26th July 2019, Volume 132 Number 1499

Samarina MA Musaad, Geoffrey CE Herd

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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Summary

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.

Abstract

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.

Author Information

Samarina MA Musaad, Chemical Pathologist; Labplus, Auckland District Health Board and Labtests, Healthscope Laboratories, Auckland; Geoffrey CE Herd, Point-of-Care Testing Coordinator, Whangarei Hospital, Northland District Health Board, Whangarei.

Acknowledgements

This article reflects the views of the Northern Region Point-of-Care Testing Group. The authors acknowledge the support of the Northern Region Point-of-Care Testing Group and would like to thank Melanie Adriaansen and Chris Finlay for their helpful input and advice. The authors are members of this Group and the other representatives are: Waitemata DHB: Stephanie Williams, Melanie Adriaansen, Benjamin Jones, Dr Matthew Rogers; Auckland DHB: Chris Finlay, Andrew Meisner, Nadia Al-Anbuky; Counties Manukau DHB: Mark Burnett, Agnes Le, Kim Le, Dr Ross Boswell.

Correspondence

Dr Samarina MA Musaad, Chemical Pathologist; Labplus, Auckland District Health Board and Labtests, Healthscope Laboratories, Auckland.

Correspondence Email

samarina.musaad@labtests.co.nz

Competing Interests

Mr Herd reports affiliation with Radiometer Pacific Ltd and Roche Diagnostics NZ Ltd outside the submitted work; he is a member of the New Zealand Point of Care Testing Advisory Group and the Northern Region District Health Board Point of Care Testing Group.

References

  1. New Zealand Best Practice Guidelines for Point-of-Care Testing 2018. New Zealand Point-of-Care Testing Advisory Group. 
  2. Health and Disability Services Code of Consumers Rights 1996 http://www.hdc.org.nz/the-act--code/the-code-of-rights accessed 27/9/2018.
  3. Musaad S, Herd G. Point-of-care testing governance in New Zealand: a national framework. NZMJ 2013; 126:72–79.
  4. Medsafe http://www.medsafe.govt.nz/ Accessed 27/9/2018
  5. Medicines and Health Care Products Regulatory Agency http://www.gov.uk/government/collections/regulatory-guidance-for-medical-devices accessed 7/1/2019.
  6. Scandinavian evaluation of laboratory equipment for point of care testing (SKUP) http://www.skup.org/ accessed 7/1/2019.
  7. New Zealand Government. Ministry of Health 2018. Minister’s press release - http://www.beehive.govt.nz/release/have-your-say-new-rules-medicines-and-medical-devices accessed 14/12/2018.
  8. Ministry of Health. 2018 Therapeutic Products Regulatory Scheme: Consultation Document. Wellington: Ministry of Health. http://www.health.govt.nz/publication/therapeutic-products-regulatory-scheme-consultation-document accessed 14/12/2018.
  9. International Accreditation New Zealand http://www.ianz.govt.nz/directory/ accessed 7/1/2019.
  10. International Standard NZS/ISO15189:2012 Medical testing – Particular requirements for quality and competence.
  11. International Standard NZS/ISO22870:2016 Point of care testing (POCT) – Requirements for quality and competence. 
  12. Musaad S, Khan S, Herd G. Point–of–care testing: High time for a dedicated National Adverse Events Monitoring System. Clin Biochem Rev 2015; 36:3–6.
  13. Pharmaceutical Management Agency PHARMAC http://www.pharmac.govt.nz/ accessed 14/12/2018.
  14. Herd G, Musaad S. Clinical governance for point-of-care testing at provider level. NZMJ 2015; 128:41–46. 

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