Overcoming the Challenges of Complaint Reporting with IMDRF Adverse Event Terminology
The Challenges Associated
Jamie Hijmans
09/25/2024
Medical device manufacturers are increasingly under pressure to standardize adverse event reporting to meet global regulatory expectations. In many organizations, post-market surveillance (PMS) teams face the challenge of managing inconsistent and unstructured complaint data, which complicates compliance efforts. The task of sorting through complex spreadsheets of complaint data often diverts attention from more strategic initiatives, and manual processes heighten the risk of regulatory findings, recalls, and, in some cases, loss of market access.
Historically, complaint data processing and adverse event reporting in the medical device industry have faced several challenges:
- Lack of Standardization: Different organizations and countries use varied terminologies and classification systems, making it difficult to harmonize and compare data. Without standardization, maintaining consistent reporting and avoiding compliance pitfalls can be challenging.
- Inconsistent Data Entry: Manual entry processes introduce variability which can result in incomplete or erroneous reports. This inconsistency compromises data quality and creates inefficiencies in tracking and analyzing adverse events.
- Complex Terminology: The medical terminology used to describe adverse events can be complex and nuanced, leading to misunderstandings or misinterpretations when inputting data. The lack of uniform terminology slows down reporting processes and increases the chance of inaccuracies.
- Evolving Standards: The terminology and guidelines for adverse event reporting have evolved over time, requiring ongoing updates and retraining for those involved in reporting. As standards like the International Medical Device Regulators Forum (IMDRF) adverse event terminology become more widely adopted, organizations must adapt quickly to remain compliant.
- Technology Integration Issues: Legacy systems and varying levels of technological sophistication across institutions have contributed to difficulties in implementing and maintaining uniform reporting systems.
These challenges not only create inefficiencies but also increase compliance and patient safety risks. However, the IMDRF framework offers a solution by providing a standardized set of terminologies for adverse event reporting, streamlining processes, and improving the accuracy of reported data.
IMDRF Adverse Event Terminology: The Key to Standardized Reporting
The IMDRF is an international body of volunteers who work on international medical device regulatory harmonization and convergence. The IMDRF adverse event terminology framework provides a consistent, hierarchical coding system for categorizing adverse events.
The complete terminology is divided into seven annexes, which fall under four distinct sets of terminologies. Each annex is assigned its own set of alphanumeric codes, enabling precise categorization of adverse events. Level 1 codes correspond to more generic terms while Level 2 or Level 3 codes are more detailed. According to the IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes document published by the IMDRF Adverse Event Terminology Working Group in March 2020, the terms/codes should be reported for all seven annexes in order to fully characterize each serious incident. Multiple terms/codes from each of the seven annexes are often needed to sufficiently code a serious incident.
- Medical Device Problem Terminology (Annex A)
- Annex A: Medical Device Problem Terms and Codes
- Cause Investigation Terminology (Annexes B, C, D)
- Annex B: Cause Investigation – Type of Investigation Terms and Codes
- Annex C: Cause Investigation – Investigation Findings Terms and Codes
- Annex D: Cause Investigation – Investigation Conclusion Terms and Codes
- Health Effects Terminology (Annex E, F)
- Annex E: Health Effects – Clinical Signs, Symptoms and Conditions Terms and Codes
- Annex F: Health Effects – Health Impact Terms and Codes
- Components Terminology (Annex G)
- Annex G: Component Terms and Codes
A key factor in the global adoption of IMDRF terminology is the FDA's active participation in the IMDRF Adverse Event Terminology Working Group. The FDA has mapped each of its adverse event reporting codes to the corresponding IMDRF reporting code, ensuring consistency between U.S. regulatory requirements and international standards. This alignment allows manufacturers to use IMDRF codes to seamlessly report adverse events to both U.S. and global regulatory bodies.
By ensuring that adverse event reports adhere to IMDRF standards, manufacturers not only meet FDA expectations but also improve their global compliance capabilities. This standardized framework provides a unified approach to adverse event reporting across different jurisdictions, simplifying the process for multinational manufacturers.
The Role of IMDRF Adverse Event Terminology in EU MDR 2017/745 Compliance
In MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 (MDR) issued by European Commission's Medical Device Coordination Group (MDCG), several recommendations were made regarding adverse event reporting using IMDRF standards:
Reporting Serious Incidents
- Serious incidents should be characterized by the device problem, root cause, and health effects on the affected person(s)
- Serious incidents should be categorized using the IMDRF Adverse Event Terminology, when available. IMDRF Level 2 terms/codes are considered sufficient to enable grouping of serious incidents. Both codes and terms should be reported.
- To characterize serious incidents by device problem, root case, and health effects, IMDRF Annex A (Medical Device Problem), Annex C (Investigation Findings), and Annex F (Health Impact) can be used. Annex F (Health Impact) can also be used for the 4-year summary data and split by Annex D (Investigation Conclusion).
- The most relevant investigation conclusion terms/codes (IMDRF Annex D) which are related to the health impacts (IMDRF Annex F) should be used. Report the most common health impacts (IMDRF Annex F) as well as any cases resulting in death, regardless of whether they are included in the most common health impacts.
- The number and rate of each serious incident should be presented for each reporting period (up to 4 years), and the data should be grouped both by region, including the European Economic Area (EEA), Turkey (TR), Northern Ireland (XI) and worldwide.
Reporting Non- Serious Incidents
- Non-serious incidents should also be reported, preferably by IMDRF Annex A (Medical Device Problem) terms/codes.
Manufacturers should implement minimum applicable IMDRF adverse reporting standards in their complaint reporting for all serious incidents to comply with EU MDR requirements for their PSURs. Furthermore, it is encouraged that IMDRF terminology be adopted generally for all complaints.
These requirements can pose a challenge for manufacturers who are not currently incorporating IMDRF adverse reporting standards in their complaint management systems. Changes to systems and processes will need to be swiftly made and implemented to capture and categorize this data.
While the MDCG guidance does not require historical data to be reported using IMDRF Adverse Event Terminology, nevertheless, there are significant benefits in ensuring retroactive data consistency as requirements change. This includes increased data accuracy, improved reporting, and enhanced patient safety. Traditionally, the upfront cost of updating historical datasets has made it impractical to reclassify data, leaving manufacturers with a fragmented view of the safety of their products.
A Path to Simplified Compliance with SmartComplaints™
The advent of Artificial Intelligence (AI) and Machine Learning (ML) technologies, however, now makes it possible to automate the process of coding complaints and significantly reduce the cost of managing large datasets.
Global Exponential Technologies (GxT) has developed an intuitive application called SmartComplaints™ that allows manufacturers to quickly and efficiently categorize complaints using IMDRF terminology, helping to reduce manual effort by providing initial categorizations for review.
Begin your transition to IMDRF adverse event reporting today and try SmartComplaints™ for yourself! Click the link to access our free interactive demo and see the application in action!
https://lnkd.in/gFf_2rAp
FAQs
What is the IMDRF, and why is it important for medical device compliance?
The International Medical Device Regulators Forum (IMDRF) is a global organization that works to harmonize medical device regulations across different countries. It establishes guidelines and standardized terminologies that facilitate consistent compliance and streamline the regulatory approval process. IMDRF compliance ensures that medical device companies can meet international standards, enhancing patient safety and enabling access to global markets.
How does IMDRF terminology benefit adverse event reporting?
IMDRF terminology provides a standardized coding system for adverse event reporting, which improves the clarity, accuracy, and consistency of data. This unified approach allows healthcare professionals, manufacturers, and regulators to communicate more effectively, reducing misunderstandings and improving the monitoring and evaluation of medical device safety. Standardized terminology also supports better data analysis, leading to more informed regulatory decisions.
Why is compliance with EU MDR crucial for medical device companies?
Compliance with the European Union Medical Device Regulation (EU MDR) is mandatory for marketing medical devices within the European Economic Area (EEA). The EU MDR sets high standards for the safety, quality, and performance of medical devices. Adhering to these regulations ensures that medical device companies meet the stringent requirements needed to gain market access in Europe, protecting patient safety and maintaining the company’s reputation.
How can a regulatory consulting firm help with IMDRF compliance?
A regulatory consulting firm can provide the expertise and guidance necessary to navigate the complexities of IMDRF compliance. These firms have in-depth knowledge of regulatory requirements and can assist with implementing IMDRF standards in adverse event reporting, ensuring that submissions meet all necessary guidelines. Consulting firms offer tailored solutions, training, and support, helping companies achieve compliance efficiently and effectively.
What role does technology play in achieving regulatory compliance?
Technology, particularly AI and machine learning, plays a crucial role in achieving regulatory compliance by automating and streamlining adverse event reporting processes. These technologies can quickly analyze large datasets, identify patterns, and categorize adverse events according to IMDRF standards, reducing manual effort and minimizing errors. Leveraging technology helps ensure accurate, consistent, and timely reporting, supporting compliance with regulatory requirements.
