I am Dr. Caitlin Kennedy and I am speaking on behalf of the National Research Center for Women & Families and our president, Dr. Diana Zuckerman. Our organization is a nonprofit think tank that uses research to determine the comparative safety and effectiveness of medical products and procedures.
Our Center does not accept funding from pharmaceutical or medical device companies, so I have no conflicts of interest.
My remarks today are very similar to written comments previously made by the Patient, Consumer, and Public Health Coalition. These written comments were signed by our organization as well as the American Medical Women’s Association, the Community Access National Network, National Consumers League, National Women’s Health Network, Our Bodies Ourselves, and WoodyMatters.
We strongly oppose the reclassification of External Pacemaker Pulse Generator Devices from class III (high risk devices) to class II (moderate risk devices). We urge you to recommend that these devices should remain class III and they should require Premarket Approval Applications (PMAs) because they are life-sustaining devices and because clinical data are urgently needed to provide useful information to health professionals about the benefits and risks.
We agree with the Cardiovascular Devices Panel recommendations from March 1979 that “external pacemaker pulse generators be classified into class III because the device provided temporary life-support and that certain kinds of failures could cause this device to emit inappropriate electrical signals, which could cause cardiac irregularities and death.”
Performance standards have been used to support marketing applications over the years, and yet there were 3,739 adverse event reports in the FDA’s MAUDE system for these devices in 2011 and 2012 alone. Our review of the MAUDE database for the last five years (1/01/2008 through 12/31/2012) shows at least 13 deaths associated with these devices.
It undermines public health and the integrity of the FDA when life sustaining devices that have resulted in death are classified as Class II – moderate risk devices. They are high risk, not moderate risk.
Since the law specifies that high-risk devices are considered Class III, we see no justification for down-classifying this obviously high-risk device used for high-risk indications. We believe that high-risk cardiac devices should remain Class III devices and be subjected to the more stringent PMA approval criteria because they are life-supporting and life-sustaining. When devices aren’t held to the higher standards of PMA, we lose 4 important safeguards:
1. Proof of safety and efficacy based on short-term clinical trials
2. FDA’s authority to require post-market, long-term clinical trial safety data as a condition of approval
3. FDA’s authority to inspect the manufacturing facility prior to approval
4. FDA authority to rescind approval if the device is later found to be unsafe
The law requires objective, consistent categories for determining whether a device is Class III or Class II, but the proposed down-classification is based on subjective judgments about how special controls can reduce the risks of these high-risk devices.
The FDA has noted that substantial risks of these devices include a failure of the electronic circuitry, which can cause failure to pace the patient’s heart; improper pacing leading to high rate-electric failure, which can lead to arrhythmias or unwanted stimulation; and micro/macro shocks resulting in an arrhythmia or cardiac tissue damage.
If these devices are down-classified, as FDA has proposed, that means that any new External Pacemaker Pulse Generator Devices that any company wants to sell from now on will NOT be subject to clinical trials or inspections. Such devices could potentially be better or worse than other similar devices on the market, but there will be no scientific data to help physicians decide which devices to use. There will be no scientific data to even ensure that they are safe or effective.
In summary, there are several reasons to keep External Pacemaker Pulse Generator Devices as class III devices:
• They are life-sustaining devices;
• They have had numerous MAUDE adverse events reports, including deaths associated with the devices;
• They pose significant “risks to health.”
• If new devices don’t go through the PMA process, we lose the 4 crucial patient safeguards provided by clinical trials, inspections, the ability to require post-market studies if needed at the time of approval, and the ability to rescind approval if a device is later found to be unsafe.
I urge you to tell the FDA that cardiac patients deserve life-saving medical devices that are proven to do their job. Without clinical trials or inspections, Class II special controls would not provide reasonable assurance of their safety and effectiveness. To protect the lives of cardiac patients, these devices must remain as class III, and they must go through the more stringent PMA process, which requires clinical trials and inspections.
- Food and Drug Administration (October 17, 2011). Class II Special Controls Guidance Document: External Pacemaker Pulse Generator, Draft Guidance.
- Federal Register Volume 76 (October 17, 2011). Proposed rule: Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices (Docket No. FDA-2011-N-0650).