Health care is the second largest contributor to waste production in the United States. (The food industry holds the dubious distinction of being the first largest contributor.) So, it’s significant that more than 25 percent of U.S. hospitals now reprocess medical devices as a way to decrease waste –and cut costs.
But, does the phrase “reprocessed medical device” make you cringe?
After all, this isn’t a post about re-using tongue depressors or cotton swabs.
It is, by contrast, a post about a new trend among hospitals to use regulated, quality-control standards to recalibrate, clean, sterilize, remanufacture and test certain pieces of medical equipment, such as particular non-invasive items (compression sleeves, pulse oximeters, e.g.), operating room devices (trocars, harmonic scalpels, e.g.) and electrophysiology equipment (EP catheters, e.g.).
Indeed, the FDA now allows the reprocessing of more than 100 different items previously designated as “single-use devices” (SUDs). And, in an opinion piece in this month’s Academic Medicine, researchers at Johns Hopkins University School of Medicine say they have found reprocessing to be a “commonsense strategy” that has a “reliable safety record of excellence identical to that of new equipment, while being friendlier to the environment.”
But, how did all these medical devices become designated as “single-use” in the first place? Haven’t hospitals always relied on medical devices that were manufactured for multiple uses, provided they were properly cleaned and sterilized?
The answers to those questions may surprise you.
Manufacturers changed labels from “reusable” to “single use”
While it’s true that since their inception, hospitals have relied on equipment that could be cleaned and sterilized for reuse, that started to change about two decades ago, when original equipment manufacturers (OEMs) began changing the labels on certain medical devices from “reusable” to “single use,” says Daniel J. Vukelich, Esq., president of the Association of Medical Device Reprocessors.
Remarkably, this shift in labeling was not required by FDA. In fact, the FDA does not require any device to carry a single use label.
What’s more, Vukelich says that OEM documentation from this time-period demonstrates that, in some cases, device labeling was changed from “reusable” to “single use” without any significant design, performance or material changes to the devices that would preclude safe reuse. Consequently, this change in labeling was perceived by many hospitals for what it was – i.e., a marketing strategy aimed at increasing sales of new products.
Over the past few years, skepticism of the single use label has been growing –and for good reason.
In at least one case, the manufacturer of pulse oximeter sensors sold hospitals what it called “remanufactured” sensors at a reduced price if the hospitals returned their used, “single use” sensors to the company. As Vukelich points out, this “recycling” of devices by the manufacturer — who itself had originally labeled the devices as “single use only”—exemplifies the ambiguity and confusion surrounding the SUD designation.
Reprocessing is alternative to throwing away single use devices
Fortunately, more and more hospitals are now exploring alternatives to simply throwing away SUDs.
Reprocessing is growing in popularity, and recently–owing to strict FDA regulations and diminished hospital staffs–there has been a major shift in from in-house reprocessing to third-party reprocessing companies. One of the leaders in the field is Ascent , a company that in 2008 saved hospitals in excess of $138 million dollars in supply cost and waste savings, while diverting 4.3 million pounds from community landfills.
“It is common to believe that there has to be a trade-off between sustainability, quality and cost: You improve performance in one area and the others will suffer. However, with single-use device reprocessing, there is no such trade off. Reprocessed and remanufactured devices are substantially equivalent to original ones and just as safe,” says Lars Thording, senior director of marketing at Ascent. “And while many sustainability initiatives are costly, reprocessing is a unique solution that simultaneously saves money while improving environmental responsibility.”
Even so, some clinical personnel remain apprehensive. As Thording sees it, that’s because they are unfamiliar with today’s advanced reprocessing operations.
“Education is helping to overcome the misperceptions,” he explains. “Some hospital administrators are unaware that reprocessing today is a safe and regulated activity–and an activity that can save the hospital hundreds of thousands of dollars.”
Thording says the market demand for remanufactured devices will continue to rise as hospitals face increasing pressure to control costs and meet broad-based sustainability goals. Already, Ascent’s reprocessing programs are in use at more than 1,800 leading hospitals and hospital systems across the U.S. Industry analysts have projected the industry will grow 20 percent year-over-year, over the next five years.
“Remanufacturing programs give hospitals a medical device strategy that not only saves money, but allows them to deploy more of their scarce resources to enhancing patient care through quality initiatives while reducing their environmental footprint,” Thording concludes.
Photo caption: The cleaning process for re-manufactured devices is rigorous, and providers such as Ascent have engineered special device-specific machines that can safely dismantle devices, such as this arthroscopic shaver, for cleaning.