Reprocessing: From FDA regulation to best practices

April 10, 2017
By Dan Vukelich

The Association of Medical Device Reprocessors (AMDR) turns 20 this year. As the global trade association representing the legal, regulatory and other trade interests of the regulated, commercial “single-use” device (SUD) reprocessing industry, it’s nothing less than extraordinary the changes that have occurred in the reprocessing industry in the last two decades.

Reusing single-use devices. It flat-out seems counterintuitive, and yet, what was once shunned is now an FDA regulated industry providing services to a majority of U.S. hospitals, saving hospitals hundreds of millions of dollars a year and reducing medical waste. Safety, savings and sustainability are the cornerstones of the positive financial and environmental impact of reprocessing.

These participating hospitals, including most on the Honor Roll of facilities as listed by U.S. News and World Report, utilize medical device reprocessing to bring economic and environmental benefits to the nation’s health care system, its practitioners and the patients they serve.

How it works: Single-use device (SUD) reprocessing
The growth of SUDs — both in number and in cost — was one factor that led many hospitals to reuse SUDs in the late ‘90s. Greater reliance on SUDs was wasteful, inefficient and expensive. A spent SUD (or one that is opened, but not used) also becomes trash, adding to costs to the environment and a hospital’s waste removal costs. If, technically speaking, the manufacturer or other third party could extend the life of the product to another use, while meeting the same FDA safety standards, why wouldn’t we encourage this? This is where AMDR’s members have stepped up, to provide the FDA with the data demonstrating that they can safely reprocess these products to reduce costs and waste.

Reprocessors turn these former SUDs into new, rebuilt SUDs meeting the same FDA standards for device manufacturing that apply to any other original equipment manufacturer (OEM). The reprocessed devices are, in the FDA’s terms, returned “substantially equivalent” to the predicate OEM device — assuring health care providers and patients that reprocessed SUDs are “as safe and as effective” as a new device. Reprocessors become the manufacturers of these reprocessed SUDs, assuming all manufacturer obligations. This is distinct from the “reprocessing” done in hospitals for reusable devices, whereby OEMs have provided instructions and hospitals implement those cleaning protocols.

Commercial reprocessing is essentially manufacturing, and complies with internationally accepted standards. Devices are collected, disassembled, cleaned, function-tested, repackaged and sterilized. The devices are 100 percent traceable, enabling quality controls and accountability. Reprocessed devices are as safe as the original product they replace, a finding confirmed by the FDA and a 2008 Government Accountability Office (GAO) report.

Reprocessed devices
There are three main categories of devices that are reprocessed and that can be found within a hospital’s reprocessing program: cardiovascular devices; OR instruments; and noninvasive devices. But reprocessing companies offer hospitals a variety of ways to reduce cost and waste by finding more SUDs to reprocess.

One of the greatest savings opportunities we’re seeing is in the cardiac catheterization lab. Reprocessors have FDA clearance for many models of diagnostic cardiac catheters. And by using reprocessed catheters, hospitals can cut the device costs portion of these procedures by up to half.

Another area for savings is the OR. More complex laparoscopic instruments have escalated costs for hospitals. Reprocessors can offer alternatives, ranging from trocars to ultrasonic scalpels to graspers and forceps. The third area for savings is noninvasive devices. Examples include compression sleeves, tourniquet cuffs, bed alarms and pulse oximetry sensors. Nurses and physicians can use the same brands they have always used.

Savings and benefits
Reprocessing is one of the most impactful initiatives a hospital can implement to reduce costs and waste. According to the 2016 Practice Greenhealth sustainability benchmark report, a survey of its members showed that hospitals saved $30.5 million in combined savings between purchase and avoided waste disposal fees on medical device reprocessing. The average facility saved $295,238 annually. Additionally, reprocessing eliminates red bag waste, which can cost 10 times as much to dispose of as regular waste.

Over the course of the growth of the reprocessing industry, there has been a bending of the cost curve, and the cost of original manufactured devices has decreased due, in part, to the competition from reprocessed devices. This further brings savings to the supply chain within hospitals.

Best practices
One key to a successful program is placing used devices in the proper bin to maximize reprocessing savings. Devices should be treated as valuable assets, not as waste, so extra care should be taken to ensure they are not damaged when being placed in the bins. Also, hospitals should use reprocessed devices first. Train all staff to use the reprocessed devices first to lessen dependence on new devices and keep the savings within the institution. The savings can be used to retain staff, buy new equipment and make investments in education.

Other aspects of a successful reprocessing program require more diligence. Some device companies bundle new and reprocessed SUDs as “comprehensive or circular device programs,” claiming to offer consistent, predictable supply and pricing. However, these bundled programs can negatively impact savings and waste reduction potential. After all, the manufacturer may stand to gain by selling you more “single-use” devices and less reprocessed to keep their profits high. Remain vigilant and take ownership of your program. Will the promised savings be guaranteed? Are there minimum purchasing requirements hidden in these proposals? What percentage of the devices will be reprocessed and will the vendor be transparent with this information.

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.