AMDR Policy Agenda

AMDR advocates for policies that promote the use of reprocessed (“remanufactured” in some jurisdictions outside the U.S.) single-use devices (SUDs) to reduce costs, waste, and greenhouse gas emissions while strengthening the supply chain and increasing resilience to economic and geopolitical disruptions. The following policy objectives aim to drive systemic and cultural changes in healthcare purchasing and regulatory oversight for SUD reprocessing globally.

Policy Objectives by Jurisdiction

United States:

• Overturn Veterans Health Administration’s Prohibition on Reprocessed SUDs: Currently, the only major health system in the U.S. to prohibit the use of reprocessed SUDs is the Veterans Health Administration (VHA). This senseless policy seems to be based on outdated assumptions of risks, and may cost taxpayers hundreds of millions of dollars a year, by AMDR’s estimate. But it also drives more greenhouse gas emissions and ultimately is worse for the health of America’s veterans. The ban should be overturned as soon as possible as the supply chain for medical devices needed to treat our Veterans is vulnerable due to tariffs, price increases and supply chain disruption.

• FDA:
  • We urge FDA to establish expedited regulatory pathways for domestically produced devices, which includes most devices cleared for reprocessing, to shore up supply chains, reduce costs, and promote the on-shoring of manufacturing. For example, the FDA should ensure that any accelerated review mechanisms, such as the Commissioner’s National Priority Voucher Pilot Program(for drugs), are amended or expanded to recognize the value of domestically reprocessed devices for meeting clearly defined national-priority criteria (e.g., cost reduction, onshoring of manufacturing).

• • The “Single-Use” Label: For decades, the “single-use” label has promoted the mistaken belief that SUDs cannot be safely reprocessed. As FDA has explained, this label means the OEM has chosen not to perform the validation tests necessary to label a device “reusable” and does not necessarily mean it cannot be cleared by FDA for reprocessing. In many cases the single-use label unnecessarily causes more waste.

AMDR urges FDA to examine and address proliferation of this label and counter “kill chips” and other forced obsolescence measures to make devices for single-use or that aim to thwart reprocessing. Such tactics do little more than drive up consumption, and thus profits, for the OEM, leaving hospitals and consumers with greater costs, waste, emissions and supply chain vulnerabilities.  Inappropriate abuse of the regulatory process to drive profits should be countered at the premarket level at FDA.

• FTC: We urge appropriate federal investigative agencies (such as the Federal Trade Commission) to investigate and address anti-reprocessing business practices of some OEMs, including forced obsolescence measures, to promote a more competitive market for medical devices, including reprocessed SUDs.

European Union:

• Eliminating the “Opt-In” Model: Under Article 17 of the current EU Medical Device Regulation (MDR), medical device reprocessing (referred to in Europe and outside of North America as “remanufacturing”) is permitted, but individual member states must proactively “opt-in” in order for it to be allowed in their jurisdictions. This unnecessary, additional step required of national-level regulators needlessly complicates the adoption of a circular economic practice. Instead, the EU should amend the MDR such that remanufacturing will be allowed across the continent, if the remanufactured device meets CE marking requirements. To learn more about AMDR’s recommended amendments to Article 17, please see our position paper.
• CE Mark Adoption: Absent EU action above, AMDR urges EU member states to harmonize a consistent regulatory approach for remanufacturing and ensure that all remanufactured products that obtain a CE mark are entitled to be placed on the entirety of the EU market. With the availability of CE-marked, remanufactured SUDs, hospitals have access to lower-priced devices that provide competitive downward pricing pressure on manufacturers for new devices, and lower waste and emission options while building supply chain resilience.

Global Policy Objectives

1. Promote Favorable Procurement Policies for Reprocessed Devices that Reward Value Over Volume

AMDR wants governments and healthcare systems to prioritize the considerable cost and environmental benefits associated with reusable and remanufactured devices rather than wasteful purchasing of disposable products in high volumes. This means treating devices as long-term assets that can be reused safely and effectively, rather than relying on single-use, disposable models that prioritize convenience or upfront purchasing simplicity. By shifting the procurement focus from volume (i.e., using once and discarding) to value (i.e., maximizing utility and lifespan), health systems can achieve significant cost savings, reduce waste, and improve supply chain resilience.

To this end, we urge governments to:

• Adopt a clear procurement preference for remanufactured devices whenever they meet required specifications.
• Penalize products that deploy anti-remanufacturing mechanisms, such as firmware locks or contractual prohibitions.
• Develop payment incentives that reward hospitals for promoting cost-efficiency, sustainability, and supply chain resilience through remanufacturing. Rewards should be adjusted, over time, to encourage increasingly ambitious remanufacturing targets.
  • We support stand-alone incentive payments to hospitals meeting reprocessing benchmarks to quickly achieve measurable reductions in costs, waste, and carbon emissions, and
• Create accelerated regulatory pathways for devices that demonstrably advance national health priorities—such as strengthening domestic manufacturing, lowering healthcare costs, and reducing greenhouse-gas emissions. Regulatory review should give preference to products and technologies that are domestically produced and/or have clear economic, strategic, and environmental benefits.
• Require government funded or reimbursed institutions to participate in regulated remanufacturing programs to capitalize on immediate sustainability and emission reducing opportunities.
• Through relevant medical device regulatory authorities and reimbursement/procurement entities, empower healthcare procurement staff by creating a webpage listing devices cleared for remanufacturing in their jurisdictions. We urge authorities to alert healthcare systems about regulated remanufacturing options, especially for devices with anticipated shortages due to supply chain issues or other disruptions

2. Address Forced Obsolescence and Other Anti-Remanufacturing Practices

Some original equipment manufacturers (OEMs) engage in practices to inhibit or discourage the use of remanufactured devices, such as by intentionally limiting device usability or outright prohibiting remanufacturing in contracts. AMDR calls on regulators to aggressively investigate and put a stop to these practices – particularly as they have been successfully challenged in federal court. Regulators should, for example, prepare reports to help healthcare buyers make informed decisions and push back against linear sales models that hinder sustainability efforts.

3. Focus on Reducing Emissions from Healthcare Supply Chains

While AMDR supports accrediting group prioritization of sustainability programs (e.g. the Joint Commission and Joint Commission International’s voluntary sustainability accreditation), we would like to see regulatory authorities and payors require hospitals to report on emission reductions. These should specifically target supply chain (Scope 3) emissions, which constitute 60 to 80% of healthcare sector emissions. Regulators and payors should establish goals and reporting requirements, inclusive of remanufacturing, that can be updated to drive significant reductions in greenhouse gas emissions, waste, and costs.

4. Educating Stakeholders

Regulators and payors should partner with stakeholders such as group purchasing organizations, healthcare staff, and remanufacturers to identify and overcome barriers to the adoption of circular economic business models. They can also showcase easy-to-adopt, successful, working models, including remanufacturing “best practices” to address healthcare emissions.

5. Promote Global Harmonization of Remanufacturing Standards

AMDR envisions a harmonized global market where remanufacturing is governed by the same regulatory standards as OEMs, and where these standards are the same or similar across international boundaries. We urge all nations to adopt regulations building towards a consistent, global standard for medical device remanufacturing. In countries that lack the resources to provide regulatory oversight, we encourage officials to accept or allow US or EU compliant remanufactured devices to be placed on their markets.

6. Fund Life Cycle Assessments and Cost Research

Governments should promote funding independent Life Cycle Assessments of healthcare products to inform purchasers about the environmental impact of disposable vs. remanufacturable SUDs. Specifically, they should encourage research on:

• Price differences between disposable and remanufacturable products.
• Differences in carbon emission impact between disposable and remanufactured products.
• Lifetime or “cost per use” expenses.
• Waste disposal costs for healthcare institutions.
• How supply chain savings can improve care for underserved populations.

Additionally, research should investigate how remanufacturing savings could fund beneficial activities such as expanded surgical and other medical interventions, environmental initiatives, and staff compensation. Finally, researchers should aim to scrutinize greenwashing. Existing recycling and other end-of-life programs should be carefully evaluated to determine their real impact in comparison with alternatives, such as remanufacturing. To ensure comparability and consistency, this research should ideally contribute to a standardized data framework across healthcare procurement systems.

AMDR’s recommendations would strengthen medical supply chains while reinforcing national goals of healthcare cost containment, sustainability, and industrial resilience and autonomy. By advancing these policy initiatives, AMDR aims to create a more cost-effective, sustainable, and resilient healthcare supply chain that benefits providers, patients, and the planet.