Accessibility: People’s ability to obtain and appropriately use good-quality health technologies when they are needed.
Adverse event: Any untoward medical occurrence in a subject, whether device related or not.
Affordability: In the context of this report, the extent to which the intended recipients of a service can pay for it, be it a public, governmental or private service.
Appropriate(ness): Medical methods, procedures, techniques and equipment that are scientifically valid, adapted to local needs, and acceptable to both patient and health care personnel, and that can be utilized and maintained with resources the community or country can afford.
Assistive products: Any external product (including devices, equipment, instruments or software), specially produced or generally available, the primary purpose of which is to maintain or improve an individual’s functioning and independence, and thereby promote their well-being. Assistive products are also used to prevent impairments and secondary health conditions.
Capital medical devices: Medical equipment and devices that providers of health services have acquired during the accounting period and that are used repeatedly or for more than one year in the provision of health services. 1
Clinical guideline: Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.
Consumables/single-use medical devices: Supplies required for the use of the equipment but allowing only limited, or no, reuse.
e-health: The use of information and communication technologies for health.
General medical devices: Indispensable medical devices for basic use of the clinical unit to perform a majority of interventions for a wide scope of diseases. Range of specification may vary depending of the level of healh.
Health care: Any type of service provided by professionals or paraprofessionals with an impact on health status
Medical device: An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological or metabolic means. Medical devices include medical equipment, surgical instruments, implantable medical devices, in vitro diagnostics, solutions and disinfection substances, clothing, accessories and single-use devices.
Medical equipment: Medical devices requiring calibration, maintenance, repair, user training and decommissioning – activities usually managed by clinical engineers. Medical equipment is used for the specific purposes of diagnosis and treatment of disease or interventions provided during rehabilitation following disease or injury; it can be used either alone or in combination with any accessory, consumable, or other piece of medical equipment. Medical equipment excludes implantable, disposable or single-use medical devices.
Medical furniture: Furniture used in medical settings (hospitals, or any other health care units) for medical purposes (for example, cabinets to store medical equipment).
Personal protective equipment and clothing: Personal protective equipment, commonly referred to as PPE, is equipment worn by health care workers to minimize exposure to a variety of hazards. Examples of PPE include such items as gloves, foot and eye protection, protective hearing devices (earplugs, muffs) hard hats, respirators, lead aprons and full body suits. This category includes the equipment used to cover and protect the patient, such as gowns and face masks.
Priority assistive products: Those assistive products that are highly needed, an absolute necessity to maintain or improve an individual’s functioning and which need to be available at a price the community/ state can afford.
Priority medical devices: Those medical devices that are indispensable to perform a health intervention, of an evidence based clinical practice guideline of a priority diseases or health condition. These medical devices need to be of good quality, effective, appropriate, affordable, accessible and acceptable to the final user. They need to be available to respond to the priority health needs of the setting and should be used safely by the health care worker or final user. The priority medical devices, especially the ones that are most costly and complex, require specific infrastructure and trained human resources, and need an assessment process to evaluate if these can be placed for public procurement or considered in the package of interventions as a reimbursable procedure/product. These assessments consider not only the safety and efficacy of the technology, but also feasibility, cost effectiveness, ethical, organizational and human resources requirements. Those devices have specific intended use from prevention and protection to diagnosis, monitoring, treatment or palliation, to inform the development of national priority lists.
Quality assurance equipment: Equipment clinically relevant to carry out a calibration process needs to meet international standards considering calibration factors. Also called auxiliary dosimetry equipment, for example ionization chambers, phantoms and chamber sleeves.
Specific medical devices: Medical devices for diagnosis or treatment of a specific type of condition or disease and used for specific clinical intervention.
1 A system of health accounts: 2011 edition. OECD, European Union and World Health Organization; 2011 (https://www.who.int/health-accounts/methodology/sha2011.pdf).