January 10, 2024 By Robert J. Kerwin On Monday the U.S. Department of Health and Human Services announced the creation of a new HHS officer position entitled ‘chief competition officer’ to promote competition and lower health care costs. Stacy Sanders, most recently counselor to HHS secretary Xavier Becerra, will assume the role. While some industry [...]
In its continued efforts to harmonize with international regulatory authorities, the U.S. Food & Drug Administration has an nounced its intention to amend the current good manufacturing practice requirements of the FDA quality system regulation, 21 C.F.R 820 et seq. to align more closely with the international consensus standard for devices, ISO 13485. This is [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 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 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 [...]
An opinion piece by Robert J. Kerwin Senator Ron Wyden (D-Ore) and Rep. Yvette Clark (D-NY) filed today in the U.S. Senate and the U.S. House of Representatives the first federal right to repair legislation. “There is no excuse for leaving hospitals and patients stranded without necessary equipment during the most widespread pandemic to hit [...]
