Summit Medical Receives FDA Clearance for Additional Sterilization Cycles


Summit Medical, Inc. announces that it has received Food and Drug Administration (FDA) clearance for sterilization methods on the company's instrument protection trays. These validations ensure that the product will not inhibit sterility of valuable surgical instrumentation. And now, more sterilization cycles mean additional options for hospitals.

“Instru-Safe® trays continue to be an industry leader for organizing and protecting surgical instrumentation," says Kevin McIntosh, executive vice president and chief operating officer of Summit Medical, Inc. "As part of our efforts to continually improve our unique product and differentiate ourselves in the market, we have gone through rigorous validation testing and multiple 510(k) submissions. We do this to ensure customer confidence in our instrument protection products and to demonstrate our commitment to the sterile processing community.”

Summit's Instrument Protection Trays are used to organize and protect other medical devices that are sterilized by a healthcare provider. Summit’s team of product developers, engineers and field representatives around the country work closely with hospitals to customize trays to meet the preferences of the surgical teams who use them on a daily basis.

Instru-Safe® Instrument Protection Trays are now cleared for the following cycles:
• 4 minute Steam Sterilization Cycle
• 8 minute Steam Sterilization Cycle
• Ethylene Oxide
• STERRAD ® 100S
• STERRAD ® 100 NX Standard Cycle

Source: Summit Medical, Inc.

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