Last week, the Food and Drug Administration (FDA) issued a notice, “Concerns About the Steris System 1 Processor, Components, and Accessories, and FDA Recommendations,” which reads as follows: “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 legallymarketed replacements for the SS1. On Jan. 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).”
Rosemary Niewolak, product manager for the System 1 at STERIS Corporation, responded with the following letter dated Dec. 4, 2009: “On Dec. 3, 2009, the United States Food and Drug Administration (FDA) issued a notice to healthcare facility administrators regarding the regulatory status of the STERIS SYSTEM 1® Sterile Processing System and actions you should take if you have this medical device in your facility. The FDA’s Dec. 3 Notice apparently relates to the FDA Warning Letter sent to STERIS on May 15, 2008, stating its view, among other things, that STERIS made changes or modifications to the STERIS SYSTEM 1 Sterile Processing System requiring STERIS to submit to FDA a new premarket notification (“510(k)”) and obtain marketing clearance for the changed device. Accordingly, FDA stated that the currently marketed device does not have a cleared premarket notification. The regulations require a new 510(k) when changes are made to a legally marketed device that “could significantly affect the safety or effectiveness of the device” (21 CFR 807.81(a)(3)(i)).As described in our January 20, 2009 Customer notice, STERIS agreed to submit a new premarket notification for an updated STERIS SYSTEM 1, which includes the changes referenced in the Warning Letter and other technology updates. STERIS submitted this new 510(k) to FDA on Jan. 5, 2009. In conjunction with the submission of the 510(k) for the updated STERIS SYSTEM 1, STERIS discontinued sales in the U.S. of the SYSTEM 1 processor that is the subject of the warning letter, except for sales related to product replacement. STERIS notified Customers that it would continue to support existing System 1 Processors for at least two years from the date of this notice. This support consisted of selling accessories and STERIS 20 sterilant, providing service and parts, and selling replacement units on a one-for-one basis. We disagree with FDA’s Dec. 3, 2009 notice. The SYSTEM 1 Sterile Processing System is safe and effective when used as directed. We are working to engage in further dialogue with FDA about this matter. However, FDA has stated that if you have an acceptable alternative to the SYSTEM 1 processor to meet your sterilization needs, you should transition to that alternative. When considering the availability of acceptable alternatives to meet sterilization and disinfection needs, you may wish to consider the following:
-- Consult the device manufacturer’s written instructions for reprocessing procedures.
-- Note that not all devices can be reprocessed using the same sterilization technology.
-- Healthcare facilities need to assess their validation/verification requirements.
Since its introduction in 1988, more than 23,000 SYSTEM 1 units have been used safely and effectively in more than 5,000 hospitals and clinics in the United States, sterilizing more than 300 million medical devices, approximately 30,000 per day. There has not been a documented case of infection directly caused by a SYSTEM 1 Sterile Processing System when proper guidelines and instructions are followed by certified health professionals. As always, customers should report any serious adverse event that you suspect is associated with the use of the STERIS System 1 to STERIS at 1-800-548-4873 and the FDA (see http://www.fda.gov/medwatch/report/hcp.htm). If you have any immediate questions, please contact STERIS at 440-392-7223. We will continue to update customers via http://www.steris.com as more information becomes available.”