Over 300 types of medical devices labelled for “single-use” are regulated or cleared by the U.S. Food and Drug Administration (FDA) and other Notified Bodies for commercial reprocessing (known as “remanufacturing” in Europe). While over 10,300 hospitals use at least some reprocessed devices, most hospitals are not realizing the full benefits of reprocessing.
Purchasing managers may not know the full list of reprocessed devices available to them, or they may not realize that all “single-use” medical devices (SUDs) cleared for reprocessing are substantially equivalent to new devices. The FDA has found them to be as safe and effective as the original devices.
By using commercially reprocessed SUDs, hospitals save 25 to 40% compared with using original devices. They cut waste, strengthen the supply chain by keeping devices more domestically located, and reduce greenhouse gas emissions.
Commercial SUD reprocessing is the only FDA-regulated process for the safe reuse of single-use products used by hospitals. A circular economy is a systematic solution that tackles the problems of climate change, biodiversity loss, waste, and pollution through reuse or remanufacturing, whenever possible. The reprocessing of SUDs drives a circular economy in hospitals and surgical centers.
Follow these steps to start a reprocessing program, or to expand existing programs.
1. Determine your goal(s) for commercial reprocessing.
Does your hospital seek to reduce costs, waste, or greenhouse gas emissions? Perhaps some combination of the three? Then learn about the savings your hospital will gain by starting, growing, or expanding reprocessing programs.
To reduce costs, identify expensive medical devices that are labelled for “single-use,” and that the FDA has cleared for reprocessing. Reprocessed devices typically cost 25 to 40% less than their original counterparts, so the more expensive the product, the more you will likely save. Use the links below to see our member offerings, ask for their current costs, and compare to what you currently pay for original devices. Create an analysis looking at a few different devices and multiply the amount saved per device by the number of that same original device used in the last 12 months. Because product costs may change throughout the year, this is an approximate savings.
To reduce waste and/or greenhouse gas emissions, think about larger devices labelled for “single-use,” such as a transfer mat or an electrophysiology (EP) catheter. Because these devices take up more space, using their reprocessed counterparts will reduce your volume of waste. Published life cycle assessments (LCAs) indicate that reprocessed devices cut greenhouse gas emissions in half compared with original devices. Subscribe to AMDR’s free newsletter to stay up to speed on publication of additional LCAs comparing the environmental impact of original versus reprocessed devices. AMDR members may have additional data on waste and greenhouse gas emission reductions for various devices.
AMDR members are ready to assist. Search product offerings to see the breadth of reprocessed SUDs available for purchase.
2. Get to know your reprocessing partner(s) and how they work.
You may work with only one commercial reprocessor or you may work with several. As you’ll see from the links above, commercial reprocessors offer a range of products, but not all reprocessors offer the same devices. You may need several partners to maximize your program.
Learn the great lengths reprocessors go through to assure every device works. This includes how they are collected, sorted, labelled, cleaned and disinfected, tested, and processed through high-level disinfection and sterilization before they are returned to hospitals.
If you have skeptics in your leadership or more detailed questions, we suggest setting up a tour or virtual tour with any of our members. Seeing is believing!
3. Commit to sustainable procurement.
If reducing greenhouse gas emissions and/or waste are your goals, turn to sustainable purchasing guides, such as Practice Greenhealth’s Sustainable Procurement Guide, which includes a calculator for reducing greenhouse gas emissions in the supply chain. Turn to these guides to learn about the full range of tools available to reduce your hospital’s carbon footprint.
Look for new app-based tools entering the marketplace that can help you calculate the reduction in greenhouse gas emissions your institution will save if as many reprocessed devices as possible were used. When we learn of them, we will write about them in our newsletter and list them here.
Now you can set goals for your program. Even though 100% collection of reprocessable used SUDs may not be possible, one hospital saw a 20% gain in collection simply because they set the 100% goal (Supply Chain Strategies Solutions Magazine (AHRS) March/April 2019).
AMDR has also provided a template for creating a reprocessing standard at your hospital or surgical center. Please see our Sample Policy for Use by Hospitals Purchasing Reprocessable and Other Reusable Products at the end of our Growing the Circular Economy guidance.
4. Simplify the collection process.
Be sure to educate and train all staff involved in the chain of custody of your hospital’s SUDs to follow collection and reuse instructions – from capturing used supplies to creating an appropriate inventory of reprocessed devices.
Reprocessors frequently work to match the color or type of packaging so that staff can easily transition between original and reprocessed equipment.
Create simple and consistent systems to label and organize collection of used SUDs. Ask your reprocessing partner what collection practices seem to work best at their other customers. Place and keep containers in convenient locations that make it simple for staff to place used items in the proper bins. Consider reducing the size of red sharps bins in the operating suite to encourage clinicians to place appropriate devices in the SUD reprocessing collection containers (Supply Chain Strategies Solutions Magazine (AHRS) March/April 2019).
5. Be strategic when you engage staff.
Work with leadership to mandate compliance with your reprocessing program, using the financial savings and/or environmental benefits that work toward your goal as the message to win support.
For example, if net zero greenhouse gas emissions is the goal, inform across the management matrix that reduction of emissions starts with more sustainable supply chain decisions. Most emissions come from the supply chain (Bloomberg Business News, June 2022). Inform what the circular economy is and what your institution is doing to convert from linear to circular thinking. Position reprocessing as vital to the success of efforts to reduce emissions from the supply chain and drive the circular economy.
Remember to inform that, contrary to the perception of greener decisions costing more, reprocessed devices reduce costs. Consider adding a regular column in internal newsletters, intranet news portal, blog, or other internal comms materials to continuously bring employees up to speed on sustainability changes and the reasons for them.
Include clinicians in the discussion about reprocessing. As the surgeon decides what devices to use, learning their comfort level with using a reprocessed device is critical to your program’s success. Surgeons may have had a bad experience with a reprocessed device. However, studies show reprocessed devices fail less frequently than original devices (usually because if an original device doesn’t work it’s discarded and not reprocessed, and reprocessors function test 100% of devices and discard those that don’t work) (ASME Journal of Medical Devices, December 2015). Remind staff that liability changes from the original equipment manufacturer (OEM) to the commercial reprocessor once the device is reprocessed and that in over 20 years of FDA experience, no increased risk to patient safety has been found.
Transparency helps: Surgical teams need to “buy in” and understand the financial implications of reprocessing – and its impact on their ability to reduce environmental impact.
High-volume devices often have the lowest collection rate (ASME Journal of Medical Devices, December 2015). For example, staff may be more likely to toss devices like pulse oximeters or electrocardiogram leads into the nearest waste bin after use. Poor compliance is typically seen with surgical and patient care products, so pay attention to strategic placement and container labeling where these devices are commonly used. Also, be sure to educate staff about the hospital’s goals for the reprocessing program and to celebrate successes as you hit these milestones. Ask your SUD reprocessor if they offer incentive programs to help increase collections of high-volume items (ASME Journal of Medical Devices, December 2015).
6. Remain vigilant.
SUDs should be viewed as hospital assets, not trash. Educate clinical teams to treat them with care and put them in the proper receptacle intended for reprocessing.
Some reprocessable devices in cardiology yield savings of more than $1,000 per device, so failing to place even one of these in the reprocessing collection system is wasteful financially and environmentally. Your reprocessing team may need to go to great lengths to educate staff about what can be reprocessed and what can’t, yet collection compliance can be an issue. Repetition of messaging makes the practice “stick.”
Make sure the reprocessor collects in a timely fashion. Encourage staff to use reprocessed devices first. Be aware of vendor interference in reprocessing programs. Devices are not to be tampered with by non-hospital employees. Breaking or bending of devices to prevent reprocessing, destroying or hiding of collection bins of devices intended to be reprocessed, or removing of used devices from collection points should not be tolerated.
7. Unlock additional savings by committing to buy back from the reprocessor.
Hospitals find significant cost-savings benefits from contracting to buy back reprocessed devices. The more reprocessed devices you buy, the fewer original devices you buy, resulting in more savings for your organization.
8. Be aware of anti-reprocessing agendas.
Ask for transparency in contracts with the manufacturers. Adopt a purchasing strategy that does not restrict your ability to maximize the savings of a robust reprocessing program. When presented with new contracts or offers, look for minimum purchase requirements and ensure you do not restrict your freedom to buy what you want, when you want, and from whom you want. When looking at reprocessor contracts, ensure accountable and transparent reporting on the devices you have reprocessed. Ask yourself, “Are you maximizing your potential?”
Finally, we all want the latest model of new devices, but does it really offer patient benefits? Some device “upgrades” provide nothing more than microchips that intentionally prevent hospitals from reprocessing their assets. Ask your vendor before you sign on the dotted line.
Every reprocessed device used is one less original device sold. That may not sit well with some OEMs. OEM contractual limitations are a leading hurdle to hitting reprocessed savings targets each year. A health system in North Carolina, for example, saw savings drop 43% in one year due to restrictive OEM agreements (ASME Journal of Medical Devices, December 2015). The savings impact from just one contractual limitation can impact your facility for years. Before you sign a contract that has minimum purchase requirements, consider your options, read the fine print, and consult with your reprocessing partner about optimizing your contractual outcomes.
Other tactics are aimed at locking out reprocessing. Some OEMs design “next generation” technology and software that cause the device to stop working after one use. In some cases, OEMs have refused to support cases in the EP lab when reprocessed devices are used. Devices used in the EP lab often come with substantial price tags and, as a result, can deliver the greatest value from reprocessing. To ensure you can maximize the value of your reprocessing program, talk to your OEM suppliers and emphasize that reprocessing is a crucial savings initiative for your organization. If they truly want to serve as a partner, they should work with you to meet your goals.
Commit to regular internal audits of your sustainability program to determine what advances and new science have revealed to help further reduce greenhouse gas emissions. If you don’t have a sustainability officer, advocate for creating the position and for the need for environmentally cleaner decision making across your organization. Remember to produce graphics annually on the amount of reductions realized through Scope 3 (supply chain) procurement decisions. Simple images help bring in more supporters who share your vision.
For more tips on managing SUD vendors to integrate your reprocessing program, please visit http://sudreprocessing.amdr.org/AMDR-Practical-Contracting-Considerations.pdf