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type: resourceresource: DeviceDefinition

DeviceDefinition

Introduction

Note to Balloters: To ensure the DeviceDefinition resource is ready for Normative status, we are seeking ballot comments on the substantive content. The key changes made since R5 include:

  • Updated DeviceDefinition to a CanonicalResource and the necessary element and search parameter changes.
  • Removed DeviceDefinition.owner.

All OO Resources were updated to use the canonical, however other Resources (not owned by the OO Work Group) might not have the canonical reference to DeviceDefinition.

Scope and Usage

The DeviceDefinition resource is used to describe the common characteristics and capabilities of a device of a certain type or kind, e.g., a certain model or class of a device such as a x-ray model or personal wearable device model, whereas a Device resource documents an actual instance of a device such as the actual x-ray machine that is installed or the personal wearable device being worn. Devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health, as well as devices such as a machine, cellphone, computer, software, application, etc.

Devices can also be subdivided into the following categories:

Active device

'Active device' means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device. MDR (EU) 2017/745

Active Implantable Medical Devices include the definition for both active devices and implantable devices (see below). Examples include: Implantable cardiac pacemakers; Implantable defibrillator; Implantable neurostimulator systems; Leads, electrodes, adaptors for implantable pulse generators; Brachytherapy systems; Ventricular Assist Devices (VADs); Cochlear implants; Implantable infusion pumps; Implantable glucose monitors; Micro Electro-Mechanical Systems (MEMS); and their accessories where applicable.

Communicating device

This category of devices communicates electronically to peer information systems or possibly another device. In addition to patient observations for use by clinicians in providing care and for building a health record, the device communicates metadata about its own state and the protocol used to transfer that information.

To support the use and evaluate the reliability of the patient data, it is important to collect and record data about the identity and operational status of the device that generated the observations. The Device resource is an important locus for such information. The information it generates for clinical and other purposes goes into other resources such as the Observation or Medication resource depending upon what the device does. To support device-related information about Communicating Medical Devices the Device resource needs to have elements that describe not only the basic information like the serial number, manufacturer name and model number, but information about the protocol, its version, its certification, the properties it has to perform its purposed tasks such as internal clocks, synchronization state, resolution, etc.

Durable Medical Equipment

Equipment and supplies that provide therapeutic benefits to a patient in need because of certain medical conditions and/or illnesses, and which are ordered by a health care provider for everyday or extended use.

Examples include: oxygen equipment, suction pumps, traction equipment, home infusion services, continuous positive airway pressure (CPAP) devices, hospital beds, wheelchairs, crutches walkers, canes, or blood testing strips and meters for diabetics.

Home Use device

A home use medical device is a medical device intended for users in any environment outside of a professional healthcare facility (although that does not preclude such devices being used in a professional healthcare facility).

Implantable device

Implant means a device that is placed into a surgically or naturally formed cavity of the human body. A device is regarded as an implant for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner determines otherwise to protect human health. 21CFR Part 860.3 Accessed 12 May 2022

'Implantable device' means any device, including those that are partially or wholly absorbed (i.e., a bioresorbable substance which is taken in or degraded) by the body, which is intended:

by clinical intervention and which is intended to remain in place after the procedure.

Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device; MDR (EU) 2017/745 Accessed 12 May 2022

InVitro Medical device

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be used to monitor a person 's overall health to help cure, treat, or prevent diseases.

In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies. These in vitro diagnostics can include next generation sequencing tests, which scan a person 's DNA to detect genomic variations.

Some tests are used in laboratory or other health professional settings and other tests are for consumers to use at home. US Food and Drug Administration Center for Devices and Radiological Health In Vitro Diagnostics and Drug Administration Center for Devices and Radiological Health In Vitro Diagnostics Accessed 12 May 2022

Patient-use device

Patient-use (also known as personal health device), or home use devices, intended for users in any environment outside of a professional healthcare facility. This includes devices intended for use in both professional healthcare facilities and homes US Food and Drug Administration Center for Devices and Radiological Health. Home Use Devices. Accessed 13 March 2020. Personal Health Devices (PHDs) are the subset of patient-use devices that report their information to a peer via a protocol.

Personal Health device (PHD)

One class of communicating devices is the Personal Health Device or PHD. PHDs are medical devices that can be used by patients or others who are typically not medical professions, to gather patient observations and information. These devices can often be purchased in department stores or online by anyone. They may be regulated as medical devices, or not.

PHDs include the popular fitness trackers often combined with heart rate monitors, but also blood pressure monitors, weight scales, pulse oximeters, thermometers, and, for those that require them, glucose meters. Over time more sophisticated devices such as continuous glucose monitors, insulin pumps, vital signs monitors including ECGs, and even spirometers are entering the PHD consumer market. These devices communicate measurement data and data about themselves via a digital transport protocol to some peer entity, often a mobile phone or tablet. The protocol may follow a standard but most protocols are proprietary. In either case, it is common practice for manufacturers to provide free applications that run on these mobile platforms for the purpose of communicating with their devices.

The fields populated in the Device resource by PHDs, typically via a gateway, is the information a PHD reports about itself electronically. There is no input by the patient except for information the patient may enter on the device through some UI. This device reporting capability distinguishes communicating PHDs from the general set of patient-use devices.

Point-of-Care Device (PoCD)

Point-of-care medical devices (PoCD) are intended for use by qualified professionals. PoCDs are typically found at the patient's bedside and convey measurements and supporting data to receiving systems for use in electronic medical records, clinical decision support, and medical data archiving for aggregate quality measurement and research purposes.

PoCDs are of another level of complexity compared to PHDs: they include devices like multi-parameter physiological patient monitors, anesthesia workstations, infusion pumps and numerous other kinds of devices that provide near-real-time information about patient condition or therapy, potentially including dozens or hundreds of variables coming from a single device system. They may be structurally complex, involving multiple subsystems that are themselves complex, such as a ventilator or gas analyzer functioning within an anesthesia workstation, or pluggable modules in a patient monitor controlling invasive blood pressure or gathering EEG data.

Information systems using such data need to be able to understand the structure and dynamic state of the devices originating them. This requires more than a single Device resource - a hierarchy of Device resources is constructed carrying data about the top-level containing device (for example a monitor), and a hierarchy of contained Device resources representing subsystems (in the monitor, builtin and attached modular measurement capabilities), channels, and DeviceMetric resources representing individual measurements or computations.

Single-Use device

A device that is intended to be used on one individual during a single procedure; MDR (EU) 2017/745 Accessed 12 May 2022

Reusable device

Reusable medical devices are devices that health care providers can reuse to diagnose and treat one or multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes and laryngoscopes. US Food and Drug Administration Center for Devices and Radiological Health Reusable Medical Devices

Software

A Device may be a software component or application. A software item like a data transformer or converter, or a clinical support algorithm, may be an independently deployed, managed and configured entity that contributes to patient care and needs to be documented just a surely as, say, a physical cardiac monitor. It can also represent the relationship of the software item to other device and information system components through reference linkages. This category includes software regardless of whether or not is regulated. Device instances documenting software items are important to traceability of data and analyzing adverse events, and so have important patient safety roles. These may also be considered Digital therapeutics (DTx) in some contexts.

Software as a medical device may include not only traditional applications but also standalone algorithms, rule engines, artificial intelligence (AI), machine learning (ML) components, and decision-support modules. These software-based devices may operate independently or be embedded within physical hardware to be used in clinical and non-clinical contexts.

Boundaries and Relationships

There are a number of resources that either represent other aspects of a device and/or reference a DeviceDefinition:

DeviceDefinition: this resource.

Device: Represents an actual instance of the device, references the DeviceDefinition for further description and characteristics of the device that do not change across the same “kind” of device. For example, the physical characteristic would not change, while the actual configuration used is within the valid configurations that may be documented in the DeviceDefinition.

Where the DeviceDefinition is referenced by other resources listed in References to this Resource, beyond Device, the DeviceDefinition is a choice between DeviceDefinition and a Device depending on whether a specific device is to be considered or a kind of device. For example one may indicate a specific device as part of a ServiceRequest order detail or a kind of device using DeviceDefinition; one may indicate a specific device to always perform the observation or a kind of device as part of an ObservationDefinition; one may document a specific device or kind of device used to collect a Specimen.

Note that in some jurisdictions a regulated product might not be considered a device, but may be regulated as a medication or a biologic. These boundaries are not controlled for in the FHIR Resources, but should be considered when working in the healthcare product space, specifically:

Notes

Notes:

StructureDefinition

Elements (Simplified)

Mappings

Resource Packs

list-DeviceDefinition-packs.xml

<?xml version="1.0" encoding="UTF-8"?>

<List xmlns="http://hl7.org/fhir">
  <id value="DeviceDefinition-packs"/>
  <status value="current"/>
  <mode value="working"/>
</List>

Search Parameters

Full Search Parameters

Examples

Full Examples

Mapping Exceptions

devicedefinition-fivews-mapping-exceptions.xml

Unmapped Elements