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OEM trade groups may be seeking to expand definition of ‘remanufacturing’ quickly and quietly

An op-ed by Robert J. Kerwin As the 2021 Federal Trade Commission (FTC) report to Congress on repair restrictions acknowledged, some medical equipment manufacturers are limiting the availability of diagnostic software and firmware necessary to make repairs. That situation may soon worsen, if legislation proposed by a manufacturer trade association is filed and approved. This [...]

By |2022-03-24T14:08:38+00:00March 24th, 2022|Business, Government, Healthcare|Comments Off on OEM trade groups may be seeking to expand definition of ‘remanufacturing’ quickly and quietly

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 [...]

By |2022-02-22T21:26:07+00:00February 22nd, 2022|Uncategorized|Comments Off on IAMERS 28th Annual Meeting

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 [...]

By |2021-12-09T17:50:53+00:00December 9th, 2021|Business, Conference, Healthcare|Comments Off on Considerations for effective healthcare vendor management in 2022

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 [...]

By |2021-11-02T12:15:49+00:00November 2nd, 2021|Government, Governments, Healthcare, Legal Advice, Reform, Regulatory|Comments Off on Copyright Ruling May Pave Way for Greater Access to Medical Device Service Manuals

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 [...]

By |2021-09-07T17:35:30+00:00September 7th, 2021|Business, Government, Governments, Healthcare, Imaging, Legal Advice, Reform, Regulatory, Used Medical Equipment|Comments Off on FDA Says Sharing Device Manuals With ISOs Does Not Create Cybersecurity Concerns

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 [...]

By |2021-08-05T21:07:51+00:00August 5th, 2021|Business, Government, Healthcare|Comments Off on FDA Remanufacturing Guidance Comment Period Extended

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 [...]

By |2021-07-22T11:09:01+00:00July 22nd, 2021|Reform, Regulatory, Uncategorized|Comments Off on Biden’s Executive Order on Competition Offers Path Forward to ‘Repair Markets’

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 [...]

By |2021-07-16T23:14:09+00:00July 16th, 2021|Uncategorized|Comments Off on FDA Service and Remanufacturing Draft Guidance: Key Takeaways
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