Improving access to medical devices and equipment in LMICs

IMPROVING ACCESS TO MEDICAL DEVICES AND EQUIPMENT IN LMICS

Universal Health Coverage (UHC) aims to ensure that people can access essential health services across the continuum of care, from prevention, diagnosis, and treatment to rehabilitation or palliative health services1. Limited access to quality, affordable, and effective medical devices and equipment (MDE) is a significant barrier to achieving UHC2 . Combined with fragmented health systems and policies, poor infrastructure, and shortages of qualified health workers, the world is unlikely to meet the current UHC targets by 2030.

More than 2 million MDEs are available for disease prevention, diagnosis, treatment and rehabilitation3. However, most MDEs are designed for use in high-resource settings and are unsuitable for deployment in facilities with fluctuating electricity and internet services, limited water supply and waste management and extreme operating conditions4.

The agenda of the World Health Organization (WHO) led Global Initiative on Health Technologies (GIHT) aims to improve access to appropriate MDEs that meet the “5 As” criteria: Availability, Accessibility, Appropriateness, Awareness and Affordability. However, studies suggest that 40 to 70% of MDEs in resource-poor settings are not operational due to defects, lack of trained users or consumables or are unfit for purpose5.

This study, focusing on Sub-Saharan Africa, explores the challenges and barriers to MDE access prevalent across LMICs.

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BARRIERS TO MEDICAL DEVICE AND EQUIPMENT ACCESS IN LMICS

RESEARCH AND DEVELOPMENT

MDEs should be appropriate for implementation in different healthcare contexts in settings with constrained resources. However, most MDEs are developed by global manufacturers for deployment in high-resource settings, and there is limited local production of MDEs in Africa.

• Barriers to building a business case for low-resource innovation investment:

• Fragmented, incomplete and inaccurate epidemiologic, demographic and market data, especially for non-communicable diseases (NCDs)

• Clinical guidelines, population health priorities and technological needs data for low resource settings are available for a limited number of diseases (infectious diseases and RMNCH).

• Inadequate dissemination of available data to multinational medical device manufacturing stakeholders, leading to unawareness and bias in their knowledge of local needs.

• Limited local innovation and manufacture of MDEs:

• Limited capital available for financing medical technology innovations in local settings

• Fewer collective resources are available for R&D activities such as prototyping, pre-clinical and clinical studies, and design transfer to manufacturing settings.

• Less established routes to market for commercialising innovations from local research institutions through partnerships with local and global stakeholders.

BARRIERS TO MEDICAL DEVICE AND EQUIPMENT ACCESS IN LMICS

REGULATORY AND QUALITY

Medical device regulation encompasses a set of mandatory processes to determine the safety and effectiveness of medical device products. Regulatory processes take a risk-based approach to balancing the potential risks of a medical device against its potential benefits when used for a specific intended purpose.

• The absence of national regulatory authority processes in many countries leads to the following:

• Reliance on foreign medical device products that have international regulatory approvals but may be costly or unavailable in local markets

• Impedes the verification of international certifications

• Where national regulatory agencies exist, they may concentrate on product registration and import licensing processes rather than pre-market approvals of local products.

• Access to relevant international standards is limited due to complex navigation and high costs.

• Less established routes to market for commercialising innovations from local research institutions through partnerships with local and global stakeholders.

BARRIERS TO MEDICAL DEVICE AND EQUIPMENT ACCESS IN LMICS

HEALTH TECHNOLOGY ASSESSMENT

Assessment includes activities promoting selecting the most appropriate medical devices for the local context to maximise effectiveness in resource-constrained settings. These processes may include formal Health Technology Assessment (HTA) and procurement.

• Health Technology Assessment (HTA):

• Many countries lack a formalised HTA body or process to perform health needs assessments and match population health priorities with appropriate technologies

• HTA studies are challenging in low-resource settings due to lacking HTA specialists and other experts (BMETs, health economists), funding for studies and limited data on health impacts, coverage, and total costs associated with MDEs.

• Total expenditures associated with medical device deployment, in particular, user training and maintenance, are often unknown or difficult to quantify

• Clinical guidelines may not include technical specifications or use recommendations for MDEs required to perform specific interventions.

• Procurement:

• Lack of transparency on the availability of MDEs in local markets

• Global manufacturers may face challenges in identifying local distributors with appropriate facilities and expertise to market, install and service MDEs to comply with international Quality Management Systems requirements.

• A lack of information and data available on MDEs for decisionmaking

• Fragmented procurement process for MDEs and lack of maintained lists of approved MDEs

• Where governments have implemented dedicated medical device assessment and procurement processes, they are often restricted to public sector health services with limited or no engagement of private sector facilities.

BARRIERS TO MEDICAL DEVICE AND EQUIPMENT ACCESS IN LMICS

MEDICAL DEVICE MANAGEMENT

MDEs may be complex devices requiring extensive user training, ongoing preventative and corrective maintenance, consumables for continuous operation and spare parts for repairs. Unfortunately, many countries lack a medical device management system at the government and facility levels.

• Non-operational MDEs result in service interruption, reducing the capacity for patient care and may be caused by:

• Lack of correct installation and preventive and corrective maintenance services causes service disruption, reduces the life expectancy of MDEs and increases the overall cost of ownership.

• Limited local production of spare parts leading to extended periods of downtime

• Disrupted or unreliable consumables supply chains.

• Lack of Biomedical Engineers and Technicians (BMETs) to maintain, manage MDE inventories and advise on MDE procurement.

• Post-market surveillance systems are required to monitor adverse events and customer complaints and provide feedback to quality systems.

• Lack of appropriate user training programs for using MDEs in resource-constrained environments

• Provision for safe medical device decommissioning and disposal is lacking in most settings.

IMPROVING ACCESS TO MEDICAL DEVICES AND EQUIPMENT IN LMICS

MEDDEV CENTRAL

STUDY METHODS

This mixed methods study combined quantitative and qualitative data to identify barriers to MDE access in Africa. The methods included systematic literature reviews (SLRs), surveys and interviews with stakeholders representing healthcare providers and professionals, Biomedical Engineers and Technicians (BMET) and medical device industry professionals.

Systematic Literature Reviews (SLRs)

A series of systematic reviews of peer-reviewed and grey literature was conducted in October 2022 following the Cochrane Handbook for Systematic Reviews of Interventions6 guide. Smaller-scale scoping and landscape reviews performed between April and September 2022 informed the search terms and inclusion/exclusion criteria. No language or time restrictions were imposed on database searches. Reference management was performed in EndNote (EndNote X9, Clarivate, Philadelphia, PA, U.S.A.), and systematic reviews managed in Covidence systematic review software (Veritas Health Innovation, Melbourne, Australia)7.

Surveys

Surveys were constructed in SurveyMonkey online software (Momentive Inc., San Mateo, California, USA)8. Surveys were distributed on an ongoing basis to interested participants by email from August 2022 to 31st December 2022. Data was collected and analysed in the SurveyMonkey online software platform and exported to Google Data Studio (Google, Mountain View, CA)9 for further analysis and data visualisation on completion.

Interviews

Remote interviews were conducted continuously with interested respondents between August and December 2022. Initial exploratory interviews followed an unstructured format with open-ended questions to identify the optimum questions for structured interviews between October and December 2022. Interviews were recorded if the participant agreed, and the recordings were transcribed. If the participant does not agree to the recording, the interviewer recorded extensive notes on the conversation.

Data Analysis

The data was analysed periodically to construct a pathway mapping identified barriers to stages in the medical device lifecycle.

REFERENCES

1. Tracking Universal Health Coverage: 2021 global monitoring report. 2021, World Health Organization and International Bank for Reconstruction and Development / The World Bank: Geneva.

2. Medical devices: Managing the Mismatch (An outcome of the Priority Medical Devices project). 2010, World Health Organization: Geneva.

3. Global atlas of medical devices. 2017, World Health Organization: Geneva.

4. Medical Device Regulations: Global Overview and Guiding Principles. 2003, World Health Organization: Geneva.

5. Perry, L. and R. Malkin, Effectiveness of medical equipment donations to improve health systems: how much medical equipment is broken in the developing world? Med Biol Eng Comput, 2011. 49(7): p. 719-22.

6. Higgins JPT, T.J., Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors), Cochrane Handbook for Systematic Reviews of Interventions 2022, Cochrane.

7. Innovation, V.H., Covidence systematic review software. 2022, Melbourne, Australia.

8. SurveyMonkey Inc., SurveyMonkey. 2022, San Mateo, California, USA.

9. Google, Google Data Studio. 2022, Mountain View, CA.