The last thing you need to deal with is a medical device recall. Whether a correction or complete removal from the market, a single medical device recall can cost up to $600 million. The U.S. Food and Drug Administration (FDA) has strict guidance on how and when a recall should be initiated.
It’s a lengthy process that involves a lot of moving parts. You need to be recall ready. Are you? Thankfully, there’s a solution on the market to make developing, training, and executing a mock recall streamlined – while relieving common pain points and managing multiple recalls. Let’s dive into the FDA’s medical device recall requirements.
FDA Medical Device Recall Management Requirements
The FDA can legally require a company recall a device if it poses a significant health risk, including death. However, voluntary recalls are much more common. Even though you’re doing it voluntarily, you still need to notify the FDA, so it can monitor the recall process for compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act.
The FD&C Act covers a variety of sectors, including medical devices, which are divided into three distinct classes:
I: Medical devices that don’t require FDA approval but must follow general controls, like elastic bandages, enemas, and dental floss.
II: Medical devices that must be cleared using the FD&C Act’s 510(k) process. This includes hearing aids, powered wheelchairs, and some pregnancy kits.
III: Medical devices undergo a Premarket Approval (PMA) process like pharmaceuticals. This includes anything implanted, like pacemakers and breast implants.
Any firm responsible for a recall must submit a written report within 10 days outlining the corrective actions taken. Full device information and any related injury or illness must also be reported, and that’s just notifying the government.
You also need to keep your customers informed every step of the way. The FDA posts public notices of recalls, but you’ll create a stronger customer relationship by managing it yourself and keeping them in the loop. That’s where automated recall management comes into play.
Automating Recall Management Compliance
Lives are at risk with any product recall, but it’s especially true with a medical device recall. Everything needs to be handled quickly and efficiently using an assembly-line process. This simply isn’t possible without digitizing the entire platform and using powerful cloud-based analytical tools to increase response rates and maintain all documentation needed for FDA compliance.
Many firms simply don’t have the resources to complete this process and involve tedious emails, spreadsheets, and meetings. Meanwhile, fast-paced deadlines continue to pound you, putting stress on already thinly stretched resources.
Automation makes things easier by enabling mass data import and upload into convenient databases. From here, templates enable easy workflow throughout the project management process. Alerts, analytics, and reporting are all managed automatically, keeping all stakeholders informed and freeing resources for more high-level analytics.
Best of all, everything is contained in one intuitive dashboard that provides at-a-glance access to both top-level and detailed data. Recall progress can be tracked from the recipient response to product disposition, return/replacement, and completion. All details are taken care of, so you’ll save millions on your overall recall process.
Of course, the best usage of resources is to utilize a software-as-a-service (SaaS) platform for your recall management. This is why Trievr created a custom solution built from the ground up to serve the medical device industry. In fact, let’s discuss the premium benefits we provide to ensure your recall process runs smoothly from front to back.
Implementing the Best Way to Recall Medical Devices
There are two categories of actions the FDA considers an official recall: correction or removal actions. Some examples of actions that fall into the correction category are repairs, inspection, adjustments, and relabeling, along with notifying patients and monitoring them for health complications.
Meanwhile, destroying a device removes it from the market entirely, because it represents a health hazard. Products that fail to abide by all FDA rules and regulations above, or even potentially violate these legal requirements, will trigger a recall. It’s a good idea to keep an eye on any official press releases from the FDA, as they may pertain to your company.
You don’t even need to wait until a recall hits – you’re welcome to contact MockRecalls at any time to discuss the steps to assess your organizations recall readiness.
MockRecalls is a mock recall planning, training and consulting program to test your recall readiness. We are purely focused on protecting your product investment by working with you to create a new recall plan or analyze your current recall plan and then put it through a mock recall or recall simulation test to insure you are prepared for a possible product recall. We use our on-demand SaaS based recall management platform that eliminates common mistakes manually conducting recalls, by automating the most tedious steps of a product recall. It is a simple to use platform that just focuses on handling product recalls quickly and efficiently. Through our mock recall training using our dedicated recall platform, companies can improve the recall process, increase response rates, and document and communicate with all stakeholders.
Our program can analyze your company’s readiness in many of the typical elements of the recall process including:
- Initiation, investigation, and communication process
- Recall working team and decision team composition and dynamics
- Team roles and responsibilities
- Process flow and lot traceability
- And retrieval capability and effectiveness checks
Our recall simulation program is conducted as an escalating model using real product facts and potential issues, with multiple inputs such as consumer complaints, social media, FDA/USDA/local health department and law enforcement. Conducting a recall simulation will also allow the recall team and all involved personnel to become familiar with their responsibilities throughout the recall procedure. This gives them time to effectively communicate any concerns about the plan while the company isn’t dealing with the pressure of an actual recall.
Looking to test your product recall readiness across your organization? MockRecalls will help create and/or test your recall program. Click here to learn more or call us!