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Growing Concern Over Alarm Hazards Signals Need for Change

A prominent theme at the 2013 AAMI conference, alarm hazard reduction is a major objective of clinicians and clinical engineers. But has it fully captured device manufacturers' attention?

The issue of alarm hazards--most notably alarm fatigue and differentiation troubles—had attendees buzzing at the Association for the Advancement of Medical Instrumentation (AAMI) 2013 Conference and Expo this past weekend. And while clinicians have made it clear that they're ramping up efforts to address the problem, medical device companies have been less proactive in quieting the noise surrounding alarm hazards.

Concern about medical equipment alarm hazards has escalated to a fever pitch in the past several years, thanks, in part, to landing the top spot on ECRI's list of the Top 10 Health Technology Hazards two years running. Soon after alarm hazards earned this dubious honor, The Joint Commission issued a sentinel event alert focused on medical device alarm safety in hospitals that further underscored the need for collaboration between clinicians, hospital clinical engineers, and medical device manufacturers to address the growing problem.

"The number of alarm signals per patient per day can reach several hundred, depending on the unit within the hospital, translating to thousands of alarm signals on every unit and tens of thousands of alarm signals throughout the hospital every day," according to The Joint Commission. "As a result, clinicians become desensitized or immune to the sounds, and are overwhelmed by information--in short, they suffer from 'alarm fatigue.' In response to this constant barrage of noise, clinicians may turn down the volume of the alarm setting, turn it off, or adjust the alarm settings outside the limits that are safe and appropriate for the patient--all of which can have serious, often fatal, consequences."

The kicker, The Joint Commission notes, is that of these many incessant alarms, a staggering 85 to 90% of them do not actually even require clinical intervention. And yet, the constant chorus of "nuisance alarms" continue to pose a significant threat to patient safety.

While the onus of overcoming alarm fatigue seems to fall heavily on clinicians, medical equipment manufacturers can help shoulder the burden and improve patient care.

Attempting to be part of the solution is Masimo. Hot on the heels of its $1-million performance guarantee announcement, Masimo was working the AAMI expo crowd this past weekend and extolling the ability of its pulse oximetry signal extraction technology (SET) to help reduce alarm hazards.

"Pulse oximeters are the most common monitors in the hospital," Michael Becker, Masimo's chief nursing officer, acute care, East Coast, said during a presentation at the AAMI expo. "The issue is that conventional pulse oximetry is really unreliable when needed most; that's when you get some of those alarms that become nuisances and are not actionable."

Nuisance alarms in conventional pulse oximeters, Becker said, are often triggered by inaccurate measurements that can occur as a result of patient movement. "Masimo has SET, which uses infrared light--similar to conventional pulse oximetry technology--but we use additional algorithms to be able to filter out that venous movement [from patient movement] for true arterial saturation," he explained. The result, he added, is true arterial saturation data, fewer alarms, more-actionable alarms, and, ultimately, better workflow.

And while Masimo has taken steps to reduce alarm hazards through design innovation, many medical device companies appear to be much less motivated to take action. Among the biggest barriers to progress appears to be the IEC 60601-1-8 standard, which is focused on medical device alarms.

"FDA insists that [medical device] companies conform to standards that are imperfect--they're not bad, just imperfect. But it takes the standards bodies a certain amount of time to get current with what new technology can provide," Jim Welch, vice president of clinical engineering and patient safety at Sotera Wireless, told MD+DI after an AAMI roundtable on alarm hazards. "Companies have to be careful of protecting themselves and their shareholders, and they're reasonably going to configure their devices to be hypersensitive. So, [the device] has the high sensitivity to alarms, but not necessarily a high specificity to alarms."

And while Welch acknowledges that there is, in fact, a certain amount of innovation within the current standards model, he notes that there are other factors also at play. "Hospitals have got to manage alarms within the context of a lot of legacy equipment that has limited capabilities to adjust alarm configuration such that they reduce the amount of unnecessary or nonactionable alarms," he said. "So, there are all kinds of workarounds because the normal capital equipment cycle in a hospital is seven years."

Legacy equipment, limiting standards, and an overly cautious FDA and medical device industry, have, consequently, somewhat impeded the medical device industry's contribution to reducing alarm hazards in the clinical setting. But prodding and increased calls for collaboration on this front by clinicians and clinical engineering staff could, according to Welch, prompt progress--and hopefully soon. "I think we're at the beginning of a change in attitudes here," he said. "But it's up to the end-users to force and insist on that change in a collaborative way."

Shana Leonard is the executive editor of the UBM Canon MedTech Group.

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