The Debate Over Reprocessing of Single-Use DevicesReprocessing of single-use devices (SUDs) has been an extremely controversial issue for more than two decades.
The Debate Over Reprocessing of Single-Use Devices
Reprocessing of single-use devices (SUDs) has been an extremely controversial issue for more than two decades.
It’s one of the fastest growing — and most discussed — areas in the healthcare industry today, and depending on whom you talk to, you will receive vastly different opinions. Hospital administrators and materials managers will tell you how they saved tens of thousands of dollars while finding an easy way to reduce the amount of waste that ends up in landfills. But mention purchasing reprocessed SUDs to a surgeon and you might get a wince. So, what does it mean to reprocess SUDs, and why is it so controversial?
Reprocessing of SUDs is the FDA-approved practice of inspecting, cleaning, testing, sterilizing, and packaging single-use surgical devices and implants so that they can be safely used again, at a fraction of the original device cost. Historically, original equipment manufacturers, or OEMs, have pushed back, selectively educating surgeons and clinical staff on the risks of reprocessing SUDs. OEMs will cite liability and patient safety as drivers for avoiding third–party reprocessing services. Given that designating a product as single use is at the sole discretion of the manufacturer, the Association of Medical Device Reprocessors (AMDR) maintains that the OEMs’ opposition to reprocessing is based on a “concern for profits, not patient safety.” The rationale is that if a product can be used only once, the number of units sold in any given sales cycle will be greater, resulting in greater profit for the manufacturer.
However, some major manufacturers such as Arjo, Stryker, Medline, and Cardinal are now members of the AMDR and are among the world’s leaders in reprocessing.
Among the many benefits of reprocessing SUDs are positive environmental impacts, indirect health and safety benefits, and cost reductions.
- Environmental benefits include saving energy, material resources, and landfill space. According to a Healthier Hospitals Initiative (HHI) case study, in 2011 Hospital Corporation of America (HCA) diverted 728,000 pounds of medical waste from entering the landfills.
- There are additional health and safety benefits when it comes to implementing reprocessed SUDS. By spending less on supply costs thanks to reprocessing SUDs, hospitals can redirect resources to initiatives that impact patient care directly, such as hiring more nurses, investing in new technology, or serving more patients.
- Finally, reprocessing and purchasing SUDs reduces a hospital’s cost for these devices because it is much less expensive (up to 50 percent savings) when compared to purchasing OEM products. There are also significant savings associated with reducing waste management utilization since you are not disposing of the SUDs after each use. Depending on the size of the hospital/system, organizations can save millions of dollars annually by reprocessing SUDs. According to an HHI case study, in 2011 HCA saved $21.7 million by reprocessing SUDs.
Example – reprocessed versus new cardiac catheters
Case studies can be found at the following websites:
In the late 1990s, the FDA’s medical device reporting system documented 245 adverse events associated with the reuse of SUDs between August 1996 and December 1999. Among these 245 adverse events were seven 7 deaths, 72 injuries, 147 device malfunctions, and 19 other incidents as reported by manufacturers, but there was no pattern of failures that differed in any way from those observed with their initial use.
In February 2000, the FDA estimated that 464 of 3 million reported adverse events could have been attributed to the reuse of a SUD, meaning 99.8 percent of reported adverse events may have occurred with new OEM devices. Furthermore, a study published in March 2016 reported that OEM devices are nearly five times more likely to be defective than a reprocessed SUD.
The FDA’s review resulted in the establishment of the Medical Device User Fee and Modernization Act (MDUFMA), in October 2002. The act held the reprocessing manufacturer to much more rigid standards than the OEM, and it imposed several additional requirements to further regulate the reuse of SUDs. MDUFMA mandated the FDA to review the critical and semi-critical reprocessed SUDs that were previously exempt from premarket notification requirements and determine which of these devices now required premarket approval (PMA).
Before medical devices can be reprocessed and reused, a third-party or hospital reprocessor must comply with the same requirements that apply to OEMs. Reprocessing firms must:
- Register and meet FDA requirements.
- Submit documents for premarket notification or approval.
- List all products that they can reprocess.
- Submit adverse event reports.
- Track devices whose failure could have serious outcomes.
- Correct or remove from the market unsafe devices.
- Meet manufacturer and label requirements.
The FDA also requires that reprocessors of SUDs be able to demonstrate that:
- the device can be adequately cleaned and disinfected or sterilized.
- the physical characteristics or quality of the device will not be adversely affected by these processes.
- the device continues to comply with applicable FDA requirements.
The FDA divides reprocessed SUDs into three categories:
Approximately 65–75 percent of reprocessed SUDs fall into Class 2, including pulse oximeter sensors, ultrasound catheters, drills, compression sleeves, and most laparoscopic equipment such as scalpels, forceps, graspers, and trocars. Other typical devices that are remanufactured include electrophysiological and ablative cardiac catheters.
While the FDA states that a reprocessed device should be viewed the same as a new OEM device and has not placed limits on the number of times a device can be used, The Joint Commission suggests specific procedures and policies. According to TJC, devices should be marked with a unique identifying number: “This number should be tied to a database that includes all steps taken throughout the reprocessing process, collection site, job control number, and the number of times it has been processed.”
Setting up a Reprocessing Program
Because some surgeons and OR staff are skeptical of the collection and use of reprocessed SUDs, it will take dedication to attain understanding, acceptance, and support for the program. Data, communication, and collaboration across disciplines are crucial to success. Ideally, mutual respect for all viewpoints will be considered, and decisions will be evidence–based. This will allow OR staff and surgeons to be part of the decision-making process rather than being forced to comply.
The following excerpt from Sustainability Roadmap for Hospitals describes fundamental steps for implementing and sustaining a successful reprocessing program:
- 1. Assess and select FDA-approved single use device reprocessors in the marketplace. They have a lot of experience with implementation and can help with all aspects of an implementation plan. Use the Association of Medical Device Reprocessors (AMDR) to guide the selection process. AMDR is a trade association for third-party reprocessors whose members account for approximately 95 percent of the third-party reprocessing done in the United States.
- 2. Form a multidisciplinary task force at the department and hospital level. Stakeholders include all impacted clinical groups, supply chain managers and key value analysis members, OR managers, CSR managers, sustainability coordinator, OR Environmental Services, and Shipping/Receiving. Stakeholders may vary depending upon implementation vs. ongoing management issues.
- 3. Determine your metrics for success and develop a plan throughout the sourcing and early implementation phases for how you will continuously collect that data, and present the plan to leadership.
- 4. Introduce devices to be reprocessed and implement the program with a “phase-in” approach, then broaden the scope with success. Start with non-invasive items. Your preferred vendor can also help you decide where to start and what to phase in at various points. A wide range of SUDs are commonly reprocessed, from cardiovascular and orthopedic devices to general surgery accessories. The following list provides a sampling of SUDs that may safely be reprocessed; a complete list is available on http://www.amdr.org/.
- Arthroscopic shavers
- Biopsy forceps
- Blood pressure cuffs
- Clamps and dissectors
- Compression sleeves (DVT)
- External fixation devices
- Electrophysiology catheters
- Harmonic scalpel
- Laparoscopic scissors and forceps
- Orthopedic drill bits and burrs
- Phaco tips
- Pneumatic tourniquet cuffs
- Pulse oximeter sensors
- Scissors and staplers
- Soft tissue ablators
- Unused items
- 5. Prepare an FAQ sheet and coach the team with answers to barriers that might arise. Clinicians and staff members may resist implementation due to concerns over quality and safety, compliance, and reporting; they may also have strong preferences about certain items. The key to addressing these concerns is to provide administrative support and education about the environmental and cost saving benefits as well as the program’s strict adherence to FDA regulation.
- 6. Plan a stakeholder group visit to the reprocessor plant and to a facility that has successfully implemented similar programs.
- 7. Implementation and ongoing management strategies include designating a clinical and/or initiative champion in the OR — a go–to person for questions and problems. The champion may also be responsible for tracking collection of used products and restocking of reprocessed products. Clarify all roles.
- 8. Establish a regular routine for placing collection containers and sending them out in prepaid shipping boxes (consider assigning this responsibility to an individual or select team).
- 9. Collaborate with staff to agree on a system by which reprocessed items are placed on the supply carts for first use. (Not doing this is a common barrier to realizing projected savings.)
- 10. Regularly review quarterly reports from the reprocessor and purchasing/invoicing to understand and communicate savings and quality control monitoring.
- 11. Continuously assess and be aware of changes in single–use devices by the OEMs. The supply chain contracting process provides a good opportunity to better manage your relationship with the OEMs about your sustainability commitment and preference to reprocess.
- 12. Place collection policies for reprocessed products in department manuals.
Changes in reimbursement, such as reduced revenues under capitation, have presented healthcare providers with a major financial challenge. The question of how to reduce operating costs without compromising the standard of patient care is confronted daily by healthcare professionals at all levels. Personnel cuts, along with various materials management programs, have already been implemented by most institutions. Unfortunately, the changes have not produced sufficient savings, and it appears that the coming years will see further reductions in revenue and allowable patient billing. Government agencies, hospitals, healthcare professionals, patients, and manufacturers must all become part of the solution.
Reprocessing of selected SUDs can be a viable cost-reduction program that does not diminish patient care standards when performed under proper guidelines. In fact, an effective reprocessing program may improve patient care if the associated cost reduction helps maintain adequate hospital staffing levels. Every product, whether disposable or reusable, has a functional life, which should not be subjectively determined by the manufacturer. Expensive reusable items have been known to break on first use, whereas single-use devices have often proved useful for many successive procedures. Functionality is the key: if a product can be economically reprocessed with validated protocols and deemed to be functional, there is no reason to discard that product after one use. A prudent program of reprocessing saves money, jobs, and the environment — without changing the standard of patient care.
Medical Device and Diagnostic Industry– FDA Updates Guidance on Reprocessing of Single-Use Devices
Les Bookoff, October 1, 2006
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