コンビネーション製品のリスクマネジメント

抄録

 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.