Issued: December 3, 2009
Dear Healthcare Facility Administrator and Infection Control Practitioner:
The Food and Drug Administration (FDA) is providing this notice to inform you of important information regarding the regulatory status of the STERIS System 1 Processor (SS1) and actions that you should take if you have this medical device in your facility. The SS1 is typically used in surgical and endoscopy suites for reprocessing, i.e., sterilizing or disinfecting, medical devices.
STERIS Corporation (STERIS) 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. Use of a device that is promoted to sterilize or disinfect a medical or surgical device, but that does not properly perform these functions, poses risks to patients and users. Improperly disinfected or sterilized instruments may transmit pathogens to patients and healthcare staff, or expose them to hazardous chemicals. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments.
FDA has received some reports of malfunctions of the SS1 that had the potential to cause or contribute to serious injuries to patients, such as infections. Infections that occur after a procedure using a medical device reprocessed in the SS1 may be difficult to attribute to the SS1 and may go unreported. There have also been reports of injuries, mostly burns from exposure to the sterilant solution, to healthcare facility staff operating the device.
On May 15, 2008, FDA issued a Warning Letter advising STERIS that its changes to the SS1 caused it to be adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act (see http://www.fda.gov/ICECI/ EnforcementActions/WarningLetters/ 2008/ucm1048303.htm).As FDA stated in the Warning Letter, the changes made to the SS1 could significantly affect the safety or effectiveness of the device.
In response, STERIS stated that it would work with its customers to transition them to legally‑marketed replacements for the SS1. On January 20, 2009, STERIS advised its customers of this commitment and the steps that it would take to respond to FDA’s concerns. However, based on a recent inspection of STERIS and meetings with the firm, FDA is not satisfied that the firm has been working effectively to transition its customers to replacements for the SS1. FDA is therefore sending this letter to make recommendations on actions that you should take.
If you have an acceptable alternative to the SS1 to meet your sterilization and disinfection needs, you should transition to that alternative as soon as possible to ensure continued patient safety. If you do not have an acceptable alternative to the SS1, you should promptly assess your facility’s patient-care needs and sterilization and disinfection requirements and take steps to obtain legally-marketed substitutes for the SS1.
For additional information, including information on FDA cleared or approved medical devices, see the “Questions and Answers” document on the FDA web site.
Please note that user facilities, including hospitals, are required to report suspected device-related deaths to FDA and the manufacturer, and serious injuries to the manufacturer or to FDA, if the manufacturer is unknown (see http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/PostmarketRequirements/ ReportingAdverseEvents/default.htm). Also, FDA solicits voluntary reports of adverse events from healthcare professionals (see http://www.fda.gov/Safety/ MedWatch/HowToReport/ ucm085568.htm).
Answers to many of your questions are contained in FDA’s “Questions and Answers” document. In addition, FDA will host a call during the week of December 7 for healthcare facilities using the SS1. Healthcare facilities that wish to participate in this call should contact Heidi Marchand, Office of Special Health Issues, by phone at 301-827-4460 or by email at email@example.com. These facilities may also send an email to the NewsHealthCareProfs@fda.hhs.gov. E-mails and voice-mail messages should include the name of the healthcare facility, a point of contact at the facility, and a contact phone number and E-mail address.
Questions can also be directed to Candace McManus, DrPH, at the Office of Compliance, CDRH, 10903 New Hampshire Avenue, WO66, Silver Spring, Maryland, 20993, by email at firstname.lastname@example.org, or by telephone message at 1-877-260-3731.
Timothy A. Ulatowski
Director, Office of Compliance
Center for Devices and
Food and Drug Administration