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

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

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

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

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

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

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

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

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

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  

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

6 Thank You