Manufacturers of AEDs and accessories take notice: By docket number FDA-2013-N-0234, the FDA is considering requiring a premarket approval application or notice of completion of a product development protocol for AED systems and accessories, including pad electrodes. A decision on this docket is expected soon from the FDA.
If the proposed order is issued, manufacturers who wish to continue to market the devices will be required to submit a PMA (or submit an intention to file) within 90 days of the order’s issue date. If the intent to file is received by the FDA within the 90 day window, then the FDA will consider enforcement 15 months from the date of the order. Further, the FDA has committed to reviewing the PMAs within 180 days of their submission.
As background, the FDA has moved to this position after reviewing and finding problems with the Medical Device Reporting (MDR) system. Further, the number of recalls, and review of inspection information indicates that the currently used 510(k) approval system may be inadequate to allow control of AEDs and accessories.
The proposed PMA will augment the information now required by the 510(k) program by adding review of the company quality control practices and change procedures:
- Review of manufactuirng information such as procedures and processes to ensure compliance with the Quality Systems Regulation
- Review of the quality system in place to ensure adequacy for manufacture and distribution of the devices
- Review of policies and procedures to ensure the manufacturing facilities, procedures and systems are adequate
- The post market review policies are adequate and properly assess significant changes
Because of the length of time the AEDs have been used in the field, the FDA believes that most manufacturers have clinical and historical data available to them. Consequently, they believe that manufacturers can make a timely submission of the PMA.
The time period for submitting comments ended on June 24, 2013 and the final order has not yet been published, but as noted above, an FDA decision is expected in early 2014.
The Standard to be used to judge performance compliance is ANSI/AAMI/IEC 60601-2-4 “Medical electrical equipment – Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators”. The FDA is aware that current marketed AED systems do not meet all the requirements of IEC 60601-2-4, but have indicated that they expect manufacturers to report all the results of their compliance testing to IEC 60601-2-4, including data on non-compliant tests.
The pad electrodes for AEDs will be subject to the following tests in IEC 60601-2-4, and acceptance limits for the tests are noted below:
- 22.214.171.124 – 10 Hz Impedance (AC10)
- Impedance measurement range shall be 0 to 3000 ohms. Current not to exceed 100 uApp, voltage measurement source shall be sinusoidal with a frequency of 10Hz ±10%, the impressed current shall not exceed 100uApp.
- 126.96.36.199 – 30 kHz Impedance (AC30)
- Impedance measurement range shall be 0 to 5 ohms. Current not to exceed 100 uApp, voltage measurement source shall be sinusoidal with a frequency of 30 kHz ±10%, the impressed current shall not exceed 100 uApp.
- 188.8.131.52 – AC Large Signal Impedance (ACLG)
- Impedance measurement range shall be 0 to 3 ohms – with applied 360 J biphasic waveform (calibration curves)
- 184.108.40.206 – Offset Instability and Internal Noise (NOISE)
- Voltage measurement range shall be 0 to 100 uVpp in the pass band 0.5 to 40Hz as measured from the output of the pass band filter, NOISE measurement shall be recorded after 1 minute from the start and shall record the maximum Vpp for the next 5 minutes
- 220.127.116.11 – Defibrillator Recovery (DEFR)
- The test sequence for 1 360-DR cycle shall be (once electrodes have been connected gel-to-gel and attached to the tester):
- 3 shocks of 360 J at 1 minute intervals
- DCO voltage measurement limited to 400 mV @ 4 seconds after last shock delivered
- DCO voltage measurement limited to 300 mV @ 60 seconds after last shock delivered
- 18.104.22.168 – DC Offset Voltage (DCO)
- Voltage measurement range shall be 0 to 100 mV accuracy of ±1 mV, measurement input characteristics shall be 10nA or less bias current, 10 Mohm or greater input impedance
- 22.214.171.124c – Pacing (PACE1/PACE2)
- Pacing for 60 minutes as applied for intended use
Test equipment designed to efficiently conduct the tests and report test data for pad electrodes are is available in the marketplace, and the FDA is not expected to extend submission deadlines due to difficulties in conducting the tests and obtaining data.
Assuming the FDA announcement requires a PMA, it will be interesting to see how manufacturers react to the new orders. In addition, it will be interesting to see how the FDA copes with their promise to review the PMAs within 90 days of receipt; as it seems likely that most PMAs will be received at the deadline: 15 months after the date of the FDA announcement.
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