What actions should healthcare facilities take if they use a SYSTEM 1?

"We disagree with the FDA’s recent notice and are working to engage in further dialogue with the Agency about this matter. Since its introduction in 1988, we estimate that the SYSTEM 1 Sterile Processing System has safely and effectively sterilized more than 300 million devices when used as directed," said STERIS President and Chief Executive Officer, Walt Rosebrough. "We understand our customers’ concerns and apologize for the inconvenience the FDA notice will cause to their sterilization and decontamination processes."

The FDA has stated that healthcare administrators should transition to acceptable alternatives to meet their sterilization and decontamination requirements. If they do not have an acceptable alternative, FDA has stated that customers may continue to use SYSTEM 1 while they assess their sterilization requirements. FDA has also stated it is not aware of any confirmed cases of infection directly attributable to inadequate reprocessing by SYSTEM 1.

There was an additional FDA teleconference held on December 10, to answer the numerous healthcare facility questions about STERIS SYSTEM 1 usage. An initial teleconference took place on December 4th.

STERIS issued another Dear Customer letter December 11, to further update their SYSTEM 1 customers. In the letter they reiterate if an acceptable alternative is not readily available, FDA stated that healthcare facilities should not cancel surgical procedures and may continue using SYSTEM 1. The FDA has requested that healthcare facilities prepare a transition plan, which the Agency believes could be implemented within three to six months.

Further, the FDA requested input from SYSTEM 1 users on obstacles they may encounter in developing and executing a transition to an acceptable alternative. The Agency said that it may grant exceptions to healthcare facilities who are unable to complete the transition within the three to six month timeframe. SYSTEM 1 users who need more time to complete the transition should seek guidance directly from the FDA.

STERIS will continue to work with the FDA to help SYSTEM 1 users make a smooth transition to an acceptable alternative. They will continue to provide SYSTEM 1 Customers with S-20 sterilant and accessories, parts and service.

STERIS also stated that SYSTEM 1 has been used by more than 5,000 hospitals and other healthcare facilities for the last 20 years. In that time, there haven’t been any reports of a single patient infection caused by SYSTEM 1, when used as directed. STERIS will continue to provide further updates as soon as new information is available.

During the teleconference, the FDA said they knew that their action regarding the STERIS SYSTEM 1 had generated questions from many facilities. They stated that they had been receiving many emails from individual facilities. More than a thousand people registered for the telephone conference.

As a reminder, the FDA has posted three major documents related to the STERIS SYSTEM 1 processor on their website. The first is a notice about the concerns of the processor. Second, is the May 15th 2008 warning letter that summarizes FDA observations, deeming the STERIS SYSTEM 1 processor as adulterated and misbranded. The third is a Q&A document specifically addressing the December 3, 2009 FDA safety concerns that summarize what facilities should do, alternative products, notifying patients, and where additional information may be found for alternatives.

At the beginning of the teleconference, Tim Ulatowski, director of the FDA’s office of compliance and the center of devices and radiological health, gave an overview of the situation stating, "It has now been a week since the FDA issued its notice to healthcare facility administrators and infection control practitioners that we posted on our website, entitled ‘Concerns about the STERIS SYSTEM 1 Processor Components and Accessories’. FDA recommended in the notice that if you have an acceptable alternative to the STERIS SYSTEM 1 to meet your sterilization and disinfection needs, you should transition to this alternative as soon as possible to ensure continued patient safety. If you do not have an acceptable alternative to the SYSTEM 1, you should promptly assess your facility and patient care needs and sterilization and disinfection requirements, and take steps to obtain legally marketed substitutes for the SYSTEM 1."

He continued, "notice on the question and answer document we describe the chain of events that led us to publish our notice, and summary, and in as plain language as I can use…FDA warned STERIS that it made changes to the SYSTEM 1 that could significantly affect the safety or the effectiveness of the device. Those changes cause the modified device to be an unapproved device that violates federal law. Given the illegal status of the SYSTEM 1, STERIS needed to either submit a new application to FDA for the modified SYSTEM 1, and have the FDA clear the application for the modified SYSTEM 1, or STERIS needed to take their SYSTEM 1 off the market, including retrieving devices in use.

STERIS disagrees with our position on the need for a new application. They were afforded the opportunity to respond to our warnings, and did so. After careful review, we did not change our decision on the status of the SYSTEM 1. STERIS then took steps to respond to the updated warning. They stopped selling SYSTEM 1 units to new customers, they submitted an application for a new product. I cannot assure you when or if or for what scope of use their new product will be cleared."

He continued, "The FDA must be fair and consistent in our enforcements, and cannot permit an illegal product to remain on the market. Too much time now has gone by that could have been spent on that transition—the transition to legally marketed products must occur." Ulatowski stated several times that the current action by the FDA was not a recall.

The teleconference continued for well over an hour with the FDA taking questions from the audience. It was obvious to this HPN reporter that there are many hospital professionals still confused by the FDA directive and unsure of what direction they should take. Many of the callers noted budget constraints, apprehension over possible safety issues in having to train staff on new equipment and procedures, and concerns in finding new equipment compatible with decontamination guidelines provided by the manufacturers of their scopes and instruments.

STERIS has established a dedicated hotline for more information: 440-392-7223. STERIS will also continue to update Customers via the STERIS website as more information becomes available at www.steris.com/ss1/

• www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm191585.htm

• www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm192685.htm

• www.cdc.gov/ncidod/dhqp/bp_sterilization_medDevices.html

• www.hpnonline.com/ce/pdfs/0807cetest.pdf