Joint Commission lists most challenging requirements

The Joint Commission in its March 26 Joint Commission Online newsletter listed the most challenging requirements in 2013 for hospitals, critical access hospitals and a variety of other health care facilities based on its data collected for the year. Among the life safety, environment of care and infection control concerns were means of egress, fire protection features, utility system risks and infection risks associated with medical equipment, devices and supplies.

AHA offers emergency preparedness principles

The Centers for Medicare & Medicaid Services (CMS) have generally chosen the correct framework for its proposed emergency preparedness Conditions of Participation and Conditions for Coverage for Medicare and Medicaid providers, but should ensure that the proposed requirements enhance readiness without adding confusion or administrative burden, the American Hospital Association (AHA) told the agency in submitted comments. Specifically, AHA Executive Vice President Rick Pollack encouraged CMS to consider five guiding principles as it finalizes the requirements: align policies with existing standards; define leadership roles for community planning; accept an integrated approach to emergency planning; collaborate to develop interpretive guidance; and balance implementation and compliance with education.

Medical device recalls nearly double over decade

The annual number of medical device recalls increased by 97 percent between fiscal 2003 and 2012, to 1,190, according to a new report from the Food and Drug Administration's Center for Devices and Radiological Health. "The most frequent causes for recalls are related to device design, software, and nonconforming material or component issues," the report states.

NFPA seeks comments on several key documents

The National Fire Protection Association (NFPA) has made available first drafts of several key documents and is seeking public comments, according to an item in the American Society for Healthcare Engineering's ASHE Insider e-newsletter. Documents open for public comment include NFPA 13, Standard for the Installation of Sprinkler Systems; NFPA 72, National Fire Alarm and Signaling Code; NPFA 80, Standard for Fire Doors and Other Opening Protectives; NFPA 101A, Guide on Alternative Approaches to Life Safety; and NFPA 110, Standard for Emergency and Standby Power Systems. The draft documents can be reviewed on NFPA's website and the deadline to comment is May 16.

FDA issues draft health IT regulatory framework

The Food and Drug Administration (FDA) recently released a draft report proposing a risk-based regulatory framework for health information technology (HIT), as required by the FDA Safety and Innovation Act. Developed with the Office of the National Coordinator for Health Information Technology and Federal Communications Commission, the draft report proposes separate risk categories for HIT products with administrative functions, health management functions and medical device functions. Under the proposal, the FDA would focus its oversight on HIT products with medical device functions due to greater potential safety risks.