A successor to a popular but troubled medical device sterilizer received U.S. Food and Drug Administration clearance Tuesday, the agency announced.

The device, dubbed the STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System, is set to replace the STERIS System 1, a widely used re-processor that the FDA urged customers to turn away from after STERIS made what FDA considered to be unapproved changes to its software and design.

The new STERIS 1E machine is used for disinfecting endoscopes and other devices that would be damaged by steam or other heat-sterilizing methods. The STERIS system washes the devices with a chemical germicide. To ensure the product is safe to use inside a person, it is then rinsed clean with ultraviolet light-treated water.

In May 2008, the FDA sent warning letters to Mentor, Ohio-based STERIS, noting that because of changes to its STERIS 1 system, made over a 14-year period, the agency could no longer vouch for the effectiveness of the machine. In December 2009, the FDA then told customers to begin looking for alternative products, while in January STERIS re-submitted an application for the device and halted all sales.

But these troubles appear to be a thing of the past.

"The recently cleared device does address all of the issues that were noted in the warning letter issued on May 2008 on System 1 as well a some other technology enhancements we included in the application," Stephen Norton, a STERIS spokesman, tells DOTmed News.

Though cleared for marketing the device, STERIS is holding off rolling it out to customers until the FDA delivers transition plans for the thousands of health centers still using the STERIS 1 system. Still, Norton says they hope to start selling the new product later this summer.

Upgrades

According to Norton, the new device will offer some advantages over its predecessor. At 23 minutes per cycle, it will have a 20 percent faster cycle time. It also uses almost one-third less water, with two rinse cycles compared to the original four. To answer FDA concerns, the water used in rinsing is blasted first with germ-killing UV rays to keep it sanitary. The sterilant cup is also more environmentally friendly, according to Norton.

"System 1 has a long legacy of use, and has processed more than 300 million devices during its time in the market," Norton says. "Now...our customers have a logical successor to consider as they evaluate alternatives."

Read DOTmed's prior coverage: DM 11219, DM 11553, DM 10921, DM 7965.

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