RESEARCH
	Standards for Sterile Supply in low-income countries How international are international standards? The standards for sterilization as formulated are developed by the industrialized nations and designed to the living standards and socio-ecomic standard prevailing in these countries. Knowing that a majority of the world's population is concerned, it is of utmost importance to consider what the consequences are, when implementing such standards in low-income countries. How feasible is it that they are implemented successfully and are they sustainable on the long term? It therefore is necessary to reconsider the implementation of international standards. The core requirements should be taken over, but implementation of certain technological solutions which are recommended in these standards need careful reconsideration taking the local situation into account. Move up The financial gap The annual per capita expenditures on health care greatly varies throughout the countries of the world. The average for high-income countries, such as Western Europe and North America are in the order of USD 1300 whereas the average in Sub-Saharan Africa is below USD 10. A difference of more than 100 times! Equipping a sterilization department for a moderate size hospital (200-300 beds), according to the latest international standards requires an investment which can also finance all medical equipment and furniture for the essential services of a complete similar size district hospital in a low-income country according to guidelines as formulated by the World Bank. The huge gap is also illustrated, when observing the world population and the amount of money spent on health care in the various regions of the world: Of the total expenditures for health care, 90% is spent in the high-income countries. Whereas almost 80% of the earth population lives in low-income countries! Move up The annual per capita expenditure on health care in Africa is a fraction of the finances available in the high-income countries. When introducing any technology this huge gap should be considered. Global expenditures on health care versus world population. High-tech ending-up as trouble-tech In the past years the author has been visiting many health facilities on the African continent and in several of them the sterilization department was arranged and equipped according to the latest standards of sterilization. However advanced and expensive steam sterilizers (autoclaves) were found broken down for years due to lack of spare parts, unreliable electricity supply, problems with the steam supply or lacking know-how. Because of the breakdowns, the machines quickly become a great financial burden and drain the already so limited hospital budget. In the end, often the high-tech machines are abandoned and replaced by basic hand-operated or semi-automatic autoclaves. The hospital would have saved great amounts of money, disappointment and frustration, when from the start, it had been equipped with a technology feasible in the context of the country. Move up High Tech may become Trouble Tech. In a large, regional hospital in Kenya those advanced sterilizers were found broken down for already 3 years. Due to lack of funds and support, they could not be repaired anymore. Currently a hand-operated sterilizer is used (as just visible in the bottom left corner. Towards a concept for sterile supply in the health services in low income countries When considering appropriate standards for low income countries the essential requirements for sterile supply as formulated in the international standards for sterile supply should remain in place such as: The standard definition of what is considered as sterile Quality assurance of all steps in the chain of sterile supply In order to meet these basic principles, technological requirements for sterilizers have been defined; such as the need for an automatic control system of the sterilizers. Based on state-of-the-art technology, this results in sterilizers with computer controlled processes, with advanced electronics, electro-magnetic/pneumatic valves and control systems, etc. Moreover this technology requires a complete infra structure to support it such as high-quality water and electricity supply, trained technical personnel, manufacturer support with spares and supplies etc. Not to speak of an adequate telecommunications network and good access roads for safe and quick delivery of all the supplies and services. Thus implementation of the standards implies investment in expensive equipment and services. However it is not feasible to impose such requirements in counties which have no means to finance the implementation and long term enforcement of such standards. It is even dangerous, as it may drain the meager resources required in other essential fields within the health system. It is necessary to find a balance between what is desirable and what is feasible within the financial constraints of a country. The following example shows that there are possibilities for improving prevailing procedures and standards considerably even with basic technology and still keeping costs down. Move up Drastic improvement of performance of hand-operated steam sterilizers In many rural health facilities manually operated or semi-automatic steam sterilizers are commonly used. With the limited resources available, only the use of such models has proven to be sustainable. Measurements in autoclaves as used in local hospitals were conducted during a course for hospital technicians at the end of 1997 at the Mombasa Polytechnic in Kenya. The measurements proved that especially for porous loads such as drapes and gowns, the performance of the processes used is not sufficient for producing safe sterile products. Temperatures of only 70-80ºC were measured in the centre of textile packs, where 121ºC-134ºC is required. Poor sterilization practices may be one of the hidden causes for many hospital-acquired infections, which could not be traced. Poor air-removal and thus poor steam penetration is the reason of the bad performance. For porous loads the air-removal, and thus the performance of the sterilization process, can be considerably improved by performing steam pulses before the actual sterilization phase starts. Steam pulsing, a technique where steam is released and admitted again by short pulses, is a well known method of stimulating air-removal. It is a standard procedure in processes of automatic sterilizers for porous loads. It however is a procedure, which for some reason is not applied in the operation of hand-operated autoclaves. The pulses can be easily performed by opening and closing of the appropriate valve(s) of the sterilizer and result in drastically improved performance. Concluding one can say that through only changing the operating procedures of the sterilizers, significant improvement of the 1performance of sterilization processes can be realized, also in very basic, pressure cooker-type autoclaves. Move up Recording of a sterilization cycle of a standard test pack of textile (Bowle and Dick test pack) during a process as normally performed in the sterilizers of one of the visited hospitals in Kenya. Main process parameters: 120 degrees C. for 30 minutes, with pre and post vacuum. Due to the air trapped inside the pack, the temperature in the centre of the pack at the end of the 30 minute sterilization phase is only 80 degrees C. Compare this to the theoretical temperature which should be reached at the given pressure (approx. 125 degrees C) The effect of steam pulsing: Process recording of a standard Bowle and Dick test in a jacketed, horizontal sterilizer. Process profile: Prevacuum, 2 pulses down to 0 Bar. 3.5 minutes sterilization at 134 degrees C., post vacuum and air admission. By applying steam pulsing, air-removal is greatly improved. After 2 pulses the temperature inside the pack quickly reaches the required sterilization temperature. Research needed for formulating concept for sustainable sterile supply In the same way as the performance of the sterilization process can be improved, also the other steps in the sterile supply cycle may be apt for cost-effective improvements. The steps to be looked into should comprise all links of sterile supply: from instrument transport systems, cleaning, disinfection, packaging, loading, sterilizing upto sterile storage and distribution. Research in each of the steps can result in an appropriate overall concept. Such research should follow a number of guidelines: Any measures to improve sterile supply should be compatible with the socio-economic background of the country where the concept is to be implemented The quality of each step in the reprocessing of sterile goods should be ensured through an adequate Quality Assurance system. A people-oriented rather than technology oriented approach: standards developed in the industrialized world, tend to solve problems through technology. However through protocols and adequate training programmes, good results could be achieved with a technology level, sustainable in a low-income country. Products should be developed which meet the specific needs of this market. The equipment should be designed to withstand the tropical climate. The presence of poor quality of water and electricity supply should be considered. The equipment should survive rough handling and shipping over poor roads etc. Also the use of solar energy for sterilization should get more attention. Priority on training. Through the more people oriented approach, an adequate training programme is essential at all levels: management, users and technical personnel. Move up First phase of the research programme has been started In order to make a start to the formulation of this concept, a research programme was started in the first quarter of 1999. In this first phase we focus on improvement of processes for the basic models of sterilizers and formulating design recommendations. Also the instruction protocols will be formulated. This first is planned for a period of half a year. If funding can be found, in subsequent phases of the programme, all other aspects of the chain of supply of sterile goods such as improved sterilizer design, appropriate packaging systems, sterilizer control systems and sterile storage will be covered. All these modules will result in the overall concept for sterile supply in low-income countries. Move up A double wall, vertical, hand operated sterilizer being tested at the laboratory of the RIVM in Bilthoven, The Netherlands. The first phase of the research should result in a adequate sterilization process and appropriate operating procedures. Parties involved The following parties are currently involved in the research programme: Department of Medical Engineering, Enschede Polytechnic, The Netherlands. During first phase of the research (1999) a student, in cooperation with the RIVM and HEART consultancy worked out an appropriate process for basic steam sterilizers for various types of loads RIVM (Dutch National Institute for Public Health and the Environment), Bilthoven, The Netherlands. Offered facilities and equipment for the first phase of the research program. Provides general technical know-how in the field of sterile supply. Mechanical Engineering Department, Technical University in Eindhoven, The Netherlands. On-going research for design and building of prototype for improved steam sterilizer for all types of loads for health facilities in low-income countries MMI (Medical Mission Institute), Wuerzburg, Germany. Financial support for the research programme. The MMI also supports a training programme for managers, users and technicians of sterilization equipment. In these courses the results of the research will be incorporated. The first course is planned in Moshi, Tanzania, in spring 2001. TTM (Technologie Transfer Marburg), Germany. Financial support for the first phase of the programme. KSG Sterilisatoren GmbH, and Webeco GmbH, Germany Provided both a sterilizer used in our research Move up			How international are international standards? The financial gap High-tech ending-up as trouble-tech Towards a concept for sterile supply in the health services in low income countries Drastic improvement of performance of hand-operated steam sterilizers Research needed for formulating concept for sustainable sterile supply First phase of the research programme has been started Parties involved In search for an appropriate concept Within the health services, sterilization of medical supplies is an essential issue in the battle against the advance of many infectious diseases. In order to improve the quality of sterile supply, international standards have been developed which specify the requirements for the equipment and procedures in the sterilization departments in health facilities. These guidelines have been developed in the industrialized world, and assume a strong economy as a background for implementation of these standards. However simply transferring such standards to low-income countries is bound to fail and may even work against improvement of quality. There is a need for a concept for high-quality sterile supply, which is sustainable in low-income countries, and at the same time offers the highest possible safety of patients and staff. Jan Huys, HEART Consultancy Healthcare through Appropriate and Reliable Technology Jan Huys, jh@heartware.nl Pieter de Ruijter, pdr@heartware.nl