Management of Medical Devices: a case study from Sudan

By Gamal Khalafalla Mohamed Ali[1] PhD, MSc, PG Dip.

 Othman Awad Mohamed[2], MSc, PG Dip.

Introduction

In Sudan, the National Medical Supplies Fund (NMSF)[3] is mandated to be responsible for the procurement and supply chain services to the public health sector, through its Act of 2015. The range of medical supplies at NMSF includes medicines, vaccines and other biological, medical consumables and a wide range of medical equipment/devices[4]. The NMSF Act (2015), therefore, mandates the NMSF to be responsible for procurement, supply and maintenance of medical devices and related furniture (such as hospital beds, mattress and wheel chair) mainly for public health facilities including rural and lower level hospitals, and also serves the private sector, in addition to many other organisations. The NMSF is the executive arm of the Federal Ministry of Health (FMOH) in ensuring access to medical devices across the country. In this role, the NMSF works with health programmes on products’ selection, justification, and thereafter procurement and distribution. In addition to installation and maintenance services, the NMSF is required to ensure provision of adequate human capacity to support users and medical devices in use. For example, from 2013 to 2018, and within its Universal Health Coverage programme, the FMOH distributed more than 28,500 medical devices worth US $88.63 million. These devices ranged from basic medical equipment to very advanced devices, such as MRI machines and endoscopes for targeted health facilities.

This case study documents experience of NMSF in managing medical devices. It answers the following questions:

1.      How hospital equipment is procured, managed and maintained?

2.      Is there any software used for managing medical devices?

3.      Whether maintenance is being outsourced or being managed by manufacturers/distributors?

4.      How medical devices regulated?

5.      Is it manufacturer or distributer that respond to the tenders?

6.      Who trains biomedical engineers (BMEs), technicians and users of the medical devices?

General Directorate of Biomedical Engineering

The general directorate of Biomedical Engineering (GDOBE) manages administrative and technical activities concerning medical device supply chain. It is responsible for Medical Devices testing, installation, maintenance and disposal of equipment. It also supports the division of medical device procurement within the General Directorate of Procurement and contracting (see below). In addition, the GDOBE develops guidelines and SOPs for all steps in medical device supply chain, including, for example, selection, specifications, quantification, purchasing, storage, distribution, maintenance, disposal and so on. Lastly, GDOBE conducts assets inventory for medical devices, using International Coding System (ECRI – Emergency Care Research Institute).

The GDOBE comprises three departments: Calibration and Testing; Research and Projects; and Maintenance Workshop. There are departments at NMSF branches at state level with the role of assisting in the planning and procurement of medical devices as well supporting the identification of medical equipment requirements for new hospitals.

Regulatory Bodies

The regulation of medical devices and consumable items, their registration for import and the application of standards are fairly complex issues, mainly due to the presence of different bodies performing overlapping activities. In Sudan, The regulation of medical devices and the related standards and registration, is in its infancy. Nevertheless, there is more than one authorized body addressing these issues, creating overlap and in some cases confusion and difficulties for the clients. The lack of a coordination framework for medical device planning, selection and procurement weakens the ability to develop robust medical devices services to the public health sector.

The National Medicines and Poisons Board (NMPB) is national authority that responsible for registration of medical products, including medicines and medical equipment/devices. Although the Medicines and Poisons Act 2009, clearly states that the NMPB is the authority that responsible for the regulation and registration of medical devices, it does appear that there is duplication and overlap of responsibilities between the NMPB and the Sudanese Standards and Metrology Organization (SSMO). The SSMO has the mandate to define/adopt standards for any commodity imported into or built in Sudan, and has a committee dedicated to Medical Device Standards. This committee is working on adapting internationally recognized standards and publishing these as official documents. The Sudan Atomic Energy Commission (SAEC) plays an important role in delivering medical devices assessment and monitoring-related services to both public and private healthcare sectors. The SAEC is mainly dedicated to servicing and/or control of radiation therapy equipment but also plays a regulatory role. Indeed, no equipment in these categories can be returned to service after a maintenance procedure unless SAEC has done a final check (although there are times when this does not happen). SAEC also provides a specialized maintenance service for imaging and radiotherapy equipment to hospitals without competent technical personnel in-house.

The biomedical engineering department at FMOH is responsible for policy-making, planning of medical devices as well supporting the identification of medical equipment requirements for new hospitals in close collaboration with GDOBE. The department also supports and leads the FMOH in creating guidelines and SOPs for medical devices. This includes supporting setting up product selection, preparing specifications and justifications for procurement of specific products. Lastly, this department mandated to develop and to regularly update the National List of Essential Medical Devices (currently there is no list for medical devices that could guide the NMSF procurement).

Selection

NMSF maintains its own list of medical devices that includes approximately 1,360 items. This list covers medical devices such sphygmomanometers, nebulizers, stethoscopes, cardiac valves, pacemakers. The selection of the list is based on the needs of public health facilities. The DGOBE in collaboration with health technology department at the FMOH updates the list every 3-year, immediately before the NMSF tender. Expensive, long-lasting medical devices, such as MRI, Cardiac Catheterization, CT-Scan, x-ray Machines are demand-driven. Holding stocks of equipment is wasteful as it ties up capital and unused equipment may deteriorate or become obsolete. Equipment should only be ordered following health facilities’ requirements and according to an annual agreed schedule (depending mainly on budget availability). New Equipment is usually budgeted for so the requirements are known when the budget is accepted. For example, in 2017, NMSF bought 60 x-ray machines for the FMOH’s Universal Health Coverage programme.  

Procurement

All procurement activities (i.e. selection forecasting and quantification, purchasing, monitoring the fulfillment of orders by suppliers, tracking of shipments) of medical devices and medical furniture is the responsibility of the medical device division within the department of purchasing, which is a subordinate of the NMSF’s General Directorate of the Procurement and Contracting. A key and essential component of the supply chain is accurate quantification and forecasting for medical devices. However, concerns in this area have been identified, and include a lack of effective coordination, inaccurate or non-existent quantifications for health commodities.

Quality Assurance systems for medical device supply chain, which based on the Model Quality Assurance system for procurement agencies is done by the Directorate of Quality Assurance, which under direct supervision of NMSF’s Director General. As part of its role in the purchase, installation and maintenance of biomedical devices at public health facilities, the NMSF passed a policy and set clear criteria for securing certain medical devices from reputable and internationally recognised sources in Japan, Western Europe and North America. These devices include medical devices that have been classified internationally with a very high-risk factor—for example, implantable devices (pacemakers; cardiac valves; devices used for vertebral fixation), replacement devices (heart and lung machines; devices for hip and knee replacement), cardiac catheters, DNA analysers, surgical and diagnostic endoscopes, devices used for the neurosurgery and devices used for the diagnosis and treatment of cancer.

According to the procurement Act 2010, its own Act 2015, and the by-law on ‘Procurement, Storage and Distribution of Health Products, the NMSF must purchase its needs through public tenders. NMSF floats an open national tender for equipment every 3 years. Both international and limited tender are used for procuring medical equipment. However, when there is only one supplier for a certain medical device or in cases of emergency, NMSF is allowed to make a direct purchase.

The GDOBE in collaboration with the Directorate of Procurement and Contracting review medical devices’ specifications and legal requirements to ensure completeness and appropriateness of the tender document. Then, the Directorate of Procurement and Contracting (the Secretariat of the tender committee) with support of Directorate of Information Technology posts the tender and issues tender invitations to suppliers.

Local agents and their principals from abroad can fill in the tender electronically or access the e-procurement platform to obtain information on the tender status at any time, from anywhere. The agents of the manufacturers in Sudan submit the offers in the NMSF tenders and taken accountable if something went wrong. They also coordinate trainings with the manufacturers when needs arise, e.g. training on how to operate, use and maintain new machines. Sometimes they bring technicians from the manufacturer of the machine to do on-the-job training. All the costs of the training are covered by the manufacturer of the machine.

The tender committee evaluates quotations, clarifies offers, and negotiates with suppliers as appropriate. It also evaluates suppliers with respect to delivery performance quality of the product. Since 2011, at the beginning of the first meeting of each tender, the Tender Committee and immediately after introducing themselves, all committee members swore an oath and signed a conflict of interest declaration.

After the announcement of the tender awardees, the NMSF signs contract with the local agents of manufacturers (suppliers) of medical devices. The local agents are responsible for delivering medical devices to the NMSF’s warehouse. On its arrival, all technical conditions of the device must be verified by NMSF’s experts and/or experts from abroad when needed. The NMSF’s contracts with the local agents (and not their principals) includes, but not limited to, the following:

1.     Warranty - at least two years from the date of commissioning.

2.     Providing spare parts for a period of no less than 8 years (i.e. during the lifetime of the machine).

3.     Preventive maintenance according to agreed schedule of maintenance based on the performance of the device.

4.     The device is constantly calibrated according to the manufacturing requirements.

5.     Providing the necessary consumables and reagents to operate the device throughout its lifetime.

6.     Carrying out radiation tests if necessary.

7.     Proper disposal of devices when they exceed their lifetime.

8.     NMSF’s reserves 10% of the value of the device for a period of two years starting from the date of commissioning the device by its supplier.

9.     Training of the BMEs, technicians and users on how to operate and do maintenance of the medical device.

According to the NMSF’s regulations 2015 on Procurement, Warehousing and Distribution of Medical Products, written criteria for acceptance or rejection of bids have been published on the NMSF website. All evaluation criteria and conditions are included in the tender document, as the tender document will become a part of the contract to be signed with the supplier.

Warehousing and Inventory Management

The General Directorate of Distribution is responsible for storage and distribution of medical devices and logistics management information systems, in close collaboration of GDOBE. The warehouses for equipment are not yet equipped with a bar code system. The NMSF also keeps reasonable stocks of spare parts to enable common items of equipment to be maintained and run.

NMSF uses ERP to manage its inventory of medical devices. The ERP capture the main four data items that are required to run a logistics system: stock on hand, receipts data, consumption data and losses/adjustments. The data on these four items have been available electronically at central and state levels. Data from the states were entered into ERP and used to process orders for facilities. It provides the central level with near-real-time inventory stock and logistics data for better and timely health commodity Supply Chain decision-making nationally. However, the NMSF could not track medical devices down to the health facility level. As a result, NMSF schedules protective maintenance manually or upon a request from its state branches, state ministries of health or hospitals.

Distribution

Using ERP, the NMSF has designed a web portal to provide an online marketplace where public and private health institutions can purchase their medical devices online, since December 2010. NMSF receives order from its customers, mainly state ministries of health, hospitals through online system. The NMSF has signed a long contract with a courier service company (Sudapost) to address the logistic services issue.

Maintenance

The NMSF is responsible for preventive and corrective maintenance to ensure reliable functioning of the equipment, devices, computer systems and software over its expected lifetime. This after sales service is provided by well trained technicians who visit health facilities to maintain the equipment delivered by NMSF. In big hospitals BMEs are recruited with responsibility for maintenance and assisting the hospital management in the identification of equipment needs and placing orders to the NMSF for the procurement of new equipment. The NMSF trains technicians in hospitals and providing specialized tools to those trained to use them. NMSF provides a service to hospitals if there are no in-house or locally available engineers or technicians. The NMSF strategy is to establish workshops for maintenance of medical devices at certain states with a clear mission to support the State Ministries of Health and health facilities in the maintenance of medical devices at health facilities. However, during warranty period, the maintenance is done by the manufactures through their local agents. There are no private workshops for the maintenance of the medical devices (i.e. no outsourcing).

Disposal

In Sudan, public health facilities, such as hospitals, dispose medical equipment by selling them in auction as scrap. In doing so, the health facilities should follow the Procurement, Contracting and Disposal of Access Commodities Act 2010 and its regulations, which ensures all actions are documented.

Training of BMEs and Technicians

NMSF uses its professional human capacity ability and support Medical Engineers skills and experiences to ensure acquiring of skilful and competent engineers and technicians. There are established formal training programs for BMEs which commenced in 1996 in from Sudan University for Science and Technology, and University of Al-Jezira. NMSF has its own training centre, which is located within the equipment administrative building that allows in-house training sessions for about 40 participants at a time. The BMEs and technicians should continuously develop their knowledge and skills that to apply preventive and corrective actions to ensure reliable functioning of the devices, computer systems and software over its expected lifetime. They must be able to install, test and calibrate medical devices and demonstrate knowledge and ability in equipment replacement parts.

[1]He was the Director General of NMSF (September 2010 – March 2019). He was the Secretary General of the NMPB, Medicines Regulatory Authority of Sudan (November 2007 – September 2010).

[2] The Director of NMSF’s General Directorate of Biomedical Engineer.

[3] The NMSF stretches back in history to the mid 1930s, is the national government agency responsible for procurement and distribution of medicines and medical supplies to public health facilities and in certain circumstances to the private health facilities in Sudan. The NMSF is the successor of the Central Medical Supplies Public Corporation, which was established in 1991 as a semi-autonomous organization. It was converted to an autonomous, non-profitable public organization in 2015 and renamed NMSF.

[4] Medical devices range from tong depressors to highly sophisticated medical technology, such as cardiac valves, pacemakers, X-ray machines and MRI machines from tong pressers to MRI.