The right of Hospitals to repair-- or to choose who will repair their own medical devices is integral to patient safety and to controlling costs. Never was this more apparent than during the Pandemic. Healthcare systems continue to face the existential challenge of sustained cost increases. As the American Hospital Association has noted, the financial [...]

We are excited to announce our 32nd Annual Meeting in Nashville. Click below to learn more and check out our Nashville Brochure. Nashville E Brochure

By Robert J. Kerwin, IAMERS General Counsel EDITOR’S NOTE: This article is for informational purposes only and cannot be construed as providing legal advice. Readers are advised to consult their own counsel relative to the DMCA and its exemptions. It was originally posted on TechNation Robert J. Kerwin, IAMERS General Counsel The U.S. Register of [...]

As the U.S. Copyright Office conducts its triennial Section 1201 rulemaking proceeding on DMCA exemptions this year, the FDA has issued a letter supporting the proposed renewal of the DMCA Exemption Regarding Repair of Medical Devices and Systems. On June 21, 2024, Suzanne Schwartz, director of the FDA Office of Strategic Partnerships and Technology Innovation, informed the [...]

It is well understood that healthcare systems in the United States are navigating an ever-challenging operating environment. In the wake of the COVID-19 pandemic, increased costs, tightening labor markets and lagging reimbursement rates — all have contributed to significant financial stresses on the national healthcare system. In Delaware, like many other states, between Medicaid and [...]

Today the FDA released its final guidance to provide the medical device industry clarity on the definition of "remanufacturing" for reusable devices needing maintenance or repair, a lingering point of ambiguity in an overarching discussion about right-to-repair. A draft of the guidance was initially released for comment and consideration back in 2021, at which time [...]

Last week, IAMERS (the International Association of Medical Equipment Remarketers and Servicers) celebrated its 31st birthday in Charleston at the IAMERS Annual Meeting. After IAMERS President Diana Upton welcomed the group, the Annual Meeting kicked off with a keynote presentation by Dr. Mike Bivins, president of Urology Centers of Alabama. Dr. Bivins offered some candid [...]

By Robert J. Kerwin While efforts in Washington D.C., and indeed nationwide, have sparked momentum toward widespread acceptance of the rights of device owners to choose who would repair the devices they own, recent approval by the European Parliament and the Council of the EU of the European Data Act may be a great leap [...]

Dear Members, We’re looking forward to seeing you in the beautiful city of Charleston for the 31st Annual IAMERS meeting. Meeting Times Monday 29th April 6:30 pm – Reception & Dinner at The Charleston Place Tuesday 30th April 8:00 am – Breakfast 9:00 am – Business sessions (lunch included) 4:00 pm – Meeting adjourns for the [...]