A panel of experts yesterday recommended the FDA down-classify several types of cardiac devices from the high-risk Class III category to the less-stringent Class II.
The panel evaluated external cardiac compressors, external pacemaker pulse generators and triple-chamber pacing system analyzers. External cardiac compressors and external pacemaker pulse generators are so-called "pre-amendment Class III devices," meaning they were grandfathered in when Congress passed the Medical Device Amendments in 1976, according to the FDA
If the FDA follows the panel’s recommendation, the devices would need to meet the same regulatory burden required of them so far under the watchdog agency’s 510(k) clearance program, a less burdensome path than the pre-market approval program required for Class III devices. But if the FDA keeps them as Class III devices, they may need to undergo new clinical trials.
Triple-chamber pacing systems are now classified as Class III, because they came onto the market after the amendments. The FDA proposes to down-classify them to Class II with special controls.
External cardiac compressors
There are 2 types of external cardiac compressors, or chest compressors, both are used to aid in cardiopulmonary resuscitation. Automated ECCs are powered manually, pneumatically or electrically and are placed directly on the patient’s chest to provide automatic chest compression at a fixed compression rate and depth, according to the FDA.
The 2nd type of ECCs are CPR aids, which provide audio and/or visual feedback to assist emergency personnel in maintaining the recommended rate and depth of compression during CPR. They go either beneath the hands of the medical professional or in the vicinity of the cardiac arrest victim, the agency noted.
The FDA’s Circulatory System Devices Panel generally agreed yesterday that both types of ECC are safe and effective.
"There is no question that when a person arrests, if you don’t do something, the person is dead. That’s zero survival," said Dr. Jeffrey Borer of State University of New York, Downstate Medical Center in New York.
"Now the optimal approach would be to start with manual compressions. If you can’t carry on because some situations preclude doing the ideal CPR technique, you had to have a way to continue the compressions somehow with a device like this, that’s probably better than nothing," Borer said. "And, if we look at the data that’s presented to us … there were positive outcomes, so I think we do have some evidence that this device can support survival."
A majority of panelists also agreed with the FDA’s proposal that general controls and software design controls are adequate for CPR devices without feedback. For CPR devices with feedback, they agreed with the agency’s proposal to use special controls including performance testing, labeling, human factors testing and analysis, electrical safety and electromagnetic compatibility testing where appropriate, and software verification validation and hazard analysis.
Both ECC types, according to the majority, should be down-classified to Class II, though a small minority argued that the devices should remain in the more stringent Class III until more clinical trial data can be gathered.
"There was a suggestion for potentially modifying the devices to have audible signals, and certainly post-market surveillance would be important," panel chairman Dr. Richard Page of the University of Wisconsin School of Medicine & Public Health said.
External pacemaker pulse generators, triple chamber pacing system analyzers
During a later, same-day session, the panel generally agreed with the FDA’s proposal to down-classify external pacemaker pulse generators and triple-chamber pacing system analyzers with external pacing capability to Class II with special controls, "with some word-smithing" even though these devices are life-supporting.
EPPGs have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. They’re used outside the body as a temporary substitute for the heart’s intrinsic pacing system, until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. They may be adjusted for impulse strength, duration, R-wave sensitivity, and other pacing variables, according to the FDA.
Triple-chamber pacing system analyzers with external pacing capability provide pacing and sensing in up to 3 heart chambers while pacemakers or defibrillators are implanted, so that the placement and integrity of the implants’ pacing leads can be determined, the agency said.
The panel’s recommendation came despite opposition in public commentary from Caitlin Kennedy, a senior fellow at the National Research Center for Women & Families.
Kennedy urged the panel not to recommend down-classification of EPPGs and PSAs because certain types of device failures can cause cardiac arrhythmias and death.
"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," she said.
Kennedy listed 4 important safeguards that keeping devices in Class III provides: Proof of safety and efficacy based on short-term clinical trials; the FDA’s authority to require long-term post-market surveillance as a condition of approval; the FDA’s authority to inspect manufacturing facilities prior to approval; and the agency’s authority to rescind approval if the device is later found to be unsafe.
"We hear you about issues of safety," Page said at the end of the day. "I think I speak for this committee in acknowledging that these are life-supporting devices, but I’m hearing a strong consensus from this panel that we will be able to provide adequate assurance of safety and efficacy and proper level of rigor, in terms of labeling and classification, in the actions that we’ve undertaken today, so we feel that the regulation is appropriate for the devices that we’ve discussed today."
