Elevating Medical Device Complaint Management: Strategies for Enhanced Resolution and Mitigation of Complaints
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avril 30, 2024
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In today’s rapidly evolving and highly regulated healthcare landscape, managing complaints related to medical devices has transcended basic regulatory compliance to become a pivotal element of quality management systems. It plays a crucial role in operational efficiency, product design, risk management, and corporate reputation. An efficient complaint management system not only addresses customer grievances, but also harnesses any derived insights to drive systemic improvements, leading to the development of safer and more reliable medical devices. The increasing complexity of global regulations and a competitive market have underscored the necessity for robust post-market surveillance mechanisms.
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The global market for medical device complaint management systems was valued at approximately $6.9 billion in 2022 and is anticipated to surge to $12.4 billion by 2030, reflecting a compound annual growth rate (CAGR) of 7.5% from 2023 to 2030.1 This growth is driven by increasing organizational awareness of the benefits provided by cloud-based complaint management solutions.
The financial repercussions of not addressing quality events efficiently – including major observations, recalls, and legal actions – are substantial, costing the industry an estimated $2.5 billion to $5 billion annually.2
Let’s walk through the complexities of complaint management, and how best to navigate the regulatory standards and optimize a complaint management system.
Strategic Workflow for Complaint Management
Success in complaint management hinges on adopting a workflow that not only addresses current issues but also anticipates challenges. Here are the six key components of an effective complaint management workflow:
- Complaint Intake: Streamlining the collection of complaints from multiple channels, ensuring rapid identification, categorization, and escalation of complaints by skilled professionals.
- Complaint Investigation: Creating a collaborative environment across departments to facilitate thorough investigation stages, including root cause analysis, while ensuring patient safety through timely identification of reportable events.
- Data Analysis and Proactive Measures: Leveraging complaint data to identify trends, enabling the implementation of corrective actions and preventive measures to reduce recurrence and implement field safety action.
- Regulatory Communication: Ensuring timely and accurate reporting of adverse events to regulatory bodies, in compliance with medical device reporting requirements.
- Customer Engagement and Feedback: Maintaining customer trust through responsive feedback mechanisms, providing updates on complaint resolutions, and implementing measures to prevent future incidents.
- Continuous Improvement and Compliance Monitoring: Instituting regular reviews and monitoring for process compliance and effectiveness to uphold the highest quality standards across products and processes.
A well-designed process utilizing these six components can mitigate the risk of product failures, recalls, regulatory actions, and remediation activities.
Common Challenges in Complaint Management
Navigating the complexities of complaint management presents significant challenges that can adversely affect both patient safety and product quality. In the Life Sciences sector, there are three primary areas where companies encounter the most difficulties:
- Operations: From complaint intake to closure, assigning managers and process owners for all day-to-day activities to ensure process awareness and compliance with company policies and procedures.
- Risk and Compliance: Establishing a complaint management team to ensure complaint procedures are followed throughout the institution and a risk management team to ensure risks are identified, measured, mitigated, and monitored throughout the organization.
- Audits: Establishing an effective audit process to ensure all programs are effective and are being monitored as documented in the procedures.
Navigating Regulatory Compliance and Mitigating Risks
Adhering to global regulatory standards, including but not limited to 21 CFR 820,3 21 CFR 803,4 ISO 13485,5 and EU MDR,6 is paramount for maintaining a compliant complaint management system. Regulatory bodies intensify scrutiny on post-market surveillance to ensure comprehensive oversight of medical device complaints. Non-compliance can result in significant repercussions, including:
- Citations
- Warning letters
- Removal of the product from market
- Prohibition of marketing and sales
- Destruction of the product
- Market recalls and field safety notices (FSN)
- Injunctions and seizures
- Civil monetary penalties and criminal prosecution
These repercussions pose a threat to a company’s operational and financial goals, resulting in customer and stakeholder dissatisfaction.
Three Steps to Complaint Management Remediation
- Process Discovery and Analysis: Engaging with stakeholders across functions to understand the current state, identify gaps, and outline a vision for optimized processes.
- System Design and Implementation: Collaborating to develop and implement best practices, tools, and technologies that support efficient end-to-end complaint management.
- Organizational Engagement and Change Management: Facilitating the adoption of new processes through comprehensive training and change management initiatives, ensuring that improvements are deeply integrated and sustainable.
In response to these evolving challenges, adopting a proactive approach to complaint management is essential. The approach to remediation should include these three steps:
Following this proactive approach can help mitigate various problems within an organization, navigate the regulatory standards and optimize the complaint management system.
Case Study: Remediating the Complaint Management process – Medical Device Company
A global medical device manufacturing company engaged the FTI Life Sciences practice to provide direct support to their complaint handling team as an Interim Complaints Manager, which included oversight of the day-to-day complaint handling activities as well as remediation of their complaint handling process.
The client struggled with a significant and growing number of open and aging complaints and the complaint handling team struggled to keep up with this growing complaint backlog. In addition, an Internal Audit was conducted across five client sites in United States, which identified several observations related to the client’s Quality Management System (QMS) and the complaint management process. The client also received a Form 483 from FDA following an FDA inspection, which had several observations related to their complaint handling and MDR-related processes.
FTI Consulting assumed immediate oversight of the complaint handling team and began an investigation into the root cause of open and aging complaints. FTI Consulting also developed a remediation plan by identifying gaps in their process and developing and implementing a new complaint handling process. FTI Consulting conducted a workshop with stakeholders and developed a new standard operating procedure (SOP) to align complaint handling processes across all US sites.
Footnotes:
1: Medical Device Complaint Management Market Size is Projected to Reach USD 12.4 Billion by 2030, Growing at a CAGR of 7.5%: Zion Market Research, Globe Newswire (11 May 2023)
2: Carla Neves, Cost of quality in MedTech, Critical Manufacturing (7 December 2022)
3: Code of Federal Regulations Title 21, Part 820 Quality System Regulation (22 December 2023)
4: Code of Federal Regulations Title 21, Part 803 Medical Device Reporting (22 December 2023)
5: International Organization for Standardization, ISO 13485:2016 (2016)
6: European Union Medical Device Regulation, Regulation (EU) 2017/745 (26 May 2021)
Published
avril 30, 2024
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