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Medical devices: managing the mismatch:
an outcome of the priority medical devices project


ISBN 978 92 4 156404 5 (NLM classification: WX 147) -
World Health Organization 2010



Available online PDF [36p.] at: [Ссылки могут видеть только зарегистрированные пользователи. ]

“….Medical devices are important to provide health care and to improve the health of individuals and populations. The World Health Organization (WHO) recognizes this. One of WHO’s strategic objectives is to ensure improved access, quality and use of medical devices. Without medical devices, routine medical procedures—from bandaging a sprained ankle, to diagnosing HIV/AIDS or implanting an artificial hip—would be impossible. Concurrently, modern technology is producing an overwhelming abundance of medical devices at a rate that soon makes the latest device obsolete.

Key issues affecting progress include the extreme diversity of the medical device arena—diverse in terms of types of devices, degrees of complexity, applications, usage, users and categories and issues like the context dependency of medical devices and research in medical devices often not based on public health needs.


However, as a crucial component of health care, medical devices will be most effective when considered in the wider context of the complete health-care package necessary to address public health needs: prevention, clinical care (investigation, diagnosis, treatment and management, follow up, and rehabilitation) and access to appropriate health care. Therefore, rather than just focusing on the technological issues involved in medical devices, it is necessary to frame medical devices in another way—as an agenda to improve global access to appropriate medical devices.



This agenda is composed of the crucial “4 As”—Availability, Accessibility, Appropriateness, and Affordability.

These four components help to widen the scope of the medical device agenda so that it does not just focus on “upstream” innovation efforts but also on choosing which medical devices to procure in a rational way, responding to the needs, and in ensuring that they are used as effectively as possible to best improve health….”

The First Global Forum on Medical Devices
The World Health Organization is pleased to announce the First Global Forum on Medical Devices to be held 9-11 September, 2010 in Bangkok, Thailand. A webcast is available to view the sessions. Overview


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Medical devices: managing the mismatch – Contents

Overview

1. Introduction 1

1.1 Prioritizing medical devices: setting the scene

1.2 The Priority Medical Devices project

1.3 The mismatch

1.4 This report

2. Medical devices

2.1 Medical devices: what’s in a name?

2.2 Past, present, and future

2.2.1 Recent key trends

2.2.2 Future trends

2.3 Assistive products

2.4 Pharmaceuticals and medical devices: similarities and differences

2.4.1 Access to essential medicines

2.4.2 Access to appropriate medical devices

2.5 The medical device market

2.6 Medical device regulation

2.7 An introduction to medical device innovation

2.7.1 Applying non-medical innovation to health care

3. Public health needs

3.1 A health-based approach to choosing medical devices

3.2 Identifying current and future public health needs

3.2.1 Disability

3.2.2 Global trends

3.3 Public health: the missing research target

3.3.1 Drivers of research

3.4 The gap

4. Priority Medical Devices project: methods used

4.1 Methodology

4.1.1 Identifying key medical devices in high-burden diseases

4.1.2 Identifying the medical device gap

4.2 Results

4.2.1 Identifying key medical devices in high-burden diseases

4.2.2 Identifying the medical device gaps

4.3 Identifying key assistive products for high-burden diseases

5. Medical devices: problems and possible solutions

5.1 Choosing medical devices

5.1.1 Barriers to choosing medical devices

5.1.2 Possible solutions to overcoming these barriers

5.2 Using medical devices

5.2.1 Barriers to using medical devices

5.2.2 Overcoming barriers to using medical devices

5.3 Medical device innovation

5.3.1 Barriers to innovation

5.3.2 Barriers to appropriate innovation uptake

5.3.3 Overcoming the barriers to medical innovation

5.4 Assistive devices

5.5 Emerging themes

5.5.1 Applying the 4 As to medical devices and medical interventions

6. Towards appropriate medical devices: options for future research

6.1 Methodology

6.2 Results

6.2.1 Scoping exercise

6.3 Future research areas in cross-cutting areas

6.3.1 Study design and clinical outcome

6.3.2 Laboratory diagnostic tools

6.3.3 Telemedicine and labour-saving technologies

6.3.4 Safe injections

6.4 Future research areas in global high-burden diseases

6.4.1 Perinatal conditions

6.4.2 Lower respiratory tract infections

6.4.3 Unipolar depressive disorders

6.4.4 Ischaemic heart disease

6.4.5 Cerebrovascular disease (stroke)

6.4.6 HIV/AIDS

6.4.7 Road traffic accidents

6.4.8 Tuberculosis

6.4.9 Malaria

6.4.10 Chronic obstructive pulmonary disease

6.4.11 Cataract

6.4.12 Hearing loss

6.4.13 Alcohol use disorders

6.4.14 Diabetes mellitus

6.5 Future trends in high-burden diseases

6.5.1 Alzheimer disease and other dementias

6.5.2 Cancer (malignant neoplasms)

6.5.3 Osteoarthritis

6.6 A possible way forward

References

Glossary

Annex 1 List of background papers and methods used in preparing the report

1. A stepwise approach to identifying gaps in medical devices (Availability Matrix and survey methodology)

2. Building bridges between diseases, disabilities and assistive devices: linking the GBD, ICF and ISO 9999

3. Clinical evidence for medical devices: regulatory processes focusing on Europe and the United States of America

4. Increasing complexity of medical devices and consequences for training and outcome of care

5. Context dependency of medical devices

6. Barriers to innovation in the field of medical devices

7. Trends in medical technology and expected impact on public health

8. Future public health needs: commonalities and differences between high- and low-resource settings

Annex 2 Conflict of interest statement

Annex 3 Steering bodies of the Priority Medical Devices project