On April 24, 2015, the US Food and Drug Administration (FDA) issued a Warning Letter to a replacement battery supplier that has raised some interesting issues about replacement manufacturer responsibilities and possibly battery quality.1 It is likely that at least some of these issues are also applicable to other replacement part manufacturers.
The manufacturer that received the Warning Letter specifically labels its batteries for medical device use. From a regulatory perspective, this situation is different from one in which a supplier is selling generic batteries and the buyer is determining whether or not they are suitable for a particular medical device.
One of the overriding issues outlined in the Warning Letter is that according to the FDA, a replacement battery falls under the same regulations as the device for which it is intended. As a result, the battery supplier is required to meet the same level of FDA compliance as the device itself. Thus, a battery would be subject to only registration and listing for a Class I device, to 510(k) clearance for a non-exempt Class II device, or to PMA approval for a Class III device. Moreover, for Class III the FDA asserts that the device PMA holder—not the battery maker—would have to seek approval of the battery via a PMA supplement. This seems highly unlikely to occur in many cases, since the PMA holder in general wants you to buy its battery, not someone else’s.
Since the battery maker discussed here was deemed subject to FDA regulation, then all the FDA regulatory requirements in addition to those concerning marketing also apply. The Warning Letter found the manufacturer wanting in a number of general and particular areas, including not being registered as a medical device manufacturer—which, interestingly, was remedied during the FDA’s inspection with an instant online registration. However, the company was still cited for not “listing” its products. The absence of proper marketing permission was also said to render the batteries “misbranded.”
Other alleged failings included neglecting several specific regulatory requirements, including design controls, incoming component inspections, finished device acceptance procedures, complaint handling, corrective and preventive maintenance (CAPA) procedures, medical device reporting (MDR), proper equipment inspection and calibration, and a lack of management controls. These kinds of FDA–specific failings are hardly surprising for a company that didn’t consider itself subject to FDA jurisdiction. In some instances, it may have had similar procedures in place, but not those specifically required by the FDA.
None of the cited shortcomings necessarily mean that there was anything wrong with the batteries, and there was no corresponding recall. In fact, Warning Letters are rarely linked to recalls, since the issues they address are typically procedural ones rather than actual product defects. Most Warning Letters, including this one, result from FDA inspections, which mostly deal with specific aspects of the FDA’s Quality System Regulations (QSR). But QSR issues are not the same as product issues.
In this regard, I once asked a senior FDA official whom I knew, “Do the Quality Systems Regulations lead to quality systems that then lead to quality products?” His answer, in the spirit of my question, was, “That’s our position and we are sticking to it.”
Although this response was meant to be partly humorous, there is actually very little evidence of the effectiveness of FDA regulations, or indeed any safety-related standards, on improving safety. This is largely because there is often no relevant “before” scenario with which to compare, even if such a comparison were undertaken. The new rule from the Centers for Medicare and Medicaid Services (CMS) and The Joint Commission (TJC) on following the manufacturer’s maintenance requirements, at least for certain devices, is a case in point here. Since there was no evidence of a maintenance issue before the rule, there can be no indication that the rule improved anything, other than perhaps the manufacturer’s maintenance-related income.
Another core issue raised by the Warning Letter that affects all non-OEM replacement parts is the degree to which the replacement part is identical, seemingly identical, or otherwise similar to the original part. Analysis of this question should always be well-documented. Risk management is also applicable here, in terms of anticipating the consequences of a replacement part failure.
Another issue, newly illustrated by this Warning Letter, is the need to perform due diligence to determine if a parts supplier is FDA-compliant where applicable. Since a curiosity of Warning Letters is that they do not directly stop sales, customers could purchase batteries while the manufacturer is under such a warning. If noncompliance ever became an issue, the customer might have some explaining to do. Using non-OEM parts could also become a problem with devices that must adhere to the CMS/TJC mandate to follow the manufacturer’s maintenance requirements, especially when the OEM specifies, as many do, to use only its own parts.
William A Hyman, ScD, is professor emeritus, Biomedical Engineering, at Texas A&M University, College Station, Tex, and adjunct professor of Biomedical Engineering at The Cooper Union, New York.
Maybe I’m reading too much into CMS 482.41(c)(2) but I’m going to ask anyway….
“The manufacturer that received the Warning Letter specifically labels its batteries for medical device use. From a regulatory perspective, this situation is different from one in which a supplier is selling generic batteries and the buyer is determining whether or not they are suitable for a particular medical device.”
Just for clarification:
If I contact an independent battery distributor, such as R&D Battery, and state I need a battery for a class 2 or class 3 device and they send me a battery from a different vendor than the one which came initially in the medical device, I have now deviated from the manufacturer’s recommendation? If I use this battery, do I have to place this on my AEM (CMS 482.41(c)(2)? If the equipment has no history, I have to use the manufacturer’s batteries (or the same battery model as there’s no justification for an AEM without the history)?
If I use another model of battery have I (rather my healthcare facility) then taken all the responsibility/liability as the FDA tested a medical device with a specific battery model and this battery model is the only one which can go into the unit (for 510k compliance)?
These are all challenging questions that are deep in the murky waters of both FDA and CMS regulations, and device maintenance.
My interpretations are:
1. To what degree is the battery vendor standing behind their recommendation?
2. If the manufacturer says use only my battery, or use only xyz battery and you use a different battery then you have not followed the manufacturer’s recommendations. In order to not follow the manufacturer’s recommendations the device has to be AEM. But would you have no history if you are already up to replacing the battery? However there might be a tricky issue of history with the new battery which you can’t obtain until after you start using it. This might suggest close monitoring in order to establish an appropriate history.
3. The FDA in the vast majority of devices has not tested the device or the battery. The FDA acts on manufacturer submitted information.
4. In most cases–as I understand it–employee liability if any accrues to the employer. You might want to inquire about this and be sure that your actions meet the expectations of your employer. This issue goes well beyond replacement parts.
5.Liability from an adverse event should only arise if there is a failure of the device related to the battery. If a claim is brought the manufacturer will certainly point out that you didn’t follow their recommendations by using an unauthorized battery. They should have to follow this with proof that the battery you used deviated from theirs in a way that caused or contributed to the injury.
You should be prepared to justify your actions which might include a formal risk analysis. Risk analysis in general might suggest not using non-OEM batteries where battery failure could have serious consequences.
6. 510(k) compliance is the responsibility of the manufacturer. The end user doesn’t comply or not comply with 510(k)s.
Thank you for your reply William and thank you for the article…I understand that 510k is the responsibility of the manufacturer; however, as you already know, we need to perform our services to equal level. I thought I was doing that as I’ve used only mfg parts in repairing equipment until I read your article and looked at the FDA letter you cite in the article. I’ve used ‘equivalent’ batteries in the past in order to save my facility money and haven’t had second thoughts about it…until now.
Our team has discussed this and plan on using the make and model of battery the manufacturer sent with the equipment and no longer obtain equivalents going forward.
As far as patient safety/liability…yes healthcare facilities do have insurance to protect themselves but they could easily cite their MEMP and state the BMET who performed the repair did not follow their MEMP nor CMS guidelines (if not in AEM) thus producing substandard work. I believe this would be ‘just cause’ to fire this technician and could make them a pariah in this close knit field. Last, and most important, I would feel awful if something I worked on hurt a patient due to my actions because I wanted to save a few bucks.