Readers of the ECRI Institute's Top 10 Health Technology Hazards For 2011 report who saw "Data Loss, System Incompatibilities and Other Health IT Complications" sitting at fifth on the list might have
Put another way, are health information technology problems more of a risk than are "oversedation during use of patient-controlled analgesia infusion pumps," "needlestick injuries," and the 600 "surgical fires" (at No. 7 and No. 9 on the list) occurring annually in U.S. health care facilities?
Turns out, in ECRI's estimation, health IT problems are more significant than those others, a conclusion the institute based on the number of incident reports, severity of risks and the potential for future problems. The last item carries more weight with health IT technology than with the other items in the top 10 list. One reason is the rapid expansion of health IT implementation, thanks to federal efforts to build a nationwide network of health information exchange. The other is the general proliferation of wireless medical devices in the health care environment.
Electronic health record (EHR) safety is a major component of health IT problems because EHR applications collate the various data from health IT technologies into digital patient records, said James Keller Jr., the institute's vice president of health technology evaluation and safety.
"[EHRs] are a big part of the technology we're talking about," Keller said. "The rapid growth of [health IT], the increased complexity of this technology compared to non-IT based devices and systems, and the potential broad negative effect this technology can have on patient care, were factors that led us to put this topic on the top 10 list."
That's the bad news. The good news, Keller said, is that ECRI has received few adverse event reports involving health IT relative to other items on the list. In addition, he believes EHR systems will reduce errors in health care in the long run. Along the way, however, EHR implementation will cause some patient safety "bumps in the road."
Interestingly, ECRI listed data loss as one potential hazard of health IT. Once the health care world jumps from paper to electronic workflows, the lack of information in a patient record can lead to less-informed care decisions that could lead to errors, Keller said.
EHR safety regulations loom on horizon
IT leaders like to look at software applications and hardware as separate entities, but the Food and Drug Administration (FDA), from its regulatory perspective, more and more frequently lumps them together as "devices." It makes sense to consider them as a unit, because many devices often are controlled by software or firmware, Keller said.
Ultimately, 2011 could be a year when the FDA takes a stance on EHR safety regulation. In addition, the Institute of Medicine (IOM) recently announced it will convene a panel to examine EHR safety. Sometimes reports emerge from IOM panels that directly influence regulators; at other times, they end up issuing what amount to guidance documents. Either way, there is no question that EHR safety is a hot topic worthy of consideration, Keller said.
"I don't know for sure what will come out of [the IOM panel], or what the trigger point would be to cause regulations to start happening," Keller said. "Definitely, the IOM initiative is going to help focus more attention on health IT-related safety. We'll just have to see where it goes from there."
A key facet of EHR applications that makes them look to the FDA more like devices than separate hardware and software is how they affect the patient-care decision making process, Keller said. The more these applications influence care decisions, with such features as decision support and clinical data analytics, the more they resemble devices.
Advice for improving EHR safety
That said, Keller and the ECRI report authors offer a few tips for improving EHR safety -- and your facility's health IT safety in general:
• Beef up IT support. Many facilities view IT help desks as support for back-office business functions. Make them available 24/7 to clinicians. The answers help desk personnel give could literally save lives.
• Evaluate and improve project management, risk management and change management processes. Rolling out technology that best fits a facility's workflow -- and making sure the change has the smallest possible negative effect on patient care quality -- are essential to preventing adverse events. Start by reviewing the recently published International Electrotechnical Commission's IEC 80001-1 standard, "Application of risk management for IT-networks incorporating medical devices -- Part 1: Roles, responsibilities and activities."
• Encourage nurses and physicians to file adverse event reports when they have health IT problems. Give them a template that helps create consistent documentation that can be used to solve problems and track trends. At minimum, reports should include information on the clinical effect of the problem, a clear description of the problem, a standard reference to the products involved, and description of the follow-up actions to the reported incident.
Let us know what you think about the story; email Don Fluckinger, Features Writer.