The organizations, which have sent letters to the Centers for Medicare & Medicaid Services, are concerned that this step would lead to lax standards.
The Hill: Medical Groups Resist Possible Standards Loosening
Medical trade groups are resisting a potential change to regulations on medical imaging and radiation therapy equipment that they worry would lead to lax standards. In recent weeks, organizations have sent letters to the Centers for Medicare and Medicaid Services (CMS) urging the agency not to lower standards for the maintenance of devices that perform MRIs and other procedures (Hattem, 7/22).
Also in other oversight news, Bloomberg reports -
Bloomberg: Medical Device Hackers Find Government Ally To Pressure Industry
Although there are no known incidents of patients being harmed from hacking attacks against their medical devices, the potential for that is growing as more medical products feature wireless connections, according to Bill Maisel, deputy director for science at the FDA's Center for Devices and Radiological Health. ... The agency doesn't force device makers to respond directly to complainants, but it does require that companies reply to the FDA within 45 days of being notified of a complaint, Maisel said. That often means the companies will contact the complainants first to gather information to mitigate security threats, medical device makers such as Medtronic and Animas have hired hackers to probe their products (Robertson, 7/23).