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 last week’s 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, Va.
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 healthcare 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.
One of the most recent high-profile cases of HAIs associated with medical devices occurred between 2012 and the spring of 2015 when at least 250 patients, based on a U.S. Senate committee report, were infected with antibiotic-resistant bacteria after undergoing endoscopic procedures with devices that had not been properly disinfected.
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 healthcare facility, healthcare 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 healthcare professionals. “I don’t think we’ve paid enough attention…to the impact (of) water and air…with regard to healthcare-associated infections,” said Lisa Waldowski, an infection control specialist at the Joint Commission.
The role of heating, ventilation, and air conditioning systems was just one factor identified during the forum as contributing to HAI risk. Other factors—which were named by a diverse group of clinicians, sterilization and reprocessing professionals, microbiologists, regulators, healthcare technology management professionals, representatives from accreditation bodies, and other experts—included:
Inadequate facility design Inadequate surface/fixture disinfection
Inadequate risk management practices
Issues with steam/water quality
The actions of healthcare providers, housekeeping and environmental services staff, as well as the C-suite
Failure to consider reprocessing requirements when purchasing equipment
Inadequate resources and training for sterilization and reprocessing staff
The complexity of reusable devices and other design issues that make them difficult to clean
Issues with instructions for use
Inadequate point-of-use treatment, such as decontamination
Insufficient maintenance and repair of equipment and devices
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 healthcare facilities is expected to be published sometime next year. However, fixing the issue of device-related HAIs does not rest solely on the shoulders of standards developers or central sterile processing staff everyone has a role to play, Suzanne Schwartz, associate director for science and strategic partnerships at CDRH, articulated during her keynote speech. “Solutions are needed at an ecosystem level,” she said. “Until we change our model to more of a systems approach, our siloed efforts will only get us so far.” 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 healthcare delivery organizations conduct HAI risk assessments in 2017.