Needs Assessment for Medical Devices
Introduction[edit | edit source]
Digital Health has brought the issue of health technologies back in the spotlight.
Health technologies apply organised knowledge and skills in a way that promotes solutions to health problems and improve overall quality of life; they may take the form of devices, pharmaceuticals products, or medical procedures and systems. Some use the term health care technology interchangeably.  Health technologies have always been essential for the functioning and improvement of health systems and their importance has been highlighted several times in achieving healthcare goals.  However, their selection and management, especially for medical devices has always been arbitrary. 
Medical devices refer to any type of machine, apparatus, instrument, implant, software, reagent for in vitro use that is intended for a medical purpose  e.g. the prevention, diagnosis and treatment of a condition or disease; or the detection, measurement, restoration, correction or modification of a structure or body function. Medical devices are used in diverse settings, e.g. by patients at home, clinicians in their clinics, and by healthcare professionals such as physiotherapists and occupational therapists.  To date, 2 million different kinds of medical devices are available in the world market, with more than 7000 generic devices groups reported. 
Needs assessment[edit | edit source]
In 2011, the World Health Organisation produced a document highlighting the necessity and providing generic guidance for needs assessment for medical devices.  In this document, the methodological approach, tools and examples were provided for assessment of current situation and future needs of individual facilities as well as wider networks e.g. at a national level. Needs assessment were divided into a general approach process and a specific section.
General approach process[edit | edit source]
Questions[edit | edit source]
- What should be available in terms of health services?
- What is available? (in the facility, regionally or nationwide)
- What are the national or global standards and best practices?
- Comparison with the ideal for a particular demand or situation - Identidying the gap / List of general needs
- What resources (human, equipment, financial) are available? - Prioritised needs / Prioritised List of needs
Specific approach steps[edit | edit source]
The specific approach is a 7-step process of data collection and analysis.
- Baseline information on health service requirements
- Baseline information on health service availability
- Baseline information on medical devices
- Baseline information on human resources
- Baseline information on finances
- Analysis and interpretation
- Prioritisation and appraisal of options
Conclusion[edit | edit source]
Needs assessment of medical devices is a complex process that requires information from various sources. If conducted methodically and in-depth, it can lead decision - makers to the necessary information for the selection and prioritisation of appropriate medical devices.
Resources[edit | edit source]
The 2011 WHO document on needs assessment for medical devices can be found in languages other than english here. (french, greek, chinese, and spanish)
References[edit | edit source]
- World Health Assembly, 60. Health technologies. World Health Organization. Document WHA60.29 (2007). Available from: https://apps.who.int/iris/handle/10665/22609 [accessed 23/8/23]
- WHO. Needs assessment for medical devices. June 2011. Available from: https://apps.who.int/iris/bitstream/handle/10665/44562/9789241501385-eng.pdf?sequence=1&isAllowed=y [accessed 23/8/2023]
- WHO. Medical devices. Available from: https://www.who.int/health-topics/medical-devices#tab=tab_1 [accessed 23/8/23]