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So far kguthro has created 10 blog entries.

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|0 Comments

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|0 Comments

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 In 2018, the agency disseminated a remanufacturing white paper, and now the circulation of a draft guidance indicates [...]

By |2021-08-05T21:07:51+00:00August 5th, 2021|Business, Government, Healthcare|0 Comments

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|0 Comments

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|0 Comments

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, [...]

By |2021-09-08T13:08:06+00:00February 11th, 2021|Uncategorized|0 Comments

Brexit agreement begins now: Are you ready?

By Robert J. Kerwin It was four years ago that Britain’s then-prime minister, David Cameron, set a referendum on  the U.K.’s continued membership in the European Union. In June 2016, the citizens of the U.K.  voted to leave the EU.  In January 2020, the U.K. officially withdrew, and since that time the EU and the [...]

By |2021-01-06T03:54:31+00:00January 6th, 2021|Business, Government, Healthcare|0 Comments

FDA adverse event reporting form to include question as to third-party service

By Robert J. Kerwin Medical device manufacturers, importers, distributors and user facilities have long been required to report deaths, serious injuries and malfunctions that have, may have or would be likely to cause or contribute to a death or serious injury. The FDA regulation pertaining to "user facilities" provides that reports should be filed on [...]

By |2020-10-02T12:49:18+00:00October 2nd, 2020|Government, Healthcare|0 Comments
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