AcuityLink-clinical-notification-system

At the AACN/NTI, Welch Allyn launched the alarm notification system that was shown for the first time at HIMSS in New Orleans. Alarm notification has been a persistent patient safety issue of such magnitude that the Joint Commission added it to their National Patient Safety Goals in 2003 and 2004.

Conventional alarm notification can be local, i.e., the alarm is annunciated at the device; alarms can be conveyed to a central station; and sometimes includes message panels, lights and annunciators distributed throughout the unit. Of course, all the flashing lights, alarms and blinking message panels contribut to alarm fatigue – a major factor in adverse events and failure to rescue.

The optimal solution for safe and effective alarm notification is to deliver the alarm directly to the responsible caregiver, where ever they are on the unit. The first vendor with this kind of alarm notification was Baxter with their Colleague “smart” pump – they use a Symbol PDA that receives alarms based on nurse to patient assignments. Welch Allyn is the first patient monitoring vendor with such a solution.

The AcuityLink clinical notification system provides alarm notification and escalation for life critical alarms, as well as near real time surveillance of moving waveforms from one to several patients. The system is designed to be safe and effective in a wireless environment where caregivers go in and out of wireless coverage and may leave the unit to transport a patient or take a break. The system has pre market approval via a 510(k) for alarm notification. In recognition that caregivers can’t carry a PDA dedicated to each of the medical device vendors on their unit, AcuityLink does not preclude customers from loading and running third party software on the PDA. (In contrast, the Baxter PDA is “locked” and must be dedicated to running Baxter’s application.)

Here’s a link to an “editorially massaged” version of the press release, and an apparently unmodified press release. I looked for a copy of the press release and product information on the Welch Allyn sites (corporate and monitoring) and couldn’t find a thing. Perhaps someone can send me a link once something is up.

Pictured right is the AcuityLink PDA (really a HandHeld Products 7900) showing a snippet of ECG waveform that accompanies each alarm – this provides the caregiver an opportunity to determine if the alarm is a false positive (a frequent occurrence that results from patient movement) or an actual alarm. Shot at HIMSS 2007.

UPDATE: If you’re interested in alarm notification, alarm fatigue and the future direction of medical device alarms, check out this article I wrote for Patient Safety & Quality Healthcare magazine, called Trends in Point-of-Care Alarm Notification.

Commenter Dave Hoglund mentions the Philips-Cisco-Emergin integration that provided alarm notification with a sample waveform on a Cisco wireless VoIP phone (using Emergin middleware) . This was shown a couple years ago at HIMSS in Dallas and made it’s way into a Cisco brochure.

First off, alarm notification is unambiguously a “medical device” as defined by law and thus requires pre market approval by the FDA. Secondary alarm notification is a term of art created by vendors who sell alarm notification without pre market approval – the continued existence of this class of product is a consequence of the FDAs decision to look the other way if the alarm is simply a text alarm and does not include waveforms. I think the FDAs position is pretty smart – “secondary” alarm notification does provide some benefit, and the public’s interest is probably not best served by yanking all those products from the market. At the same time, regulated alarm notification systems with proven safety and effectiveness (a consequence of pre market approval) better serves the public interest, so vendors are being pushed in that direction. To effect this push the FDA has been rapping knuckles when secondary alarm notification systems include waveforms. Alarm notification for many types of alarms are of limited utility without presenting a waveform with the alarm to filter out false/positive alarms; the market wants waveforms.

In the Philips-Cisco-Emergin example that Dave mentions, Philips was in the best position to 1) know that a 510(k) was required, and 2) to actually get pre market approval for the alarm notification feature. It certainly does not make sense for Cisco to get a 510(k) on their wireless VoIP phone as a medical device. As an event management middleware vendor targeting hospitals, a case could be made for Emergin to get a 510(k) – many events that occur at the point of care could theoretically fall under the legal definition of a medical device – but this is not necessary either.

There is a savvy product strategy in all of this somewhere – actually more than one.