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Reprocessing: From FDA regulation to best practices

April 10, 2017
From the April 2017 issue of HealthCare Business News magazine

Hospitals can partner with multiple vendors (OEM and reprocessor) rather than only one manufacturer, and maintain more clinical autonomy and control over their device mix, and therefore better maximize the savings and sustainability potential of reprocessing.

To better inform and educate purchasers and hospitals about these threats to a successful reprocessing program, AMDR created a fact sheet to help identify these and other obstacles to reprocessing.

There are ethical and moral responsibility issues at stake in today’s health care arena, and reprocessing plays a role as a viable solution. Medical waste is the second-largest contributor to landfills after the food service industry. With reduced savings, there are fewer resources for patients, your staff and facility. Dr. Marty Makary, a surgeon, medical commentator and advocate for transparency in medicine and common-sense solutions to health care’s problems, was coauthor of a 2011 JAMA Surgery article, “Green Surgical Practices for Health Care,” which identified reprocessing of single-use medical devices as one of five green recommendations for safe and efficient strategies for hospitals and providers to protect the environment while delivering high-quality care. The American Nurses Association, Association of periOperative Registered Nurses, Practice Greenhealth and Health Care Without Harm have all recognized or endorsed reprocessing as a way to reduce waste.

What the future holds
FDA oversight and regulation, a proven safety record and a significant reduction in medical device and waste removal costs are the current benefits of a reprocessing program. But there’s much more we can do. Independent research shows that reprocessing has the potential to help lower health care costs by billions of dollars. One estimate states that if reprocessing was fully implemented in the U.S., we could save $2.7 billion over five years. This savings potential does not require any upfront hospital capital investment to get started, offers the same standard of care, allows doctors to use the device brands they already are using, and extends the life and value of the medical devices hospitals already own. What will you do with those savings and resources?

About the author: Dan Vukelich, Esq., CAE, is president of the Association of Medical Device Reprocessors.

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