The Critical Importance of Recall Readiness

Protecting Patients and Preserving Public Health with Effective Recall Preparedness

Medical devices play a crucial role in patient care, providing innovative solutions or enabling indispensable procedures that improve outcomes across the healthcare spectrum. Inevitably, there also will be product recalls: infrequent but potentially devastating events.

Q3 2023 Healthcare Quarter in Review Read Now

During 2Q22, there were 268 recall events involving medical devices, a 34% increase from the previous quarter; safety concerns, software issues, mislabeling and quality issues were listed as top causes.¹ More than many other commercial products, medical device manufacturing entails a level of product or usage risk that could lead to a recall. Therefore, it is essential that manufacturers have in place a well-prepared recall readiness plan to ensure a timely, coordinated and effective response in the event of a recall. The consequences of a poorly managed product recall can be severe, resulting in large financial costs, reputational damage, compromised patient safety, legal actions and heightened regulatory scrutiny.

While recalls may be inevitable, a comprehensive recall readiness plan is crucial to minimize ripple effects and protect patients along with the wider public.

The Real Cost of a Recall A global medical device manufacturing company initiated a recall in June 2021 in which they recalled 15 million CPAPs, BiPAPs and ventilators within 3 months due to small particles being released that could cause health problems, including cancer. A summary of the real cost as of August 2022:

168 Deaths
7+ Patient injuries, including cancer, pneumonia, asthma, infection, headache, dizziness and chest pain
69K Complaints
5.5M Defective devices distributed globally
300 Lawsuits
10K Employee layoffs
$631M Reserved for legal settlements

Source: Fierce Biotech, The Economic Times

Underlying Causes Leading to Medical Device Recalls

Underlying causes of medical device recalls include:^2,3

Device design and manufacturing defects: Design failures can result from excessive shelf life, lack of biocompatibility, or ignoring human factors and usability, which can affect both the user and manufacturer.⁴

Software design: Software itself can be a medical device or a component of a medical device, or it can be used to make or control a medical device.³ In short, software has become an indispensable component of most medical devices. Consequently, software failures such as programming anomalies, security vulnerabilities and network connection issues have contributed to software design being the leading cause of medical device recalls.⁵

Change & process controls: Process and change control, from design conception through the product life cycle, is a daunting undertaking that is often overlooked or incomplete, with siloed repositories adding a layer of complexity.

Nonconforming components/materials: Components of medical devices can be defective or otherwise fail to meet quality standards. Nonconforming materials or components can arise from issues with suppliers, manufacturing errors, design flaws, or a lack of requisite testing or inspection of components.

Labeling or packaging issues: Inaccurate or incomplete instructions for the use of the device can lead to a lack of clarity regarding proper or intended product usage, which can result in patient harm or injury.

Key Challenges in Managing Recalls

Common issues that can cause a lack of preparedness to respond to a medical device recall may include:

Inadequate or poorly defined recall procedures: If a company does not have a clear and well-defined plan in place for handling a medical device recall, it can lead to inaction, confusion or delays in responding to the issue.

Inexperienced staff: Responding to a medical device recall can be a resource-intensive process. If a company does not have the requisite resources, such as personnel, technology or financial resources, this can impede its ability to respond effectively.

Domestic and foreign compliance: In an ever-evolving regulatory landscape, some medical device manufacturers can lack full awareness of changes in regulations, resulting in incomplete or misinterpreted adherence to specific guidelines.⁶

Inadequate internal and external communications: When communication hierarchies do not adequately consider internal stakeholders, it can cause disconnects in providing inter-company updates on open recalls and disconnects on the impact on different functional areas and priorities. Similarly, a lack of transparency in external communications with consumers can result in brand damage and difficulty in maintaining brand loyalty.

Lack of comprehensive performance reporting and analytics: Failure to adopt fact-based analytics and reporting processes can blur the line of sight for leadership and key stakeholders on recall activity, and affect the company’s ability to respond in a timely manner.

Critical Success Factors

Medical device companies should adopt specific best practices to ensure they are recall-ready.

Proactive planning and preparation: Companies should develop and establish a comprehensive recall readiness plan that includes detailed procedures for identifying, assessing and responding to potential recall situations.

Recall communication plan: Develop a comprehensive communication hierarchy that details internal communications, communications with FDA and other regulatory authorities, and communications with customers and the broader public

Continuous training and awareness: Teams should receive regular training on recall management and be aware of their specific roles and responsibilities if a recall event is triggered.

Effective documentation: Establish essential documents or records such as standard operating procedures (SOPs), work instructions (WIs), workflows, annual review and revision, and training plans; these should be regularly updated to reflect new information, regulations and revised procedures.

Robust quality management systems: Organizations should implement robust quality management systems to ensure that their devices are manufactured and distributed in accordance with regulatory requirements.

Continuous improvement and monitoring: Ongoing monitoring and review of processes and systems, as well as analysis of recall metrics, can help organizations identify areas for improvement and ensure ongoing recall readiness.

Establishing a Vigilance Team in the United States – Medical Device Company | A Case Study

Situation

A global medical device manufacturing company engaged FTI Consulting's Life Sciences practice to assume the role of interim recall manager until a U.S. vigilance team was assembled.

The company struggled with a significant and growing number of open and aging complaints after the area manager left the company. FTI Consulting helped develop a new FDA-compliant, harmonized complaint handling process and standard operating procedure for all U.S. sites with the capability of global alignment and assisted the client in closing 1,000+ complaints within 30 days while maintaining incoming volumes.

In addition, attrition created a large recall knowledge gap, with uncertainty of event statuses and lack of documentation owing to a paper filing system. FTI Consulting assumed immediate oversight of 11 active recalls, collected document artifacts and resumed FDA reporting. Our team implemented a robust communication cascade plan, performance analytics and dashboards, and developed a client-tailored recall management playbook based in part on due diligence and “Lessons Learned” sessions led by team consultants and.

Our Approach

FTI Consulting Life Sciences professionals have advanced clients’ compliance and alignment with regulatory requirements and risk management challenges. We work to create a proactive approach that fits your company’s needs, goals and state of readiness. Here's our approach:

Discovery: We listen to and observe the customer’s needs within each functional area, and analyze process gaps and root causes, in order to make recommendations for an optimal state of readiness.
Design: Upon acceptance, FTI Consulting Life Sciences collaborates with functional teams to develop leading practice standards and toolkits to support end-to-end processes.
Company-wide adoption: We implement annual competencies across the organization to educate staff at all levels.

Footnotes:

1: MedTech Dive. “Medical Device Recalls Hit Two-Year High in Q2, Report Finds.” September 26, 2023.

2: Statista. “Top Causes for Medical Device Recalls U.S. 2019.” October 3, 2023.

3: “Medical Device Recall Report FY2003 to FY2012 Food and Drug Administration Center for Devices and Radiological Health Office of Compliance Division of Analysis and Program Operations.” October 3, 2023.

4: Digital, Johari. “8 Medical Device Design Flaws and How to Fix Them.” Johari Digital Healthcare Ltd. October 2, 2023.

5: Radiologybusiness.com. “Medical Device Recalls up 126% in Q1 2018.” September 26, 2023.

6: MedTech Intelligence. “Column - Medical Device Manufacturing: Five Challenges in Maintaining Compliance.” September 26, 2022.