醫療植入物的現況與管理──從乳房植入物談起【本期企劃】 試閱
The Situation and Management of Medical Implants: From the Issue of Breast Implants
本文從引發國際關注的乳房植入物與罕見癌症切入，分享國際間對於《植入物檔案》的檢討及因應，並檢視臺灣衛生主管機關對醫療植入物的疏於管理，以及在面對植入物所造成的健康危害時，各種的不作為與妥協，對女性健康權益造成傷害。對於醫療器材的追蹤與管制，本文提出高風險植入物管理的建議：一、建立使用登錄制度以加強高風險醫療器材的管理，監測長期有效性及安全性；二、加強「告知後同意」的程序，以健康風險及術後照護資訊為主的「檢核表」落實使用者的「知情」。
This paper cuts in from the issue of breast implants and rare cancers which aroused the international concern. We share the international review and response to the “Implant File,” examine our government’s negligence of management of medical implants and their compromising attitude and various administrative omission towards health hazards caused by implants. For tracking and surveillancing of medical equipment, we also put forward the recommendations of high-risk implant management: first, the establishment of a use recording system to strengthen the management of high-risk medical equipment, monitoring the long-term effectiveness and safety; second, to strengthen the “informed consent” procedure by using “decision check list” of risk and after-care to avoid it from falling into a formality.
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