3 June 2016
Controls on External Cardiac Compressors and CPR Aids Relaxed
The FDA has issued a final order reclassifying external cardiac compressors from pre-amendment class III devices to class II (special controls) devices. In addition, the agency has created a separate classification regulation for a sub-group of devices known as cardiopulmonary resuscitation aids and has reclassified CPR aids with feedback from class III to class II and CPR aids without feedback from class III to class I.
Medical devices commercialised in the United States are classified into one of three classes, with regulatory controls to provide reasonable assurance of safety and effectiveness increasing in stringency from class I (general controls), to class II (special controls) and class III (pre-market approval). Most class I devices are exempt from pre-market notification 510(k), most class II devices require pre-market notification 510(k) and most class III devices require pre-market approval.
An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically or manually powered to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. These devices are used as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient personnel are available to provide effective CPR). The special controls for these devices under their new class II classification are (i) non-clinical performance testing under simulated physiological conditions to demonstrate the reliability of the delivery of specific compression depth and rate over the intended duration of use; (ii) labelling that includes certain specific information; (iii) for devices that incorporate electrical components, appropriate analysis and testing demonstrating that the device is electrically safe and electromagnetically compatible in its intended use environment; (iv) human factors testing and analysis validating that the device design and labelling are sufficient for effective use by the intended user, including an evaluation of the time necessary to deploy the device; (v) for devices containing software, the performance of software verification, validation and hazard analysis; and (vi) demonstration that components of the device that come into human contact are biocompatible.
The final order divides CPR aid devices into those without feedback or with feedback. A CPR aid without feedback is a device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for a professionally trained rescuer but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim. The FDA believes that CPR aid devices that do not provide feedback can be regulated in class I, subject to general controls and generally exempt from pre-market notification (subject to the limitations of exemption contained in 21 CFR 870.9).
On the other hand, the agency believes that CPR aid devices that do provide feedback to the rescuer require special controls, in combination with general controls, to provide a reasonable assurance of safety and effectiveness. A CPR Aid device with feedback is a device that provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines. These devices may also perform a coaching function to aid rescuers in the sequence of steps necessary to perform effective CPR on a victim.
Controls for CPR aid devices that provide feedback include (i) non-clinical performance testing under simulated physiological or use conditions to demonstrate the accuracy and reliability of the feedback to the user on specific compression rate, depth and/or respiration over the intended duration, and environment of use; (ii) labelling that includes the clinical training, if needed, for the safe use of this device as well as information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations, e.g., adult, paediatric and/or infant); (iii) for devices that incorporate electrical components, appropriate analysis and testing demonstrating that the device is electrically safe and electromagnetically compatible in its intended use environment; (iv) for devices containing software, the performance of software verification, validation and hazard analysis; (v) demonstration that components of the device that come into human contact are biocompatible; and (vi) human factors testing and analysis validating that the device design and labelling are sufficient for effective use by the intended user.
The FDA further determined that due to their simple and well-understood technological characteristics exemption from pre-market notification (510(k)) is appropriate for mechanical or electro-mechanical CPR aid devices that provide feedback (e.g., devices that utilise bladders and pressure gauges to provide feedback on compression depth) when such devices comply with the special controls and subject to the limitations of exemption contained in 21 CFR 870.9. However, devices that contain software have complex and evolving levels of visual and audio feedback to users, warranting continued review under the 510(k) process.