A growing number of studies point to the need for better surveillance of patient-safety events associated with technology integration. In June, researchers at the Veteran Health Administration Center for Innovations in Quality, Effectiveness and Safety in Houston reported that complicated and confusing electronic health records pose a serious threat to patient safety. The more complex a system, the more difficult it is to trace the root cause of a mistake. They said the problem is not just technological complexity, but how people use the system. Often, such events happen under the radar, and when they are reported, they are often attributed to user or programming error.
A Food and Drug Administration report on device recalls this year said radiology devices such as linear accelerators and CT scanners were the most frequently recalled devices. But for the most part, “the problems have not been with the technology in itself, but rather with clinical use of the technology,” according to the report. Software issues, system compatibility, user interfaces and clinical-decision support accounted for more than two-thirds of radiology device recalls.
Some experts recommend mandatory training for newly introduced device or technology, while others call for more transparency to allow hospitals to quickly share usability issues and solutions.
“The problem is not always the tool,” said Dr. David Chang of the University of California San Diego. Chang coauthored a recent article in JAMA Surgery that found a brief but significant increase in prostatectomy surgery errors associated with the initial rapid expansion of surgical robot use. “The people using it, that's the part many are not paying attention to,” he said. A national surveillance system would help physicians learn from each others' experiences, he said.
MedStar Health, a 10-hospital not-for-profit system, launched its National Center for Human Factors in Healthcare in 2010 to address safety issues associated with new technology deployment. The 2011 glucometer incident was among the first events it investigated. The center works with MedStar hospitals, as well as medical-device and health-information technology developers, to discover problems and determine what changes in the healthcare environment or the products will produce safe and effective outcomes. Any clinical staffers who might potentially touch a particular piece of equipment could find themselves in the center's simulation lab, including surgeons, anesthesiologists, nurses, paramedics and other medical technicians.
Over the past year, the MedStar team has evaluated dozens of devices, including health IT software, infusion pumps, patient beds and wound-treatment devices, among others. About half of the projects were researched for manufacturers, while the other half were evaluated to examine new or existing devices the health system flagged as posing potential hazards.
At the center's two simulation labs, mannequins with automated voices serve as patients and are outfitted with sensors that send cues to staff monitors indicating the success or failure of a process. The sensors beep when there are sudden changes in the patient's blood pressure or heart rate. Clinical staff who participate in the lab simulations wear a headpiece that tracks their eye movements, which helps human-factors engineers analyze where safety issues are cropping up on the devices being tested.