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By the time Harvey found the posting online, the medical examiner had sent Coleman’s body to the Health Science Center. “‘Did he actually die?’”After Victor Honey’s body arrived at the University of North Texas Health Science Center, the harvesting began. NBC News informed Getinge, the Army and National Bioskills about the center’s regular use of unclaimed bodies and Honey’s family not providing consent. He said his company would ensure that it no longer accepted unclaimed bodies and would adopt policies to make certain future specimens were donated with families’ permission. On a call, the reporter broke the news of how Honey’s body was used.

Persons: Moore, Yenner, ” Moore, Honey, she’s, “, ”, Darryl Martin, Michael Dewayne Coleman’s, Coleman, Louisa Harvey, Michael Dewayne Coleman, Louisa Harvey ., Harvey, Harvey couldn’t, Shea Coleman, Yellott, Michael, ’ ”, Victor Honey’s, Fort Sam Houston —, Getinge, Douglas Hampers, Hampers, Victor Honey, Zerb Mellish, Honey’s, Victor, She’d, Victor didn’t, he’d, Patman Organizations: NBC News, Army, Dallas, Health Science, Fort, Fort Worth National, Health Science Center, Dallas Police Department, Dallas Police, NBC, Texas, Service, University of North Texas Health Science Center, Getinge, Brooke Army Medical, National Bioskills Laboratories, Facebook Locations: Wichita Falls, Dallas, Dallas County, Fort Worth, New Jersey, Tarrant County, Swedish, Fort Sam, Pittsburgh

☆ US FDA classifies recall of heart devices by Getinge as most serious
▼ + stars: | 2023-03-17 | by ( ) www.reuters.com time to read: +1 min

March 17 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday classified the recall of Getinge AB's (GETIb.ST) heart devices as the most serious type, saying their use may cause injuries or death. The Swedish medical equipment maker's unit, Datascope, recalled an estimated 2,300 devices in the United States in January. Coiled cable connecting the display and base on some devices of the company may fail, causing an unexpected shutdown, according to the FDA. In January, Datascope had also recalled 4,454 units initiated back in December. Reporting by Raghav Mahobe in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ Medical device makers drop products as EU law sows chaos
▼ + stars: | 2022-12-19 | by ( Maggie Fick | ) www.reuters.com time to read: +9 min

LONDON, Dec 19 (Reuters) - Nicola Osypka's German company has been selling medical devices used in surgery on newborn babies in Europe for decades, but new European Union rules have forced her to make tough decisions. While some companies say the products they have cut have no impact on patients or profits, others say some of withdrawn devices are essential, and doctors agree. Under the EU's Medical Devices Regulation (MDR), which came into effect in May 2021, all medical devices, from implants and prosthetics to blood glucose meters and catheters, must meet stricter safety criteria, sometimes with new clinical trials. Under the old system, it took about 15,000 euros and a few months to get a similar device approved, he said. Tom Melvin, an associate professor of medical device regulatory affairs at Trinity College Dublin, said there were nearly 100 such agencies a decade ago under the old system.

☆ Getinge slashes sales outlook on supply chain, China uncertainty
▼ + stars: | 2022-10-19 | by ( ) www.reuters.com time to read: 1 min

Oct 19 (Reuters) - Swedish medical equipment maker Getinge (GETIb.ST) cut its 2022 sales outlook for the second time this year on Wednesday, citing uncertainty around supply chain disruptions and China's zero-COVID policy. The company forecast a 3% to 6% decline in its full-year organic sales. It had previously guided for sales in line with last year. It also said elective surgeries at hospitals had not yet recovered to pre-pandemic levels, leading to lower order intake and sales in the third quarter. Register now for FREE unlimited access to Reuters.com RegisterReporting by Marta Frackowiak in Gdansk; editing by Milla NissiOur Standards: The Thomson Reuters Trust Principles.

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