Thousands of Steris System 1 sterilizer users have to make room in their capital equipment budgets to replace their SS1s, an unplanned purchase they must make by mid-year thanks to last month's loosely worded safety alert from the U.S. Food and Drug Administration that one surgical facility manager called a "non-recall recall."

"The safety alert will result in significant time, money and effort being expended in our 4 surgery centers," says Nancy Burden, RN, MS, CPAN, CAPA, the administrator of Trinity Surgery Center and director of ambulatory surgery for BayCare Health System in Tampa, Fla. "If this alert results in the actual need to stop the use of the SS1s in all our settings, we will incur significant unbudgeted replacement costs. Additionally, there will be team member orientation time and the potential for case delays."

Besides stating that the current version of the SS1 has been significantly modified and hasn't received FDA approval, the safety alert says the FDA has received reports of operational malfunctions in the popular tabletop liquid chemical reprocessor that could cause such "serious injuries" as patient infections. Steris has countered that the product is safe and effective when used as directed. In a letter to customers, Steris says that it is "proud that over the past 20 years, more than 5,000 hospitals and other healthcare facilities have used System 1 safely over 300 million times. In that time, not a single patient infection has been shown to have been caused by System 1 when used as directed."

'How dangerous can it really be?'
Even though the FDA considers the SS1 to be "adulterated and misbranded," officials say that you may continue to use the SS1 for another 3 to 6 months — the time the FDA expects it will take you to purchase "another legally marketed" sterilizer. The FDA has prepared a document that lists approved sterilization and disinfection products to help System 1 owners find a replacement (see "On the Web").

"How dangerous can it really be if they're not making us shut it down immediately?" asks the administrator of a West Coast ASC. "The FDA has not provided any documentation that there's any real danger to the modified System 1. I don't see any reason why they would want to make this non-recall recall."

In a teleconference with SS1 users, an FDA official confirmed that "we have not directed that the use of the Steris System 1 stop immediately. We want you to have suitable alternatives in place, staff trained and other necessary logistics attended to in a seamless process. Do not interrupt diagnostic and therapeutic procedures using devices reprocessed in the [SS1] until these suitable alternatives are in place."

FDA wants you to 'voluntarily transition'
FDA officials clarified a few other points during the teleconference. First, the notice applies to all SS1s, regardless of the model or how long you've had it. Second, the FDA is not recalling the SS1, but rather recommending that you voluntarily transition to another sterilizer. And finally, the FDA may grant exceptions to facilities that are unable to complete the transition within the 3- to 6-month timeframe.

Steris is in daily communication with the FDA, says a company spokesperson, and has created a Web site (www.steris.com/ss1) where you can register for e-alerts and follow Steris on Twitter.

The FDA has grouped alternatives to the SS1 into 5 categories:

• endoscope washer disinfectors/automated endoscope reprocessors;
• liquid chemical sterilants/high-level disinfectants;
• low-temperature sterilizers that use hydrogen peroxide or ozone;
• ethylene oxide sterilizers; and
• steam sterilizers.

The FDA urges buyers to contact the manufacturers of the reprocessing devices they're considering for their facilities to check their availability and confirm that they will be compatible with the devices to be reprocessed.

As a matter of principle and economics, the West Coast ASC administrator says he's "seriously looking at continuing to use our SS1 off label. We believe that there is enough data in the field to support this decision. Where is any documentation of increased infection or harm to a patient in any of the hundreds of thousands of System 1 cycles since these simple modifications were made? There isn't any."

The SS1 was introduced in 1988. More than 23,000 units have been used in more than 5,000 hospitals and clinics in the United States, sterilizing more than 300 million medical devices or about 30,000 per day. Users who have questions or require immediate assistance can contact Steris at (440) 392-7223.