| 摘要: | 醫療器材產業的範疇十分廣泛，而各國對於產業發展的方向也不盡相同。由於已開發國家邁向高齡化以及對於提升醫療照護品質的訴求，醫療器材產業快速成長。一般而言，歐美醫材產業多以醫院用品為主，台灣則是以消費型醫療產品為主，例如：電動代步車與電動輪椅，而成為全球主要的供應國。
醫療儀器的安全度直接影響病人安全，因此各國政府極為重視醫療器材與產品的控管與審核。對於台灣電動代步車的廠商，如何確保產品在整個生命週期中的安全性，成為極重要的課題。產品生命週期管理的概念在於利用資訊系統以管理與整合與產品相關的各種活動，包括研發、製造、行銷、客服、財會等，而所有活動皆以提升品質與確保安全為核心目標。
本研究將以產品生命週期管理為範疇，電動代步車為例，建構一產品生命週期管理系統。除了界定產品生命週期中各階段的重點活動，並且針對產品的關鍵特性，建議應用失效模式及效應分析(FMEA)以及糾正預防措施（CAPA）等方法，以強化醫療器材的品質與安全。
;The scope and the development directions of medical devices industry are varied among the countries. Owing to the ageing society and the high-quality healthcare requirements, rapid medical devices industry growth is occurring. The medical devices industry is mostly of hospital consumer products in Western countries. Comparing to Western, the main market in Taiwan is medical consumer products, like Electric Handicapped Scooter (EHS), and electric wheelchair, etc. It can be expected, Taiwan becomes the main supplier in the world.
Safety of medical devices directly impacts on the patients. Therefore, the government attaches importance among the medical devices, products control, and verification. For the electric handicapped scooter suppliers in Taiwan, how to ensure the safety during the entire product life cycle becomes a major issue. We describe an information system to support the Product Lifecycle Management (PLM) concept holds the product details of supervising, integrating, and the omnigenous processing. Including research, manufacturing, marketing, customer service, financial, etc. Every step aims to enhance quality and safety assurance.
This research illustrates three circumstances. First, we focus electric vehicle wheelchair industry on constructing the PLM system. Furthermore, applying Corrective Action and Preventive Action (CAPA) to inspect the manufacturing procedures. Using Failure Mode and Effect Analysis (FMEA) to find out the potential failure modes and calculate Risk Priority Number (RPN). Using before and after RPN number to know the improving approaches are worth. Finally, strengthen the approaches in CAPA to intensify both the quality and safety of medical devices. It can be applied to any sector, but special attention must be given to each industry particularities in the future. |
