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Postsurgical Infections Associated with Nonsterile Implantable Devices

Two recent cases of postsurgical infection reported to CDC occurred after the implantation of devices labeled and sold as nonsterile. Although there was no evidence that the infections resulted from the implants, these occurrences serve as reminders of the importance of monitoring the sterility of implants.

Because manufacturers may supply implantable devices such as orthopedic (e.g., hip prostheses), cardiovascular (e.g., cardiac valve grafts), and neurologic (e.g., shunts) devices as nonsterile, hospital personnel must ensure that nonsterile devices are adequately sterilized before implantation. The sterilization process used for an implantable device should be closely monitored and documented in the patient's medical record, including the sterilization method; the duration of exposure to the sterilization agent; conditions such as pressure, temperature, chemical concentration, date, time, and biological monitors; and other process indicators.

Steam or ethylene oxide sterilization is recommended for sterilization of implantable devices (1). Specific manufacturer recommendations for sterilization of the device should be available in the product packaging; if they are not, hospital personnel should contact the manufacturer for sterilization recommendations and/or to ensure that the sterilization method to be used will not adversely affect device safety and performance. If the information is not available in the product packaging and recommendations cannot be obtained from the manufacturer, the device should not be used.

Adverse effects associated with implantation of implantable devices received from the manufacturer as nonsterile must be reported to the manufacturer, who must report the event to the FDA by mail (Center for Devices and Radiological Health, FDA, FDA User Report, P.O. Box 3002, Rockville, MD 20847-3002) or by fax ((301) 881-6670). User facilities must report deaths related to implanted devices or adverse effects when the manufacturer is unknown directly to the FDA at the above address or by fax ((301) 427-1967)). To ascertain the extent of complications resulting from infections associated with implantable devices labeled as nonsterile, hospital personnel are requested to report these events through state health departments to CDC's Hospital Infections Program, National Center for Infectious Diseases; telephone (404) 639-1550.

Reported by: Center for Devices and Radiological Health, Food and Drug Administration. Hospital Infections Program, National Center for Infectious Diseases, CDC.

Reference

  1. Garner JS, Favero MS. Guideline for handwashing and hospital environmental control, 1985. Am J Infect Control 1986;14:110-29.



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