Kimberly-Clark Health Care Receives FDA Clearance for Sterilization Wrap Usage with STERIS Low-Temperature Sterilization Systems


Kimberly-Clark Health Care announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market the use of its KIMGUARD ONE-STEP (KC 100-600) Sterilization Wrap in conjunction with the Amsco® V-PRO™ 1 and Amsco V-PRO 1 Plus Low Temperature Sterilization Systems from STERIS Corporation.

“Sterilization is a key component in preventing cross-contamination, which is a major cause of healthcare-associated infections (HAI),” said Jay Hexamer, general manager of North America medical supplies, Kimberly-Clark Health Care. “We are pleased to join forces with one of the top sterilization system manufacturers in the industry to help improve the quality of instrument sterilization and the reduction of infectious microorganisms.”

The KIMGUARD ONE-STEP (KC 100-600) Sterilization Wrap is made of strong Spunbond Meltblown Spunbond (SMS) nonwoven fabric, which features two layers of wrap that are ultrasonically seamed along two sides. By providing the protection of double-wrapping in a single step, the time to open or wrap sequential wrapping is cut in half, saving both time and money. Each grade of wrap features Kimberly-Clark Health Care’s exclusive DAISY bond pattern, providing easy identification from one wrap to another.

 “We value collaborations that help our customers more easily and efficiently meet their sterility assurance protocols,” adds Sudhir Pahwa, vice president and general manager of STERIS’s Infection Prevention Technologies division. “Our collaboration with Kimberly-Clark Health Care assures that sterile processing professionals have a compatible high-quality, timesaving wrap product they can safely and confidently use with our V-PRO systems.”

The V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems can quickly process high volumes of heat and moisture-sensitive devices using vaporized hydrogen peroxide, an environmentally friendly sterilant. In addition to the single 55-minute automated cycle of the V-PRO 1 system, the new V-PRO 1 Plus sterilizer includes a second 28-minute cycle specifically for sterilizing non-lumened devices. This allows operators to enhance productivity by choosing the cycle that best matches the devices being sterilized. Both systems have a one-touch control that requires minimal training, and both are equipped with remote monitoring capabilities for increased uptime.

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