FDA, ECRI Institute post lists of alternatives to STERIS Corp.’s System 1 sterilizer

Updated 2:02 p.m.

WASHINGTON, D.C. — The U.S. Food and Drug Administration has posted a notice on alternatives to System 1, the medical instrument sterilizer made by STERIS Corp. in Mentor, Ohio, that the administration considers a “violating device.”

The lengthy list of alternative sterilizers, posted on Monday, comes after the FDA issued a safety alert about System 1 on Dec. 3, saying the administration had received some reports of malfunctions “that had the potential to cause or contribute to serious injuries to patients, such as infections.” The FDA also said it was aware of injury reports by workers who used the system.

Last week, ECRI Institute, a nonprofit organization that seeks to apply scientific research to improve patient care, posted its recommendations, as well as a side-by-side product comparison chart, to help hospitals find alternative devices.

The System 1 saga began in May 2008 when the FDA sent STERIS a warning letter telling the manufacturer that it had made so many changes to its first sterilizer since its 1988 launch, the administration no longer considered the device approved as safe and effective.

STERIS disagreed with the FDA, saying changes made to System 1 through the years did not warrant a new market application and the changes complied with FDA requirements when they were made. In January, STERIS applied to the FDA to sell a next-generation chemical sterilization system — essentially an updated and improved System 1 — largely to put to rest its ongoing disagreement with the regulator.

The new system eventually would replace System 1, if approved by the FDA. STERIS said it would stop selling System 1, but continue to service and support it through 2011.

The FDA has acknowledged several times this month that it is unaware of any confirmed cases of infection caused by inadequate processing by System 1. Still, it has recommended that hospital leaders plan to replace 23,000 System 1 sterilization units worldwide.

STERIS is keeping a running tab of FDA communications on System 1 at its Web site.

The company also is “engaged in daily discussions with the FDA, including the sharing, review and input on information to be shared with health care administrators,” said Stephen Norton, corporate communications director for STERIS, in an emailed response to a reporter’s questions. “We expect to communicate and carefully coordinate” information with the FDA, “and it is likely that we will continue to publish information to our respective Web sites.”

Shares of the Mentor manufacturer have dropped 17 percent to $27.74, as of noon today, since the FDA’s recent actions on System 1 began. Prior to Dec. 3, STERIS shares had gained 28 percent from mid-year, partly on the sales strength of hand sanitizers used to ward off H1N1 infections.

Mary Vanac

Mary Vanac is co-founder of MedCity News and serves as its vice president of operations.

Tags: FDA, Mentor, Ohio, safety alert, STERIS, System 1, U.S. Food and Drug Administration, Washington D.C.

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With interest I have followed Ms. Vanac’s columns on the recent rebuke of the STERIS System 1, which the FDA calls a â€œviolating device.â€

While the list of alternative reprocessing devices posted by the FDA is of interest, arguably of equal or more interest to health care practitioners, clinicians and patients (and veterans) alike are the answers to the following germane questions:

(1) The FDA two weeks ago (circa December 10th, 2009) questioned Steris’s published statement that the continued use of the STERIS System 1 warrants no changes in clinical practices.

What specific changes in clinical practice (e.g., informed patient consent?) are the FDA and health care organizations – including the ECRI Institute, which Ms. Vanac’s column discusses – therefore recommending?

Ms. Vanac’s article notes that “Last week, ECRI Institute, a nonprofit organization that seeks to apply scientific research to improve patient care, posted its recommendations, as well as a side-by-side product comparison chart, to help hospitals find alternative devices.”

For context and background information, ECRI has been a stauch supporter of the System 1 (refer to the front page of both the “Wall Street Journal,” dated 12-24-04, and “Investors Business Daily,” dated 02-14-00) and, just before the FDA issued its order two weeks ago to stop using the System 1, the ECRI Institute upheld the System 1′s dubious “sterilization” claim and published this past summer a recommendation to continue using the STERIS System 1 (without informed patient consent), despite the FDA censure of this device. While employed by ECRI in 1993, I discussed with it my concerns about the System 1 and its misleading labeling claims and increased risk of disease transmission, but to no avail.

(2) In response to well publicized endoscope-disinfection breaches and the potential for as many as 10,000 veterans to have been exposed to HIV and the hepatitis C virus, last summer the Veterans Administration’s Office of Inspector General (OIG) conducted unannounced inspections at 42 VA facilities, to determine whether they were in compliance with accepted infection-control standards. (Note: Although the STERIS System 1 has been and was at the time of these inspections standardized throughout the VA system of medical facilities, this Office’s report, oddly, makes no mentioned of the adulterated and misbranded STERIS System 1 and its ubiquitous use throughout the VA.)

What is the VA’s current position on the continued use of the System 1, if for only 3 to 6 more months? Is the VA mandating informed patient (veteran) consent and clinician notification, per the Food, Drug and Cosmetic Act’s explicit provisions via-s-vis the use of such an “investigational” device?

Comment by Lawrence F Muscarella, PhD — December 23, 2009 @ 3:45 pm