FDA’s new stringent evaluation standards are set to improve dependability of automated external defibrillators (AEDs).
What are the penalties of using non-Pre-Market Approved devices?
Q: What are the consequences of purchasing and using a non-PMA device?
A: While it is unlikely that the FDA is going to randomly catch users of non-PMA devices and fine them, we do see significant risks to using non-PMA devices on people in the U.S. These defibrillators are lifesaving machines. If a patient/victim was to expire, which happens daily through no fault of the device, the user could face significant liability for using a non-approved device—even if it performed flawlessly.
Q: What happens if the FDA finds out that I have a device purchased after the May 4, 2015 deadline to submit the intent to file?
A: The FDA’s ruling says that the equipment is subject to seizure.
Source: Read the FDA webinar transcript here. On page four, paragraph two, seizure of an AED/defibrillator is mentioned.
Q: What is the penalty if I buy a device that is not going through, or has received, the PMA?
A: There is not a defined penalty (stated at this time). If there was a violation and the FDA was involved, the penalty would be at the discretion of the FDA.
Devices which were purchased before the deadline cut-off are “grand-fathered” in and may be used after the May 4, 2015 deadline; however, if you considering purchasing one of these devices after this date, it could potentially create unnecessary liability.
As a business, our goal is to make sure our consumers and users of the devices we distribute are educated and informed. Additionally, these devices are meant to be used on individuals who have suffered Sudden Cardiac Arrest and need the shock from a defibrillator to restart their heart rhythms to live. In relation to the FDA’s PMA, buying a non-PMA device could put both of these parties in danger. If the SCA victim does not make it, it is possible the purchaser of a non-PMA device could be held liable and deemed negligent of the FDA requirement of the devices they acquire.
A few recent models previously sold by DXE Medical, which DXE no longer sells in the U.S. market are:
- Physio-Control Lifepak 500 AED
- Physio-Control Lifepak 10, 11
- Philips HeartStart FR2 AED
- Philips XL
- Zoll PD1400
- Zoll M Series monitor/defibrillator
- Zoll E Series monitor/defibrillator
*For a complete list of affected devices, please contact DXE Medical at 866-349-4363 or email CustomerService@DXEMed.com.
About the DXE Medical PMA Series:
The DXE Medical PMA Series contains pertinent information regarding the FDA’s recent change in regulations for PMAs on devices with AED functionality. This series will answer many questions, but if you have an immediate question you would like us to answer, please call 866-349-4363 or email firstname.lastname@example.org. To view previous PMA Series releases:
- Introduction: http://www.ireachcontent.com/news-releases/fda-sets-new-regulations-affecting-entire-aed-market-530233411.html
- Part 1: http://www.aed.com/blog/dxe-medical-pma-series-part-1/
- Part 2: http://www.aed.com/blog/dxe-medical-pma-series-part-2-affected-devices/
- Part 3: http://www.aed.com/blog/dxe-medical-pma-series-part-3-where-you-buy-is-important/
About DXE Medical:
DXE Medical, Inc. was founded in 1999. It provides new and refurbished defibrillators, AEDs, EKGs, as well as other medical equipment and has grown to serve customers in all 50 states and 40 countries worldwide. For more information, please visit: http://www.cardiopartners.com/.
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