March 13, 2009

Letter About Defective Welch Allyn AEDs

Frank Torti, M.D., M.P.H.
Acting Commissioner, Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Torti,

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.

Table 1. Problems with AED 10 and MRL JumpStart defibrillators in 2009 class I recall
Problem	Affected units	Date manufactured	Serious injury or death reported by Welch Allyn
Voice prompt failure	5,336	Oct 3, 2002- Jul 26, 2004	No
Unexpected shutdown	10,735	Oct 3, 2002- Dec 30, 2004	11 incidents, 1 death
Inappropriate shock or appropriate shock not delivered	10,735	Oct 3, 2002- Dec 30, 2004	8 incidents
Low energy shock	14,012	Oct 3, 2002-Jul 11, 2005	20 incidents, 1 death
Blown fuse	4,568	May 18, 2004- Dec 30, 2004	No
Shutdown in cold weather	89	Received software upgrade in 2007	No

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.

Table 2. Previous recalls of Welch Allyn AEDs
Model	Date recall initiated	Date recall posted	Class	Reason	Affected units	Patient complaints
AED 10	Oct 26, 2007	Nov 6, 2007	1	Delay or non-delivery of the defibrillating shock due to defective capacitor	1,795	49 failures and 3 customer complaints
AED 20	Aug 24, 2007	Sep 19, 2007	1	Failure of the device to analyze ECG*	1,637	21 complaints received
PIC 50	Nov 15, 2006	Jan 19, 2007	2	Shock delay (due to ‘ECG Comm’ error message)	510
PIC 50	Jun 30, 2006	Jul 8, 2006	1	Failure of the device to analyze ECG*	1,184	18 related complaints, with 2 instances of delayed resuscitation
AED 20	Jun 15, 2006	Jun 22, 2006	1	Failure of the device to analyze ECG*	580	30 related complaints, with one instance of delayed resuscitation
AED 20	Apr 28, 2005	May 12, 2005	1	Failure of the device to analyze ECG*	597	12 related complaints and 1 death
AED 10	Apr 26, 2004	Jul 20, 2004	2	Intermittent shock button failure	460
*Due to ‘Defib Comm’ error message. This problem occurs because of an intermittent electrical connection within the device. This problem was identified in multiple  previous recalls.

Regulatory status: Automatic external defibrillators

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] Thus, the amount of data, specifically clinical data, submitted by manufacturers prior to marketing AEDs is sparse.[12]

Therefore there is minimal data concerning the technical performance of AEDs.[13] Moreover, the number of advisories (recalls and safety alerts) and the number of devices affected by these advisories increased between 1996-2005.13 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?

Sincerely,

Sidney M. Wolfe, M.D., Director

Jonas Hines, Researcher
Health Research Group at Public Citizen