Japan’s Ministry of Health, Labor and Welfare (MHLW) announced that it will temporality allow reuse of single-use parts of air ventilator concerning the epidemic of COVID-19. Followings are the summary of points where manufacturing authorization holders and medical institutions must be careful of.

For Manufacturing Authorization Holders:

1. Manufacturing Authorization Holders must make sure single-use parts of air ventilators are imported or manufactured to make sure stable supply. In case stable supply is expected to be disturbed, contact with MHLW.

2. In case the stable supply is expected to be disturbed, manufacturing authorization holders can provide information about temporary reuse of the single-use parts. When providing this information, they must refer to guidelines of related academic conferences and foreign health authorities that are equivalent to PMDA, and consider procedures of disinfection, sterilization to make sure if it is possible to reuse. If stable supply is disturbed, make a report to the MHLW.

3. Manufacturing Authorization Holders must fully inform instruction for use (including reuse) of single-use parts to medical institution, collect post-market safety information, and make a report regarding PMD Act.

For Medical Institutions:

1.  Only in unstable supply situation that medical institutions can reuse the single-use parts of air ventilators, following the latest version of instruction for use provided by corresponding manufacturers. However medical institutions must make sure these reused parts were not used for patients suffered from COVID-19.

2. When storing the used single parts, the medical institutions should make sure these used devices are separated from new products. The infection shall be prevented

3. When using reused single-use parts, the medical institutions should explain to the patients and consistently check malfunction or medical hazard.

4. When medical hazard is caused, the medical institutions should report to PMDA.

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References:
新型コロナウイルス感染症の拡大を踏まえた医療機関等における人工呼吸器の単回使用構成品の例外的取扱いについて