台灣重處理單次使用醫材現況初探

Reprocessing and Reuse of Single-Use Medical Devices in Taiwan: An Exploratory Study

2019年新聞報導台灣醫院重複使用單次醫材（single-use medical devices, SUDs），隔年政府提出管制政策。單次醫材重處理在國際文獻中已有許多不良事件與不同層面影響之討論，各國亦有不同政策脈絡。本文透過立意抽樣訪談16位利害關係人，包含食品藥物管理署、財團法人台灣醫療改革基金會、醫療人員、醫院管理人員、醫材廠商，以探討台灣現況與政策影響。研究發現，各級醫院普遍存在重處理單次醫材，主要原因包括機構成本及病人經濟負擔。政策過渡期規範與現況間存有落差，且各方對政策認知及態度分歧。建議政府加強稽查、積極鼓勵廠商投入市場、檢視健保點數合理與否、有效評估政策影響並調整，避免醫療機構惡性競爭，以期達成政策目的――安全性、效能性、經濟可負擔。

In 2019, news reports revealed that hospitals in Taiwan were reusing single-use medical devices (SUDs), prompting the government to introduce a phased and progressive regulatory policy the following year. This policy aims to fully implement formal regulations by 2027. The reprocessing of SUDs has been widely discussed in the international literature, with numerous reports of adverse events and impacts. Countries have adopted varied policy approaches in response to this issue. The objective of our study was to examine current SUD-related practices and regulatory challenges and responses in Taiwan. Employing a purposive sampling approach, we interviewed 16 stakeholders, including representatives from the Taiwan Healthcare Reform Foundation, healthcare professionals, hospital administrators, and medical device manufacturers; we also collected official responses from the Taiwan Food and Drug Administration (TFDA). We found that reprocessing of SUDs is a common practice across various levels of hospitals in Taiwan, primarily to control hospital costs and the financial burden on patients. The transitional regulatory framework has not caught up with actual practice, and stakeholders exhibit divergent perceptions and attitudes toward the emerging framework. Based on our findings, we recommend that government policy objectives ensure safe, effective, and affordable SUDs by strengthening policy communication and inspections, incentivizing manufacturers to enter the market, assessing the appropriateness of National Health Insurance reimbursement policies, and establishing a robust policy evaluation and adjustment mechanism to prevent unfair competition among healthcare institutions.