Brian Matovu- BSc. Biomedical Engineering, Makerere University

Introduction

Technical health workers in a hospital such as biomedical engineers and technicians, hospital managers, planning officers, procurement officers, and other health related stakeholders such as ministry of health, regulators, manufacturers, NGO and UN agencies have a vital role to play as far as patient safety is concerned in line with patients interacting with medical devices and bio-materials.

As outlined in the World Health Assembly resolution on health technologies, WHA 60.29, “Medical devices are essential for safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease. The achievement of health-related development goals, including the Sustainable Development Goals, depends upon proper manufacturing, regulation, planning, assessment, acquisition, management, and use of medical devices which are of good quality, safe, and compatible with the settings in which they are used.

The term “medical devices” includes everything from highly sophisticated computerized medical equipment down to simple wooden tongue depressors (WHO, 2003). The Global Harmonization Task Force (GHTF) and the international medical devices regulator forum (IMDRF) proposed the following harmonized definition for medical devices which may be of help in setting standards and regulations i.e. a Medical device means any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, 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 purposes of; diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification, or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means of in-vitro examination of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means (GHTF/SG1/N71:2012).

With that definition, the essential principles of safety and performance of medical devices as recommended by the GHTF (SG1-N020R5) states that; medical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience, education or training of intended users, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety (WHO, 2003; WHO, 2010; ISO/TR 16142:2006).

Streamlining and harmonizing regulatory processes may reduce delays and unnecessary expense and improve access to new medical products inclusive of biomedical equipment that are safe for the patients, medical personnel and environment. Whereas pharmaceutical products are widely and highly regulated in Uganda and internationally, less attention has been placed on the regulation of medical devices (Rugera, McNerney et al. 2014).

Background

The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities. It was recently observed that improvements on biomedical devices and systems used in diagnosis and treatment of illnesses have progressed parallel to the technological developments. However, the tendency to regulate and set standards for health equipment and other biomedical devices is still a puzzle in many developing countries like Uganda.

According to the Second African Regulatory Forum on Medical Diagnostics that was organized by London School of Hygiene and Tropical Medicines in collaboration with the East African Community EAC Secretariat, Pan-African Harmonization Working Party, et al, from 21st to 23rd January 2014, it had a forum that convened to provide a platform for national regulatory authorities on the continent to share best practices and interact with medical diagnostics industry. The EAC Secretariat was represented by Senior Health Officer (Medicines and Food Safety Unit) and National Medicines Regulation Officer from the Republic of Uganda with a major goal of having a harmonized and functioning regional medical devices and diagnostics regulatory system within the region in accordance with national and internationally recognized policies and standards so that there is improvement in the access to safe, efficacious and affordable medical devices and diagnostics for diagnosis and management of communicable and non communicable diseases in the region. This is also in-accordance with the mandate provided by Article 118 of the Treaty on the establishment of the East African Community (Mashingia & Angole, 2014).

Uganda as an active member of the EAC is therefore obliged to abide by the objectives of this recent forum of 2014 which mainly included; development and implementation of regional harmonized regulatory and mutual recognition frameworks and guidelines for regulation of medical devices and diagnostics based on risk classification, building human resource and infrastructural capacity for the regulation of medical devices and diagnostics in the EAC partner states, implementation of a quality assurance, audit and management system in each of the EAC Partner States national medicines regulatory authorities for regulation of medical devices and diagnostics and implementation of a common information management system for registration and post market surveillance of medical devices and diagnostics in each of the EAC Partner States’ National Medical Regulatory Agencies (Mashingia & Angole 2014; EAC secretariat 2015).

Access to medical devices and diagnostics for health in Uganda and in the rest of East African Countries is limited by their availability and cost; and there is uncertainty as to the safety and effectiveness of some products. Regulatory control of medical devices and bio-materials is weak in these countries with efforts to control the quality of imported products largely confined to national disease programs for pathogens such as HIV/AIDS and malaria. Weak regulatory strategies bring about poor quality products to be marketed and delay access to beneficial new products and increases costs to manufacturers, inflating prices for consumers. Through streamlining and harmonizing regulatory processes in Uganda and the rest of other countries, can reduce delay and unnecessary expense, and improve access to new products.

According to a recent research by Mori, the quality of medical devices and In Vitro Diagnostics in resource limited settings showed that there were limited reports and evidence with regards to poor quality medical devices and this was mainly due to; the poor regulatory oversight of medical devices and in vitro diagnostics in resource-limited settings, a general lack of awareness of the problem of poor-quality medical devices and in vitro diagnostics amongst the scientific community and decision-makers; and poor quality assurance in diagnostic laboratories in resource-poor settings, precluding tracing quality problems of IVDs from the other potential causes of diagnostic inaccuracy.( Mori M, Ravinetto R,  Jacobs J et al, 2011).

Regulatory Agencies in Uganda

A regulatory authority in this context is a government agency or other entity that exercises a legal right to control the use or sale of medical devices within its jurisdiction, and may take enforcement action to ensure that medical products marketed within its jurisdiction comply with legal requirements. Different governments have the responsibility to oversee the efforts of manufacturers and vendors and ensure that medical devices sold or made available in their countries are safe and effective. They provide leadership in creating healthy cooperation among stakeholders in establishing policies and regulations that are fair and clear to all. Policies and regulations should be reviewed periodically to respond to changes in technologies by incorporating appropriate amendments.

In Uganda the government has been able to set up different bodies that are responsible for the regulation and setting of standards for medical devices. Some of these bodies include; Uganda National Bureau of Standards, Ministry of Health, Uganda National Drug Authority, National Medical Stores, Uganda Revenue Authority, among others. These bodies are able to set standards and regulate medical devices and other medical supplies in the country in accordance with the international standards and to what is fit for the standards of Uganda. The ministry of health was also able to set up different committees like the Uganda Advisory Committee on Medical Equipment (NACME).

Uganda National Bureau of Standards (UNBS)

The Uganda National Bureau of Standards (UNBS) is a statutory body under the Ministry of Trade, Industry and Co-operatives (MTIC) established by the UNBS Act of 1983 and became operational in 1989. It is mandated to co-ordinate the elaboration of Uganda standards. A Standard is a document declared as such by the National Standards Council that may either be a specification, a code of practice or specify other aspects such as terms and definitions, symbols, sampling and test methods and quality systems. In fulfilling its mandate UNBS collaborates with partners within and without and subscribes to regional and International standardization organizations. It is a member of the International organization for Standardization (ISO); the African Regional Organization for Standardization (ARSO) and the East African Standards Committee (EASC). UNBS is also the National Contact point for the FAO/WHO Codex Alimentarius Commission on international Food Standards and the National Enquiry Point for the WTO TBT agreement.

The mandate of UNBS is to formulate, promote and enforce national standards to enhance the competitiveness of Ugandan products, promote fair trade and protect consumers. This mandate is two-fold i.e. 1) Promotional- Promoting and facilitating the adoption and use of standardization services to enhance the quality and competitiveness of locally manufactured products and 2) Regulatory- Enforcing standards to protect consumers and ensure fairness in trade. In fulfilling its functions as stated in the UNBS Act (Cap 327), UNBS is obliged to promote harmonization of standards with trading countries, assist government, industry, or other persons in adopting and practical application of standards, encourage and undertake educational work, seek membership to international standardization organizations and develop and seek recognition of the bureau by any other country.

The work of preparing Uganda Standards at UNBS is carried out through Technical Committees (TC) which are established to deliberate on standards in a given field or area and consists of representatives of consumers, traders, academicians, manufacturers, government and other stakeholders. The committees review the comments before recommending the draft standards for approval and declaration as Uganda Standards by the National Standards Council. Among the committees is the Medical Devices Standards Technical Committee (UNBS/TC 14) that is responsible for the development of different standards for medical devices in the country. The committee currently has representatives from Joint Medical Stores, Makerere University School of Publics Health, Meridian Techsystem, Ministry Of Health, Mulago Hospital Complex, National Drug Authority, National Medical Stores, Paragon Hospital and Uganda National Bureau of Standards (UNBS- FDUS, 2011). According to an interview with Mr. Peter Oryang, the secretary of UNBS/TC14, he points out that the way these people are appointed is through UNBS secretariat writing to the different institutes to appoint experts to be on the committee.

Mr Peter further points out that the committee basically adopts the ISO and IEC standards (mainly for consumables and equipment respectively) which are international standards and incorporates and or adopts them into Ugandan standards. There is insufficient expertise on medical equipment and biomaterials in this committee dues to the wide diversity of these commodities and limited availability of professionals in that field in the country. He also points out that the body also lacks legal mandates to clearly develop medical device standards. These are the major drawbacks that it’s facing. UNBS does carry out both standards development and regulatory roles for different sectors which do not have a regulatory body. For the case of medical devices and biomaterials, UNBS has only the role of standards development and the role of regulations are left to National Drug Authority. But the two bodies still work together to ensure quality and consumer/ patient safety.

Mr Peter also defined the standards process that they follow to develop them. These is a systematic process which is followed and they follow the basic principles of standards development that are internationally recognised. Standards are developed at industry/company level, at organisational level, at international level and can also be developed at individual level. Standards developed at international level can be used at national level while those developed at industry level can be lifted to national level. Due to lack of locally available manufacturing companies for medical devices and biomaterials in Uganda, UNBS resorts to adopting international standards for different medical devices and biomaterials.

Ministry of health

This is the mother body of regulating all healthcare related products and services in the country. It over sees all healthcare product supplies in the country. It does this through setting up agencies like the National Drug Authority, the infrastructure departments, the National Advisory Committee on Medical Equipment and many more. These agencies become organs of the entire ministry in setting policies and carrying out regulations.

The Ministry of Health and other central level departments/agencies have the mandate to supervise the health sector. In line with the decentralisation framework, district health offices have the responsibility of supervising the district health system. Technical supervision is provided at all levels of care with each level supervising the level below. Monitoring relies on the Health Management Information System (HMIS) and compilation of quarterly and annual reports which are verified during quarterly monitoring visits and reviewed by Joint Review Missions, the National Health Assembly and the Uganda Parliament.

Periodic evaluations of the sector’s performance such as the mid-term review of the HSSP are also carried out. Health professionals’ councils and the National Drug Authority are autonomous bodies charged with ensuring maintenance of professional standards and safety of pharmaceuticals, equipment and procedures. Challenges exist in terms of inadequate human, logistical and financial resources for supervision, monitoring and evaluation. Other additional challenges are limited mechanisms that incorporate private sub-sector performance into overall sector performance and lack of coordination of community/civil society organisations and monitoring with mainstream health sector.

National Drug Authority (NDA)

Like other national regulatory bodies in East Africa, Uganda has the National Drug Authority (NDA) that was first published in 1993 and established by the National Drug Policy and Authority Act Cap 206 of the Laws of Uganda(2000 edition). It was updated in 2002 to include new strategies to guide implementation and reflect legislative changes. The changes in the access to medicines landscape over the past decade have prompted Ministry of Health to revise the policy in 2015 (MOH, 2015). The National Drug Authority, the Uganda National Council for Science and Technology and the National Health Research Organisation form part of the Ministry of Health of Uganda and have the regulatory responsibility for clinical trials, medicines and medical supplies inclusive of medical devices for the safety of humans in Uganda, both in public & private sectors, though not explicitly mandated by the law (NDPAA, 1993). NDA, as the regulatory body in the country, is mandated to monitor equipment imported into the country for both Government and non-government health facilities to ensure that the equipment being acquired is safe (NMEP, 2009).

NDA being the main regulator in the country for medical devices and biomaterials, its mandated, although not clearly by the law, to ensure that valuable new technologies are made available to the clinical community and to patients and consumers expeditiously while preventing unsafe or ineffective devices from reaching the market. Its decisions are expected to be made based on strong and clear scientific evidence, free of external influences and consistent with the directives of the available laws in the country. Its quality assurance division follows prescribed rules and procedure that are already in place for effective public protection.

In assuring the safety of medical devices, the NDA is expected to carry out a post market survey since safety entails more than the functioning of the device itself, but also overseeing the usage of the devices by the end-user. This is really still lacking and is mainly put on the lack of enough expertise to carry out the expected duties although its somehow efficient to the regulation of drugs in the country.

No evidence of product risk has been openly communicated with health professionals and consumers conveying in understanding terms what the scientific community knows and explaining in cogent terms the range of uncertainty that remains and this mainly with the increased usage of biomaterials by Ugandans. Furthermore, documentation on medical device regulation and biomaterials by NDA hasn’t been evidenced much for over years despite the fact of it having divisions to carry out the expected regulatory roles.

Although pre-border controls have been put in place, these are not efficient and substandard products are left to be found on the Ugandan market. Establishment of a standard and publicly known procedure for identifying manufacturers, business operators in the country, maintaining vigilance over marketed products, implementation of a broad-based regularised program inspections at manufacturing sites and carrying out audits may improve the regulatory goals of NDA in the country.

For examples; the illegal re-processing and re-packaging of second-hand machines for re-sale; the availability on the market of equipment that fails minimum quality and safety standards; or simply no trace of what devices are being sold in the country among other issues. Such a listing is essential to enable Ugandan government and basically NDA to issue alerts or recalls for unsafe or ineffective medical devices. The agent has tried to implement some of these.

National Advisory Committee on Medical Equipment (NACME)

NACME was appointed in 1989, by the then Hon. Minister of health, to prepare a policy to guide the sector on acquisition and management of medical equipment. The committee produced the first National Medical Equipment Policy in 1991 which assisted both government and non-government agencies to rationalize procurement and management of medical Equipment. Over the years, the medical equipment policy and guidelines have been reviewed to update equipment specifications so as to conform to new technological advancements and medical techniques (NMEP, 2009). The main objective for appointing NACME was to review the country’s medical equipment needs and determine the appropriate policy on procurement, maintenance and rehabilitation and disposal of medical equipment. This further included formulation of policy on procurement, standardization, maintenance and rehabilitation, and disposal of medical equipment, bearing in mind cost-effectiveness and appropriateness of technology (NMEP, 2009) and hence defines the major role of this advisory committee. The health infrastructure division of the ministry of health and other bodies like UNBS and NDA are responsible for the implementation of the work and advice from NACME.

These bodies with their different committees mainly concentrate on the safety and performance of medical devices which depend on two critical elements; Pre market review contributes to product control, and post-market surveillance ensures that medical devices in use continue to be safe and effective. There is an important third element, which is the representation of the product to the user. This is controlled through labelling (during the pre-market stage) and advertising of the product. Another aspect of product representation, however, is verbal presentation by the vendor. User/public education is key in guarding against misrepresentation.

Conclusion

Regulatory systems for medical devices are less developed than those for other health products such as medicines or vaccines. Many countries have drafted regulations for medical devices but have made little progress in implementing them. This is largely because the market dynamics for medical devices and diagnostic products for health are distinct from those for pharmaceutical products and their regulation requires a different approach to that for medicines. Medical devices present a wide range of technologies that put a greater challenge to the acquisition of expertise and technical knowhow of regulating and setting of local standards for these items.

Generally, the regulatory landscape for medical devices and diagnostics in Uganda has found to be weak and inefficient. While much effort and resources have been placed in strengthening regulation of medicines, the area of medical devices has been forgotten or very little effort has been made towards their regulation. Weak regulation tend to present defective or substandard products no the marketed. Inefficiency in regulation has caused unnecessary delay and increases costs to manufacturers and consumers. Wrong diagnosis resulting from a defective or substandard device may result in a complete failure of the whole treatment cycle including wrong medication and may result into death. Therefore, the issue of safety and performance of medical devices and diagnostics cannot be underestimated.

The government need to put in place policies that will address all elements related to medical devices, ranging from access to high quality, affordable products, through to their safe and appropriate use and disposal. However, these policies will be unsuccessful unless they are translated into national regulations that are enforced by legislation and correlating sanctions, and that form an integral part of the overall national health system.

References:

  1. WHO, 2003-World Health Organisation, Medical Devices Regulation (A global overview and guiding principles) ISBN 92 4 154618 2.
  2. Rugera, S. P., R. McNerney, et al. (2014). “Regulation of medical diagnostics and medical devices in the East African community partner states.” BMC health services researches.
  3. WHO, 2010-World Health Organisation, Medical Devices Regulation (A global overview and guiding principles) – ISBN 92 4 154618 2.
  4. MOH 2015- Ministry of Health, National Medicines Policy, first Edition.
  5. NADPAA- Uganda National drug policy and authority act Chapter 206- 1993.
  6. Mori M, Ravinetto R & Jacobs J et al (2011) “Quality of Medical Devices and In Vitro Diagnostics in Resource Limited Settings”.
  7. EAC secretariat 2015 East African Community Regional Project Proposal On Strengthening And Harmonization Of The Regulation Of Medical Devices And Diagnostics In The East African Community Partner States (EAC Secretariat Arusha Tanzania)
  8. Peeling, R. and R. McNerney (2011). “Increasing access to diagnostics through technology transfer and local production.” Book Increasing access to diagnostics through technology transfer and local production.
  9. Ecclestone R. “A model regulatory program for medical devices: an international guide”. In: Hernández A, ed. Washington, D.C.: World Health Organization and United States Food and Drug Administration, 2001.
  10. ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices.
  11. ISO/TR 16142:2006 Medical Devices – Guidance on the Selection of Standards in Support of the Recognized Essential Principles of Safety and Performance of Medical Devices.
  12. GHTF/SG1/N71:2012 Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’.
  13. GHTF/SG1/N055:2009 Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer.
  14. UNBS, FDUS 2011-3: Medical devices: Surgical gowns, drapes and clean air suits- Part 3: Performance requirements and performance levels.
  15. Jane Mashingia and Apollo Angole (2014). EAC Region Moving Towards Harmonization of Regulation for Medical Devices & Diagnostics
  16. NMEP: 2009- National Medical Equipment Policy, 4th Edition by Ministry of Health.
  17. Rugera, S. P., R. McNerney, et al. (2014). “Regulation of medical diagnostics and medical devices in the East African community partner states.” BMC health services research 14(1): 1.

 

 

 

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