"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
says they hope to start selling the new product later this summer.
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