Action Alerts and Technical Tips
AMDR’s Action Alerts and Technical Tips provide awareness and guidance on important industry developments that could impact your facility’s ability to deliver affordable, sustainable healthcare. Whether it’s about anti-competitive behavior or a critical regulatory shift, you’ll find what’s at stake—and what to do next—right here.
So, what’s the difference?
Action Alerts are urgent. Each Action Alert breaks down complex legal, regulatory, or market issues into clear, actionable steps for hospital leadership, supply chain and procurement staff, and commercial reprocessors. If a hospital needs to do something, it’s an Action Alert.
Technical Tips are designed to educate. These are insights or updates on emerging trends in the healthcare, medtech, and reprocessing space that don’t require immediate action, but help your team stay informed and ahead of the curve. If it’s about learning something, it’s a Technical Tip.
For more information, please contact AMDR.
Action Alerts
A federal court has issued a permanent injunction barring Johnson & Johnson’s Biosense Webster unit from interfering with reprocessing, following a trial in which the jury found the company liable for unlawful tying and monopolization. The court has barred Biosense from tying case support to device purchases, disabling reprocessed devices with chips, and hoarding used devices to cut off reprocessors’ supply.
This Action Alert explains the ruling, what hospitals should watch for, and how to report violations.
After a major OEM used various tactics to prevent hospitals from using a competitor’s reprocessed devices, a federal jury has found the OEM liable for unlawful tying and monopolization. AMDR has created a short form so hospital staff, supply chains, and reprocessors can report anti-reprocessing interference and route evidence to the right authorities. Reports may be submitted anonymously.
Read the Action Alert for the checklist of what to document, who to notify internally, and the downloadable reporting form.
Medtronic is marketing reprocessed Nellcor™ sensors as “remanufactured”—a label their FDA clearance doesn’t support—while pushing misleading superiority claims. They also limit sensors to one reprocessing cycle, inflating waste and emissions, while FDA data show multiple safe cycles are possible. Hospitals should verify claims against FDA filings, demand independent validation, and report misleading marketing.
This Action Alert explains what to watch for, the questions to ask vendor reps, and next steps.
Technical Tips
AMDR’s contracting policy template (click here to download) helps health systems formalize their commitment to reprocessing, resist OEM interference, and embed fair contracting standards into procurement.
This Technical Tip offers guidance about protecting your hospital’s right to reprocess—with a procurement policy built for the purpose. Includes customizable language, enforcement mechanisms, and legal precedent.
Regulated reprocessed SUDs are just as safe and effective, and meet the same regulatory standards, as any other device. Still, some providers have concerns about safety—and all want to protect their patients.
This Technical Tip, a companion to our Patient Safety webpage, brings together all of the regulations and science to help address safety concerns, explain what the “single-use” label really means, distinguish regulated reprocessing from unregulated reuse, and more.
Informed consent is not required for reprocessed devices, despite claims to the contrary by some OEMs. FDA-regulated reprocessed devices are legally equivalent to original devices, and no U.S. state mandates separate consent for their use.
This Technical Tip helps legal, compliance, and risk teams correct misinformation, protect patients from fear-based messaging, and reinforce trust in hospital reprocessing programs.
CMS reimburses reprocessed devices—no special billing codes required. Despite claims of some OEMs, Medicare pays for procedures using FDA-regulated reprocessed devices just like those with originals.
This Technical Tip debunks myths, explains compliant billing practices, and provides action steps to correct misinformation, audit charge masters, and protect reprocessing savings.