Point-of-care testing (POCT) devices are in vitro diagnostic devices used to provide medical laboratory test results quickly and near to the patient.1 POCT devices are used in public and private…
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Point of care testing (POCT) is testing outside of the main laboratory, like urine pregnancy testing at home and blood glucose testing at home for people with diabetes. These tests can be done by the patient or by a caregiver. The numerous POCT devices in the market means that without suitable advice and guidance, patients and healthcare workers who are not trained in laboratory medicine are at risk of purchasing devices that are not accurate or would not deliver what is medically (clinically) needed. Guidance should be provided at several levels, including: the government (Ministry of Health and Medsafe in New Zealand) through adequate regulation should provide devices that are safe and that are clinically fit-for-purpose; funders should support government by ensuring that devices they fund are defensible and safe; healthcare providers, eg, pharmacists and doctors, should receive comprehensive training on all aspects of using the device and testing, then ensure that when they provide a device to a patient, the patient has been fully informed about all technical intricacies of testing, what a result means, possible sources of erroneous results and who to contact for help if needed; and finally patients should know their rights, ask questions and take responsibility for their health, devices they use and tests that they undergo. New Zealand is updating its laws that govern medical devices. The Therapeutics Products Bill 2014 was released for consultation by the Minister of Health in December 2018. It is expected that the Bill will ensure that the new laws will be aligned with International Standards but should consider the uniqueness of individual populations, the New Zealand population. The authors propose a vision that is consistent with the aims of the Bill and also supports safe and fit-for-purpose POCT devices and tests are provided in New Zealand.
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.