Hospital-acquired conditions decline 8 percent
Hospital-acquired conditions (HACs) declined by 8 percent between 2014 and 2016, preventing an estimated 8,000 deaths and saving $2.9 billion in health care costs, according to results reported by the Agency for Healthcare Research and Quality. HACs decreased by an estimated 350,000 over the period, including a 15 percent decline in infections and adverse drug events, the agency said, largely through the work of 16 Hospital Improvement Innovation Networks. “Today’s results show that this is a tremendous accomplishment by America’s hospitals in delivering high-quality, affordable health care,” said Centers for Medicare & Medicaid Services Administrator Seema Verma.
Agencies streamline N95 respirator regulation
The Food and Drug Administration (FDA) recently issued a final order exempting manufacturers from FDA premarket notification requirements for certain N95 respirators, disposable devices used to protect patients and health care providers from infection. Under a new memorandum of understanding (MOU) among the FDA, the National Institute for Occupational Safety and Health (NIOSH) and others, organizations seeking to market N95 respirators that do not exceed certain criteria need only NIOSH certification. The final order and MOU are intended to streamline regulatory requirements to help ensure an adequate supply of the devices during emergencies.
AHA comments on security of legacy devices
Legacy medical devices are “a key vulnerability for hospitals,” related to cybersecurity, and device “manufacturers must support end users in providing a secure environment for safe patient care,” the American Hospital Association (AHA) told leaders of the House Committee on Energy and Commerce in May. “This support should include wrapping security precautions around these devices, adding security tools and auditing capabilities where possible, conducting regular updates and patching all software, and communicating security vulnerabilities quickly through consistent channels,” AHA stated in response to a request for information.
FDA further defines ‘facility’ for drug compounding
The Food and Drug Administration (FDA) recently issued final guidance clarifying that an organization may operate both a compounding pharmacy and outsourcing facility at the same address or general location if they are completely segregated by clearly identified boundaries — for example, permanent physical barriers such as walls or doors that are locked. If the pharmacy is not completely segregated from the outsourcing facility, the FDA would generally consider the pharmacy part of the outsourcing facility and subject to Section 503B of the Federal Food, Drug, and Cosmetic Act and current good manufacturing practice, the agency stated. Both compounders also should clearly label their drug products as compounded at a pharmacy or outpatient facility, the FDA stated.