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).