Reprocessing: Making Tough Choices - FDA regulations force hospitals to look at costs, options

August 2000 marked a significant change for hospitals that perform in-house reprocessing of single-use medical devices (SUDs). The Food and Drug Administration (FDA) announced new guidance for hospitals as well as third-party reprocessing companies that now holds them to the same rigorous premarket submission requirements as manufacturers. For every device a hospital wants to reprocess, it must submit information to the FDA that demonstrates the safety and effectiveness of that device.

The news meant that hospital decision-makers--from the operating room to risk management to infection control--faced tough choices, with a wide range of factors to consider. In the months since, many hospitals have determined that they lack the resources to meet the arduous premarket submission requirements. Hospitals that performed their own reprocessing have been forced to decide whether to continue at great expense, stop using reprocessed devices altogether, or outsource to a third-party reprocessor. Many have decided to outsource the service.

There is good news for those hospitals that are choosing to outsource the reprocessing of their devices. The FDA's new regulatory framework eliminates many of the questions raised in the past about the safety and effectiveness of reprocessing SUDs. Hospital leaders and staff now can have the same level of confidence in a reprocessed device that they have in a new one.

Reprocessing proponents strongly believe that cleaning, testing, and sterilizing durable medical devices rather than discarding them after one use is the right thing to do. Reprocessing--whether in-house or by a third-party company--can result in as much as a 50% savings over the purchase price of new medical devices. It does not compromise a hospital's standard of care or patient outcomes, and it can help broaden access to health care in a community by making the best use of a hospital's limited dollars.

To maximize the benefits of third-party reprocessing, the Association of Medical Device Reprocessors encourages hospitals to ask the following questions before engaging the services of a third-party reprocessor:

Is the company registered with the FDA?

• Does it comply with applicable Quality System Regulation requirements?
• Will the company permit you to visit its plant and review its quality manual?
• Is sterilization performed by a commissioned and certified sterilization system, in accordance with ANSI/AAMI/ISO ST 11135 ST 1994?
• Is the sterilization cycle requalified annually?
• Are biological indicators used to monitor routine sterilization?
• Are the sterilization systems routinely calibrated?
• Is the residual sterilant level routinely tested?
•   Does the company have reprocessing procedures tailored to the specific types of medical devices you wish to have reprocessed, and has the company validated these procedures?
• Is the product functionality routinely tested?
• Does the company track the number of uses per device?
• Does the company comply with Medical Device Reporting requirements?
• Does the company have adequate liability insurance coverage?

Making informed choices enables healthcare organizations to use their dollars wisely, helping to ensure quality care for patients.

Mark Salomon is senior vice president of corporate development for Vanguard Medical Concepts Inc., a nationwide reprocessing company with headquarters in Lakeland, Fla.

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