台、美醫療器材律法演進如何創造市場價值-以安全針具為例

Abstract

各國的醫療職業災害預防，多數皆透過政府制定職業安全標準程序，以要求雇主遵守其規定，但此管理制度模式在職業衛生安全的推動執行上，似乎無法將其效應完整呈現，因此，透過不同醫療政策措施介入，促使雇主、員工與政府等社會、廠商研發創新醫療，以重視與改善醫療工作環境，同時，落實職業安全在各處的完善。而銳器傷害是醫療院所機構工作人員經常發生的職業傷害，在多篇國外的研究統計中，護理人員因銳器傷害的比例居冠，其次為醫師。臨床醫護人員在處置病患時，所使用各類醫療器械因挾帶病患的血、體液，倘若因處置不當或者工具錯誤流程等，醫護人員可能因銳器傷害造成的傷口，而受到感染。儘管常見的傳染性疾病，包括B型肝炎、C型肝炎、AIDS與梅毒，但現今許多未知的傳染性疾病，甚至病患不自覺具有傳染性疾病時，讓臨床醫護人員臨床處置行為時，暴露在高感染風險中。有鑑於台灣為亞洲第一個執行安全針具立法，為了有效執行臨床的使用率，醫療法第五十六條規定自民國一百零一年起，五年內按比例逐步完成全面提供安全針具。此立法對於產業面的商業價值創造、社會面職場安全性提高與降低臨床人員發生銳器傷害率，有其影響。本論文研究分析台灣透過法條期限與影響著醫療安全環境與安全針具的使用率，以致產業醫療器械的現況；與美國的法制差異為本，分析兩國在律法上監理、管理、治理演進。 美國從1990 年《安全醫療器械法案》，即開始賦予權力要求醫療保健機構調查、記錄和報告與所有醫療器械（從心室輔助裝置、導管到縫合線）相關的嚴重事件，甚至要求設施從接收到患者使用再到處置過程中跟踪某些設備，進而要求廠商必須對員工進行培訓、實施程序並達到合規性，以病人安全為概念。其後保護醫療從業人員的安全，美國透過立法，1970年建立職業安全和健康法以保障醫療從業人員在存有安全的工作環境，後加強且為了更有效降低臨床銳器傷害比例，在2001年4月18日通過《針刺安全與預防法》(Needlestick Safety and Prevention Act，簡稱NSPA)，聯邦食品和藥物管理局 (FDA) 監管對醫療院所機構對銳器傷害程序提出改善，以減少醫護人員接觸血源性病原體的情況，搭配損害賠償機制能夠讓受銳器傷害的醫療從業人員譨有最大的保護。本論文透過台、美律法演進以安全針具為例進而分析對市場價值：從產業規模分析，到對醫護人員職場安全之差異探討。 本研究以「文獻分析法」及「次級資料」為基礎，藉由蒐集整理國內外相關的文獻資料，細究我國職業安全與醫療器材相關法規流程，與美國對其職業安全標準和安全醫療器械發展趨勢，並以此作為研究設計上之參考，分析兩地律法架構的完整性與差異，透過安全針具為例，檢討其對醫護人員職場安全之影響。繼而再從律法演進為基礎，，分析法規建置如何影響臨床與市場的醫療器材多樣性與分佈。以第三方立場與觀點出發比較美國與台灣目前法規要求及實施狀況，希望對於在臨床醫護人員的職業安全衛生與創新醫療器材導入市場，提供實質的幫助。

The prevention of occupational accidents relies on various standards or strategies depending on different countries. Requiring employers to comply with its regulations is the main purpose, although, this management system seems to not be able to be best. Therefore, the intervention of law or act could affect employers, workers, and industries in order to improve a safer clinical environment and ensure occupational safety and health. Needlestick is the most common occupational injury that occurs in healthcare workers. According to a survey by the Council of Labor Affairs, 98% of nursing staff feel the potential risks, followed by 70% of physicians. The wound caused by the needlestick is not large; however, it does come with a fatal hazard. A used syringe with the patient's blood or body fluids is a contaminated medical device. A health care worker may be suffering from the contaminated needlestick, which could be infected diseases include hepatitis B, hepatitis C, AIDS, syphilis, etc. Taiwan was the first country in Asia to amend legislation about safety medical devices, in order to effectively enforce clinical usage. Articles 56 of the Medical Care Act was amended which medical care institutions shall ensure the comprehensive provision of aseptic needles on progressive percentages within five years, starting from 2012. This legislation will have an impact on the creation of commercial value in the industry, improve workplace safety in the community, and reduce the needlesticks rate of healthcare workers. The thesis analyzes the impact of the Medical Care Act and hospital accreditation on the safety environment of healthcare workers and the usage of safety medical devices in Taiwan; in addition, comparison of whose science-based evolution is on legislation through supervision, management, and governance in the United States. Promulgated the Safe Medical Device Act in 1990, which gave medical care institutions the authority to investigate, record, and report serious incidents related to all medical devices (from ventricular assist devices, catheters, and sutures), medical care institutions must track all process of devices uses., moreover, which train employees operating procedures of medical devices, in order to achieve compliance. On the contrary, it may be subject to civil and criminal penalties in the future, affecting healthcare quality with accreditation. Subsequently, promulgated the Needlestick Safety and Prevention Act (NSPA) on April 18, 2001, in the United States, in order to reduce the needlestick rate, and medical care institutions have to be imposed improvement of needlesticks, sharp injury and blood exposure from patients, in additional medical care institutions are required on the all procedures of needlestick and sharp injury to further reduce the exposure of healthcare workers to bloodborne pathogens under the Federal Food and Drug Administration (FDA) regulation for medical care institutions. The study analyzes the market value, compared to the history of safety medical devices act in Taiwan and the United States, through the analysis of the industry scale and the differences in workplace safety of healthcare workers. This study first used 'Document Analysis' as a basis to examine the regulations and processes of medical devices in Taiwan by collecting and compiling relevant domestic and foreign literature, then exploring the standards and development trends of medical device regulations in the United States and using them as a reference for the study design. Taking the safety medical devices as an example, the integrity of the law affects the differences in workplace safety of healthcare workers. Lastly, 'secondary data” is used to compare and analyze. The study is based on the legal evolution and uses safety medical devices as an example to explore how the establishment of medical device related regulations including the rules of occupational safety and health affects the clinical market. From a third party's standpoint and viewpoint, we analyzed and compared the advantages and disadvantages of the current situation in Taiwan, hoping to provide practical assistance to improve clinical surroundings and introduce innovative safety medical devices.to the market in the future.