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Complaint Handling and Medical Device Reporting Common Mistakes

complaints Complaint Handling and Medical Device Reporting Common Mistakes This blog, “Complaint Handling and Medical Device Reporting Common Mistakes” reviews complaint investigations, MDR procedures and adverse event reporting.  

You should already be well aware that deficiencies in complaint handling and Medical Device Reporting are two of the most common reasons why the FDA issues 483 inspection observations and Warning Letters (http://bit.ly/FY2013-483-Data-Analysis). Recently, I posted a blog about “Where to Focus your Medical Device Complaint Handling Training” (http://bit.ly/Complaint-Training). The following is a summary of my responses to reader questions.

Complaint Investigations

What criteria do you think should be used to determine whether a complaint should be investigated or not?

There is only one acceptable rationale for not conducting an investigation of a complaint. If you don’t investigate complaints when required, then you might receive an FDA Form 483 observation worded like this…

21 CFR 820.198(c) – Complaints involving possible failure of labeling to meet any of its specifications were not investigated where necessary. Specifically, a missing IFU was reported in customer complaints, but no investigation was conducted. The rationale documented in the complaint record was “the missing IFU presented no patient risk.”

A missing IFU is “failure of labeling to meet any of its specifications.” Therefore, 21 CFR 820.198(c) requires you to conduct an investigation “unless such investigation has already been performed for a similar complaint and another investigation is not necessary.” This is the only rationale that is acceptable for skipping your investigation. To ensure that no one forgets to investigate a complaint, make sure you include a space in your complaint handling form that is specifically labeled as “Summary of Complaint Investigation.” This space should also include an option to cross-reference to a previous complaint record where a similar investigation is already documented.

A missing IFU is also considered misbranded product that requires correction (e.g., sending the customer a replacement IFU) or removal (i.e., recall). The FDA expects a Health and Hazard Evaluation (HHE) form to be included in your recall records (http://bit.ly/HHE-Form), and the HHE should indicate the potential risk of a “delay in treatment.” This is the FDA’s conclusion in their evaluation of risk and therefore your HHE must identify a delay in treatment is a patient risk too. The FDA also expects a CAPA to be initiated to prevent recurrence of this type of labeling error. You can make a “risk-based” determination that reporting a specific recall to the FDA is not required as per 21 CFR 806.20. However, you need to maintain records of your determination not to report a recall. If you already received a Warning Letter, you should err on the side of reporting anyway.

Note: References to “recall” in the above paragraph are meant to include field corrections.

Intended Use

If a complaint consists of a medical device being used for something other than its intended use, is an MDR required for this user error?

The answer is yes. If you don’t report adverse events involving “user error,” then you might receive an FDA Form 483 observation worded like this…

21 CFR 803.17(a)(1) – The written MDR procedure does not include an internal system which provides for the timely and effective evaluation of events that may be subject to medical device reporting requirements.  Specifically, several incidents where a death or serious injury occurred were “caused by a user error,” and the procedure did not identify this as an event requiring Medical Device Reporting.

In 21 CFR 803.3 (http://bit.ly/21CFR803-3), the FDA defines “caused or contributed” to include events occurring as a result of:

  1. Failure
  2. Malfunction
  3. Improper or inadequate design
  4. Manufacture
  5. Labeling, or
  6. User error

It is important to understand that the definition of complaints and the requirement to report adverse events should not be “risk-based.” The need for remediation and the need to report corrections and removals can be “risk-based,” but whether something is a complaint, and whether it is reportable should be “black-and-white.” For example, “Did the death or serious injury occur due to a ‘user error’–including use other than the intended use?” If the answer is yes, then it is a complaint and reportable.

Adverse Events

Do incidents that occurred outside the United States need to be reported to FDA?

The answer is yes. If you don’t report adverse events that occur outside the United States, then you might receive an FDA Form 483 observation worded like this…

21 CFR 820.50(a)(1) – An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused, or contributed to, a death or serious injury. Specifically, several instances were identified where the device caused, or contributed to, a death or serious injury, and the event was not reported to the Agency. The rationale documented in the complaint record was that the “event occurred outside the United States.”

This type of mistake is most likely due to a lack of training on 21 CFR 803–Medical Device Reporting. Some manufacturers that distribute product internationally are more familiar with the European Vigilance requirements (http://bit.ly/MEDDEV2-12-1rev8). The European Medical Device guidelines clearly indicate in the scope section that “the guidelines are relevant to incidents occurring within the Member States of the European Economic Area (EEA), Switzerland, and Turkey…”.  Therefore, standard industry practice is to not report these events, unless the events occurred in Europe.

The FDA Part 803 requirements are worded differently. Part 803 does not indicate that the event had to occur in the United States. By not stating that MDR’s are to be filed for events in the United States only, it is the FDA’s expectation that manufacturers shall report events occurring outside the U.S. if the devices are “similar” to devices marketed in the U.S. Unfortunately, the FDA’s expectations have not become “Standard Practice” for all manufacturers. Therefore, the FDA is currently circulating a new guidance in draft form to clarify this requirement (http://bit.ly/2013-MDR-Draft-Guidance).

If you need help with training on complaint handling or Medical Device Reporting, please download our free webinar: (http://bit.ly/chvg_mda).

Posted in: Complaint Handling

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But What About FDA Regulations?

The author writes that when you are auditing, you should always read the FDA regulations again to ensure accuracy.  

I hear this question, or a question with similar wording, quite frequently when I am auditing. Typically, the question is in response to a better way to do something that seems simple and efficient. Most people seem to approach regulatory requirements with the approach of…let’s bury the regulator in paperwork. While it’s true that auditors expect a certain amount of paperwork with each regulatory requirement, they frequently accept a broader range of documentation than people realize (i.e., one page can be enough).

For example, a design control procedure could be a one page flowchart that references forms and work instructions, or twelve separate documents, with a minimum length of ten pages and a maximum of forty pages per document. As long as the procedure has sufficient detail for personnel performing these tasks, and all the required elements are included, ISO clauses 7.3.1-7.3.7, then an auditor should identify the process as conforming.

However, some people are FDA inspectors looking for NONCONFORMITY!

In the case of inspectors, it is critical to present your information in such a way that it is easy for the inspector to see how you meet the requirements of the regulations. One of the best ways to do that is to reference the requirements directly in your procedures.

For those that prefer finesse…try to organize information in accordance with the regulations. For example, if I am writing a procedure for an ISO registration audit, I write the procedure to specifically address the ISO sub-clauses. I might even use a document control number like: SOP-73 for my “Design and Development” procedure.

In my previous blog posting, http://bit.ly/AuditHours I suggested a slight change to the scheduling of internal audits. In order to ensure this meets FDA requirements, the key is to READ THE REGULATIONS AGAIN. With regard to internal auditing, the applicable FDA regulation is: 21 CFR 820.22:

“Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action (s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.”

The above requirement is quite vague with regard to how many auditors and how many days must be spent auditing. These are the variables I suggested changing in my previous blog http://bit.ly/AuditHours. The FDA regulation 21 CFR 820.22 is  specific, however, with regard to documenting the “reaudit” of any deficiencies found during an audit. This prescriptive requirement can be met by reviewing previous audit findings of all audits with the audit program manager during the audit preparation process. The audit program manager can facilitate the assignment of which auditor will reaudit each finding. This may require a few more minutes of audit preparation, but this should not measurably impact the overall time allocated to an audit.

I do this out of habit when I am performing internal audits on behalf of clients, but if I am auditing the internal audit process of a client—now I’ll remember to point out this additional requirement that is specific to the FDA and not included in the ISO Standard. This is why we should always READ THE REGULATIONS AGAIN.

 

Posted in: FDA

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