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FDA Safety Alert: Warning Regarding the Use of the AbTox Plazlyte™ Sterilization System

(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:

• Do not use the AbTox Plazlyte™ Sterilization System to sterilize any ophthalmic, brass, copper, zinc, or soldered device. Be aware FDA has not cleared the safety, performance or instruction for use of the AbTox Plazlyte™ Sterilization System.

• If you have ophthalmic, brass, copper, zinc, or soldered devices previously sterilized using the AbTox Plazlyte™ Sterilization System, thoroughly clean and resterilize them using an alternative method of sterilization.

• When using other sterilizers that use peracetic acid, hydrogen peroxide, or plasma gas, strictly follow the sterilizer's labeling.

• Follow the sterilization and reuse instructions in the medical device manufacturer's labeling for all devices to be sterilized. These instructions should provide information on the type of sterilization that is compatible with the device. Review protocols for all sterilization to be sure that they are in accordance with the labeling of the medical device to be sterilized and the sterilization system.

• If sterilization instructions for medical devices intended to be sterilized are not available, contact the manufacturer for the preferred sterilization method. If the manufacturer cannot be contacted or instructions cannot be provided, follow common sterilization procedures, i.e., wet or dry heat. For example, stainless steel instruments can be sterilized in steam sterilizers.

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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