Medical Device Academy performed a data analysis of FDA 483s for 2013, and identified 4 areas of focus for your medical device complaint handling training.
One of the challenges of creating a strong training curriculum is the need for practical examples. This is why there are lots of stories about real-life companies and products in every Medical Device Academy training event. We learn more from our painful mistakes than we do from our success stories. When you recall product, report deaths involving a product your company made, or if you receive a Warning Letter—these are events that we will never forget.
Medical Device Academy recently posted a blog (http://bit.ly/outsourcing-complaints) about complaint handling, because this is one of the most common areas identified in FDA Form 483s and Warning Letters. Therefore, if you are trying to develop training on the topic of complaint handling (i.e., 21 CFR 820.198), then you should look for examples from your competitor’s mistakes. The following is a list of places you should look:
- Past inspection reports issued to your company by the FDA
- Any inspection reports or Warning Letters about your competitors that become public
- Other Warning Letters that mention complaint handling as an issue
Here’s an example of the type of 483 observation you might find: “Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).”
The example above identifies five different problems with a complaint process:
- You need a procedure
- You need to designate a complaint handling unit
- You need to define the process for receiving complaints
- You need to define the process for reviewing complaints
- You need to define the process for evaluating complaints
21 CFR 820.198 is a prescriptive requirement in the regulations. Therefore, you not only need to create a procedure specifically for complaint handling, but you also need to ensure each element of the requirement is satisfied. This is important, because FDA inspectors will verify that your procedure includes each element.
Medical Device Academy performed a data analysis of FDA inspection reports for FY2013 (http://bit.ly/Form483-FY2013) in order to identify other common mistakes related to complaint handling. The data analysis of FDA inspection reports for FY2013 identified that there are actually 15 individual citations related to complaint handling that the FDA identified using the TURBO EIR System (http://bit.ly/FDA483s). The table below summarizes the frequencies of these 15 sub-sections that were referenced in citations during FY2013 under the complaint handling category:
Medical Device Complaint Handling Training: 4 Critical Areas of Focus
The above table identifies several other sub-sections that present problems for companies. Based upon the data analysis, your company should also be training your complaint handling unit in the following four critical areas:
- Maintaining complaint files
- Reviewing and evaluating complaints for the need to perform an investigation
- Documenting complaint investigations in your complaint files
- Determining whether a complaint is reportable under 21 CFR 803
The fourth area is one of the most important, because these complaints involve injury, death and product malfunction. Therefore, you might consider reviewing the TPLC database (http://bit.ly/FDATPLC) for MDRs. The best data to review is data for the same product codes that your company distributes, but reviewing any MDRs can teach your employees which types of incidents need to be reported. This area will also receive increased scrutiny with the recent changes to 21 CFR Part 803 (http://bit.ly/udpated-21CFR803).