parent term digits), Level 3 terms using digits 5 to 6 again maintaining the level 1 and 2 – parent term digits. Each code thus reflects the relationship to the parent / child term and the body of nomenclature it belongs to. Having two digits per level allows for changes in the future (deletion of terms / introduction of terms), which requires assignment of codes so as to new allow with existing terms/codes from previous reporting and as backward compatibility compiled in data bases. 1: Overview of the four terminologies comprising the complete terminology for adverse event reporting. Nr. Name of Description Annex Coding system terminology 1 Medical device Terms/codes for describing A A|00[00][00] problem problems (malfunction, deterioration of function, failure) of medical devices that have occurred in pre- or contexts (e.g. clinical studies, clinical evaluation or post-market surveillance) 2 Cause investigation Terms/codes for describing the B Type of Investigation investigation and cause of the B1|00 device involved in the reported event. There are three sections. Investigation Section1: Type of Findings Investigation, Section 2: B2|00[00][00] Investigation Findings and Section 3: Investigation Investigation Conclusion. Section 2 and 3 Conclusion have a hierarchical structure. B3|00[00] 3 Patient Problem under development C to be C|… (to be defined) – developed 4 Component under development D to be D|… (to be defined) – developed Figure 4: The Adverse Event Reporting terminology is composed of four sets of terminologies: (1) Medical device problem terminology, (2) components terminology, (3) cause investigation terminology and (4) patient problem terminology. Note that for an effective monitoring of adverse events, means of effectively identifying devices as well as the category they belong to (e.g. GMDN) are important.
parent term digits), Level 3 terms using digits 5 to 6 – again maintaining the level 1 and 2 parent term digits. Each code thus reflects the relationship to the parent / child term and the body of nomenclature it belongs to. Having two digits per level allows for changes in the future (deletion of terms / introduction of terms), which requires assignment of new codes so as to allow backward compatibility with existing terms/codes from previous reporting and as compiled in data bases. 1: Overview of the four terminologies comprising the complete terminology for adverse event reporting. Nr. Name of terminology Description Annex Coding system 1 Medical device problem Terms/codes for describing problems (malfunction, deterioration of function, failure) of medical devices that have occurred in pre- or contexts (e.g. clinical studies, clinical evaluation or post-market surveillance) A A|00[00][00] 2 Cause investigation Terms/codes for describing the investigation and cause of the device involved in the reported event. There are three sections. Section1: Type of Investigation, Section 2: Investigation Findings and Section 3: Investigation Conclusion. Section 2 and 3 have a hierarchical structure. B Type of Investigation B1|00 Investigation Findings B2|00[00][00] Investigation Conclusion B3|00[00] 3 Patient Problem under development C – to be developed C|… (to be defined) 4 Component under development D – to be developed D|… (to be defined) Figure 4: The Adverse Event Reporting terminology is composed of four sets of terminologies: (1) Medical device problem terminology, (2) components terminology, (3) cause investigation terminology and (4) patient problem terminology. Note that for an effective monitoring of adverse events, means of effectively identifying devices as well as the category they belong to (e.g. GMDN) are important.
imdrf-cons-terminologies-aer-n43-pd1-170406.docx