Instant inspection medical equipment in the pitfalls and solution

   POCT instant inspection the development of medical devices soon, and compared with the traditional test learning, it is a big advantage. But, for now, others for real-time inspection medical equipment still has some negative awareness.

            POCT instant inspection of negative views mainly around the inspection results not guarantee the quality of the problem and put forward. If the inspection quality can't solves promptly, will not only influence POCT further development, and will have been conducted to the POCT a serious negative impact and trust crisis. Many factors including quality problem, now the main aspects to do some analysis to attract the attention of the decision-making departments.

             1. The organization management has not yet in place at present LinJian center of provinces and cities of traditional test of LinJian, biochemical, immune, bacteria are to the full range of quality management, including indoor qc and room between quality control, quality and under the assessment system build, which guarantee the quality of the traditional test. And POCT instant inspection organization management has not been set up. As a government administrative supervision department of this field are mostly not checking management on the agenda, the basic development condition in itself. The sterilization of POCT for a traditional test management foundation, the test results can often and big machine contrast, relatively well. And by clinical doctors and nurses operation of the clinical POCT, due to a lack of inspection background, the operation is not enough skilled, problems relative more. It seems to POCT organization management and monitoring of the lack of, is a cause of quality problems one reason.

            2. The lack of control measures and instrument the discretion of the content of science and technology of reagent is effect on the quality of the important factors. POCT quality control of the particularity of the large-scale instrument with the traditional biochemical determination method of different. POCT used the reagent board, the article, article, and pieces, each detection unit are their own systems. Different from common biochemical analyzer liquid reagent, standard substance and curve correction, the error of the system is fairly well. And POCT used each reagent board, by many factors such as safekeeping conditions, the effect of between each may have error, and the requirements of the reagent board than liquid reagent requirements are higher. Quality control for different object should be different. The hospital POCT users shall refer to the inspection of the traditional mode, set up quality control procedures, accept LinJian center of quality supervision and room of indoor between the field detection, blind spot quality assessment, quality control should mainly be responsible for the daily.

      POCT instrument reagents application of customer is the terminal patients, quality management more difficult. These users are mostly no medical background, and older ones are in the majority. The wide working more than quantity, quality control instruments and reagents only by the supplier of supporters to complete technology. Buy when the instrument in a comprehensive training, especially to clear possible problems and solving methods. And the daily maintenance and calibration of the instrument shall be through the users in consumable reagent outlets, in the purchase at the same time when reagent calibration equipment, to ensure instrument always in good condition. It should strengthen the responsibility to supplier service consciousness, prevent put out no matter the instrument die.
Secondly as a national SFDA, should improve directly into patients is terminal customers access to POCT instrument door column. With tiny blood sugar instrument as an example, some instrument to blood added amount is very sensitive, too much too little all can affect test results, and the elderly to blood drops of this size is easy to grasp, lead to the volatility of the test results. And new type of blood glucose meter from health effects, as long as contact blood will show the results. Therefore, to the operation cumbersome, easy to influence the results should not be POCT instrument into the terminal customers for the patient who.

Article: from perlong medical (http://www.pl999.net)
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