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More Information on the Device Review Process

Testimony on Classification of Automatic External Defibrillators

January 25, 2011

Before the FDA’s Circulatory System Devices Panel
Michael A. Carome, M.D. and Sidney Wolfe, M.D.
Health Research Group, Public Citizen

My name is Dr. Michael Carome.  I am the Deputy Director of the Health Research Group at Public Citizen.  I am testifying on behalf of myself and Dr. Sidney Wolfe, Director of the Health Research Group. Neither of us has a conflict of interest.

There have been a total of 68 recalls of automatic external defibrillators (AEDs) from January 2005-August 2010, 17 of which were serious enough to be Class I recalls, 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.[1]

Despite this, the AED industry, with the seven companies seemingly in lockstep, has asked the FDA to deregulate these life-supporting devices so as to avoid the requirement that they be tested more thoroughly by remaining in device class III.

On March 13, 2009, Public Citizen wrote to the FDA about one such Class I recall initiated by Welch Allyn, currently in a strategic alliance with Zoll Medical Corporation (one of the seven companies mentioned above), involving 14,054 of its AED 10 and MRL Jumpstart defibrillators, the largest of several recalls of these dangerously problematic Welch Allyn devices to date.[2]  This recall was for the following problems listed in table 1 below, each affecting varying numbers of the total 14,054 recalled. Welch Allyn acknowledged two deaths were associated with problems identified in this recall.[3] According to the FDA website,[4] 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.

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

In our letter, we asked FDA to promptly respond to the following questions: How are manufacturers deciding which devices are affected and are subject to the recall? Moreover, why has FDA not announced this recall? Furthermore, why is FDA permitting manufacturers to continue to introduce these potentially life-saving devices with only minimal data through the 510(k) pathway?  FDA has yet to respond to our letter in any substantive way, but today’s hearing does squarely address the last of these three questions.

Current Regulatory Status

The entire category of AEDs, a class III medical device, has been 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.[5] Because of their risk, class III devices are to be regulated under the Premarket Approval (PMA) pathway; this requires direct evidence of safety and effectiveness before being marketed.[6] However, because the FDA has failed to meet statutory requirements established in 1990, AEDs, and a handful of other types of class III devices, are still regulated under a less-stringent premarket review mechanism, the 510(k) pathway.[7] Thus, the amount of data, specifically clinical data, submitted by manufacturers prior to marketing AEDs is sparse.[8] While AED manufacturers seek to maintain the status quo, such a position fails to adequately protect the public health.

The FDA has asked the committee whether AEDs should be reclassified from Class III to Class I or II. We urge that FDA maintain AEDs as class III and require all AED manufacturers to submit new PMA applications to FDA and obtain FDA approval in order to continue marketing their devices.

Safety Concerns Regarding AEDs

AEDs are life-saving devices used by emergency responders, as well as minimally trained and untrained individuals, in a variety of settings outside of hospitals.  However, the FDA over the past 5 years has identified numerous persistent, preventable safety problems with all types of AEDs, across all manufacturers of these devices.[9] 

FDA’s review of performance testing data has identified numerous troubling failures by AED manufacturers[10]

The number of recalls per year for the period 2005-2010 has increased dramatically.  Fifty-three percent of these were due to deficiencies in purchasing controls and receiving acceptance activities, and 39 percent were due to deficiencies in design controls.[11]

Finally, FDA analysis of medical device reports (MDRs) from the Manufacturers and Users Device  Experience (MAUDE) database identified 23,591 MDRs for the time period January 1, 2005-March 31, 2010, including 721 deaths, 78 injuries, and 22,382 malfunctions, among others. The total number of reports have substantially increased over the past 5 years. More importantly, approximately 66% of reports of failed devices never report a root cause and are never evaluated by the manufacturer.[12]

Recommendations

In the interest of protecting public health and promoting innovation, it is imperative that FDA reject industry wishes and instead maintain the class III categorization of AEDs and require AED manufacturers to submit PMA applications.  Such applications must include data from robust clinical trials that reasonably assure that AEDs are safe and effective. 



[1]Food and Drug Adminstration. 515(i) regulatory classification of automated external defibrillators. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/
MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM240579.pdf
. Accessed January 24, 2011.

[2] Wolfe SM. Hines J. Letter to Frank Torti, MD, MPH, Acting Commissioner, FDA, regarding Welch Allyn initiated Class I recall of 14,054 of its AEDs. Washington DC: Public Citizen, March 13, 2009. www.citizen.org/hrg1863. Accessed January 24, 2011.

[3] Welch Allyn. Welch Allyn AED 10 recall information www.welchallyn.com/support/customer/AED_lookup.jsp. Accessed January 24, 2011.

[4] Food and Drug Administration. Search MAUDE database.  Updated January 21, 2011. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm. Accessed January 24, 2011..

[5] 21 U.S.C. § 360c(a)(1)(C).

[6] Food and Drug Administration. Device classification. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm. Accessed January 24, 2011.

[7] United States Government 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 January 24, 2011.

[8] Kessler L, Ramsey SD, Tunis S, Sullivan SD. Clinical use of medical devices in the 'Bermuda Triangle'. Health Affairs (Millwood). 2004;23(1):200-7.

[9] Food and Drug Administration, Center for Devices and Radiological Health, External defibrillator improvement initiative.  November 2010. http://www.fda.gov/downloads/MedicalDevices/
ProductsandMedicalProcedure/CardiovascularDevices/ExternalDefibrillators/UCM233824.pdf
. Accessed January 24, 2011.

[10] Food and Drug Adminstration. 515(i) regulatory classification of automated external defibrillators. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/
MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM240579.pdf
. Accessed January 24, 2011.

[11] Food and Drug Adminstration. 515(i) regulatory classification of automated external defibrillators. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/
MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM240579.pdf
. Accessed January 24, 2011.

[12] Food and Drug Adminstration. 515(i) regulatory classification of automated external defibrillators. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/
MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM240579.pdf
. Accessed January 24, 2011.

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