We are a group in Sweden that have done a translation of the archetype Medical device into Swedish. When the review round was carried out, we had a bit difficulty to do the translation of some texts, as some thoughts and questions about the original descriptions arose. We want to share these and get feedback.
The archetype is about medical devices. Initially in the description of use, the term “medical device” is used, but later in the text and in descriptions to other nodes, “device” is used. This confuses us and we think it can be a good idea to go tough the descriptions of the different nodes in the archetype and make it clearer if you refer to “medical device” or just “device”.
In the paragraph under Use “Use of the term ‘medical device’ varies depending on context.” We feel that this description can be somewhat misleading, as the meaning does not depend on the context, but on how it is defined in the legislation of each country. The term is defined and not context driven.
In the paragraph under “Use” “Within the Standards world, the term device tends to refer to mechanical or electronic devices that support healthcare and require rigorous documentation regarding location tracking, maintenance, calibration, software versions etc.” Here we are a little unsure of what is meant by “standard world”?
It is not only equipment that can be medical devices, also software and consumables and associated accessories, these also appear in the flora of standards. We feel that the description in this section is somewhat simplified and that the description could be revised.
In the third paragraph under Use “Examples of medical devices range from simple devices such as urinary catheters, tongue depressors, contact lenses, artificial joint implants, breast implants and plain dressings through to advanced devices such as artificial hearts, syringe drivers, spirometers, mobile phone applications and computerized devices that capture point-of-care medical measurements”.
We are not sure what the values it adds to the description to classify different medical devices as “simple” or “advanced” (and we do not agree that an artificial joint implant is a simple medical device). Also, the meaning of simple can be interpreted in different ways, e.g., easy to use, easy to manufacture, easy to construct? We suggest that this with simple and advanced are removed from the description, so the examples are made without evaluating whether they are simple or advanced.
The paragraph medical device says " An instrument, apparatus, implant, material or similar, used in the provision of healthcare. In this context, a medical device includes a broad range of devices which act through a variety of physical, mechanical, thermal or similar means but specifically excludes devices which act through medicinal means such as pharmacological, metabolic or immunological methods. The scope is inclusive of disposable devices as well as durable or persisting devices that require tracking, maintenance activities or regular calibration, recognizing that each type of device has specific data recording requirements.”
Here is a description of what a medical device is, perhaps the WHO definition should be used? We find the description a little unclear when you mix in what is excluded in the middle of the description. An alternative might be to put that part at the end of the description, or leave it out and only describe it under misuse.
Under misuse it is described that this archetype is “not to be used to record data about medicinal products that exert a direct pharmacological, metabolic or immunologic effect.” We wonder if it is perhaps relevant to describe a little more how to document combination products?
As we understand those combination products shall be registered using the ACTION.medication_management archetype and the CLUSTER.device can be used in the SLOT ‘Administration device’.