Kenya Medical Devices Management Policy-Draft

1. Kenya Medical Devices Management Policy-Draft March 8th , 2019

2. The Health System Approach: Continuum of care Policy Environment – All disease areas • In the context of a holistic approach that will deliver quality healthcare, it is always important to consider 3 key pillar namely, care seeking behavior of the populace, the ability of healthcare workers to render high quality services and equally important the availability of not only drugs, but also medical equipment. • As such, understand the availability and management of medical equipment is critical in order to have a seamless continuum of care. 2 3 1 Commodity/Equipment Availability Diagnosis & Case Management Care seeking Area of focus • Strengthen provider practice • Secure quality, affordable commodities & medical equipment (Policy) • Improve care-seeking behavior in the community • Promote prevention Approach

3. Situational Analysis: A sampled case study of medical oxygen situation in Kenya

4. Oxygen Source 1: Health providers resort to improvised oxygen solutions because of lack of guidelines: concentrators are some of the examples of sub-optimal solutions Single user Concentrator reconfigured to an ‘Octopus’ to serve 8 patients Maintenance & Repair parts are a challenge to find hence the need to modify Quality of oxygen produced from concentrators is sub optimal and can go as low as 21% Concentrators run for many hours without maintenance • Require consistent electricity supply • Quality challenges

5. Source 3: while oxygen from cylinders is the most used source, there are challenges around cylinder handling Cylinders retrofitted to serve multiple patients using IV lines. Cylinders next to incubator: Positioning of the cylinders can be hazardous. Positioning of the oxygen splitters can be hazardous. Donated Cylinders sometimes are not of the same standard with what is used in country rendering them useless Cylinders incorrectly set up exposing patients and HCWs to potential injury Handling & storage of Cylinders is a challenge and risky in some facilities

6. Lessons learned • 1 • 2 • 3 • 4 • 5 • There is a close link between service delivery for quality healthcare & medical equipment • Currently, there is inadequate guidance in relation to sound management of medical equipment at all levels • Inadequate attention to medical devices and budgetary allocation, leading to a number of sub-optimal donations, maintenance challenges amongst many other challenges • There is disproportionate access to medical equipment, which can be optimized • There is need to expedite the medical devices management policy in order to further support the UHC agenda

7. Iceberg Theory WHAT PEOPLE SEE • Hard Facts • Purchase price WHAT PEOPLE DO NOT SEE • Soft Facts • Cylinder purchase • Maintenance • HRH- Engineers • Power consumption • Replacement parts • Depreciation • Distribution costs 90% 10%

8. Medical Devices Policy: Introduction

9. Introduction – 3 Key Messages • The Kenya constitution provides a legal framework for a comprehensive approach to the delivery of health services • National health policies, strategies and plans play an important role in extending quality healthcare services to the people. • As recommended by WHO, Kenya recognizes the importance of health technologies/medical devices in disease prevention, treatment, diagnosis, rehabilitation and improvement of the quality of life in a health system as outlined in World Health Assembly (WHA) 60.29, 2007 resolution.

10. Unit of measure

11. POLICY DIRECTION Setting Smart Objectives Policy statement Pursuant to the aspiration of the constitution to provide quality health services, all medical devices introduced and used in the Kenya health sector shall be managed in accordance with this policy, and in compliance with all statutory requirements for health service delivery Policy Goal The goal of this medical devices management policy is to contribute towards attainment of the highest possible standard of health in a responsive manner. Policy Objective The general objective of this policy is to outline how medical devices shall be managed efficiently, economically, effectively and sustainably in provision of quality health services.

12. …bringing into life the Kenya Health Policy • The Kenya Health Policy (KHP) 2014-2030 ensures that: • Healthcare and services are attained to the highest possible standards. • Considerable investment in health products & technology

13. …which together complements the key enablers to ensure quality healthcare Health technologies Financial strategy Human resource capacity Infrastructure planning Health information leadership & Governance

14. …which seeks to address 4 key pillars • Investment in R&D • Guide management on matters related to Research, innovation and development 1 Health Technology Regulation • Guide management on Health technology infrastructure regulation 2 Health Technology Assessment • Guide management on a structured Health technology assessment 3 Health Technology Management • Provide a platform that can be used for data sharing and analysis on health issue 4

15. …..and guided by five principles Equity Diversity Guiding principles Effectiveness Social accountability Multi-sectoral approach

16. ...the scope of the policy is broad and covers a number of stakeholders • The policy applies to all medical devices, health actors involved in the R&D, supply, regulation, introduction, acquisitions, donations, installation, commissioning, training, maintenance, repair, use, operation, decommissioning and disposal of medical devices. • It applies to all medical devices irrespective of the source. • All medical devices are covered whether leased, patient owned, loaned, rentals, hire purchase, donated, gifts, trial/evaluations so long as they are for use in the health sector for diagnosis, therapeutic, monitoring and rehabilitation and for any other health service deemed to affect health outcome of a client.

17. …which together complements the key enablers to ensure quality healthcare Health technologies Financial strategy Human resource capacity Infrastructure planning Health information leadership & Governance

18. Medical Devices Policy: Objectives & Strategies

19. Definitions- Medical devices Means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purposes of i) diagnosis, prevention, monitoring, treatment or alleviation of disease, ii) alleviation of or compensation for an injury iii) investigation, replacement, modification, or support of the anatomy or a physiological process iv) supporting or sustaining life v) control of conception iv) disinfection of medical devices v) providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means (WHO definition (WHA 60.29, 2007)

20. Medical equipment Means Medical devices requiring calibration, maintenance, repair, user training and decommissioning

21. Health Technologies Means application of organized knowledge and skills in the form of devices, medicine, procedure and systems developed to solve a health problem and improve quality of life

22. Medical Device management Management in this context refers to managing the medical device life cycle from inception, research and development, regulation, needs assessment, acquisition (including donations), installation, operation and training, maintenance and repair and finally disposal. This life cycle forms the basis of development of this policy document. Further this is in line with WHO and international best

23. Challenges around Medical devices Management in Kenya • wastage of resources as a result of investing in Medical devices that do not meet priority needs, • investing in medical devices which are incompatible with existing infrastructure, • investing in medical devices which are of low quality, or do not function properly, or cannot be used correctly • investing in medical devices that cannot be serviced due to non-availability of spare parts or high cost of maintenance • investing in medical devices that are based on outdated technologies • Lack of clear guidelines and standards on maintenance and donations

24. …which seeks to address 4 key pillars • Investment in R&D • Guide management on matters related to Research, innovation and development 1 Health Technology Regulation • Guide management on Health technology infrastructure regulation 2 Health Technology Assessment • Guide management on a structured Health technology assessment 3 Health Technology Management • Provide a platform that can be used for data sharing and analysis on health issue 4

25. …To ensure management of different phases of medical devices cycle some specific objectives have been set Objectives Strengthen regulation of medical devices Promote safe use of medical devices Develop and strengthen human resource capacity in management of medical devices Streamline the management of medical devices across the ecosystem Promote research, development and innovation related to medical devices and their application Improve access to appropriate medical devices towards universal health coverage 1 2 3 4 5 6

26. Objective 1: Strengthen regulation of medical devices 1 Strategy 1: The Ministry responsible for Health shall establish a single regulatory body for all health products and technologies (HPT). Strategy 2: Establishment of a body for regulation of the medical engineering profession Strategy 3: Development of guidelines for donated medical devices Strategy 4: Development of guidelines for disposal of medical devices Strategy 5: Adoption of suitable quality and safety standards for medical devices Strategy 6: Development of necessary legislation as required by the Health Act 2017

27. Objective 2: Promote safe use of medical devices 2 Strategy 1: Awareness creation and training users on medical devices Strategy 2: Development of operating standards & procedures on the use of medical devices Strategy 3: Adoption of standards for calibration of medical devices Strategy 4: Ensure the adoption standards are complied with through regular inspection Strategy 5: Development and strengthening of mechanism for reporting adverse incidents of medical devices

28. Objective 3: Develop and strengthen human resource capacity in management of medical devices 3 Strategy 1: Regular review of the medical engineering curriculum Strategy 2: Improve mechanisms for continuous professional development and education Strategy 3: Recruitment and deployment plan for biomedical engineers as per HRH norms and standards

29. Objective 4: Streamline the management of medical devices across the ecosystem 4 Strategy 1: Development and implementation of Health Technology Assessment (HTA) plan in the country Strategy 2: Institutionalization of Health Technology Management (HTM) cycle in the country Strategy 3: Review and development of guidelines on all elements of HTM cycle

30. Objective 5 : Promote R&D and innovation related to medical devices and their application 5 Strategy 1: Development of a research agenda for medical devices and application Strategy 2: Building linkages with industry, academia, regulatory bodies and relevant research institutions Strategy 3: Mobilization of resources for medical devices research work Strategy4: Dissemination of research outputs/findings related to medical devices

31. Objective 6: Improve access to appropriate medical devices towards universal health coverage 6 Strategy 1: Maximize utilization of installed capacity of medical devices (and services) in the Kenya health sector Strategy 2: Use innovative programs to improve availability of medical devices   Strategy 3: Encourage local production of medical devices and technology transfer  Strategy 4: Adoption of cost effective financing strategies relating to medical devices  Strategy 5: Continuous engagement with stakeholders to minimize cost barriers to medical devices   Strategy 6: Integration of social accountability in the community relating to medical devices

32. Implementation will require ownership both at the National and County government level with cross-cutting responsibilities National • Ministry shall be ultimately responsible for the development of guidelines and standards required for the implementation of this policy • Mobilize resources required for successful implementation of the policy through budgetary allocation • Human capacity development • Training BMEs by way of offering internships and where possible scholarships • Setting up and co-ordination of research information related to medical devices County • Mobilize resources required for successful implementation of the policy through budgetary allocation • Human capacity development Private sector, Industry & other stakeholders • Training BMEs by way of offering internships and where possible scholarships • Help in the co-ordination of research and mobilization of resources for research related to medical devices • Comply with the policy

33. Monitoring and Evaluation will be incorporated in the implementation phase • The M&E for this policy shall be carried out in three steps; • Monitor progress towards the achievement of the policy objectives, a baseline survey shall be carried out to inform the development of indicators and set targets. Subsequently, the policy shall be monitored through an evaluation every fourth year during the policy period. • Data tools for monitoring shall be developed, integrated into the health management information system (HMIS) and institutionalized. • Implementation plans for this policy shall be expected to have in-built M&E plans

34. …and process roadmap developed Formation of TWG Draft policy Review Draft policy is reviewed by an expanded stakeholder Technical Working Group [01/2018] A group of Technical Experts is formed to steer the process [03/2016] Internal & External stakeholder processes Initial Consultations Draft Policy Policy adoption and implementation Government (METU) consultations with stakeholders Version 0 of the Policy is drafted and shared with the team [09/2017] Internal & External stakeholder consultation process (OUTSTANDING)

35. Plenary Discussion

36. Contact e-mail address • Martin.owino@health.go.ke • Martin.owino@yahoo.com