Vol.1 No.1 2008

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Research paper : Improving the reliability of temperature measurements taken with clinical infrared ear thermometers (J. Ishii)−60−Synthesiology - English edition Vol.1 No.1 (2008) that requires clinical assessment, clinical assessment with subjects including patients with fever is conducted along with an engineering evaluation by standard BBR, and an assessment of clinical reliability using the statistical method is proposed. In this case, the achievement of uncertainty 0.2 °C is strictly required, as mentioned in the article, for the engineering assessment result, but for the clinical assessment, disclosure of assessment information to users is required rather than a specified numerical value of a tolerable level.In the future, I think the two performance assessments will be conducted appropriately, and by feeding them back to product technology, higher reliability at user level can be achieved.8 Possibility of introduction of future verification by the Measurement Law Question (Naoto Kobayashi)This is related to the question for Discussion 7, but ultimately, is it preferable to have all-product verification regulated by the measurement law for the ear thermometer? For this to be done, I think it is necessary for technological development to become matured fairly and start “to wilt”, so to say, but when do you think that will happen? Or, to what level does the technology go for that?Answer (Juntaro Ishii)As mentioned in the article, verification is done to inspect the performance of measuring instrument according to law (Measurement Law) under the responsibility and authority of the government, and the measurement at a certain level or higher is maintained in Japan. Since it is a system with direct involvement of the government, user’s confidence is high, but it may be a disincentive factor to product development and marketing for manufacturers. As mentioned in the previous section, product technology development to improve long-term stability as well as to improve reliability of clinical assessment is continued for the ear thermometer, so I think a shift to verification scheme with strong technological enforcement requires a period of about five years or more to study the trend of product technology. Moreover, new skin thermometer applying the principle of the ear thermometer is being developed, and technological consideration including such new thermometers will become an issue in the future.This article discusses the consideration at the time when manufacture and sales of the ear thermometer grew rapidly in Japan from technological aspect. However in the future, if ear thermometers become a specified measuring instrument according to the Measurement Law, it will be necessary to consider not only the technological assessment, but also the economic effect on corporate activities by Japanese manufacturers, effect on the entry of overseas companies to Japanese market, and relationship with the Pharmaceutical Affairs Law (administered by Ministry of Health, Welfare and Labor). In the global flow toward free trade as exemplified by FTA, verification scheme under government large-scale auspice should be limited to absolutely necessary items to maintain safety of the citizens and reliability of trade, and creation of rules for maintaining traceability and conformity to international standards is strongly demanded internationally. Also, as mentioned in the previous Answer, clinical assessment including medical knowledge is necessary in addition to dissemination of measurement standard and establishment of engineering assessment method to obtain reliability at user level, so I think the important issue will be to consider more practical approach for both Measurement Law and Pharmaceutical Affairs Law.

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