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April 13, 1970

Medical News

JAMA. 1970;212(2):245-260. doi:10.1001/jama.1970.03170150009003

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Should medical devices be regulated? Question debated  Mrs. Virginia Knauer received nationwide attention recently by stating that toilet valves get more thorough testing than do artificial heart valves.Mrs. Knauer, President Nixon's assistant for the Commission on Consumer Interests, was illustrating a situation that genuinely concerns consumers and physicians alike: the need for safety and reliability in the thousands of medical devices used on and implanted in patients. They range from heart valves to kidney dialysis machines to surgical sutures to bedpans.A push for stricter device control is under way.But in singling out heart valves, Mrs. Knauer may have made an unfortunate choice.She was stepping into the medical territory of, among others, Dwight Harken, MD, and Arthur C. Beall, Jr., MD. Dr. Harken, of Harvard Medical School, and Dr. Beall, of Baylor University College of Medicine, are widely known developers of heart valves.They also happen