醫療法增修安全針具法對醫療人員針扎之效應

研究背景針扎或血液暴觸事件對醫療人員在執業環境安全與健康有潛在性的傷害及威脅，並可能發生憂鬱、焦慮、創傷症候群等心理衝擊，進而影響生活功能與工作安排。對個人與國家而言，針扎事件會帶來經濟損耗，可能包括病假、檢驗費用、預防性給藥以及感染後的治療費用等。臺灣於2011年12月通過「安全針具法」已逾五年，根據勞動部職業安全衛生研究所（Institute of Labor, Occupational Safety And Health, IOSH）提供中文版EPINet通報系統（Exposure Prevention Information Network）其通報的針扎事件亦有下降之勢。安全針具法的通過是否有效的讓醫療人員安全針具的使用率增加、針扎率減少及安全針具使用率與針扎率的相關性則極少人探討，故本研究針對上述三個部分進行討論。目的第一部分為醫療法第56條已漸進實施多年，故透過此次調查了解2011年至2016年間全國醫療院所其安全針具使用情形；第二部分為由IOSH所提供中文版EPINet通報資料，了解通報之醫院針扎通報情況；最後第三部分為分析2011年至2016年間，安全針具使用率與針扎率之相關性，以利未來政策方向。方法自衛生福利部衛生福利資料科學中心（Health and Welfare Data Science Center, HWDC）申請各醫療機構針具申請健保給付數量分析安全針具使用情形；另對勞動部勞動及職業安全衛生研究所管理、授權使用之中文版EPINet針扎防護通報系統資料庫，進行次級資料分析，統計區間為2011年1月1日至2016年12月31日止，以了解通報醫院之針扎通報情形，並利用全國醫事人員數回推計算出全國針扎率。另2011年為安全針具修訂於《醫療法》開始實施前一年，2012年至2016年則為根據《醫療法》，各醫療院所應於五年內按比例逐步完成全面提供安全針具期間，故申請2011年至2016年之安全針具使用率及通報之針扎率資料進行相關性之分析。結果本研究計畫根據中文版EPINet針扎防護通報系統、健保資料庫分析，得重要發現如下：（1）安全針具應於2016年完成全面使用，然而健保署針具申報資料顯示安全針具仍未完成全面替換；（2）由IOSH所提供中文版EPINet通報資料，了解加入EPINET並持續通報六年以上的醫院共有44家，回推全國針扎率，其2011年針扎率為1.60%，2013年針扎率微幅下降至1.53%，接著2014年下降至1.15%，最後2016年降為0.94%；（3）安全針具立法後，靜脈留置針使用率與靜脈留置針所引起的平均針扎發生率呈負相關，並達統計顯著差異；顯示替換率越高，針扎發生率顯著下降。而空心針頭及皮下注射針頭可能因替換率較低而未達顯著。

關鍵字

安全針具；針扎；中文版EPINet針扎防護通報系統資料庫

並列摘要

Background Needlestick injuries (NSIs) or blood/body fluids exposure incidents pose potential harm and threats to the safety and health of medical personal in their work environments. They may also cause mental impact such as depression, anxiety, or post-traumatic stress disorder, further affecting medical personnel’s life functions and work arrangement. For an individual or country, NSI events may bring economic loss, including sick leave, testing fees, prophylactic drugs, and treatment fees after infection. It has been over 5 years since Taiwan passed the Safety Needle Act in December 2011. According to the Chinese version of the Exposure Prevention Information Network (Chinese EPINet) of the Institute of Labor, Occupational Safety and Health (IOSH), the number of NSI incidences being reported has decreased. However, few studies have investigated whether the passing of the act effectively increased the usage rate of safety-engineered devices (SED) and decreased the NSI rates; or examined the correlation between the usage rate of SED and NSI rates. Therefore, this study explored these three aspects. Objective Article 56 of the Medical Care Act has been implemented for many years. The first part of this study investigated the SED usage in medical institutions in Taiwan from 2011 to 2016. The second part used the Chinese EPINet report data provided by the IOSH to understand hospital NSI incident report statuses. The last part analyzed the correlation between SED usage rates and NSI rates. These understandings are conducive for future policy directions. Method From the Health and Welfare Data Science Center of the Ministry of Health and Welfare, we applied for the data of the number of SEDs each medical institution applied for to be covered by National Health Insurance to analyze the usage of SEDs. In addition, we conducted secondary data analysis on the data from the Chinese EPINet, which was managed and licensed by the Institute of Labor, Occupational Safety and Health, Ministry of Labor. The statistical interval was between Jan. 1, 2011 and Dec. 31, 2016. The secondary data analysis was to understand the NSI report rate of hospitals. The number of medical personnel in Taiwan was used to calculate the national NSI rate. 2011 was a year before the regulations about SED were amended in the Medical Care Act and implemented. 2012 to 2016 was the five-year duration in which, according to the Medical Care Act, medical institutions should gradually increase the percentage of SED use. Therefore, this study applied for data from 2011 to 2016 regarding SED usage rate and reported NSI rate to conduct correlation analysis. Results This study analyzed data based on the Chinese EPINet and National Health Insurance database and achieved the following critical discoveries: (1) Although SEDs should be used exclusively by 2016, the declared data from the National Health Insurance Administration revealed that SEDs had not fully replaced the old instruments. (2) According to the EPINet data provided by IOSH, a total of 44 hospitals joined EPINet and had been reporting data to it for at least 6 consecutive years. By using the data, we calculated the national NSI rate. In 2011, the NSI rate was 1.60%. In 2013, it decreased slightly to 1.53%. In 2014, it dropped to 1.15%, and in 2016, it further decreased to 0.94%. (3) After SEDs were required by law, the usage rate of intravenous catheters was negatively correlated with the mean NSI rate due to peripheral intravenous catheters, and the differences were statistically significant. This indicated that a high replacement rate led to a significant drop in NSI rate. The results for hollow needles and hypodermic needles were not statistically significant, possibly due to their low replacement rates.