FDA’s new stringent evaluation standards are set to improve dependability of automated external defibrillators (AEDs).
Are you curious why non-Pre-Market Approved devices are being so heavily discounted?
To view devices that are still compliant to the FDA’s ruling and the PMA, click here.
Q: Why are some distributors still selling these devices in the U.S.?
A: Great Question. The FDA has taken the position that AED devices that have NOT filed for the PMA approval should NOT be sold in the U.S. market.As a result, it is our opinion that anyone purchasing one of these devices is opening themselves up to liability.
Q: So why are non-PMA devices being so heavily discounted?
A: Some distributors who have made the choice not to take the financial hit of having to discard non-PMA devices and are unloading these products by selling to consumers who are not aware of the FDA’s ruling. As time goes on, more and more users are going to be trading these non-PMA devices in for compliant models. By 2020 accessories for these units will no longer be in circulation, which will diminish usability considering that these units need accessories to work.
Source: On the seventh paragraph of the release on this FDA page you will find supporting information regarding accessories for non-PMA devices.
Q: Can I buy a used device that did not file the intent to pursue the PMA?
A: Our opinion is, “no” you may not purchase a device that is not pursuing the PMA.
Source: Here you will find the document by the Federal Register regarding the FDA’s ruling. Section V. Paragraph A. states:
“PMAs for currently marketed AEDs are required to be filed on or before 90 days after the effective date of a final order”
The Problem – Questionable Business Practice:
Devices that have not filed a PMA (Pre-market approval) according to the FDA’s ruling should no longer be sold into the U.S. market. Some distributors have determined that they are going to continue selling these devices, but it is our opinion that this action shows a lack of concern for their buyers – not to mention the individuals whose lives could depend on that one defibrillator.
What you need to know:
The potential repercussions of purchasing a non-approved device are not worth it. These are life-saving devices that require regulation for a reason. If you buy a device that is restricted from the market, the liability you could encounter may be substantial.
Please keep in mind:
- If an affected device is used on a victim and it was purchased after the PMA period, it will not be held under the same compliance and liability coverage.
- If it was determined your device was bought after the FDA’s PMA deadline, your unit could be subject to seizure.
If it was your family member, would you want a non-regulated defibrillator used on them?
How could a business justify selling these devices? We are not sure, and have decided to adhere to the “better safe than sorry” school of thought. Overall, this decision is potentially putting the distributor, buyer, user and possible cardiac arrest victim at risk. A risk which could be avoided by simply following regulations.
When it comes to something as serious as saving a life, it is worth doing research and paying for a device you can trust. If it came down to your loved one relying one of these machines, which would you choose – one in compliance with the FDA’s ruling or one that is not?
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
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 email@example.com. To view previous PMA Seriesreleases:
- 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/
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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