2022 IAMERS Who’s Who
We are excited to announce the publication of the latest IAMERS Who's Who. Click here to read the latest issue.
IAMERS 28th Annual Meeting
The IAMERS 28th Annual Meeting will be held in Charleston, SC from April 27th – 29th. PLEASE NOTE: room reservations at the host hotel to be made through IAMERS. Come early so you don’t miss the Wednesday morning (26th April) tour of Charleston. DOWNLOAD THE E-BROCHURE DOWNLOAD THE REGIStration Form [...]
Considerations for effective healthcare vendor management in 2022
At the annual IAMERS educational meeting in Chicago last week, IAMERS took a deep dive on vendor management trends and best practices with two seasoned industry veterans. Intermountain Healthcare's director of clinical engineering, Michael Powers, and Crothall Technical Resources' vice president, Sheila O’Donnell, presented on 2022 best practices. The 90-minute discussion drilled down about the [...]
Copyright Ruling May Pave Way for Greater Access to Medical Device Service Manuals
Two months ago, a little-known rulemaking proceeding was underway at the U.S. Copyright Office which, depending upon the outcome, was poised to have favorable implications for the use of electronic medical device equipment manuals by servicers. Today, the Librarian of Congress issued a ruling to accept for the next three years the recommendation of the [...]
FDA Says Sharing Device Manuals With ISOs Does Not Create Cybersecurity Concerns
A little-known rulemaking proceeding is underway at the U.S. Copyright Office which, depending upon the outcome, may have profoundly favorable implications for the use by servicers of electronic medical device equipment manuals. Every three years under the Digital Millennium Copyright Act (“DMCA”), the Librarian of Congress, upon receipt of the recommendation of the Register of [...]
FDA Remanufacturing Guidance Comment Period Extended
On June 24, 2021, the FDA released a draft version of the FDA Remanufacturing Guidance. At the request of industry, the time frame for providing written comments to the guidance has been extended to September 22, 2021. In 2018, the agency disseminated a remanufacturing white paper, and now the circulation of a draft guidance indicates [...]
16th IAMERS European Meeting – CANCELED
Cancelled Due to COVID-19 Restrictions The 16th IAMERS European Meeting. Amsterdam, 15th – 17th September 2021
Biden’s Executive Order on Competition Offers Path Forward to ‘Repair Markets’
On July 9, 2021, President Biden issued a comprehensive executive order on competition. Entitled Promoting Competition In The American Economy, the order sets forth, in overview, measures designed for federal agencies to coordinate actions to address the problems of unfair competition, overconcentration, and economic consolidation. The executive order acknowledges the harmful anticompetitive effects of monopolies [...]
FDA Service and Remanufacturing Draft Guidance: Key Takeaways
By Robert J. Kerwin On June 18, 2021, the FDA released its long-awaited draft guidance entitled Remanufacturing of Medical Devices. The 17-page document contains two appendices of examples and addresses both devices and software. The draft guidance, which does not apply to single-use devices and is not intended to include significant policy changes, aims to [...]
IAMERS Who’s Who
IAMERS is a trade association whose members are world-class providers of pre-owned medical imaging systems, parts and service. We act collectively to positively impact changing government regulations, to defend against anti-competitive activities, and to provide an atmosphere for continuously advancing the knowledge of our members. Whether impacting government regulation, continuing education or monitoring anti-competitive activities, [...]