Hello all and welcome back to another issue of MedTech Compliance Chronicles! This week we will follow our complaint handling post by getting into the topic of reportable events. This topic takes us outside of Title 21 part 820 and into parts 803 and 806 a little bit. Nevertheless, though technically not part of the quality systems regulation, reporting events tends to fall on quality personnel, especially at smaller companies that may not have dedicated regulatory affairs personnel.
When it comes to medical device manufacturer’s reporting responsibilities, there are, in general, three reasons a report must be filed and two types of reports depending on the origin of the events and manufacturer’s actions in response to the events that trigger a report. For the most part the information contained in the reports are similar, however, depending on the exact situation the report types and who you are reporting to can change and you might even need to file multiple reports for one event depending on the required follow-up actions. Let’s dive right into it!
What is a Reportable Event?
First things first, what exactly is a reportable event? A reportable event, for a device manufacturer, is any event in which the device in question may have caused or contributed to the death OR serious injury of an individual OR a malfunction occurred that would be likely to cause or contribute to the death or serious injury of an individual if it were to recur. These are the three general reporting criteria given for medical devices under part 803 of Title 21. Note here on the word ‘likely’ in the requirement to report a malfunction. Speakers of the English language generally use the word likely to mean ‘more probable than not,’ however, in the case of reportable events, ‘likely’ is generally interpreted to mean ‘not remote’ (i.e. the chances of death or serious injury if the malfunction were to recur is not remote).
You may also have heard the term ‘adverse event.’ Adverse events are a subset of reportable events. All adverse events are reportable, not all reportable events are adverse. The key difference is usually if a death or serious injury actually did occur, then it is an adverse event. If the reason for the report is a malfunction that could result in death or serious injury if it were to recur but no death or serious injury did occur for the event in question, then the event is reportable but not adverse.
Most reportable events will come to the organization in the form of a complaint (hence why this post followed the complaint handling post). It is possible though, that a manufacturer becomes aware of an issue before any event whatsoever happens. In these cases, it is best to take preventive action before any such event occurs. These preventive actions usually come in one of two forms: corrections and/or removals. A correction is essentially field action to correct a known defect in a device and a removal is removing devices already distributed from the market (a recall would be an example of a removal but not all removals must be in the form of recalls). There are many reasons that organizations may perform corrections and removals and most of them do not require reporting to FDA. There are two scenarios when reports of corrections and removals are required. Those are when the action is taken to reduce the risk to health posed by the device OR to remedy a violation of the FD & C act. The latter meaning, the device is not in compliance with some part of the FDA regulations which apply to it and the correction or removal was initiated to either bring the device into compliance or remove it from the market.
Types of Reports: Reportable Events, Corrections, Removals
So, now that we have an understanding of what medical device reports are and the different types of reports there could be, let's get into a little more detail on the differences between each and from what sources each might arise from. First, we will examine the potential sources of each type of report.
As already discussed, for most event related reports the organization will become aware of the event in the form of a complaint. However, healthcare facilities have their own reporting requirements to the FDA and will sometimes only report to the FDA or report to the FDA and send the manufacturer of the device an FDA form 3500A filled out with the details of the event. As you can imagine, receiving a complaint directly from the customer is generally preferable than to one day receive notification from the FDA that they have been made aware of an event related to your device that you are not yet aware of. This is why an adequate complaint handling process is necessary and should include multiple ways for a customer to submit complaints. Of note, just because a healthcare facility has submitted an event report for an event regarding your medical device does not mean that your organization no longer has to, as soon as you are notified in any way your own time clock for reporting starts.
You should become aware of reportable events involving your device by some means. Now, what if you become aware of a potential issue? Or a real issue that has not yet triggered an event to happen? These are the situations where your reports would be isolated to correction and/or removal reports. Corrections and removals sometimes happen with reportable events, such as a situation where a follow-up action to the event is to correct the device or remove it from its point of use. However, corrections and removals can also be initiated for various other reasons, such as; a nonconformity from an audit identifying a potential issue with a specific lot or batch of devices, perhaps nothing has been reported yet but depending on the issue proactive action may be required to ensure that a reportable event does not occur. Similar realizations can be observed from post-market surveillance data, continued product testing or service or installation reports. A supplier may even notify you they found an issue with a lot of parts you already included in finished devices.
When it comes down to it, there are essentially two types of medical device reporting requirements to the US FDA. If an event (death, serious injury or malfunction that could cause death or serious injury) has occurred, you must file a medical device report. This report will be to the FDA department that handles your particular type of device. If you decide to correct a device or remove it from the market for the purposes of protecting the health of users or to correct a violation of the FD & C act, you need to file a report of correction or removal. This report can be submitted in a similar manner to the reportable event report (an FDA application called eSubmitter) or it can be emailed directly to your Division Recall Coordinator, for which all regions in the United States are assigned. Foreign manufacturers must submit to their Division Recall Coordinator wherever their US representative is located. A final important piece of information to note is that if a reportable event occurs and the organization investigates it and determines that a follow-up action to the event should be a correction or removal, then both reports must be filed.
Conclusion
Medical device reporting is an extremely important factor in the FDA’s ability to maintain public health. The reports allow much of the data manufacturer’s rely on for design and development to post-market surveillance to be generated and made publicly available. Additionally, all of the regulations which mention reporting emphasize that filing a report is not an admission of guilt or violation of any part of the regulations. This is an important part to know so that you understand the purposes of these procedures are not to punish manufacturers for making mistakes but to facilitate timely and effective actions when mistakes do happen.
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