Reprocessing companies: Look before you leap
Reprocessing companies: Look before you leap
A product-specific service
About 35 years ago, suture manufacturers provided the resterilization and repackaging of unused, foil-packed suture as a service to their customers. But ten years ago, one such company found itself performing free reprocessing for 15% of the suture it sold $75 million worth of product. The company discontinued this money-losing process, and that’s when sterile reprocessing services companies were started.
Some companies charge hospitals half the original cost of the item for their services. Arthur Goodrich, vice-president of Houston-based sterile reprocessing services company SRS, says, "SRS uses cost-plus-based pricing. But price alone should not govern a hospital’s choice of company."
Hospital Peer Review asked Goodrich and Bonnie Barnard of Infection Prevention & Management Associates in Houston how a QA director should go about choosing a company. "Make sure your department does a diligent investigation of the company you choose for reprocessing," Barnard says. "Look at the company’s FDA inspection experience. Have your hospital’s central sterile processing department personnel go to the company site to ensure that the processes they use are valid."
They should do intensive visual functionality and integrity checks. They also should test for biological and chemical indicators. A specific level of sterilization must be reached. All of the resterilization procedures a reprocessing company does should attain the same standards as when those procedures are done in a hospital.
"Some reprocessing companies are not even registered with the FDA," Goodrich warns. "After following up with the FDA, ask peer hospitals for references."
There are eight questions to ask the company, according to Goodrich:
• When did the company begin serving the medical community?
• What specific services are offered?
• Is the company registered with the U.S. Food and Drug Administration?
• Is sterilization performed at the company, or is it contracted out?
• What type of sterilization systems are used?
• Is the company associated with any industry oversight organizations?
• Which provider associations does the company have relationships with?
• What type and how much product liability insurance is carried?
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.