Re: Device
Teodolinda Mattson
The ultimate judgment regarding whether a BP measurement device meets the requisite VDL Criteria rests with the Independent Review Committee and is not in any way determined or influenced by the AMA.
The Independent Review Committee, comprised of physician experts, assesses if a BP device satisfies the VDL Criteria for validation of clinical accuracy. Devices that meet the Criteria are then published on the listing page. Devices are regularly reviewed and added through this independent process.
The International Medical Device Regulators Forum (IMDRF) acknowledges the significant impact of the COVID-19 pandemic on all countries and citizens. The use of essential medical devices such as ventilators, oxygen concentrators, syringes and test kits contributed to the efforts of pandemic responses around the world, as with other products regulated in some countries such as surgical face masks.
The IMDRF held a Joint Workshop on COVID-19 in March 2021 and held regular discussions about the impacts, experiences and challenges during the pandemic. Members continue to share information about changes made to regulatory frameworks that aim to assist preparations for future pandemics. Some of these included emergency use or other systems to expedite access and supply of essential medical devices, flexible and pragmatic approaches to regulatory processes such as remote inspections, and publishing information about approval pathways and availability of critical medical devices.
This is a base resource that tracks individual instances of a device and their location. It is referenced by other resources for recording which device performed an action such as a procedure or an observation, which device was implanted in or explanted from a patient, dispensing a device to a patient for their use, managing inventory, or when requesting a specific device for a patient's use. Medical devices include durable (reusable) medical equipment, implantable devices, as well as disposable equipment used for diagnostic, treatment, and research for healthcare and public health. Medical devices may also include some types of software.
Non-medical devices may include items such as a machine, cellphone, computer, software application or algorithm, etc. In short, a Device can range from a tongue depressor to an MRI. The fields in the Device resource must be flexible enough to cover this range.
The resource may be used to document the Unique Device Identifier (UDI) and information about a device where appropriate or necessary according to local jurisdictions over time. Additional information about UDI is provided in the Unique Device Identifier (UDI) section.
Devices may be categorized and may be associated with one or more categories. Device category examples include, but are not limited to: active, communicating, durable medical equipment, home use, implantable, InVitro diagnostics, personal health, point-of-care, single use, re-usable, and software.
'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.
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 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.
Equipment and supplies that provides 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.
A home use medical device is a medical device 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.
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
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
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, 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. PHDs are the subset of patient-use devices that report their information to a peer via a protocol.
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.
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, generally requiring access to what is in effect a dynamically changing model of the device and its subsystems and measuring capabilities. 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.
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