Regulatory Issues
BMETs must conform with safety regulations, and most biomedical systems must have documentation to show that they were managed, modified, tested, delivered, and used according to a planned, approved process that increases the quality and safety of diagnostics and therapeutic equipment and reduces the risk of harm to patients and staff.
In the United States, BMETs may operate under various regulatory frameworks. Clinical devices and technologies are generally governed by the Food and Drug Administration (FDA), National Fire Protection Agency (NFPA) particularly NFPA 99 and chapter 7, NFPA 70, Life Safety Code 101, Code of Federal Regulations (CFR) 21, Occupational Safety and Health Administration, Joint Commission on Accreditation of Healthcare Organizations (JCAHO) hospital or Accreditation Association for Ambulatory Health Care standards; and ensures compliance with these codes and standards for the US government registry of biomedical devices.
Other countries typically have their own mechanisms for regulation.
Read more about this topic: Biomedical Equipment Technician
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