The Enzyme team summarizes how companies should prepare to handle customer feedback after a product is released to market.
Handling customer complaints in the medical device industry is quite different from what you’d imagine it to be in other industries. In the medical device industry, a complaint is any written, electronic or oral communication about problems with a device or its performance after it has been commercialized. Managing complaints is a business and regulatory necessity to reduce the risk of damages or harm to patients.
Why You Need an Effective Complaint Management Process
Companies that manufacture, distribute and sell medical devices are required to follow a documented process for proactively collecting feedback, rather than waiting for complaints to come to them. The FDA has very strict guidelines on how companies do this, which include setting up a process to have all complaints that come in reviewed and assessed by a person or team specially appointed to do so.
This process should include recording all details of the problem, the organization/individual filing the complaint, and the result of the investigation. One way to make sure you do this correctly is to have a Quality Management System (QMS) in place, which integrates with your existing tools to automate much of the documentation you need. Instead of guessing or having to review checklists to make sure you have covered all your bases, a QMS prompts you to collect all the necessary information to fulfill the FDA’s requirements.
Developing Your Complaints Handling Procedure
Creating a formal procedure for handling customer complaints is your best bet for ensuring compliance with the FDA. You’ll get both feedback and complaints from a variety of sources, such as surveys, technical support queries, online product reviews, analysis of data and even social media.
All complaints, including oral ones, have to be documented when they are received, and then evaluated to see:
- whether they should be reported to the FDA
- if an investigation is needed, and if not, why not and who decided why not
- whether a similar investigation has already been done, and what the results were.
If it turns out that an investigation is required, look into what happened to trigger the complaint. Was it incident-drive or review-driven, for example, did it come up during a review of the device, or did it cause death or serious injury while using it for medical purposes? All medical complaints can be counted as feedback, but it’s important to note that not all instances of feedback are complaints.
At the close of the investigation, it’s important that you take any additional corrective actions needed, and that you document both the actions and their results.
Avoiding a Recall Crisis
No medical device company wants to be involved in a recall crisis. It’s a no-win situation in which everyone loses money, vendors and medical providers lose face, and the patients lose out on potentially life-saving treatment while devices are recalled. If you’re making use of the right post-market correction and removal actions, you’re in a good position to avoid such a crisis.
Some of the complaint management steps the FDA expects companies to take include:
- Keeping a record of regulated products that allows you to identify problem lots quickly.
- Recording the location of all products distributed for two years longer than the expected device life.
- Making note of any medical complaints received about individual devices of the same type, to establish whether a pattern exists.
- Withdrawing a product from the market if it has a minor problem that wouldn’t be eligible for legal action.
- Recovering stock of any potentially-defective products that haven’t yet been sold to end-users.
- Issuing a safety alert to device users about the risks of use in certain circumstances.
If you take any of these removal actions, you’re required to send the FDA a written report within 10 working days to remain compliant with regulations. The report should include the manufacturer’s and distributer’s names and contact information, the device name and what it’s used for, and details of the actions you took.
The Pre-Certification Promise
While best practices for handling customer complaints are clearly outlined and relatively simple to follow, they are challenging because of the workload and attention to detail that’s involved. There’s a light at the end of the tunnel, however, with the Software as Medical Device (SaMD) concept that currently developing. The FDA hasn’t yet finalized guidelines for this program, but we’re expecting it to be a game-changer.
The program focuses on the pre-certification of medical device companies based on qualifications and competence, rather than the auditing and clearance of specific products or product versions. This is going to be especially useful for AI-driven medical devices. In place of having to review every product iteration, the FDA will certify the company and its process according to Principles of Excellence. This will enable certified companies to get low-risk products to market with a faster, simpler review process, if any.
The QMS Quotient
Your best option for handling customer complaints correctly is to use an effective QMS that makes sure all complaints are recorded properly, kept up to date, and the status can clearly be viewed by anyone with access, from any location.
Keeping track of complaints using paper records can become a nightmare, but a cloud-based QMS will not only give you a much more organized approach, but it will also prompt you to collect all the information the FDA demands.
Enzyme offers a comprehensive solution that is customizable to work with your current standard operating procedures. It gives you a “birds-eye” view of the situation that helps you to make sure you aren’t missing any critical factors and you have all the information you need on hand to do a proper assessment.
Find out how you can streamline your complaint management processes and improve your methods of handling medical complaints in a way that puts your company at the top of your game. Contact Enzyme today to sign up for a demo of our QMS for your team.