QUALITY CONTROL AND METROLOGICAL SERVICE IN THE FIELD OF MEDICINE

ABSTRACT

In the article, discussed the importance of medical devices that are used in every sector of Healthcare, quality control and metrology service that permits to provide accuracy of medical devices are discussed. In order to develop quality of metrology service in the field of medicine, circumstance of metrology service was learned and according to the results, recommendations are given.

АННОТАЦИЯ

В статье обсуждается важность медицинских изделий, которые используются в каждом секторе здравоохранения, а также службы контроля качества и метрологии, позволяющие обеспечить точность медицинских изделий. В целях повышения качества метрологической службы в области медицины изучены обстоятельства метрологической службы и по результатам даны рекомендации.

Keywords: measurement, principles of measurement, life span of medical devices, Clinical Engineering, Quality.

Ключевые слова: измерение, принципы измерения, срок службы медицинских изделий, клиническая инженерия, качество.

INTRODUCTION

Healthcare in Uzbekistan is one of the foreground directions of the inclusive social policy implementation which experienced major reform over the past two decades. Uzbekistan has a single statutory health care system, which includes public, private and other forms of non-public actors.

Today over 1,000 inpatient health institutions, 4,000 polyclinics and outpatient institutions, 501 rural outpatient posts, 2,606 rural health clinics (RHC) and other health institutions are providing qualified public health services.

The priorities of the Government of Uzbekistan, focused on comprehensive modernization of health system, continued gradual and targeted work on further reforming and developing of healthcare system. More attention is being paid to the protection of public health and strengthening of economic and technical base of medical institutions, as well as rendering high-quality medical services at modern requirements. With the purpose of improving the quality of laboratory services, improving the metrological service, improving the efficiency and security of medical services to the population on the basis of improvement of the system of medical equipment maintenance and testing in medical organizations, the Cabinet of Ministers of the Republic of Uzbekistan formed the decision № 112 on February 15, 2018 “On measures for improving metrological control of medical laboratory and diagnostic equipment”.

NEED FOR THE MEDICAL DEVICE

The country features high natural demographic growth rates, which total 1-1.5% per annum according to the projections. Approximately 615,000 newborns are expected annually in the next five years, whereas, 607,800 are expected annually in 2015-2020, and 596,700 annually in 2020-2025. Also absolute growth of the number of the elderly is expected thanks to the improvement of health services and better living standards.

These factors lead to higher demand for new technologies, modern equipment and high quality medications essential for treatment of pediatric diseases, mandatory vaccination of newborns and children, and treatment of diseases typical for the elderly – cardiovascular, oncologic, and neurological diseases.

To carry out any kind of activity, it is very important to follow certain rules and norms to ensure safety, reliability and do no harm to anyone. Healthcare and the production of medical equipment belong to those areas that must always take into account regulatory and legal acts that regulate it. Coming to a medical institution, we want to receive reliable information about our health, and when receiving this or that kind of treatment, we must be sure that therapeutic or surgical medical equipment is tested, meets all characteristics and is safe.

To assure adequate space system performance, it is essential that technical requirements be developed, defined and documented carefully. Clearly defined measurement requirements lead to the high reliability and quality needed to assure successful system performance and mission achievement. Thus, today metrology permeates all spheres of life. Even a newborn, not yet given a name, immediately becomes an object of measurement. In the first minutes of life with the help of instruments, determine its height, mass and body temperature. In everyday life, we are also constantly confronted with quantitative assessments. We estimate the temperature of the air on the street, watch the time, decide how profitable and rational is practically any of our actions. With the measurements, human activity is connected in any enterprise. Metrology has become a science, without knowledge of which can not do any specialist in any industry.

QUALITY CONTROL AND METROLOGICAL SERVICE IN THE FIELD OF MEDICINE

Measurements are essential in medical diagnosis and the prevention and treatment of diseases, risk assessment and monitoring of patients. Moreover, as the measurement results become more important in medicine they should be accurate, actual and comparable in different locations over time. Only then, it will be possible optimize patient care and efficient management of funds applied to health care. The use of medical devices with measuring function should not pass outside the qualification process. However, at the present time in some situations, the standards requirement for the metrological traceability is neglected. Thus, as a part of accredited/certified activities, the measuring instruments must demonstrate compliance with metrological traceability chain through the evidence of their certificates of calibration/verification on the basis of voluntary or policy regulation. These certificates will be valid if issued by a laboratory accredited for the activities concerned, or by a national metrology laboratory (both assigned the mutual recognition agreement).

International Organizations such as WHO and the European Commission itself, identify in many areas of health, medical technology and medical devices as a key input to the collective health through its contribution on reducing disease and improving health patients. Simultaneously, training of health professionals has become an essential point.

However, as a fundamental pillar of this issue, is the consolidation of knowledge on the medical device that should be a permanent organization’s strategy. The development of this culture and consequent applicability on safety and instruments performance require long-lasting actions with a widespread of monitoring. Probably, these aspects of cultural dissemination are as important as the concern about technical and legal regulate framework [3].  We analyzed circumstance of knowledge of specialists of medical device in the clinics, diagnostic centers and hospitals of Uzbekistan. According to the research questionnaire, it’s founded that there is lack of clinical engineers among uzbek clinics, diagnostic centers and hospitals. From this point of view we recommended to develop Clinical Engineering program for the master students between medical and technical HEI’s of Uzbekistan.

Figure 1. Clinical Engineering program between medical and technical HEI’s

Clinical Engineers act as a catalyst in the life span of medical device (Figure 2). It is important to recognize that any of these phases can affect the safety and performance of a medical device. For example, the development phase includes development planning, design verification/validation, prototype testing and clinical trials [2]. Thus, each target groups (manufacturer, vendor, user) should have basic knowledge on the Clinical Engineering. 

Figure 2. Major phases in the life span of a medical device

CONCLUSION

Metrology helps to determine how the device functions as well as its ability to provide reliable results. Devices have been evaluated to learn how they function. It is important to know the device limitations than to know how it performs against standard specifications. All devices have limitations, and the limitations must be identified prior to adopting the devices, to reduce the risks. Medical measurements are present in everyday life and are fundamental processes in the prevention, diagnosis and treatment of diseases. Therefore, it is crucial to provide accuracy of medical devices. But it doesn’t depend on only metrological inspection or testing, it also depends on manufacturers, vendors and users. From this point of view, in order to develop metrology service in the field of medicine, skills and abilities of clinical engineers, manufacturers, vendors, users should be improved.

References:

1. H.T.Castrup, W.G.Eicke and others “Metrology - Calibration and Measurement Processes Guidelines”, NASA Reference Publication, June 1994, 316 page
2. Aruna Ranaweera, “Medical Device Risk Management: Practical Overview & Challenges”, October 2, 2012 – San Francisco, CA
3. M. do C´eu Ferreira “The role of metrology in the field of medical devices” Int. J. Metrol. Qual. Eng. 2, 135–140 (2011)
4. Chi˜ao et al., Metrology and Standards Needs for Some Categories of Medical Device, J. Res. Natl. Inst. Stand. Technol. 113, 121–129 (2008)