KAZAKHSTAN'S MARKET POSITIONS WITHIN THE EAEU

В данной статье рассмотрена проблема реализации процесса регистрации медицинских изделий в рамках ЕАЭС. Проанализирован рынок аккредитованных лаборатории, способных проводить испытания для дальнейшего процесса регистрации. А также стоит обратить внимание на нехватку лабораторий, способных проводить различные испытания на безопасность медицинских изделий в Казахстане в рамках ЕАЭС. This article discusses the problem of implementing the registration process of medical devices within the EAEU. The market of accredited laboratories capable of conducting tests for the further registration process is analyzed. And it is also worth paying attention to the shortage of laboratories capable of conducting various tests for the safety of medical devices in Kazakhstan within the framework of the EAEU.

Comparative Assessment of Physico-Chemical Results of Air, Water and Soil Samples Tested at Accredited and Non-accredited Laboratories

There are thousands of results produced by the environmental testing laboratory for the air, water and soil parameters. The results produced by the environmental testing laboratories are always basis of the policy decision on various occasions. The results produced by the environmental testing laboratory provide the basis for the water whether it is fit for drinking purposes or not. The soil of a particular area is fit for specific agriculture or not. Similarly, the air of a specific location is under the permissible limit of the required component or not. Over some time the environmental testing laboratories are increasing in our county and these laboratories can be segregated broadly into two categories namely accredited laboratories and non-accredited laboratories. The accreditation is done by the independent authoritative body as per the international standard ISO/IEC 17025. It is believed that the accredited laboratory has a quality management system and proven technical competence to perform a specific type of testing. This work presents the comparative studies of the physico-chemical results of air, water and soil samples tested by accredited and non-accredited laboratories. In case of soil, the pH and sulfate is tested by the accredited and non-accredited laboratories in the specific environment. Similarly, construction water and drinking water are tested for various parameters as per the relevant standard. The air samples were collected from the same site and analysis was done for the various parameters like PM2.5, PM10 and other toxic gases present in air. It is observed that there is a considerable difference between the results produced by the accredited and non-accredited laboratories. It is believed that the results produced by the accredited laboratory are more reliable in comparison to the non-accredited laboratory.

Generic Pharmaceuticals as a Source of Diuretic Contamination in Athletes Subject to Sport Drug Testing

This paper describes nine instances of positive anti-doping tests that could be accounted for by the use of permitted generic prescription drugs contaminated with diuretics, which are prohibited in sport at all times under the WADA Prohibited List. The contamination levels found in the medications are reported and were below FDA limits for manufacturers that are based primarily on safety considerations. These cases demonstrate that great care must be taken to identify the source of low-level anti-doping positives for diuretics reported by WADA-accredited laboratories, and possibly other prohibited substances as well, in order to avoid sanctioning innocent athletes. An evaluation of the cases in this paper supports an approach which establishes a laboratory minimum reporting level (MRL) for diuretics found most commonly in medications. A global consensus after extensive review of similar anti-doping cases has resulted in implementation of a recently announced solution regarding potential diuretic contamination cases.

Monitoring survey of nitrate content in beetroot, radish and cabbage in Poland

Background. Nitrates, compounds commonly occurring in nature, are present for example in vegetables, where they accumulate and become their contaminants. It is estimated that approximately 70-90% of nitrates intake comes from vegetables, which are therefore the main source of human exposure to these compounds through dietary intake. The European Union legislation limits nitrates as contaminants to three leafy vegetables, i.e. lettuce, spinach and rucola. The EU Member States are obliged to monitor nitrate levels in vegetables which may contain significant levels of these compounds. Objective. To present the results of monitoring surveys on nitrate levels in radish and beetroot as well as in cabbage carried out in Poland between 2012 and 2019. Material and methods. A total of 966 vegetable samples were tested. Chemical analyses were carried out in accredited laboratories of the State Sanitary Inspection. Analyses were performed by spectrophotometric methods using nitrate reduction on cadmium columns or by HPLC. Results. The median nitrate content in beetroot was 1,260.0 mg NO− 3 /kg, whilst at the 95th percentile level - 3,222.2 mg NO−3 /kg. The levels of nitrates in beetroot preserves were lower: 1,030.3 mg NO−3 /kg (median) and 2337,2 mg NO−3 /kg (95th percentile). The median content of nitrates in radish and cabbage was 1,337.0 mg NO−3 /kg and 369,0 mg NO−3 /kg respectively, while at the 95th percentile the content of these compounds was found to be 3,381.5 mg NO−3 /kg and 1545,8 mg NO−3 /kg, respectively. Conclusions. The nitrate content in radish and cabbage does not pose a risk to the health of consumers, whilst the consumption of beetroot containing significant amounts of the above mentioned compounds may result in exceeding the ADI especially for young children.

Towards identifying nicomorphine administration in doping control: synthesis of metabolites

Aim: Nicomorphine is rapidly metabolized mainly to the biologically active 6-nicotinoyl morphine and morphine. In sport, morphine and nicomorphine use is prohibited whereas codeine use is permitted. Accredited laboratories routinely test for morphine hence must be able to distinguish morphine, as a metabolite of a prohibited substance, from that whose use is permitted. Results: Here we show a relatively simple method to synthesize the nicomorphine metabolites, 3-nicotinoyl and 6-nicotinoyl morphine, and indicate how they may be used to identify nicomorphine administration. Conclusion: This approach should help confirm that it is not codeine, an allowable analgesic in sport, that has been administered.

Analysis of the Experience of Participation in Interlaboratory Comparisons of the Radiation Control Laboratory in National Accreditation System

Purpose: Formation of the idea of laboratories accredited by Accreditation System of Russian Federation, in particular radiation control laboratories, about the possibility of confirming technical competence by means of participation in interlaboratory comparison tests at international level. Content: Description of the experience of successful passing the international comparisons by radiation control laboratories under up-to-date requirements. Conclusion: The experience described in the article can be used by accredited laboratories in practice for conformity validation with accreditation criteria.

Overview of the laboratory accreditation programme of the College of American Pathologists

Although Saudi medical laboratories have developed enormously over the past 25 years, the absence of a national body for medical laboratory accreditation has meant the number of accredited laboratories [seven] remains low. Of these, five are accredited by the College of American Pathologists’ Laboratory Accreditation Program [LAP] -the ‘gold standard’ of laboratory accreditation. It requires successful performance in the College of American Pathologists’ proficiency testing programme as well as passing on-site inspections carried out by practising laboratory technicians, after which the laboratory is accredited for a 2-year period. This article gives an insight into the current situation of laboratory accreditation in Saudi Arabia and an updated overview of the process involved in obtaining laboratory accreditation from the College of American Pathologists

The Data Evaluation of Interlaboratory Comparisons for Calibration Laboratories

National accreditation agencies in different countries have set quite strict requirements for accreditation of testing and calibration laboratories. Interlaboratory comparisons (ILCs) are a form of experimental verification of laboratory activities to determine technical competence in a particular activity. Successful results of conducting ILCs for the laboratory are a confirmation of competence in carrying out certain types of measurements by a specific specialist on specific equipment. To obtain reliable results of ILC accredited laboratories, it is necessary to improve the methods of processing these results. These methods are based on various data processing algorithms. Therefore, it is necessary to choose the most optimal method of processing the obtained data, which would allow to obtain reliable results. In addition, it is necessary to take into account the peculiarities of the calibration laboratories (CLs) when evaluating the results of ILС. Such features are related to the need to provide calibration of measuring instruments for testing laboratories. The evaluation results for ILCs for CLs are presented. The results for all participants of ILCs were evaluated using the En and z indexes. The obtained results showed that for the such ILCs it is also necessary to evaluate the data using the z index also.