World Health Organization, editor. Medical Devices: Managing the Mismatch: An Outcome of the Priority Medical Devices Project. World Health Organization, 2010.
There is a wide variety of medical devices available today, with approximately 10,000 main types of devices (pg 1)
The accessibility and efficacy of medical devices depends heavily on the resources a country has at its disposal, as well as it’s environment (pg 2).
Need for medical supplies also varies between countries with different levels of resources. For example, high-resources countries may have a higher demand for replacement joints than a low-resource country.
“Medical research priorities in most high-resource countries are based primarily on scientific and technological preferences, with little explicit regard for public health needs”World Health Organization, pg 2
Identifying Medical Devices for Public Health Needs (pg 22):
- Identify disease burden
- Select clinical guidelines
- Identify care pathways
- List medical devices according to care pathways
- Distinguish between preventative, diagnostic, and therapeutic devices
Research and development of medical devices occurs both publicly and privately, but is more directed at high-resource countries and ‘promising ideas/technological advancement’ (pg 28)
Many public research projects are not specifically geared to medical devices (pg 31).
Many countries don’t have a central database on medical device usage (pg 34).
To determine the gap in medical device usage, six random developing countries were chosen to see their usage of key medical devices for 15 global high-burden diseases, including Tuberculosis, HIV/AIDS, malaria, cataracts, and road traffic accidents (pg 35).
The devices required for each disease were arranged in an Availability Matrix. Each row signified a clinical procedure related to the disease, and the following columns contained general and specific devices for each of the preventative, diagnostic, therapeutic, and assistive [device] categories (pg 38).
Four of the six countries responded:
Choices on purchasing (type, quantity, etc…) medical devices must be made with public health in mind. E.g., The 24 positron emission tomography (PET) scanners in Netherlands have the capacity to take three times as many scans than are actually taken each year. (pg 44)
Some barriers to choosing devices effectively include (pg 45):
- Gaps in credible/extensive information (e.g. on a new technology that is supposed to replace a functioning but older technology)
- The generally small sizes of clinical trials (when testing implanted devices or scanning technology one can’t just offer a placebo to the control group like in a pharmaceutical study, making clinical trials of medical devices smaller)
- Disconnect between physicians (who might ask for new devices to please patients) and those who deal with the costs of such devices
- Also a tendency for physician’s to request their personal preference in devices (preferred brand= good, preferred vendor= not as good).
A standardized nomenclature for devices would improve decisions (pg 51)
So would using Health Technology Assessments (HTAs) (pg 52)
The context of the medical device is important too– is it one of the types listed in Table 4.5? Is it geared towards hospital use or towards home use? (pg 56)