David Lim, Ph.D. RAC, CQA FDA's policy is evolving. On a case by case in view of posed risks, it can be either a component or an accessory. As for "rechargeable" or "replacement" batteries, they would fit better into accesories per the definitioin and FDA's new policy as shown in the draft guidance at http://fdaguidance.net/2015/01/fda-guidance-for-defining-accessories-and-classification-pathway-for-new-accessory-types/

Dan O'Leary Part of my question is what distinguishes the battery as opposed to other components. For example, in the AED case there are paddles, a large capacitor, and other components. Why are they components and not accessories? In the words of the guidance, “a rechargeable battery that is intended to operate when paired with an automated external defibrillator (AED) supports an AED by enabling it to defibrillate”. Why doesn’t this reasoning apply to the paddles, capacitor, etc?

David Lim, Ph.D. RAC, CQA It is because the "rechargeable battery" is intended to "support, supplement, and/or augment the performance of the AED." On the other hand, the paddles and a large capacitor are necessary for the device. You can plug the AED into an electrical outlet and no need to use the rechargeable battery.

I'd rephrase Joanne's question: do electric outlets become medical devices then?

Andrew Kyle Li-ion batteries are quite sensitive to how their charging system. Unlike NMH, they have to include special protection circuits. Kg for kg, they store more energy than rocket fuel. The recent fires in Segway like cheap toys, the consequence of battery failure is often fire. Remember the Boeing 787 battery fires? Portable defiberlators are placed on airlines and could cause a fire - if they are recharged of course. The Chinese manufacture counterfeit batteries and the quality of replacement, perhaps purchased by cost instead of quality,which creates a reasonable risk of consequence in this instance. Manufacturing these devices under GMP control is reasonable. I doubt Boeing allows that to occur - so neither should we.

Peter Ohanian Here is some perspective from someone who has been involved with external defibrillators (manual and AED) for many years. Batteries used with defibrillators are typically custom. They are packaged in a way to fit in the device and be easily replaceable by a user. The battery cell capacity also must support device functionality. There are standards requirements for battery capacity in a defibrillator. Although manual defibrillators (with or without AED functionality) do have the capability of using AC Mains, this is typically for purposes of charging the battery(ies) but can also power the device when delivering therapy. AEDs typically are not powered by AC and strictly rely on battery power. Many of today’s defibrillator batteries also contain electronics to monitor battery charge levels.

In regard to batteries, the defibrillator manufacture specifies the battery intended to be used with the device. They test the device with that battery. (…continued)

Peter Ohanian (continued…)They include the battery as part of the FDA submission (510(k) or PMA). When a third party, such as AnyBattery Inc., offers after-market batteries for use with a defibrillator, there needs to be assurance that the defibrillator can operate safely and effectively with that battery. Further, since the battery does directly influence the defibrillator’s performance and ability to comply with standards, it is necessary for the defibrillator to be tested with any battery that claims compatibility. Since AnyBattery is a third party and is providing after-market replacement batteries, it is incumbent on them to ensure their batteries are compatible with the defibrillator. Certainly, if AnyBattery were the original battery supplier for a defibrillator, it would already be covered under the defibrillators marketing clearance.

Further, since batteries are consumable (all batteries WILL fail), they are viewed as an accessory to a device. (…continued)

David Lim, Ph.D. RAC, CQA Device industry should be well aware of potential "fire hazards" for batteries.

Andrew Kyle BTW, NMH are about as volume efficient for energy storage. The weight is more however than Li-Ion. NMH are a reasonable alternative to Li-Ion.... just does not sound so "modern". Their chemistry is less prone to failure and the internal metal does not react strongly with water as would Li.

Coming from a Regulators's perspective, If the battery (whether rechargeable or not) is specified to be used or designed specifically for the medical device, it is an accessory. So if a manufacturer specifies (and these are usually rechargeable Li Metal hydride) then these batteries are accessories. Similarly if it specifies a specific power cord, then it too is an accessory.

If the battery is off-the-shelf even though it may be some unusual type like silver oxide batteries then even though it is technically an accessory by our definition (see definition in G -12) it should not be regulated as a MD. As with OTC software, manufacturers must ensure that it is fit for purpose.

It is unreasonable to expect Union Carbide to know where its AAA batteries go and require it to register it as a medical device. This is the weakness of the Jan 2015 FDA guidance (ib para 2) where it lacks the component of specificity (specified by or by designed). This is not case by case.

In the case of Anybattery Inc, the batteries are replacement accessories i.ee. intended to replace batteries which are accessories to medical devices.

A component is never regulated as an MD or accessory either by FDA or HSA. A component is a manufacturing term.. So you will never regulate a PCB or a capacitor as a MD, even though they have to comply with the requirements of 60601 (in power supply) and flammability and hi-pot tests etc and may even be the root cause of a AE.

Feng-Chi Ho Bettery regard as repair your energy of body & soul when you tried and lose power?

Peter Ohanian (continued…) Defibrillator labeling is detailed and specific with regard to battery care, maintenance and replacement, including the recommendation that users have spare batteries available at all times. Imagine being on a 15th hole of a golf course, attempting to resuscitate someone, and the battery runs out. It happens. Pop in the replacement and continue the resuscitation. This is very different from the internal components, such as the high voltage capacitor. Failure of an internal component can render the device unusable, requiring servicing.
Reference was made to defibrillator paddles. By regulation, 870.5300, paddles are a medical device. For clarification, AEDs do not use paddles to deliver therapy. They use disposable defibrillator pads, regulated under 870.5310.
Lastly, review 870.5310. This classification defines an AED SYSTEM, which includes pads and batteries. If the battery is specified for use with an AED, it becomes part of the AED system and is classified accordingly

Stephen Glassic Here is an article that looks at the issue from the perspective of the hospital Health Technology Management Department.

http://1technation.com/importance-batteries-program-management/

Ultimately they are responsible for the proper performance and safety of medical devices used within their facility. Even if there is no incident, they can be cited by regulatory agencies for using a non-OEM battery without providing sound justification. If they decide to use a non-OEM battery for a device, they must document and justify reasons and monitor performance results. It is not as critical for non life support equipment but a poorly performing battery can still present problems with work flow and excessive service calls (wasted time). This article gives a good overview of battery management concerns within a health facility. As stated in the article, battery management is one of the top concerns along with alarm management in a health care facility.