How Design Controls Can Prevent Medical Device Recalls

According to the U.S. Food and Drug Administration (FDA) website, there were 32 medical device recalls in 2018 and 49 in 2019. While not every recall is due to errors in pre-production, one of the main causes is a lack of design controls. Having these controls in place can lower the possibility of a device being recalled by strengthening risk management. This article explores how design controls can help prevent medical device recalls.

When preparing a device for FDA approval, design controls are a set of procedures built into the design and development (D&D) process. They ensure the product is suitable for its intended user, by mapping the traceability between user requirements and the design output.

It is good practice to consider your design controls as early as possible, so you can integrate risk management at every stage of your device’s production. For instance, it is good practice to take stock of potential hazards when identifying user needs and design inputs. You can then use this information to shape your input requirements so the design output poses a lower risk to the user.

Prioritizing risk management can help establish effective nonconformance monitoring in your design controls. Nonconformance monitoring raises a flag when a device fails to fulfil its specified requirements so you can create a system for corrective action. For example, internal quality audits with batch tests can be set up or the device can be reworked. One of the main reasons devices are recalled is they fail to fulfil the intended purpose. By building risk management and nonconformance monitoring into the D&D process, you can prevent your product from being rejected by notified bodies (NBs) or recalled later down the line.

Incorporating Risk Management
Design controls demonstrate a device, such as a scalpel or endoscope, addresses the needs of users and that it is safe. Risk management starts at the D&D phase—the priority for every manufacturer is ensuring the device meets clinical needs, design inputs, and user requirements.

Detailed and structured design controls provide a solid foundation for your quality management system (QMS), but they are not a substitute for risk management. It is good practice to interlink the two as early as possible. For example, as you identify hazards, you can create a traceability matrix to demonstrate how these feed into the user needs and design inputs. This can help you understand the severity of a particular risk and the likelihood of it occurring.

“In the matrix, you specify a corresponding output for each design input,” explained Adam Freeman, freelance FDA compliance consultant at Kolabtree. “For instance, if the input is that the scalpel must be sharp enough to effortlessly cut through human flesh, the output would be that it must be sharp enough to pass a verified sharpness test. While it isn’t an FDA requirement, building a traceability matrix is good practice because it demonstrates the evolution of a medical device from start to finish.”

Risk management must cover all lifecycle phases, from initial conception and design to the device’s use and decommission. Like design controls, risk management should be a living process that adapts in line with new information. Reviewing your protocols as new hazards occur can help you avoid embarrassing recalls by putting corrective measures in place as early as possible.

Building an FMEA
Your risk management should be concise and systematic so that it can account for every possible failure. One way you can do this is by building a failure mode and effects analysis (FMEA) from the information in your traceability matrix that links your user needs to the design inputs.

The FMEA is a step-by-step process for identifying all possible failures in the design and manufacturing of your device. It will account for the various ways that a device could fail, such as metal corroding or parts breaking off. It will also document the effect of these failures, such as material waste, device defects, and harmful impacts on the user.

There are two main categories of FMEA—design FMEA (D-FMEA) and process FMEA (P-FMEA). The D-FMEA monitors a device’s components and assesses the possibility of malfunctions to identify possible risks in your device’s design. The P-FMEA tracks hazards in the production process and the impact of process changes, including human factors and any machinery used. For both types of FMEA, you can assign each hazard a unique risk priority number (RPN) and prioritize them according to severity. If you don’t have in-house knowledge of FDA and risk management guidelines, you can hire a freelance FDA compliance consultant to help build your FMEA.

Conclusion
While the number of FDA device recalls may be increasing, you can avoid the same fate by having robust design controls and risk management processes in place. As well as proving your device is safe, this can help you stay on top of potential hazards so that you can put corrective measures in place to ensure safety and compliance.