Devices

Medical device terms (such as PT Device breakage and PT Device leakage) have been part of MedDRA since Version 2.1 – the first official release of MedDRA.

In response to users’ requests, the MSSO is reviewing device terms in MedDRA, using two external reference sources:

• Patient problem codes (events/procedure in patient)
• Device problem codes (refer to device itself)

• International Organization for Standardization/ Technical Committee 210 (ISO/TC 210)

In 2007 and 2008, the MSSO reviewed the patient problem terms with CDRH experts and implemented those that fit MedDRA rules and conventions. Some term names were modified to ensure that device terms are self-explanatory to avoid confusion with patient terms. As a result, 60 terms were added to MedDRA in versions 11.0 and 11.1.

In 2008 and 2009, the MSSO reviewed terms relating to device problems with the help of a MedDRA Device Working Group (WG), which comprised representatives of MSSO, JMO, and eight companies. The goals of the review were:

• Provide intuitive device hierarchical groupings
• Realign existing PT/LLT device terms
• Develop device term acceptance/evaluation criteria
• Draft user guidance for the MedDRA Term Selection: Points to Consider document

The proposed device hierarchy groupings and subordinate PT/LLT terms will be posted on the MSSO Web site as part of the complex change review at the end of June 2009. Approved proposals are scheduled for implementation in v13.0

To view the results of the device review, please see the MedDRA Version 13.0 Complex Changes page.