Advanced Sterilization Products Announces FDA Clearance of Shorter Processing Time With Cidex OPA Solution

IRVINE, Calif. --Advanced Sterilization Products (ASP), a Johnson & Johnson company, today announced that its Cidex OPA Solution has received Food and Drug Administration (FDA) 510(k) marketing clearance for a five-minute processing time when used in automatic endoscope reprocessors at a minimum of 25 degrees C

(77 degrees F).

This reduction in processing time -- from 12 to 5 minutes -- makes Cidex OPA Solution the fastest non-glutaraldehyde high-level disinfectant available for medical device reprocessing.

Cidex OPA Solution, a low vapor and low odor solution, is designed to be compatible with a wide range of endoscopes and medical devices. Its ease of use and shortened processing time allow high-volume patient-care areas, such as GI labs, to avoid delays in procedures and decrease inventory costs by rapid throughput of endoscopes and medical

instrumentation.

Santi Corsaro, worldwide president of ASP, said that Cidex OPA Solution has been well received since its U.S. launch in 1999. "Almost half of American hospitals today safely, effectively, and conveniently utilize the solution as part of their instrument processing practice," Corsaro said. "Cidex OPA Solution now allows healthcare facilities to reduce instrument processing time up to 75 percent compared with traditional glutaraldehyde disinfectants, improving staff efficiency and eliminating the need for redundant instruments."

Medical facilities can also manually process instruments in Cidex OPA Solution -- it provides high-level disinfection with a 12-minute soak time at room temperature (20 degrees C) -- increasing efficiency by allowing facilities to standardize their use of high- level disinfectants.

Cidex OPA Solution requires no activation or mixing and has a 14-day reuse life, a 75-day open-bottle life, and a two-year shelf life. Cidex OPA Solution is a proprietary formulation that destroys 100 percent of Mycobacterium tuberculosis.

Advanced Sterilization Products (ASP), a Johnson & Johnson company, a division of Ethicon, Inc., manufactures and markets a wide range of innovative sterilization, disinfection, and cleaning technologies. The company is committed to providing safe, effective and economically sound solutions that meet the needs of healthcare providers.