Tips to help you evaluate reprocessors
Tips to help you evaluate reprocessors
When the Chicago-based International Association Health Care Central Service Materiel Management (IAHCSMM), produced a position statement on reprocessing of single-use devices, the organization recommended that member facilities not undertake the reprocessing. The IAHCSMM does recognize that members may want to outsource this reprocessing and presents some criteria that should be evaluated when selecting a reprocessor, says Anne Cofiell, consultant and IAHCSMM’s representative to the FDA/AAMI conference.
The IAHCSMM and other experts interviewed by Same-Day Surgery recommend:
• The reprocessor should be registered with the FDA.
In addition to being registered, check on the company’s inspection reports, adds Vern Feltner, president of Alliance Medical Corp., a full-service reprocessor based in Asheville, NC. Reprocessors can tell you how they did in the inspection and if any deficiencies were noted.
• Written policies and procedures for cleaning, packaging, and sterilization should be provided along with documentation that procedures are followed.
This gives the surgery program an opportunity to evaluate processes and quality control.
• Documentation of the training and certification of the staff should be available.
Staff members should be certified through a professional organization such as the IAHCSMM to assure you that they’ve been trained as well as your own staff is trained, says Cofiell.
• Insurance policies with appropriate coverage should be in place.
Be sure to review their policies to see exactly when the reprocessor is liable, says Josephine M. Torrente, JD, president of the Association of Disposable Device Manufacturers, in Washington, DC. "Some policies may state that the reprocessor is only liable if proper procedures were not followed. If a device is still contaminated after the proper procedures were followed and a patient develops an infection, the surgery program may be at risk," she says.
Another useful tool for day-surgery program managers considering the use of a third-party reprocessor is the audit tool included in an ECRI publication, Reuse of Single-Use Devices: Making Informed Decisions.
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