Thoughts and questions about medical device

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.

  1. 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”.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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’.


Hi Sofia, sorry for the delay in replying to your post.
That’s great that you’re translating the archetype into Swedish - do you have a specific use case or application that you’re going to use the archetype in?
Rather than reply to each specific point that you make, I just wanted to make a few general points.
Your question speaks to the difficulty of defining “device” in medicine. A lot has been written on this topic and as you say, the challenge is how to come up with a framework for describing real-world devices when they can be a tongue depressor, an implantable defibrillator and anything (and everything) in between.
The archetype references the HL7 FHIR Device resource - there is a small family of Device resources in FHIR, including DeviceMetric, DeviceUsage and DeviceDefinition. In the HL7 Devices Group, there is an understanding that Devices are more than just “things with plugs” but no agreement (as yet) on how complex non-electromechanical devices such as multi-lumen catheters and stimulator needles can be represented in FHIR, in their context which is usually part of an invasive device insertion procedure. I’ve written a few posts about this recently that I’d be happy to share, but I think your questions are really directed at the OpenEHR community, suggesting perhaps a v2 of the archetype?

I’ve done a bit of modelling work on device, and a few distinctions will make things easier:

  • Devices requiring a user - any device that requires a ‘user’ to be utilised
    • consumable devices: devices that are consumed in use, e.g. tongue depressor, syringe, catheters
    • re-usable devices: devices that may be used many times, e.g. anything from a stethoscope to an MRI machine
      • a further breakdown would take account of devices that are machines (MRI machines etc) and that have individual ids, service histories and so on, and devices like the stethoscope that is not usually ‘serviced’ or ‘maintained’ in any formal sense, and is considered generic.
  • devices not requiring a user to function
    • prosthetic devices
    • implantable active devices, e.g. pacemaker, loop recorder

I don’t know of any definitive ontology for devices.

As a pre-amble to a blog post on the topic, I’ve tried to mind map Medical Device, drawing heavily from the EU regulatory documents. It isn’t complete, especially in the areas of ‘borderline devices’ that seem to be even more problematic than the ones we use in Anesthesia, but hopefully it will serve as a starting point. As you say, there is no definitive ontology for medical devices - this is something that the HL7-FHIR devices group has recognised. The challenging nature of the problem is reflected in the way that FHIR has built a small group of resources, rather than attempt to capture everything in a single resource.
Here’s my mind map, comments would be very welcome:

Hi all,

There is no doubt that this area is very complicated and clear definitions and descriptions are often awkward to craft for a concept that has such a large scope and variation in use and utility. The crafting of the current archetypes took extensive thought and discussion, but it was some time ago and we are all aware of how the domain of devices has advanced significantly since then.

I read through all the previous comments and the current family of archetypes deserve to be scrutinised to ensure they remain fit for use. However, while change requests and proposals for enhanced revisions are always welcome, I thought I’d just make a few points to support framing any revision or new proposal.

At the present moment, there is a family of device-related models, designed according to the Clinical Investigator Recording ontology that underpins the openEHR reference model/specs to support real-world clinical recording rather than academic purity. Existing standards and ontologies should inform archetype modelling but not necessarily be replicated in an archetype.

  • Medical device ( published CLUSTER.device) - designed to be nested within the ‘Device’ SLOT in any ENTRY archetype (eg the order to use a specific device in an INSTRUCTION, the device used to record a measurement in an OBSERVATION or
    the implanted device during an ACTION.procedure, OR nested within the ‘Components’ SLOT of this same medical device archetype to record specific components such as software versions for an implanted pacemaker. This archetype currently has a huge scope, intended to record simple one-off consumables including tongue depressors and IV kits, through to implanted devices such as IUDs, heart valves and joint replacements.
  • Medical device details ( draft CLUSTER.device_details) - focused on reusable devices as part of asset management. It is designed to be nested within the ‘Asset management’ SLOT in CLUSTER.device (above).
  • Medical device summary (draft EVALUATION.device_summary) - designed to support a persistent summary about implantable devices, hearing aids, etc.
  • Medical device screening questionnaire (draft OBSERVATION.device_screening )

Yes, there are many types of devices. Perhaps we need to create some separate models, but, rather curiously, to date there has not been a clear use case identified for this. Maybe this is changing. Editors should always welcome a new proposal to be brought forward for rethinking this space, especially as there has been a lot of work done in this area since the archetypes were first developed.

Best wishes



Purely inside an EHR environment, there probably is not much, but once we get to plans and processes, there is usually a need to determine inventory stock, track costs and also to manage scheduling that requires resources e.g. prosthesis, loop recorder etc.

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