著者

角田 圭司 森川 実 永田 泉

出版者

日本脊髄外科学会

雑誌

脊髄外科 (ISSN:09146024)

巻号頁・発行日

vol.23, no.1, pp.24-28, 2009 (Released:2017-05-11)

参考文献数

9

被引用文献数

2 2

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The purpose of this study is to elucidate the characteristics of C3-4 level cervical spondylotic myelopathy. This study included 11 patients, 9 men and 2 women. Mean age at admission was 75.4 years. Clinically, all of the patients had clumsy hands and gait disturbance. There was also wooziness in 7 cases. This unusual symptom may contribute to late diagnosis. Radiologically, hypermobility at the C3-4 segment compensating for decreased mobility at lower segments may induce hypertrophy of the ligamentum flavum and disc bulging. This may be related to the occurrence of C3-4 level myelopathy.

著者

日本PDA製薬学会メディカルデバイス委員会 鶴丸 智彦 森川 実千代 本間 智範 柘植 裕美

出版者

一般社団法人日本PDA製薬学会

雑誌

日本PDA学術誌 GMPとバリデーション (ISSN:13444891)

巻号頁・発行日

vol.23, no.2, pp.53-64, 2021 (Released:2021-12-29)

参考文献数

25

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As the technology recently advances in healthcare industries, combination product composed of drug and medical device will be expected to be increasingly launched. To ensure the effectiveness and safety of such combination products, risk management is important. However, integrated consideration on risks from both drug and medical device perspective is not necessarily simple because risks derived from interactions between drug and medical device or usage (“how to use”) need to be considered comprehensibly. This paper discussed the inherent differences between drug and medical device from the viewpoints of their properties, applicable regulations and product realization processes along quality management system. Based on the discussion, this paper has demonstrated how to conduct integrated risk management as combination products by taking pre-filled syringe product as an example. As a result, this paper concluded the importance to recognize the difference between drug and medical device in terms of inherent product properties, their development processes, approach for risk and risk management in product realization process. Also, this paper suggested the usefulness of hazard frameworks in ISO14971 to list drug-related hazards comprehensibly and the effectiveness to consider “usage” hazard for listing hazards of combination products.