(1) Reasons for Proposal

As the Medical Service Act has been revised (Act No. 17069, partly amended on March 4, 2020, and to be implemented on September 5, 2020) to redefine the scope of disposable medical devices that are prohibited for reuse, to strengthen the healthcare-associated infection monitoring system by establishing a healthcare-associated infection monitoring system, introducing a voluntary reporting system, etc., and to provide the basis for the follow-up management of medical institution accreditation to increase the effectiveness of the medical institution accreditation, this amendment aims to prescribe matters delegated by the Act and necessary for the enforcement thereof and improve some of the shortcomings that emerged from the operation of the current system.

(2) Major Provisions

A. Clearly prescribe the scope of disposable medical devices that are prohibited for reuse (Article 3-2) 

1) Fluid injection sets and any other devices equivalent to the sets, including an injection needle, a syringe, and a tube for connection with a fluid container, which are used for the injection of medicine, blood, fat, etc. to or for collection of them from a human body

2) Medical devices notified by the Minister of Health and Welfare that are necessary to prohibit reuse because of the high risk of infection or damage

B. Stipulate details on the composition and operation of the Medical Institution Establishment Committee (Article 27-2) 

1) Deliberations: The legitimacy of the establisher, whether to meet requirements such as facility and workforce standards, policies for patient beds, supply and demand for available hospital beds, management plan, consistency, etc.

2) Composition: Consist of 15 members or fewer (the chairperson shall be appointed from among its members), the term of office is 2 years, and it is possible to repeat

C. Establish detailed operating standards for medical institutions to prevent healthcare-associated infections (Article 39-7) 

1) To prevent healthcare-associated infections, provide the general principles of infection management, patient management standards, appropriate prevention measures, notices for patients and visitors, etc.

D. Improve the system for non-covered medical expenses disclosure (Articles 42-2 and 42-3) 

1) Stipulate that items and costs shall be individually explained to patients prior to a treatment when the treatment is not a covered medical expense as announced by the Minister of Health and Welfare. 

2) Prescribe medical institutes subject to the investigation, analysis, and disclosure of non-covered medical expenses as institutes notified by the Minister of Health and Welfare.

E. Stipulate the details of the healthcare-associated infection monitoring system and voluntary reporting (Articles 46-3 and 46-4) 

1) Types of healthcare-associated infections registered in the healthcare-associated infection monitoring system

2) Provide a basis for the Director General of the Korea Center for Disease Control and Prevention to establish details such as the establishment of a voluntary reporting form and the receipt and analysis of voluntary reporting

F. Prescribe the investigation method for medical institutions applying for certification and the period of re-application for certification of intermediate care hospitals subject to mandatory certification (Article 64) 

1) Provide a basis for conducting on-site investigations of medical institutions applying for certification.

2) Stipulate the period that the head of a non-accredited intermediate care hospital shall reapply for certification as within 90 days and the related procedures.