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UPDATE: May 5, 2011

FDA extends SYSTEM 1 transition by six months

The U.S. Food and Drug Administration extended by six months the previously announced timeframe on March 18, 2011, for U.S. healthcare providers to transition from SYSTEM 1 to an alternate processing technology. As a result, STERIS Corporation will continue to support current SYSTEM 1 Customers in the U.S. through February 2, 2012, the extended date for completion of the transition. The Company recently requested the extension in light of the FDA's ongoing review of the SYSTEM 1E biological indicator 510(k) submission, and to allow healthcare providers additional time to assess their alternatives, make any necessary changes to internal protocols, install replacement devices and conduct appropriate operator training.

The FDA is continuing its review of the Company's 510(k) submission for the SYSTEM 1E biological indicator. A biological indicator is not required by FDA for the proper use of SYSTEM 1E. No assurance can be made as to if or when the FDA may clear this indicator. Visit the STERIS SEC filings page for information on this latest extension HERE.


FDA Notice: Concerns About the Steris System 1 Processor, Components, and Accessories, and FDA Recommendations

UPDATE - February 2, 2010

Dear Healthcare Facility Administrators and Infection Control Practitioners:

The purpose of this document is to inform you that FDA is extending to 18 months from the date of this notice the total recommended time period for transitioning from Steris Corporation’s modified System 1 processor (SS1) to legally-marketed alternative devices.  As FDA announced in its December 3, 2009, notice, the Agency has not approved or cleared the SS1 for its labeled claims.  Steris Corporation has chosen not to seek FDA clearance of this device and, therefore, its use should be discontinued as soon as practicable.

During a December 10, 2009, stakeholder conference call, FDA stated its view that healthcare facilities should be able to transition from the SS1 to legally-marketed alternative devices in three to six months.  That recommendation was based on discussions with a number of outside constituents.  Since then, Agency staff has heard from many other healthcare providers and professional organizations.  FDA now understands that a three to six month transition period may present significant difficulties for some healthcare facilities, which could, in turn, adversely affect patient care.

FDA’s primary objective is that safe and effective alternative reprocessing devices be identified and placed into use as soon as practicable, without compromising either patient care or employee health.  Therefore, FDA is extending to 18 months the recommended period for transitioning from the SS1 to legally-marketed alternative devices.  At this time, FDA expects that Steris Corporation will continue to support existing SS1 units throughout the extended transition period, e.g., through provision of currently-marketed components, accessories, and sterilant.  During this period, FDA will monitor the availability and supply of legally­marketed replacement products.

FDA does not expect to take regulatory action against healthcare facilities for failing to replace SS1 units within the 18-month transition period.  But these facilities should be aware that the current SS1 is a misbranded and adulterated medical device because it has not been cleared by FDA as safe and effective for its labeled claims.  Healthcare facilities should therefore transition to alternative reprocessing devices as soon as practicable.

Additional information on this issue may be found at: 
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm194411.htm and questions can be directed to Candace McManus, DrPH, at the Office of Compliance, CDRH, 10903 New Hampshire Avenue, WO 66, Silver Spring, Maryland 20993, by email at candace.mcmanus@fda.hhs.gov, or by telephone message at 1-877-260-3731.

Sincerely,
Timothy A. Ulatowski
Director, Office of Compliance
Center for Devices and
Radiological Health
Food and Drug Administration


December 8, 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.

FDA Recommendations

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).

Contacting FDA

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 heidi.marchand@fda.hhs.gov. 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 candace.mcmanus@fda.hhs.gov, or by telephone message at 1-877-260-3731.

Sincerely,
Timothy A. Ulatowski
Director, Office of Compliance
Center for Devices and
Radiological Health
Food and Drug Administration


Questions and Answers About the Steris System 1 Processor For Healthcare Facilities

What action is the Food and Drug Administration (FDA) taking today?

FDA is issuing a notice to healthcare facility administrators and infection control practitioners that conveys agency concerns about the STERIS System 1 Processor (SS1). FDA has not approved or cleared the currently-marketed SS1 and the agency has not determined whether it is safe or effective for its labeled claims, including claims that it sterilizes medical devices.

FDA is also issuing a letter to STERIS Corporation (STERIS) notifying the firm that FDA may take regulatory action against it regarding the SS1 and its components and accessories.

What is the STERIS System 1 Processor (SS1)?

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 healthcare 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.

What is the problem?

On May 15, 2008, FDA issued a Warning Letter to STERIS identifying significant changes that STERIS made to the SS1. As FDA stated in the Warning Letter, the changes to the SS1 could significantly affect the safety or effectiveness of the device. The currently‑marketed SS1 has not been approved or cleared by FDA. FDA has not determined whether this product is safe or effective, or whether the claims in its labeling, including claims that it sterilizes medical devices, are accurate.

Why is FDA acting now?

The May 2008, Warning Letter was followed by written submissions from, and meetings with, STERIS to discuss the firm’s response to the violations cited by FDA. These exchanges continued through late 2008 and resulted in the firm’s commitment to work with its customers to transition them to legally-marketed alternatives.

On January 20, 2009, STERIS issued a notice to customers informing them of the FDA Warning Letter and the actions the firm was taking in response to the letter to stop marketing its device and to transition its customers to replacement products (see http://www.steris.com/ media/pdf/products/ SYSTEM1CustomerNotice2009JAN.pdf).

Based on a recent inspection of STERIS and meetings with the firm, FDA is not satisfied that STERIS has been working effectively to transition its customers to replacements for the SS1.

In addition, STERIS apparently has been reassuring customers that there is no need for a change in their clinical practice. The firm has also continued to design or redesign new accessories for the SS1. This is inconsistent with commitments made by the firm.

FDA has determined that STERIS’s failure to meet its commitments, taken with a lack of data showing the safety and effectiveness of the SS1, supports advising healthcare facilities to transition to legally-marketed alternatives to this device. FDA believes that such actions will limit the risk of harm to patients and device users.

Does FDA have any reports of serious injuries or adverse events related to the SS1? Has the device caused deaths or injuries?

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.

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.

What risks are associated with the use of an unapproved or uncleared medical device? Are patients at risk if I use this device?

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.

What should healthcare facilities that have SS1s do?

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.

What alternative products are there?

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.

What factors should I consider in selecting an alternative product?

In order to assist healthcare 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 healthcare 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.

Should I notify patients who have had or will have procedures involving devices reprocessed in the SS1?

Each healthcare 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 healthcare facilities.

Did STERIS recall the SS1?

STERIS did not recall the SS1, but voluntarily told FDA that it would discontinue U.S. sales of the SS1, apart from one-for-one product replacement and support of existing SS1 units with accessories, service, and parts, and that it would work with customers on a timetable to replace SS1 units in their facilities.

Who will pay for the alternative processing methods?

Each healthcare 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.

Is there anything our facility can do to fix the problem with the SS1?

No. There is nothing a healthcare facility can do to resolve FDA’s concerns about the SS1.

Will FDA take enforcement action against me, a healthcare facility, if I continue to use 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.

Where can I find additional information?

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 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 heidi.marchand@fda.hhs.gov. 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 candace.mcmanus@fda.hhs.gov, or by telephone message at 1-877-260-3731.