To stop the spread of healthcare-associated infections (HAIs), more attention needs to be paid to the role of medical devices and equipment. This was the thought that sparked a two-day forum on medical technology and HAIs hosted by AAMI in collaboration with the American Hospital Association, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration’s Center for Devices and Radiological Health (FDA/CDRH), and The Joint Commission in Herndon, Virginia.
During the invitation-only event, which served as a follow-up to the 2011 summit on medical device reprocessing convened by AAMI and the FDA, 100 experts were tasked with identifying a list of HAI hazards and articulating potential solutions and mitigation strategies. The HAI risk factors they identified included facility design, water quality, device reprocessing, and competency and training.
Based on CDC estimates, there were 722,000 HAIs in U.S. acute care hospitals in 2011. About 20 percent of these infections are transmitted through the health care environment, which includes medical devices, said William A. Rutala, director of hospital epidemiology for the occupational health and safety program at the University of North Carolina.
But the problem of HAIs is much larger than device reprocessing, a number of presenters were quick to point out. For example, the FDA sent out a safety communication after the heater-cooler units found in bypass machines used during open-heart surgery were linked to the transmission of nontuberculous mycobacterium. The agency said it had received 32 reports of patient infections associated with these devices between January 2010 and August 2015.
Still, the FDA said it is unsure exactly how many people may have been impacted by this HAI, as it can take years for symptoms to develop, making it “challenging for a health care facility, health care provider, manufacturer, or patient to recognize that infections … may be associated with the use of or exposure to a particular medical device.”
This type of indirect exposure to potentially harmful bacteria is something that hadn’t been on the radar for many health care professionals.
For many in attendance, implementing a quality management system seemed like the most effective way to structure solutions to many of these problems. In fact, a new standard – ST90 – that adapts the quality management system guidance found in ANSI/AAMI/ISO 13485 to device processing in health care facilities is expected to be published sometime next year.
This event was a first step in gaining the consensus needed to take such a systems approach. A summary report of the proceedings will be available by the end of the year. AAMI is also planning to develop a guide to help health care delivery organizations conduct HAI risk assessments in 2017.