Smith & Nephew provided shaver blades for a reprocessing study.
In the past few years, SUD reprocessing has been introduced to a wider audience, and many people believe that legislation requiring informed patient consent before using these kinds of devices is a good idea. Consequently, such laws have been pushed in several states, including Massachusetts, Rhode Island, Maryland, and Virginia. Utah enacted one that places the liability associated with the original manufacturing on the reprocessors of critical SUDs.
Most recently, 22 patient-safety advocate groups in New Jersey formed Patient Groups United Against Reprocessing Dangers, or PatientGUARD, and have been campaigning for a state law there.
Dan Vukelich, executive director of the Association of Medical Device Reprocessors (AMDR; Washington, DC), thinks it is unlikely that states will pass anti-reprocessing legislation involving informed consent. He says the proposed laws mislead consumers into thinking the devices pose a higher risk than original devices. “Reprocessed devices aren't an increased risk and, in fact, are regulated more thoroughly than the original manufacturers' [devices].”
One strong supporter of informed patient consent is turning to evidence showing damage and wear on reprocessed arthroscopic shaver blades. A study conducted at Loma Linda (CA) University examined the reprocessed blades and showed damage on the devices. The study was performed by doctors and surgeons in the university's orthopedic surgery department and published in an October issue of Arthroscopy: The Journal of Arthroscopic and Related Surgery.
AMDR strongly questions the integrity of the study, mainly because of how part of it was conducted. The study's first phase was funded by the endoscopy division of Smith & Nephew, which supplied shaver blade samples for that phase.
“For many years, the reprocessors have said that there's no peer review evidence of any facts,” says Nigel Wilkinson, vice president of regulatory affairs and quality at Smith & Nephew Endoscopy (Andover, MA). “We now have an article in a credible scientific journal, and they still choose to bury their heads in the sand and not recognize its legitimacy.”
However, says Wilkinson, the academics that conducted the study set the protocol and published it on their own. In the second part of the study, for which Smith & Nephew states it had no involvement, an author collected his own samples of reprocessed devices.
Wilkinson feels that the Loma Linda study could prompt others in industry to conduct similar research. He is also concerned about the practice of bundling, which allows closely related devices to be reprocessed in quantities. For example, says Wilkinson, “They could get 510(k) [clearance] to reprocess shaver blades, regardless of the different design factors, different manufacturers, and different materials and components. Being allowed to bundle what are essentially different products seems to be a bit inappropriate.” Future studies might help change this practice.
Reprocessing supporters continue to stand by the practice's cost savings. According to AMDR, hospitals save $100 million each year by using reprocessed devices.