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SUD reprocessing: Balancing cost savings, patient safety


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Infection control

SUD reprocessing: Balancing cost savings, patient safety

Although some have IC concerns, reprocessing saves money and cuts down on waste

After reading this article, you will be able to: 

  • Explain how reprocessing single-use devices can save you money
  • Identify ways to train employees when implementing a reprocessing program
  • Demonstrate ways to address those opposed to device reprocessing 

At a time when hospitals are continually searching for ways to reduce costs while maintaining or even increasing their focus on patient safety and infection control (IC), reprocessing single-use devices (SUD) may be a viable option that is cost-effective and environmentally friendly. 

The idea of reprocessing SUDs may seem inherently incorrect to some, but doing so with appropriate devices through an FDA-regulated third-party vendor can significantly reduce waste and save your facility thousands of dollars in purchasing costs while maintaining quality care.

Reprocessed SUDs range from low-risk devices such as blood pressure cuffs or compression sleeves to high-risk devices such as balloon angioplasty catheters or implanted infusion pumps. But because these devices are labeled for single use, some healthcare providers worry that the risk to patient safety is greater than the need to save money or reduce waste. 

However, according to a 2008 report from the Government Accountability Office, FDA oversight on reprocessing SUDs has increased, and data, although limited, did not indicate an elevated health risk to patients. A survey conducted by the FDA in December 2001 to February 2002 found 24.2% of all U.S. hospitals reused SUDs. Now as many as 68% of the Practice Greenhealth “Partners for Change” award applicants have implemented SUD reprocessing, according to Janet Brown, director of facility engagement at Practice Greenhealth. 

In a recent commentary published in Academic Medicine, lead author Martin A. Makary, MD, MPH, the Mark Ravitch Chair of Gastrointestinal Surgery and director at the Johns Hopkins Center for Green Health in Baltimore, argued that reprocessing is a green practice that is gaining traction in the healthcare community because of the cost savings and the reduced burden of waste on the environment. 

“We have found it to be a common-sense strategy that uses detailed quality-control standards to recalibrate, clean, sterilize, and remanufacture medical equipment,” the authors wrote. “The result has been a significant waste reduction and cost savings. However, uptake of such green practices by hospitals has continued to be slow because of a misunderstanding of the process and concerns about patient safety.”

What is reprocessing?

Essentially, reprocessing involves sterilizing equipment that has been used or opened so it can be safely and effectively used again. Reprocessed devices are typically given to third-party vendors rather than being handled in-house. These vendors are regulated by the FDA. 

Each device is subject to premarket notification requirements set forth by the FDA. Manufacturers are required to submit 510(k)s to the FDA for that device to be approved for reprocessing. 

Healthcare facilities can collect approved devices, send them to their third-party vendor, then buy the reprocessed devices back at nearly half the cost of purchasing new ones.

Reprocessed SUDs are divided into three groups: critical, semicritical, and noncritical. Healthcare facilities will often start small by simply reprocessing noncritical devices rather than focus on every device in their facility. “I don’t think I’ve met a hospital that is reprocessing everything the FDA says they can,” Brown says. “But I think they are working in that direction.”

Getting started

Although you may face resistance from physicians or patient safety advocates initially, the best way to begin reprocessing SUDs is by starting with less-critical items, such as compression sleeves. This will net a cost savings and reduce waste within your facility while easing employees into the process and proving its effectiveness.

Michele De Meo, sterile processing manager at Memorial Hospital in York, PA, says her facility has  reprocessed external compression sleeves for the past three years. Starting with low-risk devices also allows your facility to test out a vendor to ensure that you are satisfied with the quality and the relationship. “I believe that if a company has gone through the process required to get their 510(k) and the devices are deemed safe, and the company doesn’t have any quality issues that have been noted, I think for cost savings and for the environment it’s prudent for us to explore those options as long as the quality is the same as a new device,” De Meo says. 

Even today there is much more willingness to reprocess SUDs than there was 15–20 years ago, she says. At that time, physicians and health experts were concerned with reprocessing even low-risk devices such as compression sleeves. However, as more data emerge regarding the safety of this process, the more hospitals open up to the idea, and the more common it becomes. 

“So it’s been a slow evolution to gain acceptance even with using reprocessed sleeves, and I think the same will occur with other devices; it’s just a slow process,” De Meo says. “But yes, years ago getting a team on board just to do sleeves was nearly impossible.”

Brown says some hospitals simply collect devices for reprocessing but stop there, choosing not to buy back the reprocessed devices while still saving money and reducing waste at their facilities. 

Brown suggests forming a “green team” within the hospital that includes IC, patient safety, nurse educators, and any staff members who want to get involved with environmentally conscious options. A team approach spreads the initiative across a number of people to collect evidence and present the case to your facility’s management or executive team. 

“We want to make evidence-based decisions,” Brown says. “We don’t want to just do something because it makes less garbage; we need to balance that with safety and risk management and infection control. I think those are valid concerns. So you need to gather the information, find the research, and then once that is all gathered, you realize this is something that really can be done in balance with quality care.”

Training employees 

Just like any program, getting employees to comply with a new initiative is half the battle. In this case, reminding them not to throw away an SUD that your facility has decided to reprocess is usually the primary hurdle. 

Simply putting out a bin and telling employees to segregate a particular device will not be enough, Brown says. It requires constant reminders, observation, and hand-holding in a way that is encouraging rather than disciplinary or punitive.

Monitor employees and gently remind them if you see noncompliance with the new policy. It also helps to have a leader in the operating room (OR) suite to train employees and monitor segregation. Getting physicians involved also helps bring awareness to the movement and knowledge and perspective on the issue. 

“The physician’s interest or lack of in the OR can really make or break a program, so it’s really important that they are part of it,” Brown says.

She also recommends training housekeepers to keep an eye out for devices that have been thrown away inappropriately. “[Housekeepers] are the last line of defense,” she says. “They are never put into a position to reach into a bag and fix things, but they can have the visual—an opportunity to visually inspect bags—so that if they notice an issue, they can reach out to their supervisor and address it.” 

Convincing the skeptics 

Undoubtedly, some employees will remain skeptical of reprocessing. The best way to convince them otherwise is to prove that SUD reprocessing is not only cost-effective, but that it also adheres to patient safety best practices. 

The first step may be as simple as pointing to other hospitals that have successfully implemented a reprocessing program. As with many green practices, people within the facility don’t want to be the first to take that step for fear of failure, Brown says. 

For example, many facilities on the East and West coasts have begun using reusable sharps containers that are disinfected by a third-party vendor and then shipped back to the facility instead of being discarded. Brown consulted a number of hospitals in the Midwest and faced a lot of resistance to this idea. However, once she explained that many hospitals were actually reusing devices successfully, staff members were more open to trying it. 

“I think a lot of times when there is something new or different, hospitals are sometimes scared to take that first step, and once a few try it and it catches on, then you see that groundswell,” Brown says. 

You can also point to the regulations and some of the evidence available that proves SUD reprocessing does not affect the health of patients, De Meo says. Show them how the FDA regulates third-party vendors and that it only allows certain devices to be reprocessed. Also, make sure to tell them that reprocessing has been backed by a number of major organizations, including APIC.

“I think that usually wins a person over,” De Meo says. “If that doesn’t win a person over, it doesn’t matter how much cost savings you can indicate.”

Source

Briefings on Infection Control, June 2010, HCPro, Inc.

FDA classifications 

Reprocessed single-use devices (SUD) are divided into three distinct categories:

  • Class I: A noncritical reprocessed SUD is intended to make topical contact and not penetrate intact skin. 
    • Examples include elastic bandages, pressure infuser bags, tourniquet cuffs, and general-use surgical scissors
  • Class II: A semicritical reprocessed SUD is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body. These devices require FDA approval for safety, effectiveness, and intended use equivalent to new devices.
    • Examples include pulse oximeter sensors, ultrasound catheters, drills, compression sleeves, and most laparoscopic equipment
  • Class III: A critical reprocessed SUD is intended to contact normally sterile tissue or body spaces during use. To be FDA-approved, devices require scientific data proving effectiveness along with an inspection of the reprocessing facility. 
    • Examples include balloon angioplasty catheters, percutaneous tissue ablation electrodes, and implanted infusion pumps

According to a commentary published in Academic Medicine, approximately 65%–75% of reprocessed SUDs fall into Class II.