Medsafe to regulate point-of-care kits
Medsafe will look at options to restrict the importing and sale of Covid-19 point-of-care test kits after medical workers called for greater regulation.
Chris James, group manager at Medsafe, the medical regulatory body run by the Ministry of Health, said there was currently no pre-market assessment or approval required for medical devices in New Zealand.
‘‘Those used as part of point-ofcare testing are not generally regulated,’’ James said.
Point-of-care testing is the testing and analysis of specimens outside traditional laboratories, typically near to or at the site of patient care.
Locations can include emergency departments, hospital wards, GP surgeries, health clinics, pharmacies, patients’ homes, and now, community-based assessment centres (CBACs) for Covid-19.
Medsafe was looking at options to restrict the importing and sale of coronavirus point-of-care testing kits, until there was evidence of their accuracy and to ensure they were suitable for use in New Zealand.
‘‘Any type of point-of-care testing needs to be combined with sound clinical governance to enable safe and effective testing and clinical decision-making.’’
The Government was also developing a new therapeutic products regulatory regime, he said. New legislation, called the Therapeutics Products Bill, would provide up-to-date regulation of all therapeutic products, including point-of-care testing, James said.
It would look to align with international standards where appropriate, and uphold the quality of regulation currently carried out by the Ministry of Health.
The news comes after the New Zealand Medical Association asked for urgent national regulation of point-of-care testing.
‘‘We are in the middle of a pandemic, and point-of-care testing has dramatically increased, which means right now is the right time to put in place national regulation to safeguard all concerned,’’ the association’s chair Dr Kate Baddock said.
‘‘Currently, point-of-care testing devices are not subject to effective regulation in New Zealand and this poses significant challenges to the consistency, accuracy, recording of, and quality assurance of, testing – especially for the patient.’’
Baddock said it was fantastic to see that Medsafe supported the association’s call for regulation, and had outlined specific and pertinent measures.
Particularly pleasing news was the fact that point-of-care testing would be included in new legislation, as previously this had been a grey area.