There is a huge range of technologies used in the MedTech industry, everything from specialist metals and plastics, machinery, electronics, chemicals, software and more. The industry is especially innovative and request us to update the GMDN to include their latest device or product features every day.
The GMDN Agency employs a team of highly qualified technical authors to investigate how the technology works and to create a concise descriptions, not too vague and not too prescriptive or proprietary. The language used should be accessible to non-experts, with no jargon or too many complex acronyms and the terminology and style should be consistent.
The GMDN has been used for many years and therefore there is large existing set of descriptions. As new products enter the market, the descriptions for these need to be ‘fitted-in’ to the nomenclature, not just added to the bottom of the list, as that risks the duplication of Terms. If a product is innovative and truly unique, the procedure is quite straightforward to add a new Term. Often the product is a small variant of an exiting product and an amendment to the Term Name or Definition is allowed, but only if the original scope of the Term is not reduced, which might exclude products that may have previously been described by the Term.
Occasionally technology leaps forward and we may need to review a set of GMDN Terms to determine if they reflect the current devices on the market, especially if the older technology is still commonly in circulation. In this case we may introduce several new Terms and amend Terms and may obsolete a Term, but this is quite rare (annually less than 1% of Terms are obsoleted). Obsoleted Terms remain available for historic reference / analysis purposes and remain linked to our higher-level Collective Terms too.
With so many variables, there is not a simple set of rules to determine when a new GMDN Term is created or amended. The following case studies describe some common scenarios we often come across.
Company A is planning to launch a new product which is very innovative. They search through all the relevant existing Terms in the GMDN website by carefully reviewing the Term Definition and none adequately describe their new product. They send us an Enquiry and attach the relevant product description. A GMDN Term Developer who is experienced in the product technology and application, reviews the product specification, and reviews the existing GMDN Terms for similar products. If we consider that the product requires a new GMDN Term and enough information is provided, a draft GMDN Term is provided to Company A to review. At the same time, the new GMDN Term is displayed on the GMDN website ‘Proposed’ Term’s list for any GMDN Member to provide a comment. Once the consultation period ends, the new Term is linked to the relevant Collective Terms and published.
Company B has updated its design of a product. The product has a new feature. Company B reviews the GMDN Term it previously used for this product, but the new feature does not seem to be included. There is no other GMDN Term that is suitable either. They submit an Enquiry and usefully refer to the existing Term and identify where the variation in the Definition could be made, in their opinion. The GMDN Term Developer reviews the product information and the similar GMDN Terms and decides if an amendment to the existing Term will be the best solution. Amendments are not always made if the new product feature is minor or cosmetic. A Term amendment is drafted and provided to Company B to review. There is no consultation period with Term amendments because the change should not affect the suitability of the Term for any existing users. When published the Term amendment notification is provided to members who opt for this service. All members who subscribe to Alerts also receive a monthly newsletter which list all the amendments that are relevant to the Terms they use. Amendments can be seen in the Details page for each GMDN Term with a summary note of the changes made.
Company C has developed a new product that is functionally like other products on the market, but it includes a novel electronic control system that improves patient care. There are now similar devices that have electronic control and those that do not. Company C submits an Enquiry and the GMDN Term Developer decides, in consultation with the manufacturers of similar devices, to make two new GMDN Terms to distinguish between the two variants of product type, ‘manual’ and ‘electronic control’. The existing GMDN Term is made obsolete because it no longer represents a single product group. As with Term amendments, users of the existing Term are notified by email that it has been made obsolete and are directed to use one of the two new Terms.
We can see from these case studies that decisions about Term changes are made in consultation with the manufacturers and if necessary, a consensus is reached after wider consultation, sometimes with regulators input. The timespan necessary from the Enquiry being submitted to us to the publication of any change is dependent on the complexity of the product, the responsiveness of the applicant to any question we have and the impact of any changes on the GMDN database. We aim to complete the processes as soon as possible, because we know regulators and manufacturers are waiting to use the GMDN Terms to register their products and make them available to patients.