How are adverse events systematically recorded and evaluated in clinical trials of medical devices?

In order for medical devices to be safe for patients and users, potential adverse events must be recorded systematically and consistently.

To make this possible, uniform terminology is used in clinical trials/studies or post-marketing follow-up. This enables a uniform, precise and standardized recording, reporting and evaluation of adverse events. This reduces ambiguities, facilitates communication with regulatory authorities and improves the comparability of incidents. As a result, risks can be identified more quickly, trends can be analysed better and thus the safety of medical devices can be continuously improved.

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Where can I find information about the uniform name (terminology)?

The International Medical Device Regulators Forum (IMDRF) was founded in October 2011 and is the successor to the Global Harmonization Task Force (GHTF). The Adverse Event Terminology Working Group (AE WG), which is responsible for developing the terminology in the document IMDRF/AE WG/N43 FINAL:2020, was established in 2015. This group consists of members from 11 regions worldwide and is tasked with developing and maintaining consistent, international terminology and codes for reporting adverse events associated with medical devices.

The document IMDRF/AE WG/N43 FINAL:2020 provides internationally harmonized terminology for uniform reporting and evaluation of adverse events in medical devices, which serves as a basis for consistent and transparent product safety monitoring for manufacturers and authorities.

It consists of the following points:

• introduction
• Scope of application
  • Using terminology
  • Addressees of terminology
• Bibliography
• Adverse event terminology
  • Reporting adverse events
  • Terms and definitions in the reporting system
  • Basic considerations about terms, classifications, and hierarchies
  • Four terminology sets and coding system
  • Description of the four sets of terminology
• Maintaining terminology
• Appendix A: Medical device issue terms and codes
• Appendix B: Terms and codes for the type of root cause investigation
• Appendix C: Terms and codes relating to investigative results of the root cause investigation
• Appendix D: Terms and codes for conclusions from the root cause investigation
• Appendix E: Terms and Codes for Clinical Signs, Symptoms, and Conditions
• Appendix F: Health Effects Terms and Codes
• Appendix G: Terms and codes relating to parts and components of medical devices

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The globally harmonized terminology and associated codes are important for manufacturers, including their local sales partners or representatives, authorities, patients and medical service providers.

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How is such an IMDRF code structured?

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First, “Adverse Event Terminology” is defined as a collection of carefully defined terms and associated alphanumeric codes that are used to report adverse events related to post-market follow-up of medical devices.

• The terminology comprises defined terms, each identified by unique alphanumeric codes to reduce ambiguities.
• The codes are hierarchically structured, usually with three levels (level 1 to level 3), which allow an ever more detailed description.
• The harmonized terminology consists of four sets of terminology, which together form the complete reporting terminology:
  1. Medical device problem terms and codes (Appendix A) that describe the problems with the device without evaluating causes.
  2. Describe terms and codes for investigating causes (Annexes B, C, D), the nature of the investigation, investigation results and investigation conclusions.
  3. Health effects terms and codes (Appendices E, F) that represent clinical signs, symptoms and conditions as well as health consequences of the event.
  4. Medical device component terms and codes (Appendix G) that can be used to describe the specific parts or components involved in the event.
• The coding should be as detailed as possible, and the selection of the code level depends on the level of information.
• The multiple coding from various attachments enables a comprehensive and structured recording of an event.
• The terminology is structured in appendices that correspond to the respective subject areas with codes and definitions.

Through logical hierarchies and unique codes, the coding should support clear, comprehensible and internationally uniform documentation and contribute significantly to improved product safety. Manufacturers may also add their own codes and terms.

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A complete example code that combines all letters from A to G with the corresponding numbers from the IMDRF document AE WG/N43 could look as follows:

Sample code: A12345 B78 C1234 D56 E1234 F5678 G1234567

Explanation:

• A12345: “A” stands for Appendix A, which contains the “Medical Device Problem Terms and Codes”; “12345” is a hierarchical code that describes the specific device problem, such as a specific malfunction.
• B78: “B” stands for Appendix B, which describes the “type of root cause investigation”; here, for example, “78” means a specific investigation method.
• C1234: “C” for Appendix C, the “Root Cause Investigation Results”; “1234” specifies a detailed investigation results code.
• D56 ROAD: “D” is Appendix D, the “Conclusions from the root cause investigation” with “56” as the coded variant.
• E1234: “E” for Appendix E, which describes “clinical signs, symptoms and conditions”; “1234” means the exact clinical finding.
• F5678: “F” stands for Annex F, “health effects”; this code provides the exact effect on the person concerned.
• G1234567: “G” stands for Appendix G, which describes “parts and components of medical devices”; the seven-digit number provides precise information about the affected component within the medical device.

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Using the tables A to G provided on page https://www.imdrf.org/docum ents/term inologies-categ orized-adverse-event-reporting-aer-terms-ter minology-and-codes (remove space for link), the adverse events can be assigned and presented in a harmonized manner. MEDRA codes can then also be found in Annex E. The table is updated continuously.

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Who should carry out the uniform recording and evaluation?

In the case of post-marketing follow-up or a clinical trial, the manufacturer should in principle take over the systematic collection and evaluation of clinical data and adverse events. The manufacturer sets up an appropriate monitoring system (post-market surveillance), which is integrated into its quality management system in order to identify risks at an early stage and initiate necessary corrective measures. However, if the manufacturer does not have the necessary capacity or resources, it will delegate the performance of these tasks to third parties through appropriate contractual arrangements.

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MEDIACC supports you in all phases of clinical trials and follow-up of medical devices with scientific expertise and structured processes. The use of harmonized terminologies and codes enables the accurate and standard-compliant recording and evaluation of adverse events, which makes it easier to comply with regulatory requirements. Feel free to arrange a first Appointment!