安全針具法實施後醫療人員針扎之變化

Abstract

研究背景：新冠肺炎（COVID-19）疫情讓世人警覺到醫療人員工作環境的高危險性；其中針扎即是醫療人員常發生的職業傷害之一。醫療人員發生針扎後除了血液傳染疾病的感染風險，也可能出現焦慮與憂鬱感，進一步也可能影響病人安全。為了預防扎傷，歐美國家已紛紛通過安全針具法來提升針扎預防的效果。台灣率先在2011年修正醫療法第56條，規定自2012年開始逐步強制使用安全針具。今正值此政策實施十年，故探討其對扎傷預防的成效以及推行困境，做為調整扎傷預防策略之參考。 研究目的：本研究包含三大主題：（1）確認國際間安全針具法在針扎預防上的成效；（2）了解台灣安全針具法實施後醫療人員針扎率的變化；（3）探索台灣實施安全針具法的實務困境。 研究方法：（1）針對國際上已發表文獻進行整合分析（meta-analysis），比較安全針具法之立法與非立法國家其針扎風險比例（risk ratio, RR）之差異，確認國際間安全針具法在針扎預防上的成效；（2）分析歷年EPINet扎傷通報系統數據，以台灣每百萬工時扎傷率變化確認立法後針扎的改善情形，並以卜瓦松迴歸分析了解安全針具替代率與每萬針具針扎率之關係；（3）藉由質性內容分析法，訪談曾遭到安全針具扎傷之醫療人員的安全針具使用經驗，以歸納出台灣安全針具法實務困境。 研究結果：（1）納入11篇國際文章的統合分析，立法國家醫療人員的扎傷風險在立法後3～6年間下降22%，而非立法國家在五年間的扎傷率則沒有明顯的變化。但安全針具法對醫師針扎預防的成效不像對護理人員有效。（2）分析22家EPINet通報醫院針扎資料，台灣立法後整體醫療人員針扎風險僅立法前的0.54倍，有引進安全針具的針具項目針扎風險比率比未引進者低，且預防效果持續時間較久。若安全針具替代率可提升到90%以上，針扎風險可降低將近一半。（3）訪談25位醫療人員發現，台灣在實施安全針具法上有安全針具使用不夠便利以及安全針具替代範圍不全面兩項困境；安全針具使用不夠便利的原因為沒有真正好用的安全針具、沒上過教育訓練與缺乏便於使用安全針具的環境，而安全針具替代範圍不全面主要在於台灣醫師的常見治療項目較缺乏安全針具可使用。 結論與建議：綜合以上發現，建議針具製造商可改善安全針具設計並增加安全針具所涵蓋之品項，建議醫療院所可改善教育訓練和增加工作環境便利性提高醫療人員之安全針具使用意願，建議政府單位擴大安全針具給付範圍、針對醫師族群調整針扎預防策略。最後建議未來研究可精確調查對各醫療院所之安全針具替代率以更確實了解其對針扎預防之影響，也可從針扎事件低報率的變化以及安全針具使用情形進行探討醫師針扎率變化之原因。

Background: The COVID-19 pandemic has alerted people to the high risk of occupational injury in healthcare workers (HCWs). Needlestick injury (NSI) is one of the most common occupational injuries in healthcare workers, which increases the risk of bloodborne diseases, anxiety and depression, and may even affect patient safety. Some countries passed Needlestick Safety and Prevention Act (NSPA), a regulation requiring healthcare facilities to use safety-engineered medical devices (SEMD) to prevent NSIs. Taiwan renewed Medical Law No.56 as our NSPA in 2011, and all healthcare facilities were required to replace medical sharps with SEMDs in 2012 gradually. After ten years, it is worth understanding the effect of this regulation in preventing NSIs and the difficulties when implemented, which can be a reference for preventive strategies of NSIs. Objectives: This study has three aims: (1) to determine the effect of NSPA in preventing NSI among countries; (2) to determine the change of NSI after NSPA in Taiwan; and (3) to explore the difficulties of implementing NSPA in Taiwan. Method: (1) comparing the risk ratio of NSI between countries with and without NSPA through meta-analysis to determine the effect of NSPA; (2) using the NSI data in EPINet Taiwan, calculate the change of NSI incidence rate after NSPA, and understand the association between replacement rate of SEMDs and NSI incidence rate through Poisson regression; (3) applying qualitative content analysis method to analyze the SEMDs' using experience of HCWs who experienced NSI related to SEMDs, to understand the difficulties of implemented NSPA. Result: (1) the meta-analysis included 11 articles; the NSI risk of legislated countries decreased by 22% in 3 to 6 years after legislation, and the risk of unlegislated countries did not change in 5 years. Besides, the reduction in NSI incidence was more prominent in nurses than in physicians. (2) In 22 hospitals included in the analysis, the NSI risk of HCWs after NSPA was only 0.54 times as risk before NSPA. The devices with SEMDs introduced have lower NSI risk, and their preventive effect last longer than those without being introduced. When increasing the replacement rate of SEMDs over 90%, the risk of NSI was reduced by nearly half. (3) 25 HCWs were interviewed, and there were two difficulties in implementing NSPA in Taiwan. The first one is that HCWs did not find the use of SEMDs satisfactorily convenient due to insufficient training, unfavorable work environment and SEMDs were not easy to use. The other difficulty was an uncomprehensive replacement of SEMDs, especially in physicians' daily practices. Conclusions and suggestions: this study recommended that manufacturers of SMEDs may improve the design of safety features and create more types of safety devices; healthcare facilities should improve the compliance of HCWs by proper training of SEMDs and proper workplace setting; the government could expand the payment of SEMDs and modify NSI preventive strategies for physicians. Further studies are warranted to investigate the actual replacement rate of SEMDs and exam their impact on NSI more accurately. It is also necessary to understand the change in NSI among physicians through the shift of underreporting and usage of SEMDs.