Source: http://medicaldeviceacademy.com/category/complaint-handling/
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Case Study Part 1: Packaging Complaint Investigation
Where to Focus Your Medical Device Complaint Handling Training
Posted by Rob Packard on March 5, 2014
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 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).
Tags: Medical Device, medical device complaint handling, medical device complaint handling training, medical device training
A Gap Analysis Tool for Updating Your Medical Device Reporting Procedure
Posted by Rob Packard on February 19, 2014
This blog shows you where to find the new FDA regulation for medical device reporting (http://bit.ly/udpated-21CFR803) and the associated guidance document (http://bit.ly/Part803-Guidance). There is also an explanation of how to perform a gap analysis to compare your procedure for medical device reporting against the new 21 CFR 803 (http://bit.ly/Old-21CFR803).
On January 22, 2014, Medical Device Academy posted a blog about how to create your own FDA medical device regulatory updates: http://bit.ly/4Ways-to-Follow-CDRH. That post identified a number of sources on the FDA website where you can locate information about new and revised FDA regulatory requirements. One suggestion was to register for receiving the RSS feeds from the following page: http://bit.ly/CDRH-news-updates. This page is where the FDA’s Center for Devices and Radiological Health (CDRH – http://bit.ly/FDA-CDRH) posts news and updates.
If you registered for the RSS feed from CDRH, then you received an update on February 13, 2014 announcing the new Part 803 regulation for medical device reporting. This is NOT a cause for alarm. The fundamental change is simple:
Medical device manufacturers will no longer be allowed to submit FDA Form 3500A in paper form. It will need to be submitted electronically through the Electronic Submissions Gateway (ESG) (http://bit.ly/ESG-FDA).
ESG Sign-up
This is just another small step for the FDA to move toward digital records, and to integrate with electronic medical records from healthcare providers. The FDA even created a presentation explaining the process for electronic Medical Device Reporting (eMDR). This 8 minute and 45 second presentation is available on the CDRH Learning page: http://bit.ly/CDRH-Learn. Slide 5 of the FDA’s presentation identifies the six steps for obtaining an account for an ESG:
Get a test account with the ESG
Send a letter to authenticate your digital identity (http://bit.ly/Non-repudiation-Letter)
Get a digital certificate
Contact CDRH (eMDR@fda.hhs.gov)
Test sending an MDR to CDRH
CDRH approves production account with the ESG
I have been recommending that my clients switch from submission of the paper FDA Form 3500A to eMDR since 2010, when this training became available. Now, you have 18 months to switch over to eMDR before the August 14, 2015 deadline for implementation. Alternatively, you can also outsource your eMDR reporting to a service provider that already has an ESG (http://bit.ly/outsourcing-complaints).
Comparison of Current & New Regulations
The first step in understanding the specific changes to the regulation is to compare the old and new versions. The new Part 803 regulation for MDR was released as a PDF document, and therefore it does not lend itself to a direct comparison with the previous version of the regulation. Therefore, Medical Device Academy downloaded the new regulation (http://bit.ly/udpated-21CFR803), and copied and pasted each section into a Word document. We also did this for the current version (http://bit.ly/Old-21CFR803). Then, we compared the two Word documents electronically. Finally, we wrote a gap analysis to summarize the differences between the two documents. If you would like to download this gap analysis, please visit the following webpage: http://bit.ly/21_cfr_803_gapanalysis.
Gap Analysis of Your Medical Device Reporting Procedure
After you download the gap analysis tool that Medical Device Academy created, then you need to perform your own gap analysis of your current MDR procedure against the changes in Part 803. You should create a table with one column identifying the section of the regulations, a second column identifying the section(s) of your current MDR procedure that meet the requirements, and a third column to identify changes that need to be made. You might consider adding additional columns for delegating the responsibility of revising various sections of your procedure, and implementing other tasks listed below (e.g., obtaining an account for ESG).
Download the gap analysis of the new and old versions of 21 CFR 803
Review and update your own MDR procedure to address the changes to 21 CFR 803 which are identified in the gap analysis
Apply for an ESG WebTrader account for Low Volume/Single Reports
Revise your training requirements for anyone responsible for MDRs:
Complete all four applicable CDRH online trainings (http://bit.ly/CDRH-Learn)
Pass a quiz demonstrating training effectiveness (http://bit.ly/TrainingExams)
Review the draft procedure for potential errors or sections that are unclear
Make any final revisions to the procedure based upon feedback from trainees
Implement your revised procedure
If you need help completing the above steps, please contact Medical Device Academy by emailing Rob Packard, or by visiting the webpage for Medical Device Academy’s Complaint Handling and Vigilance group (http://bit.ly/chvg_mda).
Tags: 21 CFR Part 803, adverse event reporting, gap analysis, Medical Device, medical device reporting procedure
7 Considerations for Outsourcing Medical Device Complaints
Posted by Rob Packard on January 31, 2014
Investigating medical device complaints can be a time consuming task. This blog reviews 7 considerations for outsourcing medical device complaints.
Two different clients of mine recently mentioned that they are overwhelmed by the amount of time required to investigate complaints, and to file MDRs with the FDA. I suggested outsourcing the complaint handling to a third-party service provider, but they were unaware of any suppliers with that capability.
I already was familiar with several suppliers offering these services, but I wanted to know if there were companies looking for these services. Therefore, I decided to post a discussion on one of the LinkedIn groups I manage: http://bit.ly/LinkedIn-ComplaintThread. In just two days, there were 21 different comments. Most of these were from consultants offering their services, but their comments were helpful. For example:
“The majority of complaint handling work typically involves a high volume of less critical tasks. Routine things like ensuring all potential complaints are entered into your system, requesting additional information when its needed, documenting updates when they are received, or drafting complaint/reportability decisions based on company policy are all tasks that can easily be performed by a well-qualified service provider for significantly less than if they were done domestically.” – Matts Bell
“Direct input into ESG is much better and easier than an additional third party software package, as ESG does change often and the software companies are not keeping up. Keep in mind that each change digs deeper into the quality system and information. What is acceptable today may not be acceptable tomorrow as the validation keys within ESG tighten.” – Courtland Imel
“I too have provided outsourced complaint, NCMR and CAPA investigations, customer contacts, and root cause analysis to final disposition, sometimes in an FDA remediation project. But it requires active involvement on the part of the client company, with periodic meetings to discuss each case/its resolution, as well as identified trends/their resolution.” – John E. Lincoln
“In the case of adverse events identified through the litigation process, the company cannot contact the complainant directly because the case is in litigation…Utilizing an appropriate third party service provider to work with you on this process can make this type of adverse event reporting fast, efficient and cost effective.” – Melissa Becker
It is true that parts of complaint investigations must be performed internally—such as failure analysis. You also cannot outsource responsibility for review and approval of complaint records or MDRs. However, suppliers can provide trained personnel that are capable of initiating and completing complaint records, performing follow-up with complainants, and determining if complaints are reportable to the FDA and other countries around the world. One of the suppliers I interviewed actually has the capability to translate adverse event reports for countries that require reporting of adverse events in languages other than English, and they have a professional translator verify accuracy. Some personnel even have a medical background (e.g., nursing).
Find a supplier that has many years of experience helping medical device manufacturers with complaint handling and adverse event reporting (no rookies)
Ask for a demo of the software—web-based software is best (I’ll explain why shortly)
Ask to see their complaint handling procedure and perform a procedure review
Ask how the supplier handles complaint investigations when product is not returned (http://bit.ly/DeviceNotReturned)
Verify that the rationale for MDR decisions is based upon the FDA requirements in 21 CFR 803 (http://bit.ly/Part803), and vigilance decisions are based upon MEDDEV 2.12/1 (http://bit.ly/MEDDEV2-12-1rev8)
Ensure that the software system has tracking of timelines for complaint handling and reporting already built-in
Ensure the electronic forms are adequately designed for capturing information—not just yes/no checkboxes everywhere
Why is web-based software better than hosted?
The US FDA is moving quickly toward Electronic Submission Gateways (ESGs) as the preferred method of submissions (http://bit.ly/Why-FDA-ESG). Unfortunately, there are frequent changes to ESGs that require software modifications and revalidation (http://bit.ly/ESG-FDA). Therefore, unless you prefer to have a full-time person responsible for revalidation of software, web-based software solutions are typically your best choice for regulatory submission software tools. It’s also convenient to be able to access records and print them out for an FDA inspector from any computer. This eliminates any possibility of a 483 being issued against 21 CFR 820.198(f) (http://bit.ly/820-198).
Tags: medical device complaint handling, medical device complaints, outsourcing medical device complaints
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