The reprocessing of medical devices labeled “single-use” is not terribly popular among original manufacturers. Seeing the market share of their products being cannibalized by those very same products, they have lobbied for greater regulation, citing for example, an increased risk of infection, the possibility of cross contamination, a loss of guaranteed reliability, and an increased likelihood of protein or cleaning-agent residues on the devices.
Most hospitals on the other hand already have a long history of reprocessing in-house, basically whatever could survive an autoclave. The emergence of complex devices and a greater use of disposable materials created a trend towards “single-use” labeling, but this extended to cover devices that were both expensive and potentially reusable.
FDA and ISO standards
The market stepped in and in recent decades an industry has emerged that specializes in reprocessing “single-use” devices. Crucially, the US Food and Drug Administration (FDA) has kept an eye on developments, satisfying themselves that reprocessing per se is not associated with a greater risk to patients, and issuing regulations on the formulation and validation for reprocessing reusable medical devices.
In Europe, different national health agencies have conflicting policies on reprocessing. Although sorely required, European standards are not expected to be published before 2016. The current practice is to adhere to ISO (International Standard for Organization) 13485 standard.
The imposition of strict standards by the FDA has legitimized the reprocessing industry, with healthcare providers being more assured of the safety of reprocessed products. Carl Rodia, President of Northeast Scientific, a company based in Waterbury, Connecticut and specialized in reprocessing the more technologically challenging surgical devices, explains, “Safety and sterility concerns were fomented by original equipment manufacturers, who because of reprocessing are the big losers. Reprocessing has been proven safe for more than 20 years.”
By law, products that are reprocessed according to ISO or FDA standards are tested to ensure quality consistency throughout the authorized life of the reprocessed product. Reprocessed devices must meet or exceed quality standards of new equipment.
The benefits of reprocessing
The major benefit of reprocessing equipment is cost. As Mr Rodia says: “The advantage for hospitals is the nearly 50% cost savings per use that reprocessing affords. A new cardiac ablation device costs approximately USD 3,300, a reprocessed one costs less than USD 1,500. And that single device can be reprocessed and used up to 10 times.”
Device reprocessing involves a series of steps including physical cleaning, disinfection, remanufacturing, quality control, sterilization, repackaging and finally relabeling. Third-party reprocessors generally include the collection of the equipment from the hospitals. About 2% of “single use” devices are eligible for reprocessing.
In-house versus third party reprocessing
Whenever possible, hospitals have tended to do reprocessing themselves, although the quality of these services is hampered by a lack of standards, limited monitoring and the low status and resources of reprocessing units.
A study in Germany found that of the hospitals and clinics surveyed, more than half did not have either sufficient space, adequately trained staff or had shortfalls in the decontamination process itself.
For example, washer-disinfectors were either obsolete or not suitable for performing a particular process and none of the sites had validated standards in place including all steps of the reprocessing process.
These findings highlight the need for effective regulation to improve hospital standards.
A FEW MAJOR PLAYERS
Hygia, in Birmingham, Alabama, specializes in patient room equipment reprocessing, offering savings on high volume commodities such as blood pressure cuffs, stethoscopes, splints, tourniquets, etc.
Medline ReNewal, in Mundelein, Illinois, offers clients online management of reprocessing orders and a choice of direct reprocessing, inventory-based reprocessing or a combination of the two.
NEScientific, in Waterbury, Connecticut, specializes in reprocessing the more technologically challenging surgical devices, with an emphasis on quality over quantity.
ReNu Medical, in Everett, Washington, claims a faster turnaround time than rivals, effectively reducing supply chain costs.
Sterilmed, based in Plymouth, Minnesota, stresses a consultative, stepwise “Gauge & Go” strategy to implement collection and reprocessing of single-use devices from hospitals.
Stryker Sustainability Solutions, in Tempe, Arizona, was the first global original manufacturer to offer reprocessing and remanufacturing.
Vanguard, based in Berlin, Germany, is the European leader in reprocessing of complex medical devices, with 15 reprocessing facilities in Germany, two in Austria and three in France.
The third-party reprocessing industry also has its own lobbying association, the Association of Medical Device Reprocessors, in Washington DC and the European Association for Medical Device Reprocessing, in Brussels.