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