Public Citizen | Publications - Letter to FDA Commissioner About Defective Welch Allyn AEDs (HRG Publication #1863)

Frank Torti, MD, MPH
Acting Commissioner, Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

On February 26, Welch Allyn initiated a Class 1 recall of 14,054 of its automatic external defibrillators (AEDs), the largest of a total of six recalls of these dangerously problematic devices to date.[1] Yet, as of this morning, the Food and Drug Administration has not announced this imminent threat to the American public. AEDs are life-saving devices typically used by emergency responders and hospital personnel to resuscitate patients in cardiac arrest. This recall is particularly alarming given it is the latest in a series of recalls of defective Welch Allyn AEDs, a category of devices under-regulated by the FDA (see regulatory status below). How many more deaths and near deaths because of delays in resuscitation will have to occur before the FDA takes more definitive action to end the use of these all-too-often defective Welch Allyn devices?

Class 1 recalls are the most serious type of recall, involving situations in which there is a reasonable probability that using the product will cause serious injury or death. Welch Allyn acknowledges two deaths have been associated with problems identified in this current recall.[2] According to the FDA website,[3] in January 2008, a patient died after the AED 10 shutdown in the middle of resuscitation. Then, in November 2008, a patient died after an AED 10 failed to shock during resuscitation.

This current recall is for the following problems listed in Table 1, each affecting varying numbers of the total 14,054 units recalled. According to Welch Allyn, these problems “may prevent defibrillation of a patient in cardiac arrest and could lead to death.”[1] In other words, the company is admitting that the problems listed below could prevent the defibrillator from functioning properly and thus impair its ability to prevent someone with ventricular fibrillation from dying.

Since 2005, Welch-Allyn’s AEDs have been the focus of five previous Class 1 recalls, including a recall of AED 10s in October 2007.[4],[5],[6],[7],[8] In four instances, the recall has been due to an intermittent electrical connection within the AEDs that can cause a ‘Defib Comm’ error message to appear, leading to inability to analyze patients’ electrocardiograms (ECG) and provide appropriate defibrillation. This malfunction has been associated with at least two deaths.[3] Given multiple instances of recalls for the same problem, Welch Allyn appears unable to capture all of the affected devices in their recalls. The recalls are summarized in the Table 2.

Moreover, this latest recall once again makes it clear that the entire category of AEDs, a class III medical device, is insufficiently regulated by the FDA. Class III devices are life-supporting, life-sustaining, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.[9] Because of their risk, class III devices are to be regulated under the PMA (premarket approval) pathway; this requires direct evidence of safety and effectiveness before being marketed.[10] However, because the FDA has failed to meet statutory requirements established in 1990, AEDs, and a handful of other class III devices, are still regulated under a less-stringent premarket review mechanism, the 510(k) pathway.[11] There is minimal data concerning the technical performance of AEDs.[12] Moreover, the number of advisories (recalls and safety alerts) and the number of devices affected by these advisories increased between 1996-2005.[12] Given their inappropriate regulation under 510(k), this is cause for great concern.

We request a timely response to the following questions: How are manufacturers deciding which devices are affected and are subject to the recall? Moreover, why has the FDA not announced this recall? Furthermore, why is the FDA permitting manufacturers to continue to introduce these potentially life-saving devices with only minimal data through the 510(k) pathway? Lastly, why has the FDA not taken further measures to address what is an obviously deficient device manufacturer?

[1]Welch Allyn. Welch Allyn issues voluntary recall of select AED 10 Defibrillators. March 11, 2009. www.welchallyn.com/pressroom/releases/2009/AED10_Recall_03-10-2009.htm. Accessed March 13, 2009.

[2]Welch Allyn. Welch Allyn AED 10 recall information www.welchallyn.com/support/customer/AED_lookup.jsp.
Accessed March 13, 2009.

[3]Food and Drug Administration. Search MAUDE database. Updated February 28, 2009. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm. Accessed March 13, 2009.

[4]Food and Drug Administration. Class 1 recall; Welch Allyn AED 10 Automatic External Defibrillators. October 26, 2007 http://www.fda.gov/cdrh/recalls/recall-102607.html. March 13, 2009.

[5]Food and Drug Administration. Class 1 recall; MRL/Welch Allyn AED 20 Automatic External Defibrillators. August 24, 2007 http://www.fda.gov/cdrh/recalls/recall-082407.html. Accessed March 13, 2009.

[6]Food and Drug Administration. Class 1 recall; Welch Allyn PIC 50 Automated External Defibrillators. June 30, 2006. http://www.fda.gov/cdrh/recalls/recall-063006.html. Accessed March 13, 2009.

[7]Food and Drug Administration. Class 1 recall; Welch Allyn AED 20 Automated External Defibrillators. June 15, 2006. http://www.fda.gov/cdrh/recalls/recall-061506.html. Accessed March 13, 2009.

[8]Food and Drug Administration. Class I recall; Welch Allyn AED 20 Automatic External Defibrillator. April 28, 2005. http://www.fda.gov/cdrh/recalls/recall-042805.html. Accessed March 13, 2009.

[9]21 U.S.C. § 360c(a)(1)(C).

[10]Food and Drug Administration. Guidance on the CDRH premarket notification review program (k86-3). June 30, 1986. www.fda.gov/cdrh/k863.html. Accessed March 13, 2009.

[11]United StatesGovernment Accountability Office. Medical devices; FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process; Report to Congressional addressees. January 2009. www.gao.gov/new.items/d09190.pdf. Accessed March 11, 2009.

[12]Shah JS, Maisel WH. Recalls and safety alerts affecting automated external defibrillators. Journal of the American Medical Association. 2006;296(6):655-60.

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