FDA Update: State of Recalls and Risk Analysis

While risk analysis might not be the most exciting process to execute, it’s extremely important work for orthopedic device manufacturers in order to secure regulatory clearance and avoid recalls. As regulators globally intensify their focus on risk management, it’s important for device companies to continue to consider best practices when it comes to fulfilling risk management expectations.

The FDA/Xavier MedCon Conference dedicated nearly four hours to discussing the recall landscape and important approaches to working through risk.

Of the medical devices recalled in the fiscal year 2020 (defined as October 2019-September 2020), 83.26% (or 363) fell into Class II. When breaking down this class of recalls into medical industry type, orthopedics narrowly took the largest slice of the pie with 17% of recalls (or 75 products). The main root causes of recalls for orthopedic devices included process control (43%) and device design (14%).

“Examples of recall issues in orthopedic devices involving process controls were line clearance issues, product or labeling mix-ups, inadequate record keeping and documentation, and equipment parameters,” said Meredith Andress, Recall Coordinator, Division 2, Office of Medical Devices and Radiological Health, FDA-ORA.

After highlighting the numbers, FDA representatives and industry consultants detailed both the importance of leveraging risk analysis as an evaluation tool and also having an effective risk management system in place during the design process. Here are some takeaways, including where device manufacturers often fall short.

Best Practices for Risk Analysis

Where corrective and preventive action is concerned, FDA expects that companies will have procedures in place to assess risk and then zero in on appropriate actions for different levels of risk, as well as “ultimately take appropriate corrective and preventive actions to mitigate problems from reoccurring,” said Phil Pontikos, National Device Expert, FDA-ORA.

FDA will review these procedures during inspections, he added. “In complaint handling, we expect there will be an explanation on how risk to the patient and/or the user is used to develop the level of investigation that needs to occur,” he said. Pontikos stressed that while not all complaints are equal, “Commensurate with risk some complaints may need to be evaluated and investigated rigorously. Others that have maybe low or no risk may have potentially less investigation opportunity.”

FDA’s risk analysis also covers a variety of conditions, Pontikos said. “Manufacturers are expected to identify the possible hazards associated with the design in both normal and fault conditions. Then the risks associated with those hazards, including those resulting from use or user error—those should then be calculated in both the normal and fault conditions.”

Manufacturers can address and mitigate any unacceptable risks with a redesign or warning label. However, he noted that “an important part of risk analysis is ensuring that changes made to eliminate or minimize hazards, do not introduce new hazards. It’s very critical in the process not to introduce new problems or hazards into your design.”

Yet Pontikos also noted that risk analysis is an extremely dynamic process, one that’s constantly updated when new information comes to light. “Ultimately, we need to make sure that the risk analysis is periodically updated and reviewed, especially when there are new risks that you become aware of as a medical device manufacturer.”

Risk Management Expectations

FDA expects that companies will identify all known risk conditions, preferably during the design control process, and “try to bring those risks into some type of risk management document,” Pontikos said, so they can be reviewed. “When you estimate those risks, you’re going to determine whether you can establish a probability of occurrence, for example, or a frequency of how it may occur. And then, from there, you’re going to hopefully be able to mitigate those risks.”

Steve Niedelman, the Lead Quality System & Compliance Consultant for King & Spalding, who formerly worked at FDA, stressed that it’s crucial that manufacturers plan for all sources of risk, even if they seem remote. “Don’t be dismissive of those remote issues that wind up percolating and becoming a problem later on,” he said. “If they are remote, manage them as remote, but manage them. Don’t just ignore them.”

It’s also important to have risk estimations “done by qualified individuals that have the knowledge and the experience with your device,” he added. “Don’t have a dentist, for example, reviewing the risk associated with a cardiovascular device.” Taking into account peer review of your products, as well as any issues or recalls you’ve had with previous generations of similar devices, can also help paint a bigger picture.

“Consider FDA databases for what else your competitors may have had problems with,” Niedelman said. “Are you having the same? Have you taken those into consideration? Look at what competitor recalls have been, just so that you have a full view of the landscape of what needs to be considered.”

Pontikos added that maintaining open lines of communication is vital, especially so that crucial information isn’t siloed. “Another area in which we find a number of issues with is the idea of transferring risk knowledge to employees [who are] making risk-based decisions throughout the quality system,” he said. “It’s so important for these individuals to be aware of what these risks are, especially when you have areas of the design, for example, that you know the essential design output is of high risk.

“You want to make sure that the people that are that are involved in those decision processes, or the monitoring processes, of these essential design outputs that are of high risk, are aware of it. If something does occur, it should automatically raise a flag.”

And, as with risk analysis, Niedelman said that companies should always be updating risk files regularly. “Make sure your risk reviews are complete,” he said. “They should be done routinely anyhow, but certainly when you become aware of new information, be sure to update those files, so you can minimize the need for labeling changes [and] safety alerts, which could have been avoided if the appropriate risk management was undertaken.”


Annie Zaleski is a BONEZONE Contributor.

Join us!

The best of BONEZONE content delivered to your inbox, twice each month.

RELATED ARTICLES



CONTACT BONEZONE

 

CONTACT BONEZONE