Are reprocessed saw blades as sharp as the originals? Will the failure of a reused orthopedic drill bit cause serious injury? Are reprocessed arthroscopic shaver blades more likely to be contaminated?

These are just a few of the questions that linger in the minds of many surgeons regarding the quality and safety standards of reprocessed single-use devices. Proponents of the devices say these worries, while borne out of a reasonable concern for the safety of their patients, aren't necessarily substantiated. Organizations such as AORN, APIC and ASHCSP (American Society for Healthcare Central Service Personnel) are among the many that have thrown their considerable weight behind reprocessed devices, authoring position statements supporting medical device reprocessing and remanufacturing.

Still, evidence of reprocessed SUDs' efficacy seems to be in short supply. But there are ways for you and your surgeons to separate the facts about reprocessed SUDs from the myths, and to help your reprocessing program gain traction.

Strict standards
The questions that still surround reprocessed SUDs stem partly from uncertainty about the testing process for evaluating the quality, functionality and sterility of the devices. However, reprocessed SUDs may actually undergo more rigorous scrutiny than original devices, says Kaeleigh Sheehan, project manager with Reston, Va.-based Practice Greenhealth.

The FDA, which must approve each type of reprocessed single-use device, considers third-party reprocessors the "manufacturer" of reprocessed devices, and holds them liable for any defects or quality issues, says Ms. Sheehan.

Indeed, the FDA mandates that third-party reprocessors submit documents for pre-market notification or approval before devices can be reprocessed, submit adverse event reports, and correct or remove unsafe devices from the market.

Third-party reprocessors are also required to test the functionality and safety of each and every reprocessed device, as opposed to the batch testing typically done on original devices, adds Ms. Sheehan. "In that regard, you would almost have a higher sense of security in knowing that every single reprocessed instrument is tested, rather than, say 1 in every 200 or even 5,000."

Dealing with surgeons' doubts
Stringent FDA regulations and thorough testing aside, a dearth of postmarket data continues to hamper the progress of reprocessed SUDs, says David Reiter, MD, MBA, FACS, associate chief medical officer at Thomas Jefferson University Hospitals in Philadelphia.

The literature and clinical studies don't indicate higher infection rates or a greater number of adverse outcomes associated with reprocessed SUDs. The flip side of that coin, says Dr. Reiter, is that the literature and clinical studies don't show the opposite to be true, either.

"Many surgeons inherently perceive them as inferior, and feel there has to be a reason that reprocessed devices are cheaper," says Dr. Reiter, adding that original equipment manufacturers have sponsored many of the studies that have thus far been done on reprocessed devices. "Until they see more unbiased peer-reviewed studies, that's not likely to change."

Dr. Reiter, who heads the committee that evaluates and purchases medical devices for TJU, notes that some of the university's surgeons have expressed doubts about the sharpness of invasive devices like saw blades and burrs, for example.

However, there are simple, straightforward ways to address these concerns, he says. "I wanted to give our surgeons 5 blades each — without divulging which were reprocessed — and let them cut into a thick chunk of bone with each blade.

"If they could tell the difference between blades," he continues, "then I'd say these were reasonable concerns. I'd like to see tests like that being done, but I haven't gotten anyone to bite."

Surgeons may be reluctant to participate in such "blind taste tests" within their facilities, but you can easily take them straight to the source for a firsthand look at how reprocessed single-use devices are evaluated, says Martin Makary, MD, MPH, FAC, associate professor of surgery and public health at Johns Hopkins University in Baltimore, Md.

"In recent years, the reprocessing industry has become totally transparent," he says. "Reproces-sing companies routinely allow healthcare providers to inspect their facilities. Facility managers as well as individual providers are encouraged to visit reprocessing sites so they can decide for themselves if there are any associated risks with the process."

A veteran of several such tours, Dr. Makary's observation is that "everyone who's seen the process has been impressed by the standards reprocessed instruments are held to."

Making inroads
Starting with a pilot or trial period reprocessing only non-invasive devices may be the first step toward gaining acceptance for a more robust reprocessing program in your facility, says Ms. Sheehan. For example, you could begin by collecting all devices for reprocessing, but only buying back non-invasive ones as a way to ease resistant surgeons into the process. Or start with buying back all kinds of devices, but don't force a surgeon to use a reprocessed device without his knowledge.

Indeed, it's OK not to immediately impose the use of reprocessed devices on your more skeptical surgeons, says Mary Wilson, BSN, RN, CNOR, administrator at West Virginia University Hospitals. The Morgantown-based hospital has been reprocessing devices like pulse oximetry probes, external fixation devices, sequential compression devices, ImPad foot covers and epidural catheters for 6 years, she says. Before rolling out the program in 2006, many of the facility's orthopedic surgeons were leery about being able to identify external fixation devices that had been reprocessed, and if so, how many times the devices had been reprocessed, she says. When implementing its reprocessing program, "we did allow surgeons to opt not to use reprocessed components on a patient if they were particularly concerned that there was a higher risk for complications or problems."

Taking such a steady, incremental approach may help ease resistant surgeons into the reprocessing program, and slowly build support among your physicians for the use of more invasive devices in the long run, says Ms. Sheehan.

Looking for answers
Any reprocessing company should provide in-services for your staff on procedures for handling reprocessed devices, says Ms. Sheehan, as well as guidance on the placement of collection containers, which devices can be placed in the containers during and after surgeries, which devices must be cleaned in sterile processing before being sent for reprocessing and more general information on the process.

It's natural for your surgeons and staff to have a degree of cynicism toward reprocessed instruments and their ability to help them provide the same level of care as original devices, says Dr. Makary. Don't discourage such "healthy skepticism," he says, and let your staff know that device failures or other complications with reprocessed SUDs will be taken seriously. "When you show a strong commitment to taking an interest in individual malfunctions, it sets the tone for the entire staff," he says. "They know that reprocessed SUDs aren't going to be imposed on them, and that their safety concerns are going to be heard."