FDA probes malfunctions of medical devices made by man who has championed patient safety

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A Food and Drug Administration investigation last year found that Masimo Corp. did not adequately look into reports of problems with its devices, ProPublica reports, even though the company owner, Joe Kiani, has created a foundation dedicated to eliminating medical mistakes. In addition, the Boston Globe examines how medical technology companies are looking for new strategies to boost sales.

NPR/Propublica: Medical Company May Be Falling Short Of Its Patient Safety Ideals
When medical device entrepreneur Joe Kiani announced his commitment to eliminating medical mistakes, he did it with panache. His medical device company, Masimo Corporation, funded the launch of a nonprofit called the Patient Safety Movement Foundation. And at its flashy inaugural summit in 2013 ... Kiani pledged to galvanize the medical industry to reduce the number of deaths from medical errors across the country from hundreds of thousands a year to zero. ... Now people will see whether Kiani, and his company, Masimo, walk the talk. Keeping patients safe requires device makers to respond appropriately to complaints. But an inspection by the Food and Drug Administration last year found Masimo didn't adequately investigate dozens of reports that its devices may have malfunctioned (Allen and Waldman, 10/6).

Boston Globe: Med-Tech Companies Seek Ways To Boost Sales
Facing intensified pressure from cost-conscious hospitals and doctors groups, the medical technology sector is embracing new strategies -; from merging to bundling their products with new offerings and support services -; to boost sales and profits (Weisman, 10/7).


http://www.kaiserhealthnews.orgThis article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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