(You are encouraged to copy and distribute this alert.)
April 13, 1998
To: Users of the AbTox Plazlyte Sterilization System
FDA is alerting the health care community not to use the AbTox
Plazlyte Sterilization System for ophthalmic instruments,
and is providing clarification regarding the recall of this device
and recommending options for alternative sterilization.
AbTox, Inc., of Mundelein, Illinois, issued a voluntary recall
on March 31, 1998, to all owners of the AbTox Plazlyte Sterilization
System. This recall notice said not to use the system on ophthalmic
instruments or on any other instruments made with brass, copper
or zinc, or which had been soldered. FDA is warning hospitals
and physicians against the use of the AbTox Plazlyte Sterilization
System because of serious eye injuries, including the need for
corneal transplantation in some patients, following use of ophthalmic
surgical instruments which had been sterilized with the system.
The problem appears to be deposits of copper and zinc salts on
devices sterilized with this system. Copper compounds are toxic
to human corneal endothelial cells.
Although it has not been established whether the problem identified
with the sterilization of ophthalmic surgical instruments is unique
to the AbTox Plazlyte system, FDA has not received reports
of similar adverse events with other sterilizers which use peracetic
acid, hydrogen peroxide, or plasma gas.
The marketed version of the AbTox Plazlyte sterilizer distributed
to health care facilities has not been cleared by FDA for
either safety or performance. This model may have a sticker
labeled "Model ABT 1.0" or by the 6.0 cubic foot chamber
(approximately 33" deep, 18" wide, and 17 ½"
high). FDA has received questions about the regulatory status
of this product because an earlier design (1.0 cubic foot chamber
with a different gas ratio) was cleared by FDA for use only on
stainless steel instruments. It was never distributed by AbTox,
Inc.
For health care facilities who have the AbTox Plazlyte Sterilization
System, FDA recommends the following:
The Safe Medical Devices Act of 1990 (SMDA) requires hospitals and other user facilities to report adverse events (deaths, serious illnesses and injuries) associated with the use of medical devices. To report mandatory adverse events to FDA, follow the procedures established by the hospital or other health care facility with which you are affiliated. These procedures should include how and where to submit reports. Questions regarding mandatory reporting should be addressed to the Division of Surveillance Systems, Reporting Systems Branch by telephone at (301) 594-2735 or FAX at (301) 827-0038.
Even if a report is not mandatory, it may provide important information about why these adverse events are occurring. Please submit voluntary reports directly to MedWatch, the FDA's voluntary reporting program. Submit these reports by telephone at (800) FDA-1088, by FAX at (800) FDA-0178, or by mail to:
MedWatch
Food and Drug Administration HFA-2 5600 Fishers Lane Rockville, MD 20857-9787 |
This notice is also available on the CDRH homepage at www.fda.gov/cdrh/safety.html.
If you have questions about the content of this Safety Alert,
please contact Carol L. Herman, Public Health Analyst, Issues
Management Staff, Office of Surveillance and Biometrics, HFZ-510,
1350 Piccard Drive, Rockville, Maryland, 20850, by FAX at (301)
594-2968, or E-mail at czh@cdrh.fda.gov.
Sincerely yours, D. Bruce Burlington, M.D. Director Center for Devices and Radiological Health |
Updated Aprl 15, 1998
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