Obsoleting Terms is necessary to maintain the quality of the nomenclature in the dynamic world of medical devices. These changes may cause short-term disruption, but replacement Terms are easily found on the GMDN website. The examples below highlight the most common reasons for obsoletion:
1. Systems that don’t exist at the point of sale
EXAMPLE: The GMDN Term Video capsule endoscopy system was made obsolete as it was found that these systems do not exist under a single UDI (SKU) at the point of sale (the system is compiled at the point of use). A GMDN Term represent device at the point of sale. For this obsolete Term we therefore provide these Alternative Terms:
Video capsule endoscopy system capsule magnetic manipulation unit
Video capsule endoscopy system capsule magnetic activator
Video capsule endoscopy system capsule
Video capsule endoscopy system application software
2. Excess granularity
EXAMPLE: These stent terms were made obsolete to be replaced by a single Term of broader scope that better represents the intended use of devices on the market, removing overly cumbersome granularity:
Bare-metal renal artery stent (obsolete)
Iliac artery stent, bare-metal (obsolete)
Biliary/peripheral artery stent (obsolete)
Alternative Term:
Peripheral artery stent, bare-metal
3. Unclear definition – Sometimes a GMDN Term definition is not clear or overlaps with other concepts. A lot of effort is put into this being avoided and instances are not common.
EXAMPLE: The GMDN Term Orthopaedic bone wire was made obsolete as the scope of the Term had become too broad and overlapped with related Terms. These related Terms are provided in the Alternative Terms list.
4. Innovation – As technologies evolve the attributes which distinguish devices within a particular area may need to be re-considered. The scope of a GMDN Term cannot be narrowed so if more specific attributes are to be introduced we must make Term(s) obsolete and create new, more granular Terms.
EXAMPLE: Following extensive consultation with industry the GMDN Term Multi-axis foot prosthesis was made obsolete and these Alternative Terms created:
Motorized external ankle-foot prosthesis
Mechatronic external ankle-foot prosthesis
Mechanical-resistance external ankle-foot prosthesis
Hydraulic/pneumatic external ankle-foot prosthesis
5. Regulatory Feedback – The GMDN has strong relationships with regulators and as a dynamic UDI database data field sometimes there is a need for the GMDN to specify new attribute distinctions to meet the needs of the regulators.
EXAMPLE: Following the discovery of a clinical significance of textured surface breast implants with respect to BIA-ALCL lymphoma, the GMDN was asked to specify the “textured” attribute within its Terms. These terms were made obsolete:
Saline-filled breast implant, unstructured (obsolete)
Silicone gel-filled breast implant (obsolete)
These Alternative Terms were published:
Autologous adipose tissue reconstruction breast implant
Saline-filled breast implant, internally-structured
Saline-filled breast implant, unstructured, smooth-surface
Saline-filled breast implant, unstructured, textured-surface
Silicone gel/saline-filled breast implant
Silicone gel-filled breast implant, polyurethane-foam-surface
Silicone gel-filled breast implant, smooth-surface
Silicone gel-filled breast implant, textured-surface