James (Jim) Dent, LSSBB, DTMx2 Did the device itself have an expiration date marked on the device? Where is the 5 year life indicated? On the original package? In the instructions for use? Does it say 5 years, or does it have an expiration date YYYY-MM-DD?

Minoti Patel, RAC (US) Say hypothetically it says 5 years with no specific date.

Somashekar BV When the customer calls with an issue, we have to take it as a complaint. Customer complaint has nothing to do with design life span. These are investigation opportunities to strengthen your risk management process. It could also be an issue that you need not take any corrective actions. Anything comes out only by the customer complaint investigation.
@ Jim...
This is not about the expiry date. Design life span is a design input to the medical device. It does not mean that the device will not fail before that or will fail after that.

James (Jim) Dent, LSSBB, DTMx2 @Somashekar: that wasn't the purpose of my questioning the expiration date.

Somashekar BV Sorry Jim, if I have read you wrong. Please elaborate

Tim Phipps Interesting question and some interesting comments so far.

My thoughts: if the device has a defined life-span which is clearly identified in the device specification/technical file and labelling/instructions-for-use, then any customer feedback occurring beyond the device's stated lifetime, should be used by the manufacturer as part of its Post Market Surveillance data-gathering process which (as Somashekar BV suggests) should be fed into the risk management and potentially the design change process. As far as dealing with the issue as a "complaint" this is more debatable. However, if the issue has resulted in a vigilance incident (i.e. actual or potential death or serious injury), then the incident should still be handled through your vigilance procedure. In this case, you will be fulfilling your obligation as a manufacturer but the responsibility of such an incident is likely to rest with the user.

Tom Tang, RAC Tim, Re: ",,,,,, any customer feedback occurring beyond the device's stated lifetime, should be used by the manufacturer as part of its Post Market Surveillance data-gathering process,,,,,,fed into the risk management and potentially the design change process,,,,,," Does that mean any feedback DURING the lifetime is NOT part of the Post Market Surveillance process, and not affecting design change? Thanks.

Tim Phipps Tom - thanks for the question. No, any customer feedback DURING the lifetime should also be included into the Post Market Surveillance process so that you can your risk management and design files remain live and current.. Hope this is clear. Thanks!

Tom Tang, RAC Thanks, Tim, that's what I thought. So we basically agree with what Somashekar indicated: Customer complaint has nothing to do with design life span. Correct?

Michael Santalucia Of course it is.

Minoti Patel, RAC (US) Thank you all for your contribution. My thoughts were in line with Somashekar and Tim, but I was not certain.
I would think that as long as the product is out in field and customer feedback should be considered as complaint.

I'd say once the product is released to the facilities or end users, any issues reported are complaints regardless of the product's expected lifespan.

Pedro Fregoso Yes! This is a complaint. No doubt about it.

Jonathan Wacks The issue here is not whether it is or is not a complaint. The question is what to do with it. A customer using a device past its expiry is definitely a complaint-the device doesn't work. If the use of the expired device can result in patient harm, the device may need a CAPA (e.g., mandated expiry dating/warning not to use).

It depends on your Complaint Handling Procedure. In my opinion, it qualifies as a complaint and you may justify in the vigilance report that the device is beyond the expiration date etc. Obviously, it feedbacks into your PMS data, Risk Management. You may also would like to clarify the expiration date on your device.

Matthew Bodo Short answer: Yes, it should get logged. Even if it is 50 years after a useful life. As others have pointed out, what you do with the complaint will drive the next steps. That's the part you'll need to work on.

Yes, this reported issue would be a complaint. That said, since the device has a 5 year life, and its being used past that approved timeline (assuming that is clearly documented in the IFU). Yes this would be a complaint. The required action depending on your internal complaint management processes would be to clearly indicate the device has been used past its life expectancy and notify the customer of that fact. No other action in regards to deeper investigation or design change would be required. If a patient was injured, actual device evaluation would be in the best interest of the business, but I would guess the outcome would/should be that the device has met its expected life.

Another aspect of this issue is a product obsolescence strategy - should a company institute a formal sunset of a product after its useful life with notification to customers that they should no longer use the product? Most companies are not likely to do this, even if they have a next generation product or line extension available to replace it, unless they are no longer able to repair/support the product due to obsolete/unavailable components. Even if the product is past its useful life, FDA may still consider a field action to be necessary if a product performance issue results in patient harm, as noted in the responses above.

Thank you all for reminding me why I love this group so much. This is a meaningful exchange that helps your fellow members.

Thank you.

Monir EL AZZOUZI This is really an interesting question. I am in charge of complaints on Capital Equipment and I've never heard of a hard life-span mentioned to the customer. But this is definitely a complaint. If you can repair it with an invoice to the customer, then I think you should. It will also provide you information on the issue and how to improve your product. This should be part of your Postmarketing surveillance. But if it was clear from the beginning that there is no repair or maintenance possible for this equipment then you should be able to report that on your complaint with a justification.
But, if you have a methodology to repair, it will be difficult to justify that you will not do it if the customer ask for it.

Yes, I agree that it should be logged as a complaint. Further investigation as to the actual cause of the complaint will determine next steps, regardless of it's age. Just because a product is End of Life/End of Service does not dismiss the liability that a company has to investigate the complaint.

Yes, it is a complaint and needs to be investigated. During the investigation if it is found that the device malfunctioned because of the failure of a component (which is beyond its life expectancy), then that has to be documented.

Complaint, but you need to answer 5 year "life span" question. What does this really mean?
Is this a sterile device or equipment?

Patricia Medina Great question. While we can debate the life span the issues is still a complaint. A manufactures is responsible for the device as long as it is in the market place. The complaint should be logged into the complaint handling system and processed. The next question that will need to be answered is "Was service/repair performed?" Was the failure due to a malfunction? Was there ever a recall, etc.? Keep in mind that as long as the device is serviced and maintained to meet manufacturers specifications. The issue is a complaint and the manufacturer is responsible. My experience has taught me that very few manufacturers clearly define life span and include this information in an IFU. Better to be safe and conduct the investigation than to be sorry.

It may qualify as a complaint that must be tracked but I would also argue that the company has a right to at some point give the customer the option of replacing or discontinuing the use of old equipment. There comes a time with any product (hardware or software) when the cost to maintain it in working order becomes prohibitive.

Tom Tang, RAC Patricia, could you please share with us how "life span" is defined, and how it is determined? Thank you.

Neil Isserlis lots of good comment.
This is a complaint but there are, as always, more questions.
Even though the stated life span was 5 years, had the manufacturer offered a service contract on the device beyond this end point?
As for the question of life span, the NHS in the UK ask for a pre purchase questionnaire (PPQ) to be completed. this has a section discussing life of new equipment. so was a PPQ completed?
Lastly, was the item under service contract during its 5 year life span? has it been properly serviced by qualified personnel? was it being used for the purpose it was designed for?

Mitch Finne, P.E. It's a complaint because the product failed to function as intended, period. The other facts and discussion play a role in deciding what corrective/preventative actions are appropriate. User error such as improper use or failure to perform specified maintainance do not necessarily excuse the manufacturer from a response since 14971 requires consideration of foreseeable misuse (i.e. use errors such as not following instructions or failure to perform prescribed maintainance).

It is a complaint because it meets the definition of a complaint according FDA 21 CFR part 820. Internal SOP may limit the scope for taking necassary corective actions based on proper investigation, e.g. failure of the customer to have it serviced periodically.

This should be recorded as a complaint since this gives the company valuable performance information, which could be leveraged for new product development and service strategy. The cost of fixing of the problem is dependent on the warranty terms. Irrespective of who bears the cost, the part has to be fixed if it can be fixed.

Paul Baim This is an interesting question on several levels. Since one class of risk for any device is potential for misuse, continued use beyond the lifespan is clearly in that category. if the lifespan is clearly indicated (although an explicit date does not appear to have been included), I would normally assume that my handling of this would be strongly flavored by my overall 'misuse' strategy all through the process chain from recording the problem through to my disposition of it. I would even consider that repairing the device might open me to more liability because I am aiding and abetting continued misuse. Do I need a formal end-of-life retirement mechanism? Is notification enough? Clear expiration date marking? Must I offer to reclaim and dispose of the device? The analogy to sterile products is an interesting one. No one expects sterile packaging to last forever.

Pedro Mendes Yes, it is a complaint. Despite of the fact that the repair by the manufacture may keep the client happy, it is irrelevant for the discussion. I would strongly recommend you to investigate. Besides the cause of the failure you should also investigate the misuse scenario of the use beyond the life span and address proper CAPAs to avoid it. Nevertheless if this is a known problem with CAPAs implemented or the risk benefit was evaluated (mainly the misuse of the device) you may skip the investigation.

Helen Hunter It's a disposable Device. It's past the use by date. Game over. The Industry must stop aiding and abetting Hospital administrators continually passing on accountability, the cost and they're legal obligation to industry. Stop it.

When we all are discussing a log on a complaint; Whether to consider a flaw in use after a dedicated life span as a complaint or not?; Well definitely its a complaint and as per the discussion till now most of u suggested the disposal of the device. But as a matter of fact, its a basic administrative and management move to use the device till its functional and not giving any hazardous troubles or effects to the proceedings. The equipments that pass their life span in Developed nations are sold in so called THIRD WORLD NATIONS in the name of REFURBISHED goods. Is it allowable?? If yes, then where the life span matters and if No what are the steps to be taken to check such intakes. Because believe it or not, As the example stated, Disposal of equipment on account of passage of life span, is not what people actually follow..

And in line to the discussion, what I have seen and learnt till date, this is a complaint as far as the company has not stopped support on the product and will be considered and looked into at any given point of time.

Julie Omohundro It is a complaint. The complaint should be investigated. If it turns out it has a lifespan of five years and has been used for six years, then that will be discovered in the investigation.

Neil Isserlis Helen and Shabin raise some fine points.
Helen highlights the fact that we do not have enough information. Is it a single use Item with a 5 year shelf life? If so then there is a use by date that should not be exceeded.
Shabin adds to the debate on life span. The life span of a device for multiple use is not how long it can be used for but for how long it can be supported after sale. In theory, if 500 items are sold over 7 years with a five year life then serial number one could possibly last for 12 years with good service and support, serial number 500 could last for 5 years.
The real challenge is how long a tail to put on medical equipment after you sell the last one off the production line.

James (Jim) Dent, LSSBB, DTMx2 If a customer complains, it's a complaint -- log it as a complaint first. Then handle it like any other complaint using your Customer Compliant and CAPA processes. Recording it as a compliant does not place blame or fault on anybody - it simply documents it, and helps to ensure the issue get resolved.

Stephen Glassic It seems unclear if Minoti Patel is referring to Mfg Warranty or Mfg stated life expectancy. Regardless, investigating and recording cause of failure is a prudent thing to do. This information can be used to improve reliability in the future and to uncover any potential hazards that should be addressed.

From what I could see, it looks like the company she is with makes USB ultrasound probes that can be used with any Windows computer which would also require software. If a probe has failed, it can be due to cable stress or damage or probe damage. Even cleaning agents or process can cause damage. User is responsible for proper care.

As far as Mfg warranty and length of support goes, that is all subject to regs. imposed based on location and mfrs. can choose to support beyond what is required. It is not uncommon for hospitals and med. centers to continue using some devices even after they are no longer supported by the mfg. They may use aftermarket or re-manufactured parts or cannibalize other units to maintain them. Age related failure must be considered, especially in regard to patient safety.

Julie Omohundro Perhaps the question that is more to the point is why would someone NOT want to log it as a complaint?

If there is a factual basis for the claim that the product is beyond its "lifespan" (a term that has thus far been left undefined and therefore is currently meaningless as a basis for this discussion), and, further, that the product can be expected to fail if used beyond its lifespan, then on the face of it, it's the easiest of complaints to resolve. So why even raise the issue?

In terms of resource demands, it takes less time to log, investigate, and close this type of complaint than it does to raise, discuss, and resolve this type of question. One possibility is that the situation is not so clear-cut as it is being portrayed, and this will become clear if the complaint is investigated. Another possibility is that, while these types of complaints maybe easy to resolve individually, if they are logged, then risk management will show that these types of complaints are frequent and/or increasing, raising a new issue that will have to (and should) be addressed. Or someone may simply think that logging the complaint inherently implies an obligation to provide support beyond the "lifespan," which it does not.

Robert Barber Look at the FDA definition of "complaint" - any communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after its release for distribution. Any unplanned repair is also considered to be a complaint. So record it as such, but the resolution should be easy if it was made clear to the user that the device had a limited design lifetime. If the device has a labelled 5-year expiry, then using it beyond the manufacturer's expiry is customer misuse is it not? If planned maintenance is required to maintain the performance of the device - and is stated by the manufacturer in the Instructions for Use - then an obvious question would be "did the user carry out the maintenance in line with the manufacturer's instructions or not?". Either way, a complaint has to be raised in order to answer the question in an investigation.

Whether something is marked as a complaint or not may have a practical significance:
1. Even if the investigation is simple, recording all the information (required by the regulation) takes more time than a non-complaint. If the number of such complaints is low then it makes no difference, but if a company processes hundreds of cases like that a month, then it adds up; even, if it's only an extra minute or two. (I'm not sure if this is the case in this instance, but I'm speaking in general)

2. You're not done with the complaint the moment you close it. They come up again in trends analyses. Fewer the cases marked as complaints, the better your processes appear to be.

Short answer yes. The product is still in use.

Frankly, i haven't heard about any legal definition of life span, the only lifespan-similar concept i know is end-of-support or end-of-life. As far as i know, legally , end of support happens only after certain no. of years from end-of-life. To me, it doesn't make sense to obligate manufacturer to continue supporting customer after end-of-support (complaint or non-complaint)

Robert Barber I would also note the MDR guidance which does not actually require somebody to formally "complain", but merely requires that the manufacturer acts upon "acquired information" that reasonably suggests a reportable adverse event has occurred. This information is often buried in company repair / servicing records (where the company performs servicing operations on its own products as a service to its customers) and may not be not recognised as potential "complaint data". Personnel performing repair activities need to be made aware of this and service data analysed to ensure any evidence of device malfunction is captured and dealt with.

Farhan Mahmood It's not a complaint. It falls under the Service since the malfunction occurred after the lifespan; the design verification and reliability only ensures up-to 5 yrs testing. So malfunction is expected to occur after 5 years of use.
If the malfunction occurred prior to 5 yrs that is not expected then its a complaint.

@ Farhan, there's no legal definition of lifespan and you cannot use it to get out of the requirement to provide a safe and effective product for as long as it's in use. Unless you clearly state in your sales and marketing literature that the customer should stop using the device because it will likely fail when it turns 5 (and I'm pretty sure your sales team never has or ever will do that); or you arrange to remove the device from use.
The definition of complaint does not make any presumption about the age or status of the device. It is an "allegation" that something does not work or does not meet the defined spec.

At one of my previous companies, we had to service devices that we more than 20 years old because some people were still using them. The problem was that almost nobody at the company knew anything about this device because it has not been sold or even serviced for years and nobody made replacement parts anymore. We could simply say tough luck, no can do; but try to do that when TV crews start showing up outside your door because the customer claims he/she will die without this device (grossly exaggerated claim, but media does check for that) and the company will not fix it for them.

Also, as others have noted, the fact that a device is under the Service does not preclude it from being a complaint. FDA will be all over you if you ever try to claim that.

Julie Omohundro Farhan, can you provide a reference to a regulation or guideline indicating that it is not necessary to process a complain received after the service period expired? And also that whether or not a complaint is process is contingent upon whether or not the malfunction was expected or unexpected?

Robert Barber @ Fahran, the words "device does not work properly" means it malfunctioned - it doesn't matter if the malfunction was predicted or not. Therefore it's a complaint!

The only way I could ever consider this NOT to be a complaint is if (a) the user did not report (and the repairer did not find) any malfunction and (b) the device was sent in for PLANNED servicing as directed by the manufacturer in their IFU, i.e. it was returned to the manufacturer for routine preventative maintenance. Otherwise (in my hypothetical world) one could simply predict that the device was bound to malfunction in one way or another at some point in time and think that that absolved them from ever having to record any complaints! I wonder if anyone has ever tried that and got away with it ...... ;)

Julie Omohundro Robert, in my experience, anything that can be tried as a means of avoiding compliance has been tried and will be tried again.

I will add that complaints are not limited to "malfunctions." A device malfunctions only if it does not perform as intended. A device can perform exactly as intended and still not achieve the results it is intended to achieve, and it can achieve a result that it is not intended to achieve, including cause harm to a user. These events should also be processed as complaints, no malfunction needed.

Stephen Glassic As far as I know, there always comes a time when OEM will announce that they will no longer support a device after a certain date. Working with defibrillators, I have seen this several times. These devices can only be supported for so long before it becomes impractical (and possibly dangerous) to support any longer. Some components deteriorate with age which creates reliability and safety concerns. Some components used become obsolete and no longer manufactured.

A particular defibrillator I worked with had all these issues. It was produced from the mid 80s till the late 90s. Around 2006, the company announced that it would no longer be supported. After that date you could no longer get parts from them and they no longer serviced them. Several times after that they offered incentives in the form of trade in value for a newer model.

In cases like this, there are usually ways to support a device at least for a while after discontinued OEM support but eventually it becomes impractical and possibly dangerous. A 3rd party company may buy all remaining parts from the OEM or the OEM might sell them until they run out. They might run out quickly because hospitals and service companies will be stocking up. For this particular model, there is a combination clock/memory chip with integral battery that was no longer being produced. When the battery (with 10 yr life expectancy) dies the chip will no longer function. The clock will go first but later calibration data will be lost causing inaccurate delivered energy. We were buying these chips from surplus houses in order to maintain the devices. There is also a large capacitor which is used to hold energy charge to be delivered to the patient. With age the capacitor would become leaky and make crackling sounds as energy internally arcs between the electrodes. The older devices that were produced in the early years were having this problem. At his point they would have to be removed from service or the capacitor would have to be replaced by cannibalizing a newer unit that had other problems. There were other similar aging problems which caused other performance failures. You may be able to keep them going for a while but good parts become increasingly scarce and there comes a time when they must be disposed of. At this point, as far as I know, that decision (and the liability) is up to the end user.

Phil Strong Hi All,
i have seen some conversations on many forums,however this conversation is the most
unproductive and "jobs worth" i have come across up to now.
Helen Hunter your spot on.

Julie Omohundro Phil, you and Helen have two things in common of relevance to this particular question:

* you are both located outside of the US and

* neither of you has ever held a position in either Regulatory or Quality.

Complaints handling has long been a key focus of FDA inspections, and the subject of untold numbers of 483 findings and Warning Letters, and occasional consent decree. There are NO exceptions to FDA's requirements for complaint handling in FDA regulations related to product life cycle, lifespan, end of life, servicing period, or any similar term:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=820.198

When FDA says, "any complaint," US device companies have learned through long and painful experience that it means ANY complaint, unless it expressly states otherwise.

Given that Minoti is US-based and has almost 10 years of US-based Regulatory and/or Quality experience, I expect she will give the source of all comments posted here due consideration and will not have any difficulty deciding whose guidance is most likely to meet her needs.

Phil Strong Julie,
i have to correct you regarding your perceived assumption of no regulatory or quality
position held.
I have had and held a regulatory duty of care to my patients which required me to recognise
and practice quality care.
I also design health and social care equipment which have to meet and comply with the
European Medical devices Directorates.
I also wish to point out this is an International forum and belittling self gratifying
(American jingolistic) comments are not helpful.
Times are a changing and much wider perspective is being viewed.
(as America didn't invent the World, as some times they would have us believe).

Julie Omohundro Phil, as I said, I will leave it to Minoti to assess the sources and decide which guidance will best suit her needs. Times are indeed changing and a much wider perspective is being viewed. However, in the US, the FDA is still the FDA, and it is still FDA's regulations we must follow if we want to sell FDA regulated products in America. The wider perspective is irrelevant to compliance with FDA regulations.

Neither Regulatory nor Quality as they apply to healthcare are in any way related to Regulatory and Quality as they apply to manufacturers of pharmaceuticals or medical devices.

Meeting the EU requirements for CE Marking, which I daresay the majority of US device companies do, is not sufficient to meet FDA regulations. Among those manufacturers who meet both MDD and FDA requirements, the virtually unanimous consensus is (regardless of whether the company is US-based, EU-based, or elsewhere-based) is that, in most cases, the MDD requirements are less burdensome and the oversight less stringent.

Would it help if I reached out to some of my EU colleagues and asked them to join this discussion? Or might you consider anyone from the EU who agreed that US-based companies are best served by following the guidance of people who are experienced in Regulatory and Quality as it applies to US device manufacturers to be belittling self-gratifying (EU jingoistic) too?

If the person asking for guidance was from Taiwan, I would not presume to give them guidance on what best serves them based on what FDA requires, unless they expressly asked about FDA requirements. Nor would I consider anyone from Taiwan who pointed out that, because I am US-based rather Taiwan-based, I was probably not the best person to give them guidance, as engaging in belittling self-gratifying (Taiwanese jingoistic) comments. I would think they were stating the obvious. Further, given that this is indeed an international forum, I would not provide guidance to anyone here without first determining the regulatory jurisdiction of the person who was seeking the guidance, since all things regulatory are jurisdiction-specific.

Designing equipment does not require meeting many requirements that apply only in the post-market phase. Complaint handling is one of those post-market requirements. Globally, design has very limited regulatory burden, and even less overt regulatory oversight, compared to marketing and manufacturing.

Robert Barber The definition of "complaint" is almost identical in the EU and US regulations. The key word is "alleged". The following article may provide some light relief: http://creoquality.com/all/what-is-a-medical-device-complaint/

Phil Strong Julie,
as i said and which you provided a great example in this case American "jobs worth".

Julie Omohundro Phil, seems that way, many days. Then comes a day when patients are injured, and you remember that it's not about what your job is worth, but what patients are worth.

BTW, I recently posted an informal survey on the forum of the Association of Clinical Research Professionals, which is made up of healthcare providers who conduct clinical research, sometimes institutionally funded, sometimes industry funded, and also people who monitor clinical trials on behalf of industry sponsors. It is also an "international" forum heavily dominated by people in the US.

The question that got the strongest consensus response was how the protection of patient safety today compares with 10 years ago. The overwhelming majority said it was somewhat or much better protected today. A few said it was about the same; no one said it was less well protected. I included an optional comments section, for those who wished to express an opinion as to what factors had contributed to this change. About a third chose to comment, and every single one credited FDA.

Phil, I very much encourage you and your colleagues to start conversations on topics relevant outside the United States. I'm too happy to publish them.

That's where we can all benefit from perspectives from all over the world.

Alvin Tai Great question! I've definitely been in this situation before and we ended up concluding that it was, in fact, a documentable complaint, however the investigation will reveal the marketed lifetime of the device which can lead to rationale for why no corrective action or servicing is required.

Greg Ellis To make this answer very brief: Does the device say on the label, IFU or in the filing that it will not work after 5 years? Or is the user instructed on the label, IFU or literature NOT to use it after a specified period? If not, then it is a complaint.

Look at it this way, whats the harm in calling it a complaint? a few hours worth of documentation and investigation time? What is the risk of NOT calling it a complaint? Having an inspector find it and disagree with you. Which could result in a 483 or inspection observation.

Alvin Tai Greg makes a great point. Check your marketing literature/instructions for use and determine your quality responsibility as a device manufacturer.

Julie Omohundro Greg, why is it not a complaint if the labeling says it will not work after a specified period?

The risk of a 483 or an inspection observation is the compliance risk, and the one I am always the least worried about.

If a device fails simply due to age, it is likely to fail in ways the manufacturer knows nothing about, because, as far as I know, the only way manufacturers evaluate the effects of age is to find out whether a device still meets spec after a certain period of time. They don't age out devices and then use them to see what kind of failures actually occur due to aging, as opposed to the kinds of failures that occur during the product's lifespan, which presumably are not due to aging. Different causes of failures -> potentially different types of failures -> potentially different types of risks. Companies usually try to mitigate these unknown risks with labeling.

If people keep using your device after its lifespan and your labeling says not to, then there is a problem with your labeling. It is not adequately mitigating that risk. The labeling was provided to the user with the product, in this case, 5 years ago. Where is that labeling now? And who consults the labeling for a device after they've been using it with no problems for 5 years? Nobody.

If the problem is very rare, then the risk has been well mitigated. However, in that case, managing the rare complaint is too easy to bother avoiding. If, on the other hand, the complaint occurs frequently, the risk has not been well mitigated. But you can't know that if you don't log these as complaints, because then you can't track and trend. Most important...you don't really know what the risk is that you haven't mitigated very well. And that's risky.

Finally, customers don't care why your device fails. If devices you put on the market 5 years ago start failing in significant numbers today, it is going to hurt sales today. If you have logged and tracked and trended, you have the opportunity to address the problem before it can become a tidal wave. If not, not. That's the business risk.

Greg Ellis Julie.... I don't believe I said that it wouldn't be a complaint if the literature specifically said that it is not to be used after a certain date. Rather, if there is no specific information in the labeling, etc. stating that point then it is a complaint, most definitely. I do not believe in and of itself that point would be the the sole piece of information to determine if it is a complaint. However, it could be a factor.... I was trying to be very brief in my answer to make it simple. Essentially I was asking the original poster to present some tangible evidence, other than heresay regarding the device "life", that they could show that would support their contention that it wouldn't be a complaint.

With that said, 803 speaks somewhat to this point: "Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed, as defined in 801.4 of this chapter."

FDA continues: Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.

So FDA states clearly that label claims and specifications play a part in helping determine what is or is not a complaint.

But to reiterate my point and let me be clear, I for one always err on the side of caution and if it comes across my desk I call it a complaint until I someone can prove me otherwise. I work under the premise that is is my/ my organizations responsibility to prove it is NOT a complaint. Regardless if the user made a gross and blatant error, the device is 187 years old, or the product was bought via the black market it should be considered a complaint if a consumer/ HCP/ sales person, etc. reports it. It is in every company's best interest to respond to complaints and investigate them. Not only is it good for the quality process but it is good customer/ patient focus.

Now I realize that you will probably focus in on some point and try to pick apart my answer, but I can't exhaust each and every scenario in a LinkedIn forum.

Yes, it would be considered a complaint. The key word is alleged in the definition. You will register it as a complaint and your investigation will reveal the cause. Keep in mind, if there is tend in these type of complaints then your labeling might not be adequate.

Pedro Mendes Hello everyone
The definition of complaint in ISO 13485:2003 (to mention something out from FDA) is:
customer complaint
written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market
If you see the 21 CFR 820, in the definition you will see pretty much the same.

Even if the label says that the device should not be used after 5 years, it sill being a complaint. You may not need to investigate (but is a complaint) if you have any evidence of the reason of the failure. It must be tracked back to the risk management, to evaluat the risk associated with the failure and also the risk of using the device after the intended period. If there is a statement to stop using the device after 5 years, but the user is using it, so it should be investigated and eventually corrective actions implemented to avoid reoccurrence.

Julie Omohundro Greg, I agree you didn't say that it wouldn't be a complaint if the literature specifically said that it is not to be used after a certain date. What you seemed to be saying was that, if the literature specifically said that it is not to be used after a certain date, then it was a complaint. I took this to mean that, if it did not meet this definition, it was not a complaint.

1. CFR 803 is the regulation on device reporting, which is certainly relevant to complaints and vice versa, but it discusses complaints as they relate to reporting, not complaints in their own right. 21 CFR 820 is the regulation that addresses complaints in their own right:

* b) Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

Bharath, I think it is a complaint if it alleges, and part of what is determined in investigating the complaint is whether the allegation is true?

Julie Omohundro LinkedIn ate some of my numbers. I'm going to give them another shot, more to see if it happens again than because they are needed to understand my comment. I think it's trying to make them into numbered bullets, meddling little website:

1. CFR 803 is the regulation on device reporting

820.3 b) Complaint means

Julie Omohundro Got one right this time, but it changed the other one again. The 1 should be 21 CFR.

Ole Overgaard Seen from a product risk management point of view, the use of the device beyond the stated lifetime is a reasonable foreseeable misuse. Therefore, that described situation should be treated as a complaint. This means that you must analyze the compliant and evaluate whether your risk analyses need to be updated.

Depending on the severity and probability of the misuse, the risk is either acceptable or not. E.g. if the device is a life-saving device, the risk is probably unacceptable and must be controlled. E.g. For some devices (containing electronics) the device could warn and alarm 3 months before end-of-life, and it could self-destruct at end-of life, with proper warnings and alarms.

On the other hand, for non-lifesaving devices, the risk may still be acceptable.

Gottfried Griesmayr By Minotis description of the scenario, this is a simple service call. She did not say that any patient had been affected. May be the instrument did not start and could not be used? A device outside its specified life-span must not be used, if its availability or failing could be safety-critical! I would even put the question, if the manufacturer should offer repair outside defined lifespan. This depends on the factors limiting lifespan and their associated risks.

Ole Overgaard Gottfried,

I agree that a device outside its expected lifespan should not be used. However, some people will do that for various reasons. That is "reasonably foreseeable misuse", not "abnormal use" according to EN ISO 62366:2012.

If the device warns the user (or simply stop functioning in an obvious manner) at end-of-life, then that warning (or function stop) is a risk control measure, and then the continuous use is classified as "abnormal use".

Therefore I disagree that this is a service call - it is a complaint and should be registered as such.

Gottfried Griesmayr Ole,
I am intending to keep separated risk-management and complaint handling. The "reasonably foreseeable misuse" is of course a point for risk-management, but a device failing outside its specified life-span is not necessarily fulfilling the complaint definition in ISO 13485 in my opinion. "Reliability" and "durability" cannot be claimed and if "safety" is concerned is an open question.
If every such service call is rated "complaint", I am very sure that a systematic root cause analysis will not be performed on all complaints and most of the "complaints" will not be followed by reasonable CAPA's. Therefore I am reluctant with an inflationary use of the term.
But service calls are of course subject to data-analysis and if service statistics show that a significant number of devices are used beyond their intended life-span, you found a valid point for risk-management and usability.