STERIS System 1: FDA Safety Alert!

The FDA has issued an alert to healthcare facilities using the STERIS System 1 (SS1), to discontinue its use after receiving reports of injuries. These injuries included exposure burns by healthcare staff operating the device, as well as its inability to determine if the currently marketed device can support its labeled claims that it effectively sterilizes medical devices.  The FDA strongly encourages healthcare facilities to seek alternative methods to sterilize and disinfect instrumentation.

The STERIS System 1 (SS1) is a liquid chemical system processing device that is designed to provide sterile processing of instrumentation between patient uses.  Examples of such instrumentation includes (but not limited too) endoscopes and bronchoscopes among others.  The STERIS System 1 uses a peracetic acid solution referred to as STERIS 20 Sterilant to destroy microorganisms that would cause infection among patients.

In May of 08’, the FDA issued a warning statement to STERIS due to changes that had been made to the SS1.  Since these changes had not been evaluated by the FDA, it was unknown if the device would continue to safely and effectively perform instrument sterilization. Throughout the rest of 08’, Steris and the FDA negotiated a possible resolution for the situation.  It was decided that STERIS would commit to work with current SS1 customers in order to transition them to an approved alternative.  In January 09’, STERIS issued a letter to the customers detailing the FDA warning and their plan of action to remedy the situation.  According to the FDA, STERIS has not satisfied the requirements of their previous agreement in terms of transitioning users. They have even had reports that STERIS has assured customers there is no need for any changes.  This has prompted the FDA to step in and advise all healthcare facilities to seek alternative sterilization options.  STERIS is yet to issue a voluntary recall on the SS1 units. However, they have agreed to cease any further U.S. sales and only proceed with product and part replacement, as well as, service to existing customers.

The FDA has posted guidelines on its website to offer guidance on how to choose an alternative product.  They suggest that the first step is to determine the degree or reprocessing required.  The FDA has broken these down into three device categories:  critical, semi-critical, and noncritical.  Critical devices (implants, etc.) are those instruments that have direct contact with the bloodstream or other sterile areas of the body.  Semi-critical is described as those devices (endoscopes, etc.) that contact mucous membranes, non intact skin, and those that don’t penetrate the blood barrier.  Finally, noncritical devices (bedpan, etc.) that only come in contact with intact skin.  Once the degree of reprocessing is determined, a facility will have the ability to choose the appropriate alternative.

One can find the FDA notice letter, Q&A, and alternative device information at the following sites:

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191585.htm

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm192685.htm

http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfPMN/PMNSimpleSearch.cfm

http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfPMA/pmasimplesearch.cfm.

http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ ReprocessingofSingle-UseDevices/ UCM133514.

Steris Responds to FDA’s SS1 Warning

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