1. Kenya’s Journey towards Optimal Medical Devices Management
By: Eng. Martin Owino
The Head: Medical Engineering Technical Unit
Ministry of Health
13 – 15 December, 2018
4th WHO Global Forum on Medical Devices
MTZ-Kalam Convention Centre, Visakhapatnam, India

2. 10% 90% Problem statement: Iceberg theory…
The current management of medical equipment/devices in Africa is below par, yet it has enormous impact on patient outcomes. Just like commodities, they should be optimally regulated and best practice applied – it has to be embedded in law
WHAT PEOPLE SEE
10%
Hard Facts
Purchase price
WHAT PEOPLE DO NOT SEE
Soft Facts
What is the actual need?
Understanding full costs of maintenance
HRH- You need improve HR resource
What is covered in the warranties
The cost of operations is never considered
Replacement parts & depreciation
90%
Ref: CHAI Kenya survey results in over 2400 public health facilities

3. Solution: Address medical devices management through policy framework
Unit of measure
Applies to all medical devices
Actualizing UHC agenda through 4 key pillars
Irrespective of source
Irrespective of method of acquisition (e.g. purchase, lease, donations, gifts, trials, etc.)
Includes diagnostic, therapeutic, monitoring & rehabilitation
or any other health service
equipment deemed to affect health
outcome

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

5. 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

6. Objective 1: Strengthen regulation of medical devices
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

7. Objective 2: Promote safe use of medical devices
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

8. Objective 3: Develop and strengthen human resource capacity in management of medical devices
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

9. Objective 4: Streamline the management of medical devices across the ecosystem
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

10. Objective 5 : Promote R&D and innovation related to medical devices and their application
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

11. Objective 6: Improve access to appropriate medical devices towards universal health coverage
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

12. 6
Thank You