Standing at the bedside of a terminally ill family member is difficult. Recently, two physicians told me about their experience of something that made this situation worse – the noise of multiple infusion pump alarms that were a continuous source of anxiety and aggravation.
Standing at the bedside of a terminally ill family member is difficult. Recently, two physicians told me about their experience of something that made this situation worse – the noise of multiple infusion pump alarms that were a continuous source of anxiety and aggravation. The nurses, who knew the alarms were not emergencies, often did not respond quickly. The patient, who did not know the alarms were not urgent, felt the nurses were indifferent, and family members felt that their loved one was not receiving the best possible care.
This unfortunate situation highlights an emerging area of focus for hospitals: The importance of patient and family satisfaction. The two physicians suggested a possible solution—instead of sounding infusion alarms and other medical device alarms at the bedside, send the alarms to the central nursing station and to the mobile device of the responsible nurse, which would make the hospital environment much quieter and less stressful. Fortunately, work is already underway working to make remote or “distributed” device alarms possible. These efforts, however, will need to clear multiple technical and regulatory hurdles and address several requirements:
1) The first requirement for remote alarm notification is wireless connectivity that integrates bedside devices and the hospital’s information technology (IT) network. The infusion pump industry has been at the forefront of this effort. For CareFusion, more than half of our installed pumps are already on wireless networks. Wireless connectivity makes it easier to update “smart” pump drug libraries and collect continuous quality improvement (CQI) data on alerts. Additional wireless capabilities are already in clinical use, including integrating the pump with the electronic medical record (EMR) on the hospital IT network. This interoperability makes it possible to send the physician’s orders from the EMR to pre-program the pump with the intended infusion parameters, which can help decrease human error when using the keypad. It also sends back data to the EMR to automatically document the infusion.
2) Any medical device manufacturer will need to consider regulations from the U.S. Food and Drug Administration and other international regulatory bodies for the types and sound volumes of medical device alarms when designing potential distributed alarm notifications. Under the current standards, even if an infusion pump sends the alarms to a remote communication system, the bedside alarm still must sound. Changing such standards often takes years.
3) Alarm system developers will need to ensure that critical alarms sent to a third-party system initiate communication back to the device itself to indicate that the alarm was received. Repeat alarms would also need to be sent if the device alarm is not addressed within a specified time limit. This capability does not exist in the current generation of infusion pumps, which number more than 1 million in the U.S. alone.
4) Finally, another challenge is that while medical devices are regulated by the FDA in the U.S., healthcare information technology (HIT) systems and other technologies are not.
The noise problem goes beyond just alarms and medical devices, as Pauline Chen, MD, a transplant surgeon at the University of California at Los Angeles described in her recent column in the New York Times,titled “Clatter in the Hospital Room.” Medical device interoperability is a major focus for device manufacturers, IT companies, researchers and clinicians. In October 2011, more than 300 engineers, clinicians, representatives from medical device and HIT companies, the FDA and other agencies met at the Clinical Alarms Summit convened by the Association for the Advancement of Medical Instrumentation (AAMI), the FDA, The Joint Commission, American College of Clinical Engineering (ACCE), and the ECRI Institute. For more than two days, this multidisciplinary group of experts focused on the issues and opportunities related to integrating medical devices with HIT networks. As detailed in the conference report, results included both short-term, follow-up items and a research agenda for the longer-term.
CareFusion is collecting and analyzing alarm and alert data from hundreds of thousands of its infusion pumps to better understand pump alarms. Unlike monitors, which are notorious for false alarms, we have found that pump alarms are true alarms. Our focus is to help hospitals reduce the alarms. For example, an analysis of more than 12 million alarms showed that half were associated with occlusions and more than 90 percent of these were in Intensive Care Units and medical/surgical units. Many of the occlusion alarms were related to catheter placement issues when catheters became kinked as patients moved their arms. In our analysis, a significant percentage of alarms and alerts were related to specific patient-care practices that we believe can be addressed by sharing and implementing best practices across individual hospitals.
In summary, efforts are underway in this area, led by companies that are focusing specifically on alarms. These efforts include using technology to send more meaningful messages through the nurse call systems, sending pre-alarm alerts to nurses when infusion bags are near empty, allowing nurses to remotely reset medical devices and informing nurses of where and why a specific pump is alarming.
It is clear that alarms are an important focus area for the medical device industry. While changes won’t happen overnight, the converging focus across government and industry shows promise for a solution to this important issue.