New AED Recall Notification Tool Streamlines Client Communication
San Francisco, CA – The majority of the FDA’s Circulatory System Devices advisory committee, do not believe that automatic external defibrillator (AED) manufacturers are currently doing enough to ensure the safe and reliable performance of their AED devices.
A January 27, 2011 article on www.theheart.org writes that “Since 2005, the FDA has recorded 67 AED recalls related to certain failures of a manufacturer’s quality system. Most often the breakdown was classified as a failure of purchasing controls and receiving acceptance activity or a failure of design controls. To tackle this problem, the agency proposes that it be able to review all manufacturing information and inspect the facility where the AEDs will be built prior to clearing a new AED for the market.”
While a history of recalls may exist, AED units are safe and effective life-saving devices. “Until AED units further saturate communities, we won’t see a statistical uptick in lives saved due to sudden cardiac arrest. Therefore, its vital that recalls be addressed quickly and responsibly so that future owners and, would-be buyers, gain the confidence required to ensure their decision to purchase a new unit for their facility isn’t only the ‘right thing to do’ but also a wise and practical decision,” states Micah Bongberg, President and CEO of Annuvia, the makers of the Arch AED medical direction and oversight program.
An area of principle interest relates to how these important notifications are relayed to not just the AED manufacturers and FDA, but to the AED owners themselves. Once a trend is identified and a recall or field corrective action is established as the best course of action, AED owners must be notified to mitigate the severity of a given issue. Such an effort can require notifying hundreds or thousands of customers, located in geographically diverse areas. Unfortunately, the speed at which such notifications can take place relies on close coordination between AED distributors, direct sales representatives, media and AED manufacturers.
AED owners who use the Arch program for AED Medical Direction and Oversight services log in to the website monthly to conduct AED equipment maintenance checks. “Arch offers AED owners and AED distributors a number of value-added options, including a new product related to AED recall warning and notification,” states Bongberg.
Arch allows AED distributors an opportunity to cross-reference the AED units they’ve sold or manage for their clients with the company’s recall tracking tool. With the click of the mouse distributors can determine if any of their units or accounts has been subject to a recall. Once identified and segmented from their other units under management, distributors can select the AED owners for whom they’d like to send automatic correspondence; keeping the AED distributor’s brand, name, logo, and contact information in place. Once selected and the distributor presses “submit,” Arch sends automatic correspondence directly to the AED owner via email.
“By sending direct – Channel Partner-to-AED owner – correspondence including references to the corrective action, links to the FDA or AED manufacturer’s website, and instructions on how to ‘fix’ the problem, all using our Channel Partner’s identity (brand, name, logo, and contact information), we put our Channel Partners in a leadership position while giving them tools to efficiently manage thousands of devices,” says Bongberg. Furthermore, “since we allow our Channel Partners to cross-reference and send communications, only the AED units that are subject to a recall, Arch’s service notifies those necessary, without inciting panic industry-wide.”
Arch, by tying the affected AED units of a recall, as reported by the FDA, to the AED manufacturer’s guidelines, and reporting directly to the AED owners, allows AED owners to fix their AED units more quickly while controlling the messaging to their clients. This, in turn, can help ensure AED units are updated quickly and appropriately, while tracking which AED owners have been notified, which have initiated proper corrective actions, and which accounts should receive additional communications to ensure all remediation efforts have taken place.
A commonly overlooked fact inherent in the responsibilities of acting as a distributor of AEDs is that distributors play a large role, and have a contractual obligation with the AED manufacturers, in communicating field corrective actions and recalls to their customer-base. A process that used to take weeks for large AED distributors, can be mitigated and managed in seconds, using Arch.