Hospitals use regulated, reprocessed single-use devices (SUDs) to lower costs, reduce waste and emissions, and strengthen the supply chain. But some original equipment manufacturers (OEMs) have undermined these goals by interfering with reprocessing. Research has shown that such interference can be a major barrier to the success of reprocessing programs.

This page explains explains how to recognize and report anti-reprocessing tactics and protect your right to choose regulated reprocessed devices.

Know Your Rights

Anti‑reprocessing interference might violate the law, and a U.S. federal court has ordered a major OEM to stop interfering with hospital use of reprocessed devices for five years.

In that case, a jury reviewed evidence and testimony related to the first four examples below, and found the OEM guilty of unlawful tying and monopolization. Click here to learn more.

What Interference Can Look Like

AMDR members have reported the following examples of interference with hospitals’ rights to use FDA regulated reprocessed devices:

1. Tying case support and platform/software access to purchases of original OEM devices

Internal policies, sales practices, or contractual terms that condition clinical coverage or system access on buying original devices; in practice, vendor reps withhold case support when a reprocessed device is used—some reps have even left mid-procedure.

2. “Kill” chips, encryption keys, or firmware configurations that disable reprocessed SUDs

Hardware or software controls that serve no clinical purpose beyond blocking lawful reprocessed equivalents, including “single‑use” counters and device‑ID checks.

“Kill” chips, encryption keys, or firmware configurations that disable reprocessed SUDs

3. Coercive or unauthorized software/firmware updates

Updates—often presented as routine or “cybersecurity” patches—that cause consoles/generators to reject reprocessed accessories, or that alter workflows in ways that require OEM retraining and reinforce the tie; sometimes installed by reps without proper approval.

4. Hoarding, withholding, or destroying used devices

Vendor take‑back or collections programs, exclusive bin contracts, or other limits that prevent hospitals from returning used devices to their reprocessing partners. AMDR is aware of vendors collecting devices for “recycling” when in fact these devices end in incineration or the trash. Generally, recycling programs are thought to generate more greenhouse gas emissions than remanufacturing or reprocessing programs—remember the adage, “reduce, reuse, recycle—in that order.”

5. Perks and other contracting terms that restrict reprocessing

Exclusivity, volume minimums, or “free” capital or other perks contingent on reduced reprocessing.

6. Warranty threats and support withdrawal

Assertions that using reprocessed SUDs voids warranties or eliminates case support—despite being cleared as safe and effective.

7. Tampering with hospital assets

Swapping or removing cables so devices don’t interface, hiding collection bins, relabeling shelves, or instructing staff to discard reprocessable SUDs.

8. Pricing structures that steer choices

Discount schemes for non-reprocessable versions of products, and/or price increases for reprocessable versions, that push hospitals toward disposables.

9. Facility‑circulated talking points or materials that mischaracterize reprocessed devices

OEM‑funded, non‑peer reviewed materials circulated in facilities that misstate the safety or performance of reprocessed SUDs (this has resulted in retractions or information warnings from editors).

What You Can Do About It