Product recalls and compliance issues affect all sectors, but some industries face more significant challenges than others. Medical device manufacturers, for example, should know the legal consequences of product recall non-compliance. These consequences include fines and enforcement action levied by the FDA for not responding to safety notices.
As a medical device manufacturer, you might not think product recall management is a big deal. You executed testing and quality control measures during product development, so there’s little risk of a recall. But authorities update regulations and guidance all the time, and you should know any changes that affect your products.
When medical device makers withstand the law, the consequences are severe. The FDA fined one manufacturer an enormous $17.9 million for non-compliance. It’s easy to see why authorities take strict action when medical devices can pose a risk to public safety.
Here are some challenges medical device companies like yours face in 2021:
#1. Failure to Respond to Safety Notices On Time
The FDA regularly issues safety notices for medical devices. These notices might pertain to components, manufacturing errors, or public health risks. However, safety notices can be difficult to decipher.
Some FDA notices include the reason for the recall, the people and organizations affected by the recall, and what medical device makers should do next. But other notices are far vaguer, with very little information on how manufacturers should respond — and when.
When recall information isn’t clear, manufacturers might delay action. Instead, they waste time consulting with their legal team or checking supply chains. However, the FDA often penalizes manufacturers that take too long to respond to notices.
What’s the Solution?
All medical device manufacturers require a product recall management strategy that speeds up recall response times. This strategy should incorporate digital tools that expedite recall management and make it easier to respond to FDA safety notices.
Trievr is a product recall management system for the medical device industry that includes multiple features, such as automatic alerts, real-time reporting, and recall response templates. These invaluable features facilitate recall responses, reducing the likelihood of enforcement action and million-dollar fines.
Another reason to use Trievr: Product recall management is tough enough without having to worry about software. Trievr is a SaaS-based system that’s easy to use, and you can get started in mere minutes.
Recommended reading: How to Conduct Medical Device Recalls
#2. Manufacturers Don’t Have the Time (Or Resources) for Product Recall Management
Busy medical device manufacturers have thousands of tasks to complete every week, including product development, testing, quality control, distribution, and sales. The primary aim of any manufacturer is to create devices that diagnose, treat, and prevent medical conditions, but organizations spend hours on the administrative tasks that support this goal.
With so much going on, many manufacturers don’t have time for product recall management. Others lack the resources to check FDA safety notices and respond to them on time. Unfortunately, the FDA doesn’t give busy manufacturers a pass for non-compliance. You will still face legal action for not responding to notices on time, so it’s critical you use the right technologies to automate time-consuming product recall management responsibilities.
What’s the Solution?
Trievr has a broad range of features that automate product recall responses, such as real-time dashboards and recall response templates.
Another reason to use Trievr: There’s no need to worry about sharing sensitive compliance data with the platform. Trievr keeps data private by participating in the E.U.-U.S. and Swiss-U.S. Privacy Shield frameworks.
Recommended reading: Learn how Trievr benefits medical device makers here.
#3. Some Medical Device Manufacturers Still Rely on Manual Methods
Some manufacturers, especially smaller teams, still use manual methods to manage product recalls. These manual methods include checking the FDA website irregularly, compiling product recall information on paper forms, and sharing recall data via spreadsheets.
With so much at stake, manufacturers should digitize their product recall management processes. Using digital tools instead of manual methods reduces human error and other mistakes that could cause FDA enforcement action.
Using too many digital tools, however, can be just as dangerous as using none. Keeping product recall management data across multiple programs makes it harder to share information and delays responses. Investing in one tool reduces this risk, and it makes more financial sense for manufacturers. Some medical device companies pay for software with features they never use.
What’s the Solution?
Trievr digitizes product recall management with features such as virtual collaborative tools and an import/upload data function. Users manage safety notices and recall responsibilities from one centralized hub, eliminating the need for spreadsheets and paper forms.
Another reason to use Trievr: For budget-conscious manufacturers, Trievr doesn’t charge you monthly or yearly fees. You only pay when you use the platform.
Recommended reading: Why Product Recalls Cost Medical Device Manufacturers $5,000,000 a Day
Before You Go
Medical device manufacturers need to be aware of the latest compliance issues. Otherwise, these organizations can face penalties and other enforcement actions.
Are you looking for product recall management software that speeds up response times and reduces the likelihood of FDA penalties? Trievr is your all-one-in solution for recall management, with a suite of features for medical device companies worldwide. Click here for a live demo or sign up for your FREE trial.