History of SYSTEM 1
The SYSTEM 1 Sterile Processing System (SS1), brought to market in 1988, was the health care community’s first introduction to STERIS. Since then, STERIS has sold more than 23,000 units to more than 5,000 hospitals and clinics in the U.S.

Facilities readily took to the device, sterilizing approximately 30,000 medical devices per day. For two decades, the SYSTEM 1 proved a profitable product for STERIS. But the story took a turn.

The FDA voices concerns
On May 15, 2008 an FDA Warning Letter was delivered to the company stating that changes and modifications over the years made it necessary for STERIS to file a new premarket notification (510(k)) and obtain marketing approval for the device.

In part, the letter stated that regulations require clearance whenever changes are made to a legally marketed device that “could significantly affect the safety or effectiveness of the device.”

According to the FDA warning letter, the changes included alterations to the design of the unit’s circulation pump, high pressure pump, software changes, connector design changes, chamber volume and ingredients in the sterilizing fluids.

Subsequently, by January 5, 2009 STERIS discontinued U.S. sales of the SYSTEM 1 processor except for those related to product replacement and support of existing systems. The company sent a letter to customers informing them of the move and also of the submission of a new SYSTEM 1 to the FDA’s approval process. There was no FDA-mandated recall.

In December 2009, the FDA issued its own notice to health care facility administrators and infection control practitioners. The notice expressed the agency’s concerns over the SS1 and made it clear that the device was not approved or cleared in its current state and no determination had been made about the validity of its labeled claims, including claims that it effectively sterilizes medical devices.

Initially, FDA required health care facilities to transition from the SS1 processor to legally marketed alternative devices in three to six months of the December 2009 letter. A February 2010 letter extended the transition period to 18 months. The transition was extended again in April 2011 to Feb. 2012 with another six-month extension announced on Jan. 5, 2012 to the current deadline of Aug. 2, 2012.

Debate about process, safety and service
With the FDA’s claim that the SS1 was not approved, health care professionals wondered about the repercussions of continuing to use it for their clinical needs. There was concern about exposure to patient liability issues. There were questions about whether doctors had to notify patients.

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