Biomedical Engineering

Medical devices are fundamental to the delivery of quality healthcare in Sierra Leone. Devices help clinical personnel provide a range of interventions, from visualizing and assessing biological specimen to delivering medication and monitoring patients’ responses to therapy. In a bid to provide quality, first-class healthcare to Sierra Leoneans, the Ministry of Health and partners have, in recent years, invested significantly in acquiring devices. In March 2021 for example, the Japan International Cooperation Agency (JICA) signed an agreement with the Government of Sierra Leone to provide grant aid of up to 2.383 billion yen for the construction of a children’s hospital and the installation of medical equipment. Over 700 pieces of equipment were procured ranging from complex anesthesia machines to simple blood glucose monitors. In April 2022, the United Nations Children’s Fund (UNICEF) supplied the GoSL with medical supplies and equipment procured with grant aid from the Islamic Development Bank (IsDB). The package included 10 mobile digital x-ray machines, 10 ultrasound scanners, 70 wheelchairs, oxygen therapy and other medical equipment and devices, 550 hospital beds and other furniture, 7 steam sterilizers (autoclaves), PPE, and 6 generator sets.

Accordingly, the MoH has developed policies relevant to the management of medical devices. In February 2021, the MoH with support from UNICEF and other partners published the National Policy on Management and Maintenance of Medical Equipment and Devices “to serve as a framework to support the achievement of quality health service delivery, Universal Health Coverage, and other government health care goals”. Since then, the MoH has taken important strides to implement some of the strategies including publishing implementation guidelines in February 2023 titled Operation and Management of Maintenance System of the Public Health System.

Unfortunately, despite valiant efforts by the MoH to incorporate technology into healthcare, clinical staff often find themselves without the tools that are critical to their work and some patients continue to receive sub-optimal care. Many newly acquired devices lie unused and abandoned; some of these devices need spare parts, consumables, or power, and others are simply unwanted or unfamiliar to end-users. An estimated 47% of funding spent on medical devices in one healthcare programme went to waste in 2020.

Some of the reasons the MoH continues to face major challenges in incorporating technology into healthcare are: several devices are acquired without consulting qualified technical personnel, some are assigned to facilities with inadequate infrastructure, many are procured without consumables and spare parts, end users lack sufficient training, maintenance records are incomplete, and accountability and oversight are generally inadequate. These are all signs of uncoordinated biomedical technology services which leave clinical staff unable to deliver quality, first-class healthcare. There appears to be no cohesive framework in place for caring for these assets.

To minimize waste and to realize measurable gains and optimal value for money that funders invest in medical devices, the MoH must accelerate efforts to integrate technology sensibly. The MoH will benefit from a comprehensive plan to coordinate biomedical technology services that extend beyond sporadic maintenance activities.

This plan aims to make biomedical technology services patient-focused, comprehensive from acquisition to disposal, and to foster cohesiveness among the technical staff at the national, district, and peripheral healthcare levels.

For biomedical technology services to be effective, all decisions regarding medical devices, from acquisition to disposal, should be coordinated and centered around the welfare of patients. There are five elements to consider:

1. Rational acquisitions guided by senior leadership’s blueprint — the senior leadership must abide by a blueprint for acquiring medical devices. The majority of challenges with medical devices start at the tables where decisions are made to acquire them. Whether in support of a specific health programme, to upgrade facilities, or to foster bilateral governmental relations, medical devices must be considered investment assets. Decisions to acquire and integrate devices should be rational; a surefire way to lose support is to be associated with technology that does not live up to its potential.
2. Clinically integrated — the service team must be integrated into clinical workstreams. The MoH will adopt an inclusive, comprehensive, and evidence-based operational framework which will enable biomedical technology services personnel to focus on patient outcomes.
3. Technically robust — the service team will consist of personnel skilled to work with medical devices.
4. Accountable — the service team will be accountable to the MoH as well as to patients by being trustworthy, effective, and efficient.
5. Funded — for a biomedical services team to be effective, it must have access to protected, “evergreen” funding.

Senior leadership must take on the responsibility of drafting rational agreements with funders when acquiring medical devices. Acquisition decisions are made not merely to obtain devices that are not available in Sierra Leone; they are made to provide clinical staff with tools that they can use to improve patient care over an extended period. Decisions to acquire medical devices must be initiated by clinical demand for proven, evidence-based interventions and supported by technical experts.

It is fundamental that the MoH leadership develop a blueprint to guide decisions involving requesting, accepting, allocating, and maintaining medical devices and consumables for health programmes. The blueprint will help:

1. MoH representatives determine when it is appropriate to acquire medical devices and when it might be prudent to defer such acquisitions,
2. Funders and implementing partners make useful offers of support for programmes that will not become a burden to the health system, and
3. Frontline clinical and technical staff work in a predictable environment.

The blueprint will ensure that MoH personnel and partners base their decisions and actions on verifiable factors that support the MoH’s goal of “standardizing the introduction of medical equipment and other devices through evidence-based methods”. Without this blueprint, devices will continue to enter the healthcare system in a haphazard manner and technical staff cannot be held accountable to get these assets working.

The primary responsibility of a biomedical technology services team is to ensure that clinical staff have appropriate tools they can use to diagnose, treat, and monitor patients safely and effectively. The team is responsible for, among other things, helping administrators identify relevant new and emerging technologies, providing procurement teams with specifications for medical devices, advising infection prevention and control teams, installing, monitoring, and decommissioning equipment, as well as training clinical staff on how to use devices. Biomedical technology services involve more than “just maintenance”; they involve all stages of a device’s lifespan from acquisition to disposal.

The MoH will establish work streams for biomedical technology services (medical technology) and research that are aligned with clinical care workstreams. The biomedical technology services team will provide insights and solutions to legacy challenges.

The biomedical technology service team must be effective and efficient. In the short term, the MoH will partner with tertiary education institutions to help the existing workforce improve their skills and train new staff. While these skills are under development, the MoH will actively recruit technically capable individuals (such as those with electrical or electronic engineering degrees) and introduce them to working in a clinical environment. Also in the short term, the MoH will promote service agreements that will allow private companies to fill in missing skillsets. In the long term, the MoH will establish a biomedical technology services team whose members will be rewarded for their performance and growth, held accountable to annual performance goals, trustworthy, and free of outside work.

The MoH will make end-user training and occupational safety mandatory.

Provide funding to allow technical staff to perform their jobs. Provide tools, training, and workspaces. Establish clear accounting policies and hold leaders responsible for funding spent on supplies and training.

To derive optimal value for money, medical devices must be robustly managed using an enterprise-wide framework focused on patient outcomes. One relevant framework that gained publicity globally around 2015 consists of 10 interdependent stages spanning acquisition agreements through to disposal. All stages must be carefully planned, implemented, and monitored.

1. Step 1. Acquisition

   Decisions to acquire medical devices must be guided primarily by documented evidence of clinical needs, infrastructure availability, and human resources capacity, and less so by the transitory initiatives of the GoSL, external funders, or programme implementing partners. Acquisition decisions are best documented digitally to facilitate timely sharing and revision of the information.

2. Step 2. Specifications

   After a decision has been made to acquire devices that will help clinical staff address a real clinical need, it is important to develop specifications for devices that can address the clinical needs within the broad framework of the existing health care system.

3. Step 3. Procurement

   Procurement procedures ensure optimal sustainability by incorporating elements such as service agreements, mandatory refresher training and a supply chain for spare parts. In some instances, it may be necessary to honour requests for a specific brand of device that matches the specifications, complements (and does not duplicate) existing devices, functions within the existing infrastructure of resources (electricity, water, consumables, and personnel), and can be safely disposed of within the recipient’s country at the end of its functional life. The device’s consumables and parts should fit within existing supply chain mechanisms.

4. Step 4. Shipping & Forwarding

   Shipping and forwarding expertise to expedite safe and reliable transportation of procured devices.

5. Step 5. Storage

   Devices must be stored in environments with controlled temperature and humidity.

6. Step 6. Distribution

   NMSA should conduct capital audits of devices to validate adequacy of distribution and storage mechanisms.

7. Step 7. Installation and Commissioning

   Installation and commissioning procedures must be coordinated with procurement.

8. Step 8. Clinical Training and Operations

   Operator training should be updated to complement the existing and projected inventory of devices. Training must be actively managed by a technical manager who will monitor the clinical staff’s adherence to occupational safety (IPC, fire safety) protocols.

   Clinical training programmes offered at COMAHS must incorporate practical training that takes advantage of clinical training labs for undergraduate and postgraduate students.

9. Step 9. Preventive Maintenance

   Maintenance and monitoring involve proactive surveillance of consumables, replacement parts, and other ancillary resources to ensure sustainable functionality. Information will be documented digitally and reported.

10. Step 10. Decommissioning & Disposal

    Decommissioning and disposal protocols must meet or exceed established regulatory standards.

Along with the MoH, four groups of stakeholders are interested in biomedical technology services, each with interests at various points of the framework:

• DHMTs
• Hospitals and MoH agencies
• Development Partners
• Tertiary Institutions and Private Companies

There is a minimum level of resources that each facility must have to accommodate various categories of medical devices. Hospitals must be inspected, qualified, and monitored annually for availability of human resources trained in using complex medical devices, structural integrity, internal space, ventilation, electrical infrastructure, medical gas pipelines, plumbing, lighting, fire safety, and infection control safety.

There are 30 government hospitals and 1,168 PHUs (NMSA data) supported by 35 pin-coded technicians. On average, across the country there is just 1 medical technician available per 50 facilities. This situation is untenable as each hospital has a range of 30 to 80 unique types of medical devices and 100 to more than 700 pieces of equipment.

The technicians are typically stationed at district hospitals and receive minimal supervision or financial support at these locations.

The biomedical technology service team’s primary role is to ensure medical devices are functional and appropriate for use by clinical staff of the MoH. Team members spend most of their time troubleshooting defective devices and infrastructure (electrical and mechanical systems), keeping track of the status of devices at a healthcare facility, and finding suitable technical solutions for clinical staff. They must be conversant with scientific concepts relevant to the designs of a host of medical technologies, have a strong foundation in Maths, and be familiar with rudimentary medical terminology and procedures. To be effective, the workforce must have an appreciation for human anatomy and physiology and an understanding of basic engineering principles related to clinical interventions.

The first step in standardization was to formally determine each technician’s familiarity with basic concepts relevant to their scheme of service. A brief competency assessment conducted at the end of 2023 demonstrated a gap between biomedical technology service requirements and the skillsets of the current batch of MoH medical equipment technicians and volunteers. The mean score for a short algebra test was about 20% and that for basic electricity was about 30 to 35%. Some technicians were familiar with basic electricity concepts, while others appeared to lack basic literacy and numeracy skills.

The MoH scheme of service (albeit in need of an upgrade) indicates that the accepted qualification for a Medical Equipment Technician (MET) is a diploma in Mechanical/Electronic Engineering from a recognized institution. A senior MET must have the same qualifications plus at least 5 years of relevant work experience. Only 1 of the technicians had a bachelor’s degree. 43% (15 of 35) pin-coded technicians and 18% (11 of 60) volunteers reported an ordinary diploma or better as their highest qualification — meaning the majority did not meet the minimum qualification criteria in the scheme of service.

There are currently no nation-wide training programmes that offer these comprehensive skills to technicians in Sierra Leone. To improve the service from the technical workforce across the country, the MoH should standardize the ability of technicians to manage medical devices.

Currently, medical equipment technicians are responsible for the maintenance of all equipment and machinery in some healthcare facilities — carpentry, plumbing, refrigeration (air-conditioning), waste management (in some cases) along with commissioning, end-user training, and preventive maintenance for medical devices. The skillsets required to integrate and keep medical devices operational are different from those required for facilities management. Both services are complex.

The MoH should create two lines of reporting: one for biomedical services and another for infrastructure at healthcare facilities. During a transition period, currently employed medical equipment technicians can be vetted and assigned to either the Biomedical Technology Services (BTS) unit or the Facilities Maintenance (FM) unit.

The BTS unit will support all other MoH staff from the acquisition to the disposal of medical devices — advising senior leadership on acquisition or disposal decisions, clinical use training, maintenance and research. The FM unit will advise clinical administrators on infrastructure and maintain buildings and machinery such as water filtration systems. BTS will consult FM on power, plumbing and related infrastructural issues as needed. Where duties overlap, FM takes precedence.

Biomedical technology services must be coordinated, not only from acquisition to disposal but also from the national to PHU level. Some activities are led at the national level, some at the district/facility level and some require input from both levels.

At the national level, a Medical Technology & Infrastructure Unit / Biomedical Technology Services and Facilities Maintenance unit (name to be determined) will be led by a Programme Manager reporting to the Deputy CMOs’ offices (Clinical and Public Health). The Programme Manager will directly support acquisition, specifications, allocation, decommissioning, and monitoring. One supervisor will support procurement, shipping, and storage; one will support distribution, installation, commissioning, and disposal; and a fourth will oversee clinical training, operations (care delivery), preventive maintenance and repairs. In the short term, the Programme Manager will directly oversee the BTS/F units at the hospitals and liaise with M&E officers through the DMO. Regional Medical Units (RMUs) are postponed as they would slow down resolution of issues in the short term; they will be reconsidered as technician numbers increase.

The BTS unit will consist of:

1. 1 Programme Manager
2. 4 Supervisors (biomedical engineers) — Bachelor’s degree
3. 10 Biomedical Service Technicians (1 assigned to 2–4 hospitals) — Higher National Diploma and entry exam
4. 10 Trainees/interns — post-HND and entry exam

Capitalize on strengths of the existing workforce and channel staff to skill-matched positions. Partner with development agencies to bolster on-the-job training and provide tools and workspaces. UNICEF is leading hands-on training to teach technicians how to maintain the quality of medical devices used in Special Care Baby Units. Partners In Health has a proposal under review for a preventive maintenance training programme for devices to be installed in a new Maternity Centre of Excellence. The MoH can partner with private companies to deliver missing skills while developing the Biomedical Technology Services Unit.

Partner with tertiary education institutions to offer academic training pathways into the biomedical technology services unit. According to the National Policy on Management of Medical Devices, many technicians “have no formal training in medical equipment and devices maintenance and repair and in managing a maintenance unit”. Policy 4 gives the MoH the mandate to “establish academic and performance-based career paths for biomedical engineers and technicians, develop diploma and degree courses, and create a pipeline of technicians”. Two proposals have been developed to implement this mandate.

In May 2023, the Monitoring and Evaluation team of the Saving Lives Programme proposed that the MoH initiate the development of standard operating procedures (SOPs) for decommissioning and disposing of medical devices. Devices may be donated to another facility, sold, or returned to the manufacturer/distributor as part of a trade-in. There are also third-party companies willing to pay for components of electronic devices.

These SOPs were expected to resemble the MoH SOPs for Reverse Logistics of Expired, Damaged, Deteriorated, and Excess Usable Products; and Safe Disposal of Medical Products. The MELR team devised a nine-step protocol for the safe, timely, and appropriate decommissioning and disposal of medical devices in MoH facilities following field visits, a roundtable, informal interviews with administrators and a review of the WHO decommissioning protocol. The draft was presented to DHMT staff at learning workshops in June 2022, who provided two implementation options — one for PHUs and another for hospitals.

Disposal pathway: identify the device → remove it (or its components) from the facility → donate, sell, or incinerate components → update the inventory → update the registry.

The team recommended that stakeholders meet to draft SOPs, distribute them to partners for comments, and validate SOPs for decommissioning and disposal of medical devices.

Partner with tertiary institutions to enroll students in a technicians’ trainee programme, using some of their tuition to fund the programme. Trainees will be given priority when pin-codes are available if they apply for employment within the MoH on completion. Trainees will fill gaps in human resources rather than volunteers.