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The Fundamentals of Medical Device Complaint Handling


Complaints can come from anywhere. Although they cannot be fully eliminated, they can be greatly minimized. If they can't be stopped, they can be efficiently handled. And this requires a good comprehension of the complaint handling fundamentals. This article will help you comprehend and effectively handle them from the opening through the closing of the complaint.

In the medical device industry, complaint handling involves much more than soothing dissatisfied customers. It is a regulatory requirement and a risk-reduction essential.


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Understanding Complaints

FDA 820.3

"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."

ISO 13485:2016

"Written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization's control or related to a service that affects the performance of such medical devices."

Complaints are a one-way process. They come in and hence handling them is a reactive process rather than a proactive process. Those involved in the complaint handling process will find reading the 21 CFR Part 820 and ISO 13485:2016 very useful. Also, this seminar sheds valuable insights about the topic.

Differentiating between Compliant and Feedback

A complaint can be feedback. But feedback cannot be a complaint. It is important to understand the difference between feedback and a complaint because you need to set a process for complaints to meet your requirements. You will understand more about it in the latter part of this article. Inquiries about the product, call for preventive maintenance, shipping error, and cosmetic defects are not complaints.

Turning Complaints into Opportunities

Rather than viewing the complaint-handling process as a burden, leading medical device companies highly value them. The data complaints generate helps them develop better, safer products, lower labor costs, and reduce plant downtime. A well-designed complaint capture system is one of the most valued means to monitor the quality of the product and provide feedback to the design, manufacturing, technical support, sales, and marketing teams. Such a system holds a key part of a complete responsive customer service solution and is an important component of risk management.

Sources of Complaints

Complaints can come from various sources and may be submitted by customers or from customer service staff, your sales team, or frontline representatives.

  • Telephone
  • Online forms
  • Email
  • Social media
  • Online product reviews
  • Letters

Whatever the source of the complaint may be, it is important for complaint handling staff to be well equipped to handle complaints in accord with the regulatory requirements. (21 CFR Part 803).

Classifying Complaints

The post-market complaints can be classified into two baskets:

  • Incident-driven: An incident such as serious harm or death occurred due to malfunction of the device will require immediate attention.
  • Review-driven: When reviewing your data, if a pattern of repeated failures or flaws which qualifies as a complaint are noticed, it can be categorized as a review driven complaint.

Setting up a Process to handle complaints effectively

  • FDA 21 CFR 820.198 and ISO 13485:2016 section 8.2.2 provides regulatory requirements about medical device complaint handling.
  • As per the requirements, you must have a formally designated unit with clear procedures to receive, review, and evaluate complaints
  • They must be investigated in a consistent and timely manner
  • You must evaluate whether a complaint warrants reporting to regulatory bodies under FDA 21 CFR Part 803 and/or ISO 13485:2016 section 8.2.3 requirements.
  • Your process for complaint management is something that auditors look for when you are inspected.
  • Warning letters will be issued if complaint procedures are not in place. Your complaint handling process must be properly documented.

How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation is, is covered in detail here.

A typical Complaint handling process example

Complaint handling process

Investigating the complaint

Step 1: Evaluate whether the complaint is valid or potentially reportable

Section 820.198(b) discusses the initial review and evaluation of the complaints in order to determine if the complaints are "valid." this evaluation is not the same as a complaint investigation. The evaluation is performed to determine whether the information is truly a complaint or not and...whether the complaint needs to be investigated or not. If the evaluation decision is not to investigate, the justification must be recorded. - QS Preamble, Comment 190

Review, evaluate and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary - 21 CFR 820.198(c)

Step 2: Investigate the probable cause

Step 3: Investigate to root cause where possible

Closing the complaint

After taking appropriate actions, your system may let you close the complaint.

At each step of the investigation process, ensure that you document parallel processes such as vigilance reporting, updating of risk management files, and CAPA if relevant. If your investigation came to an end at the first step, you are required to document that further investigation was not required and the reason for ending the investigation. The same holds good at whatever stage the investigation ends.

If your investigation reached the final stage where you prepare a CAPA, your process may let you end the complaint by providing a reference to the continuing of the CAPA work. This is valuable because you may have received more complaints about the same problem before the CAPA are executed.

COMPREHENSIVE COURSES FOR FURTHER LEARNING:

Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

This Seminar will have you stop spinning your wheels with nonessential activities and leave you with a comprehensive learning package that only Rita Hoffman, a former FDA CDRH Recall Branch Chief with experience across the device, drug and veterinary industries can provide.

Spotlight on Complaint Handling and Medical Device Reporting

This webinar will help you to understand the expectations of complaint handling and medical device reporting. You'll also learn about lessons from 483s and warning letters.