients and offering access to infectious disease testing.

A multidisciplinary team was established to provide a framework for responding to the recall. The plan was designed to meet six goals. Steps included patient identification, surgeon and patient notification, patient education and testing, communication of test results, and information for the public.

The institution received 55 recalled tissues, of which 48 had been implanted into 30 patients undergoing neurosurgical, orthopedic, and general surgical procedures. Patients were identified and sent notification letters within 2 weeks of the FDA and CDC recommendations. Twenty-seven patients underwent testing, which was performed at the convenience of the patients at no cost to them. One patient had evidence of previous (but not current) hepatitis B infection. Overall, patients were appreciative of the processes used. Media coverage was positive.

The response plan was generally successful in achieving the established goals. Potential improvements were identified in several areas, including initial patient notification and coordination of test result communication. It is critical to allow flexibility to meet each patient's needs. The plan may serve as a template for use in future tissue recalls by other hospital-based tissue banks.