Growing the Circular Economy in Device Design and Manufacturing Requires Policy, Thinking Shifts

Manufacturers of medical devices choose to label a device for “single-use” for a number of reasons. In some cases, the devices truly can be used only once before they become too compromised to be used again. For other “single-use” devices (SUDs), the manufacturer wants to wash their hands of liability with multiple uses of the devices. After all, proving a device can be reused requires expensive validation studies, time, and post-market surveillance. In some cases, manufacturers label devices for single use simply to sell more products. Manufacturers have also provided, and hospitals demanded, disposable versions of medical devices to avoid any risk of cross infection and to eliminate the burden on central sterile departments.

But SUDs can be surprisingly expensive and designed in ways that hold up to multiple sterilization and cleaning cycles, leaving an increasingly cost-conscious and sustainability-minded supply chain purchaser wondering why so many of these items need to be tossed.

In cardiology suites, for example, single-use devices that cost over $2,000 are commonly discarded after a single use. This contributes to the massive financial problems hospitals face and impacts their ability to provide necessary care to patients.

Let’s have 2023 be the year hospitals decide the linear, wasteful “single-use” mindset—at least when it comes to the more than 300 types of SUDs the FDA and regulatory authorities have found to be safe and effective¹—is itself thrown out with the trash.

Already, over 33 million reprocessed SUDs are purchased for reuse by over 10,500 hospitals in 19 countries. But that’s a tiny fraction of the number of SUDs regulated for reprocessing. If we want to reduce costs, emissions, waste, and strengthen the supply chain by reprocessing more, how will we get there?

The Association of Medical Device Reprocessors (AMDR) recently published its global policy agenda. Enacting these sensible advances will certainly help.

1. Incentivize hospital purchasing of “single-use” devices with value and environmental benefit in mind, not volume and wastefulness, for a stronger healthcare supply chain.
Current reward systems incentivize hospitals to buy more products, prioritizing volume to drive down prices. Fundamental changes are needed to move away from volume-based incentive structures to value-based that will drive a circular economy. Strong federal oversight is needed to develop value-based payment incentives for the use of environmentally preferable products. AMDR would like to see federal regulatory authorities incentivize—through payment or reward systems—greater hospital adoption of reusable over SUD medical device options and commercial SUD reprocessing programs to reduce emissions, waste, and cost.

Reprocessed SUDs are reimbursable as part of a larger Diagnosis Related Group. Stand-alone payments to hospitals that participate and meet certain reprocessing benchmarks would rapidly incentivize hospitals to make immediate carbon, waste, and cost reductions. In future years, the rewards could be amended to adopt increasingly ambitious targets for reprocessing program compliance. Because the infrastructure, including strong federal oversight, is already in place, reprocessing is low-hanging fruit. AMDR believes other subsets of the healthcare supply chain will seek participation and will begin to offer more circular product offerings.

2. Incentivize or require hospital reporting on emission reductions and goals, focusing specifically on the healthcare supply chain.
Since researchers have found 60% to 80% of the emissions coming from the health sector are Scope 3 related and result from the supply chain, AMDR urges federal regulatory authorities to focus hospital greenhouse gas (GHG) reduction efforts on the supply chain itself. Setting benchmarks, goals, and reporting requirements that can be amended over time will make dramatic impacts on GHG reductions and, we believe, in cost and waste reduction efforts as well, as evidenced by the reprocessing industry’s commitment to healthcare over the last two decades.

3. Fund and disseminate lifecycle assessment (LCA) studies and research on cost savings.
LCAs of healthcare products will better inform healthcare purchasers of the cradle-to-grave carbon emissions associated with disposable versus reusable or commercially reprocessable products. AMDR encourages funding for and use of these independent evaluations to assess supply chain vulnerabilities that may be associated with disposable medical equipment as compared to an alternative remanufactured/reprocessed product.

AMDR also encourages funding for research to evaluate cost comparisons, such as:

• Head-to-head prices for comparable disposable versus reusable or reprocessable products
• Lifetime costs (or full lifecycle or “cost per use”) of products
• Disposal costs, incurred by health institutions, for the proper disposal of disposable equipment versus reusable or reprocessable versions
• Assessments of how the lowering of supply chain costs associated with longer lifecycle products may find savings that can be used to provide equitable, quality, and affordable care to underserved patient populations. We urge inquiry to investigate greater surgical intervention potential associated with cardiac ablation procedures, for example, if prices were lowered for the diagnostic medical devices. Further analysis could advise hospitals how savings from reprocessing could be used to offset the cost of additional environmental remediation efforts.

4. Collaborate to create federal guidance on “best practices.”
Identifying and sharing best practices will improve supply chain reliability, promoting products with preferential environmental outcomes, and lowering long-term cost. Suggestions include:

• Coordinate with group purchasing organizations or health plans to identify impediments for using more environmentally sustainable medical device options and advise on policies to help overcome roadblocks. Our members can also help to explain these barriers.
• Identify and highlight existing circular economy business models, including medical device reprocessing, to help address Scope 3 emissions in healthcare.
• Focus first on “wins” or easy-to-adopt supply chain “best practices” that will provide guidance to hospitals and health systems on reducing Scope 3 emissions.
• Require federally run or reimbursed health institutions to participate in federally regulated reprocessing programs or other existing circular economy solutions as a means of seizing “low hanging fruit,” and to help institutions better adopt circular business models.

5. Incentivize development of apps and other handheld tools to help hospitals calculate real-time emissions reductions.
AMDR is aware of numerous efforts to develop tools for hospitals to calculate supply chain waste reduction and/or GHG-emission reduction. A perfect tool would calculate both. Involving federal authorities in these projects would increase the likelihood of accurate and valuable tools. In the United States, HHS-OCCHE could incentivize use of these programs for hospitals.

6. Address “repair restriction” issues related to healthcare products.
Federal authorities could catalyze change that would reduce emissions significantly by taking the following measures:

• Investigate “forced obsolescence” practices used by some healthcare manufacturers to intentionally limit device use and require greater healthcare acquisitions and source consumption.
• Prepare a report to healthcare purchasers so they may make more informed purchasing decisions and allow healthcare delivery organizations to exert counterpressure to linear sales models placed upon them by the current industry.

7. Educate hospital supply chain purchasers on the need to use reprocessed SUDs.
AMDR requests regulatory authorities provide a resource webpage identifying which devices have been cleared for reprocessing, particularly focusing on devices for which there are threatened supply chain disruptions. Some manufacturers are reporting to customers that supply disruptions are likely to occur for devices with chips used in laparoscopic surgery and in the electrophysiology lab. We urge federal authorities to take specific action to alert hospitals to the additional supply option that exists by reprocessing.

For hospitals, the road to net-zero emissions begins with using more reprocessed SUDs. They are the easy onramp to immediate reductions in GHGs, cost, waste, and a stronger supply chain. 

Reference

1. https://amdr.org/product/

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Daniel J. Vukelich, Esq., CAE, is president and CEO of the Association of Medical Device Reprocessors. Under his 20 years of leadership, Vukelich catalyzed the development of strong regulatory standards in the U.S. and abroad to ensure reprocessed “single-use” devices are as safe and effective as using original equipment. Today, more than 10,500 hospitals in 19 countries lower cost, greenhouse gas emissions, waste, and supply chain disruptions by reusing devices labeled for single-use that are cleared by regulatory authorities for safe reuse.