Point-of-care testing governance in New Zealand through the lens of quality: an update on a national regulatory...

Point-of-care testing (POCT) devices are in vitro diagnostic devices used in hospitals, primary care and at home to provide rapid medical test results to support decision making. Most POCT devices are not regulated in New Zealand and there is no requirement for public or private hospital providers who use POCT devices to meet minimum accreditation standards for POCT. This article describes a regulatory framework for POCT devices, which is consistent with the principles of the draft Therapeutic Products Bill 2018. The proposed framework includes thorough evaluation, laboratory validation and approval processes for devices, improved traceability, accreditation for POCT and an adverse event management system; in the interests of patient safety.