Skip Navigation LinksSkip Navigation Links
Centers for Disease Control and Prevention
Safer Healthier People
Blue White
Blue White
bottom curve
CDC Home Search Health Topics A-Z spacer spacer
spacer
Blue curve MMWR spacer
spacer
spacer

The content on this page is being archived for historic and reference purposes only. The content, links, and pdfs are no longer maintained and might be outdated.

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.

Disclaimer   All MMWR HTML documents published before January 1993 are electronic conversions from ASCII text into HTML. This conversion may have resulted in character translation or format errors in the HTML version. Users should not rely on this HTML document, but are referred to the original MMWR paper copy for the official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.

**Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.

Page converted: 08/05/98

HOME  |  ABOUT MMWR  |  MMWR SEARCH  |  DOWNLOADS  |  RSSCONTACT
POLICY  |  DISCLAIMER  |  ACCESSIBILITY

Safer, Healthier People

Morbidity and Mortality Weekly Report
Centers for Disease Control and Prevention
1600 Clifton Rd, MailStop E-90, Atlanta, GA 30333, U.S.A

USA.GovDHHS

Department of Health
and Human Services

This page last reviewed 5/2/01