Guidance on Alarm Systems

The recent release of amendment 2 of the IEC 60601-1-8:2006,Medical Electrical Equipment --Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems will provide additional guidance for manufacturers that develop medical devices that include an alarm system. This amendment is the result of many years work from a team of dedicated individuals representing manufacturers, users, regulatory agencies, and researchers from the medical device industry.

Some changes that are notable are the inclusion of alarm sounds that have been validated and are readily available on the IEC website. These are .wav files and are being made available at no cost so they can easily integrate into medical devices with little minimal design and development effort. These were developed through a grant from the Association for the Advancement of Medical Instrumentation® (AAMI) to Dr. Judy Edworthy, a renowned audiologist and Professor of Applied Psychology at Plymouth University, Plymouth, United Kingdom. These sounds are designed to guide the healthcare professional to the device that is the communicator of the alarm signal and to readily identify which type of physiologic alarm condition is responsible for that alarm signal. These are intended to be real world sounds that are different from the ding-ding-ding that we hear from medical devices today.

Additional changes/modifications to the standard are the expansion of the definitions of an alarm system. Specifically a distributed alarm system. When the original standard was developed, and even when it was amended in 2012 the types of alarm systems were not as sophisticated as they are today. For example a "secondary alarm notification" to a pager was a one way signal to a caregiver letting them know an alarm condition existed on a patient. Today, as part of a distributed alarm system, that caregiver can receive that information on a smart phone, review the alarm condition, including waveform, and respond with accept or reject responsibility (as they may be busy). When an alarm signal is rejected, the system can escalate the alarm signal to a different designated back-up caregiver. All of that is configured to fit the needs of the specific facility and specific unit.

Another update to the standard is in the requirements for the logging in an alarm system. This includes what should be included in an alarm system log and how it is stored, accessed, and managed.

If you would like additional information regarding this topic, I would be happy to share a guidance document that I have developed over the past few years that includes some examples, scenarios, and (hopefully) provides clarification about alarm systems. And you should obtain a copy of this revised standard. Compliance to its requirements will go a long way to improving patient safety.