Singapore legislation
Regulation 25
of Healthcare Services (Community Hospital Service) Regulations 2023
Regulation 25
Standards for equipment for renal dialysis service
Subregulation 1
A licensee must ensure that every piece of equipment used by or on a patient in the licensee’s provision of the renal dialysis service is safe and effective for clinical use.
Subregulation 2
Without limiting paragraph (1), a licensee must ensure that —
every part of any equipment (other than any part designed for single use only) is appropriately disinfected or sterilised in accordance with the specifications by the manufacturer of the equipment before and after it is used for dialysis;
each equipment is installed, and used or operated properly, in accordance with the instructions of the manufacturer of the equipment; and
in relation to a licensee who provides haemodialysis —
where reusable dialysers are used — the dialysers are cleaned and prepared for reuse in the manner required or recommended in the manufacturer’s operator manual for the dialyser;
any dialyser must only be used for one patient;
each dialysis machine is drained, rinsed and disinfected after each dialysis, at the end of each day and at any other interval required or recommended in the manufacturer’s operator manual for the dialysis machine; and
where there is a blood leak, the affected dialysis machine is rinsed and disinfected in the manner required or recommended in the manufacturer’s operator manual for the dialysis machine.