- What action has the Food and Drug Administration (FDA) taken for the Steris System 1 Processor (SS1)?
- What is the Steris System 1 Processor (SS1)?
- Did Steris recall the SS1?
- Does FDA have any reports of serious injuries or adverse events related to the SS1? Has the device caused deaths or injuries?
- What risks are associated with the use of an unapproved or uncleared medical device? Are patients at risk if I use this device?
- What should health care facilities that have SS1s do?
- What are alternatives to the SS1?
- What factors should I consider in selecting an alternative product?
- Should I notify patients who have had or will have procedures involving devices reprocessed in the SS1?
- Who will pay for the alternative processing methods?
- Is there anything our facility can do to fix the problem with the SS1?
- Will FDA take enforcement action against health care facilities that continue to use the SS1?
- Where can I find additional information?
In December 2009, the FDA issued a notice to health care facility administrators and infection control practitioners about agency concerns over the Steris System 1 Processor (SS1). The FDA has not approved or cleared the SS1 and the agency has not determined whether it is safe or effective for its labeled claims, including claims that it sterilizes medical devices. This followed an earlier Warning Letter and discussions with the manufacturer.
In April 2010, the FDA filed a consent decree against the device manufacturer, STERIS Corporation. The decree prohibits the distribution of the SS1, a tabletop liquid chemical system marketed to disinfect certain devices, such as endoscopes, that cannot withstand steam sterilization.
The current SS1 is a misbranded and adulterated medical device because it has not been cleared by the FDA as safe and effective for its labeled claims. Health care facilities should transition to alternative reprocessing devices as soon as possible.
All health care facilities must be transitioned from the SS1 processor to legally-marketed alternative devices by August 2, 2012.
The Steris System 1 Processor (SS1) is a tabletop liquid chemical system promoted to provide sterile processing of instruments, such as endoscopes, bronchoscopes, and other medical devices, between patient uses. The SS1 uses a peracetic acid solution (Steris 20 Sterilant) to destroy potentially dangerous microorganisms that could cause infections if left on medical devices. The SS1 is used in health care facilities including hospitals, outpatient surgical centers, and some physicians’ offices. Accessories to the SS1 include the Steris 20 Sterilant and various processing trays and quick connects.
Steris did not recall the SS1, but voluntarily discontinued U.S. sales of the SS1, apart from one-for-one product replacement and support of existing SS1 units with accessories, service, and parts. The company has been working with customers on to replace SS1 units in their facilities.
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 health care facility staff operating the device.
At present, reports of injuries are infrequent, especially in relation to the number of SS1s in use, and some of the reported injuries may be the result of user error. Nevertheless, the SS1 is not legally marketed, and FDA therefore lacks reliable information about its safety and efficacy. And as noted, there may be under-reporting of injuries caused by the SS1. FDA is therefore acting now to limit the risk of harm to patients and users.
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 device users. Improperly disinfected or sterilized instruments may transmit pathogens to patients and users, or expose them to hazardous chemicals. Improper sterilization or disinfection may also adversely affect the quality and functionality of reprocessed instruments.
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.
SS1 processors should not be auctioned, exported for sale, or otherwise resold. STERIS has developed a transition plan with a rebate program for current SS1 customers in the U.S. These customers should contact the company at 1-800-548-4873, for more information.
There are other FDA-cleared products available to sterilize or disinfect medical devices between patient uses. These include liquid chemical sterilant (LCS)/high-level disinfectant (HLD) products that may be used alone or with an automated endoscope reprocessor (AER), or sterilizers for processing (sterilizing or disinfecting) medical devices, including those that employ low-process temperatures. More than one alternative method may be needed in your facility to reprocess all of the devices that you currently process in the SS1.
However, before switching to any alternative reprocessing method, the user should consult the endoscope or reusable device manufacturer’s written instructions for use (labeling) or contact the reusable device manufacturer for appropriate, alternative, validated reprocessing procedures.
In order to assist health care facilities, FDA offers the following general guidance.
- For each endoscope or other reusable medical device currently reprocessed in the SS1, determine the degree of reprocessing (e.g., sterilization, high-level disinfection) minimally required. The degree of reprocessing depends on the intended use of the reusable device. For example:
- Critical devices are medical devices that are introduced into or have contact with the bloodstream or normally sterile areas of the body. Examples include, but are not limited to, implants and surgical instruments. Critical devices present a high risk of transmission of infection if contaminated, and therefore must be sterilized prior to use. FDA has cleared a variety of sterilizers, including steam (autoclave), ethylene oxide (EO), hydrogen peroxide (H2O2), dry heat, and ozone, for use in health care facilities.
- Semicritical devices are medical devices that contact intact mucous membranes or nonintact skin, but do not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. Examples include, but are not limited to, flexible endoscopes and respiratory therapy equipment. Semicritical devices should be sterilized, if possible. If sterilization is not possible, a minimum of high-level disinfection is required before use. High-level disinfection can be performed manually, using an FDA-cleared LCS/HLD product, or in an FDA-cleared automated reprocessing machine such as an AER.
- Noncritical devices are medical devices that only contact intact skin of the patient. Examples include bedpans, exam tables, reusable anesthesia masks, and blood pressure cuffs. Noncritical devices present a low risk of transmission of infection if contaminated. Depending on the degree of potential contamination, noncritical devices may require cleaning and/or intermediate or low level disinfection. Intermediate or low level disinfection can be accomplished with appropriate EPA-registered general purpose disinfectants.
- Determine what reprocessing methods and equipment are available in your facility, or can be acquired, that would provide the appropriate degree of reprocessing.
- Determine what specific reprocessing method is appropriate for each device to be reprocessed. For example, many devices are heat labile and cannot withstand steam sterilization. In such cases, devices can be sterilized with low-temperature gas sterilization methods, such as ethylene oxide or hydrogen peroxide, or high level disinfected with a LCS/HLD product. Other devices may be composed of materials that cannot withstand exposure to certain chemicals, such as EO, H2O2, or certain LCS/HLD product active ingredients. The final determination of the appropriate reprocessing method should be based on written recommendations and instructions for use from the manufacturer of the device to be reprocessed.
Each health care facility should be guided by its own policy on patient notification. To date, we are not aware of any confirmed cases of infection directly attributable to inadequate reprocessing by the SS1 that might require patient notification. If FDA becomes aware of such cases or other information that may necessitate patient notification, we will promptly inform health care facilities.
Each health care facility should decide whether it will bear the cost of alternative methods or seek reimbursement from an outside source. FDA does not reimburse such costs.
No. There is nothing a health care facility can do to resolve FDA’s concerns about the SS1.
We do not expect to take action against healthcare facilities solely because they are now using SS1s. However, 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).
FDA may take enforcement action against a healthcare facility that fails to submit required reports. Also, FDA solicits voluntary reports of adverse events from healthcare professionals (see http://www.fda.gov/ Safety/MedWatch/HowToReport /ucm085568.htm). If you suspect that a reportable adverse event was related to the use of SS1, you should follow the reporting procedure established by your facility.
Information on FDA-cleared or approved medical devices is available at
http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfPMN/PMNSimpleSearch.cfm and at http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfPMA/pmasimplesearch.cfm. These links access databases that allow you to search for legally-marketed devices. These databases can be searched by text keywords, such as “sterilizer,” “steam sterilizer,” “sterilant,” “disinfector,” “disinfectant,” and “endoscope disinfector,” or by manufacturer or product brand name. A list of FDA-cleared liquid chemical sterilant/high level disinfectant products is available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ ReprocessingofSingle-UseDevices/ UCM133514. Search results may include products that are no longer manufactured; you will need to confirm, with the manufacturer or your supplier, the availability of any product identified on the FDA web site.
Additional information on endoscope reprocessing can be found at http://www.fda.gov/MedicalDevices/ Safety/AlertsandNotices/ucm190273.htm
The FDA hosted a call during the week of December 7, 2009 for health care facilities using the SS1. The transcript of this call is available online http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM194981.pdf.Questions can also be directed to the Office of Compliance, CDRH, 10903 New Hampshire Avenue, WO66, Silver Spring, Maryland, 20993, or by telephone message at 1-877-260-3731.