FDA warning forces alternative sterilization methods

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FDA warning forces alternative sterilization methods

STERIS problem is one of many worries for ASCs preparing for CMS and accreditation surveys

After reading this article, you will be able to:

  • Recall the FDA’s warning on STERIS System 1 (SS1) processors

On December 3, 2009, the FDA issued a safety alert to healthcare providers concerning adverse reports from users of the STERIS System 1 (SS1) processing system, a device most commonly used for surgical and endoscopy equipment disinfection. The FDA advised healthcare facilities using the device to find an alternative method and transition to that alternative as soon as possible to ensure patient safety. If facilities cannot find an acceptable alternative, steps should be taken to obtain legally marketed substitutes for the SS1.

More than 23,000 SS1 units have been used safely in more than 5,000 hospitals and other healthcare facilities, sterilizing approximately 30,000 medical devices per day, according to a STERIS press release.

“STERIS Corporation has significantly modified the SS1, and FDA has not approved or cleared this modified product. Thus, FDA has not determined whether the SS1 is safe or effective for its labeled claims, including claims that it sterilizes medical devices,” according to the alert.

On an FDA conference call December 10, 2009, FDA representatives said that facilities would be expected to find an alternative within three to six months, says Rose Seavey, RN, BS, MBA, CNOR,CRCST, CSPDT, president and CEO of Seavey Healthcare Consulting, Inc., in Arvada, CO.

“My feeling with all of this is if there is a silver lining in regards to this STERIS System 1 issue, and also the FDA’s issue on steam sterilization and CMS’ focus on infection control and surgical instrument reprocessing in ambulatory surgery centers [ASC], is that finally the spotlight is being put on surgical instrument reprocessing and the need to clean,” Seavey says.

What you need to do now

Seavey says she has seen a few types of reactions to this warning. Initially, some people panicked. They wanted to stop surgeries and treat it as an emergency.

Then there is another group of professionals that is methodically looking at what devices they have, what alternatives are available to them, collecting manufacturers’ written instructions for verification, and adjusting patient schedules to accommodate the necessary adjustments.

Seavey says healthcare professionals in charge of sterilization at their facility should be in the latter group.

The warning is not a reason to panic, rather to reevaluate your processes if you are using the STERIS system.

“Over the years, I have heard many ambulatory surgery people say they like this because you don’t have to wrap,” Seavey says. “But it’s still a liquid unwrapped device afterwards, so really it’s equivalent to a flash sterilizer.”

Rescheduling patients

One thing many ASCs can take advantage of is the ability to reschedule noncritical patients.

Many facilities may be under pressure because alternative disinfection methods take longer to reprocess and patients are scheduled back-to-back, or the facility has limited equipment.

“Don’t schedule 20 eye patients in one day if you only have two sets of instruments,” Seavey says. “Or you could schedule other cases in between that don’t use that specific set so you have enough time to turn it around. It’s all about the patient; it’s not about the bottom line.”


Adapted from Briefings on Infection Control, February 2010.