Steris Corp. is defending its System 1 liquid chemical sterilization system in the face of recent FDA warnings, but says further regulatory sanctions, including marketing restrictions, recalls or monetary fines, are possible.

"We disagree with the FDA's recent notice and are working to engage in further dialogue with the agency about this matter," Steris CEO Walt Rosebrough stated Dec. 4. However, "there is no assurance ... FDA will not pursue an administrative or enforcement action" against the firm, Steris added.

FDA warned health care facilities Dec. 4 that the System 1 sterilizer system on the market had not been properly cleared or approved by FDA, and urged them to find alternatives "as soon as possible." The agency says the marketed product is so substantially changed from the product originally cleared in 1988 that its safety and effectiveness are unknown (¹ Also see "Regulatory News In Brief" - Medtech Insight, 7 December, 2009.).

The agency notified Steris that it "may take regulatory action" against the firm regarding the product, which is used by hospitals to sterilize such instruments as endoscopes and bronchoscopes.

According to Steris, FDA could demand that the firm stop sales of System 1 and any related services, accessories and sterilant; require labeling changes or marketing restrictions; require a recall; or impose "significant" monetary fines or civil damages.

FDA has received a few reports of malfunctions and injuries related to System 1, but there have been no confirmed cases of infection directly attributed to inadequate reprocessing with the device, Steris emphasizes. The firm stresses that System 1 has safely and effectively sterilized more than 300 million devices "when used as directed."

FDA, however, says device-related infections may be difficult to attribute to the sterilizer system after the fact and may go unreported.

The agency held conference calls with health professional organizations and with the media Dec. 4 to field questions about its recommendations regarding System 1. Health care groups were particularly confused about which System 1 devices were subject to the advisory, as the device was modified gradually over time.

All System 1 products on the market are affected, FDA clarified.

If alternative systems are not readily available, FDA urges facilities to quickly take steps to obtain them.

"We understand that this won't occur overnight," Tim Ulatowski, CDRH director of compliance, told health professionals on the Dec. 4 call. "But we are asking you to take action now, and to set that in motion."

According to an unofficial transcript of a Dec. 10 call with health care facilities, FDA said it believes facilities can move to alternative systems within three to six months.

Firm Made Changes Over Several Years

A May 15, 2008, FDA warning letter about System 1 noted numerous changes that Steris had made to the product between 1988 and 2002, including changes to the device's centrifugal circulation pump, high pressure pump, software, chamber size and sterilant ingredients.

According to FDA, each change would have required a new 510(k) in and of itself, and cumulatively, the changes resulted "in a change in the overall device design that could significantly affect safety and effectiveness."

Following discussions with FDA, Steris agreed in January to transition companies to legally marketed replacement devices, and submitted a new 510(k) for System 1. FDA could not say if or when that device will be cleared.

But based on a recent inspection and meetings with Steris, FDA says the firm has not delivered on its promise to transition customers to alternatives.

"Steris apparently has been reassuring customers that there is no need for a change in their clinical practice," FDA noted in its "Questions and Answers" document for health care facilities.

FDA does not plan to penalize hospitals for using System 1, but is reminding the facilities of their obligation to report device-related serious adverse events or deaths on MedWatch.

- Jessica Bylander ( ² j.bylander@elsevier.com )

Steris Defends Sterilizer System, Awaits Further FDA Action

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