AED Accessories – Third party brands may put you at risk

Bargain or bad idea?

There are several companies offering AED electrode pads and batteries which they claim work with specific AEDs, and they may seem like a great way to save some money. In this article, we tackle the tricky question of third-party accessories and why you should never consider using them with your AED. In our article “AED Accessories – why don’t manufacturers make them interchangeable?” we talked about how AED manufacturers spend large amounts of money to obtain FDA clearance on their devices and how manufacturing accessories which only work on their devices ensure functionality and reliability. The best choice to ensure your AED has the best chance to save a life is to always use the accessories produced directly by the AED manufacturer. But why?

With regard to electrode pads, third-party pads are usually all the same adhesive electrode pads, and only the connectors have been changed. Most of these are unbranded, produced in countries other than the U.S., and have not been given FDA PMA clearance for use with the AEDs with which they claim to be compatible. Some will claim they have 510(k) clearance, but 510(k) clearance only means the item has the same intended use and technological characteristics of the legally marketed device. It does not mean the cleared device is an equivalent substitution. “Because the 510(k) clearance allows the manufacturer to skip the PMA process, devices given 510(k) clearance are by definition not “approved” by the FDA, and manufacturers may not refer to them as “FDA-approved.” However, they are allowed to legally be sold in the U.S.^[1]”

As far as AED batteries are concerned, research on reseller sites (such as eBay) bring up batteries listed as “new, in-package” but also say they are “seller refurbished”. Just like with electrode pads, many times they are unbranded, manufactured in countries outside the U.S. with no connection to the manufacturers, and have not been given FDA clearance for use with AEDs. While purchasing a refurbished battery may seem like an environmentally conscientious thing to do, placing one in a device designed to save lives with the use of electricity can literally be a matter of life or death.

If your AED is still within its warranty period, using accessories not produced by the manufacturer will almost certainly void your warranty. AED Superstore recommends reading your device’s warranty statement carefully before using third-party or refurbished accessories.

To give you an idea, the warranty statement for the Cardiac Science Powerheart G3 AED states the warranty is void if: “Any Cardiac Science product is used in conjunction with incompatible products, parts or accessories, including but not limited to batteries. Products, parts, and accessories are not compatible if they are not Cardiac Science products intended for use with the Powerheart AED.”^[2]

Physio-Control phrases it a little differently for its popular CR Plus AED – the operator’s manual states: “Using cables, electrodes, or accessories not specified for use with this device may result in increased emissions or decreased resistance to electromagnetic interference which could affect the performance of this defibrillator or of equipment in close proximity. Use only parts and accessories specified in this manual.”^[3] and their Limited Warranty Statement states, “The product must have been used in accordance with applicable operating instructions…”^[4]

Defibtech’s Warranty documentation states, “The limited warranty is immediately voided if…the defibrillator is used with one, or more, unauthorized accessories…“^[5]

Not following the operator’s manual instructions with regard to all aspects of AED maintenance, including the use of replacement parts produced by the manufacturer, will also certainly put any protection you may have under your state’s Good Samaritan laws at risk, should there be an AED failure during a rescue.  

The most compelling reason for not using third-party parts and accessories, however, is the fact these devices are used to save people’s lives! Pinching pennies at the risk of having the unit malfunction during a cardiac emergency is not a wise move. Know the parts you are using will function properly by purchasing only those made by your AED’s manufacturer.

AED Superstore carries only manufacturer-authorized AED parts and accessories.

 

1. ^[1]https://www.rotlaw.com/legal-library/what-is-the-fdas-510k-approval-process/↩
2. ^[2]https://www.cardiacscience.com/wp-content/uploads/2014/10/70-00914-01_F_Operator_and_Service_Manual_G3Plus.pdf↩
3. ^[3]https://www.physiocontrol.com/uploadedFiles/Physio85/Contents/Emergency_Medical_Care/Products/Operating_Instructions/3201686-015.pdf Page 11, subheader “Possible Electrical Interferance”↩
4. ^[4]https://www.physiocontrol.com/uploadedFiles/Physio85/Contents/Warranty_Statements/WarrantyStatement_USCanada_3315920_C.pdf Page 2 ↩
5. ^[5]https://www.aedsuperstore.com/assets/images/pdf/warranties/Defibtech%20Lifeline%20AED%20Semi-Automatic%20Warranty.pdf Page 1, subheader LIMITED WARRANTY VOIDED↩