Is Your AED Reliable?

The standard answer to that question historically has been, “With proper maintenance, yes.”

However, certain events over the past several years have presented issues and challenges that need to be examined, and addressed.

• The issues are:
• End Of Support notices
• PMA approvals
• Supply chain interruptions
• Product failures

End Of Support

When a manufacturer is phasing out a specific AED model, they will issue a notice stating that they will neither be manufacturing nor supporting that model with supplies (battery and pads), and the date when the supplies will no longer be manufactured.

We have seen this process for many years now, and the most recent example is Cardiac Science making the announcement in 2021.  In that year, they stopped production of the Powerheart G3 (9300x), G3 Plus (9390x), and G3 PRO (9300P) AEDs.  They did state that defibrillation pads, non-rechargeable batteries, carry cases, and select accessories will remain available for the duration of the warranty period. The standard warranty period of the G3 AED is seven years.  Suffice it to say that you will be able to supply your battery and pads needs until sometime in 2028.

• Other AEDs that have been taken off of the market in the past several years are:
• CardioVive AT
• Cardiac Science FirstSave® AED G3
• HeartSine samaritan® AED (350, 360, 450 models are still on the market)
• HeartStart FR2 & FR2+
• Physio-Control LIFEPAK EXPRESS®
• Physio-Control LIFEPAK CR® Plus Fully-Automatic
• Physio-Control LIFEPAK® 500 AED
• Welch Allyn AED 10
• Welch Allyn AED 20

Please contact us should you currently have a Cardiac Science G3 AED, or any of the other AEDs listed above. To see the options available to you through RTI, please click here.

PMA Approvals

Recently, the FDA imposed Pre-Market Authorization (PMA) requirements on manufactures of AEDs that will directly affect all automated external defibrillators (AEDs) and AED capable devices in the market.

The FDA ordered in February of 2015 that current and future AEDs would have to complete the PMA process.  If done successfully, the AED would have the FDA’s approval.  This order affected AEDs in businesses, and even defibrillators in healthcare setting that had the ability to analyze or otherwise had automated defibrillation functions.

The PMA process would be extensive, and expensive, for AED manufacturing groups. With that in mind, each manufacturer decided which AED models would be chosen to proceed through the PMA gauntlet.

FDA announced that February 3, 2022 would be the last date for the AED manufacturers of any new-to-market AED products or previously manufactured AED products to be PMA-approved. After that date, any AED, or regulated AED supply item, without a PMA approval could not be sold in the U.S.

As the FDA PMA requirement was for all AEDs and supplies, the requirement was also held to manufacturers of aftermarket AED supplies. If a manufacturing group chose not to enroll their batteries or pads into the PMA process, they too would have to cease sales after the February 2022 deadline.

The bottom line is this:  If your AED is not on the PMA approval list below, as of February of 2022 you will not be able to obtain supplies to keep your AED maintained as per the manufacturers recommendations.

If your AED isn’t on the list below, we can offer you several alternatives to the replacement of your older AED.  To see the options available to you through RTI, please click here.

Supply Chain Interruptions

You’ve seen the challenges to doing business in our country.  Domestic and foreign manufacturing stalled due to staffing issued associated with the pandemic.  Ships sitting anchored in massive numbers off our coastlines waiting for their turn to have their cargo unloading.  Trucks, and those to drive them, seemingly in short supply to move the products out of the ports to their intended destination points.

But the challenges extend to the availability of parts to complete the assembly of everything from garage doors, bicycles, coins, and the list goes on-and-on.  Most importantly to agencies that depend on AEDs for their initial response to medical emergencies, the list includes computer chips.

These electronic components obviously in every AED, but also all AED batteries and most AED pads as well. Chips control the AEDs, determine when AED pads are to announce their expiration date, and when an AED battery is depleted enough to require replacement.  Additionally, chips are also needed in the newer AEDs that have wireless capability for remote monitoring.

We’ve even seen supply delays for the plastic components for the AED pad connector, the part you plug into the AED.

So until we have a more reliable supply chain, probably through domestic production, we can expect to see the “backordered” stamp on our invoices around the country for months or years to come.

Due to the expiration dates on each item, stocking up on AED batteries and pads obviously isn’t a wise decision.  At RTI, our goal is to have or find a way to say “yes” to our client’s requests.  If we can’t, we try to find a workable solution or compromise.  With a supply chain interruption challenge, I admit that we don’t have a solution, or a compromise.

Product Failures

It isn’t often you hear of a catastrophic failure of an AED, AED battery, or AED pads. Occasionally, we will see that an update is required for an AED.  At times, some limited number pads or batteries needed to be replaced due to an issue or out of “an abundance of caution”.

However, a very recent problem has been announced that will have a very far reaching effect into the safety preparedness of many agencies.

On February 22, 2022, Philips Medical issued an Urgent Medical Device Correction. The focus is on Philips AED pads for the HS1/OnSite/Home AEDs.

The manufacturer states:
HS1/OnSite/Home AED pads (PN: M5071A, M5072A) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. Any pad currently installed in or stored with an HS1/OnSite/Home AED could experience this problem, and it is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. Philips has received 115 complaints about this issue since 2010 (of which 84 complaints in 2021) for a total of approximately 5 million shipments of M5071A and M5072A pads. Users should continue to use the HS1/OnSite/Home AED and pads as-is, and follow the voice prompts because the AED will step the user through the necessary actions.

Although the notice goes into further details regarding the issue, the “correction” is stated in the following excerpt:

Describe the actions that should be taken by the customer / user in order to prevent risks for patients or users

Continue using the HS1/OnSite/Home AED and pads as-is. During use, ensure the majority of the pad surface is covered with gel and apply the pads to the patient. If you notice the gel beginning to separate from the foam backing as you peel, try to prevent the gel from folding onto itself if possible. Do not hesitate to apply the pads to the patient unless the gel has almost completely separated from the backing as in Figure 3. In case of trouble, install spare pads if available and continue the rescue. No matter the state of the pads, follow the voice prompts because the AED will step you through the necessary actions.

Do not try to examine the pads gel prior to patient use. It is not possible to know if your pads are affected by the problem prior to use because the pads are protected by a foil seal. The foil seal on the pads cartridge should be opened only for patient use in an emergency because the pads will quickly dry out if the foil seal is broken.

Philips recommends that you store a spare pads cartridge with your HS1/OnSite/Home AED, but those are also at risk for the issues described in the notice.  As stated in the notice, “Note, subsequent shipments will still be affected until updated pads are available.”

The “correction” is to use the pads that you currently have and hope that if you need them, and the issues do exist with them, is to use them anyway as they might still be able to provide a therapeutic shock.  Notice they did not say that Philips would send you a replacement set, as they don’t have any sets in stock to replace them with.  There is an absence, across the nation, of any replacement pads for the HS1/OnSite/Home AEDs.  Maybe it’s a supply chain issue (read above).

When will Philips have a solution for this problem?  They state:

Philips is actively working on design changes intended to eliminate the issue in the M5071A and M5072A pads. Philips projects to release updated pads later in 2022, dependent upon design activities and subcomponent availability. Philips plans to notify eligible customers and supply updated pads.

As of today, Philips did not have any estimated date of availability of pads.  Should you have an HS1, OnSite, or Home AED, with expired(ing) pads, please consider buying a replacement AED.  To see the options available to you through RTI, please click here.

Greg Landin, Capt/Paramedic (ret)
Greg Landin is a 30 year fire service veteran. He was employed with several fire and EMS agencies throughout the Sacramento area completing his career as a Fire Captain and Paramedic with the Sacramento Metropolitan Fire District.  He is the president of Rescue Training Institute which provides safety training and supplies throughout California.  He is a Training Center Coordinator and past Regional Faculty for the American Heart Association, a Master Instructor for Medic First Aid International, as well as past faculty of the American River College paramedic program.  His expertise is in emergency pre-hospital care education as well as Automated External Defibrillation (AED) program implementation.