, , , , , , , , ,

Radio New Zealand : News : National : Hip implant probe sparks call for better NZ system.

Hip implant probe sparks call for better NZ system

Updated at 7:45 pm on 26 October 2012

Manufacturers of medical devices say hip implants and other medical devices imported for use in this country are made to a very high standard and regulation is not needed.

Calls for better scrutiny of medical devices used in this country are being renewed in the wake of an investigation in Europe.

An undercover investigation by Britain’s Daily Telegraph newspaper and theBritish Medical Journal has exposed flaws in the European Union system of approving devices.

The probe revealed that some European regulatory bodies will approve devices even when they have been modelled on hip replacement systems that have already failed and been withdrawn.

Some regulatory bodies admitted to investigators they were on the side of manufacturers rather than patients.

Manufacturers wanting their products used in New Zealand, which does not regulate devices, must register them on a Ministry of Health database.

Increased scrutiny not considered practical

Auckland transplant surgeon Stephen Munn says there are weaknesses in international regulatory systems and New Zealand should increase its scrutiny of medical devices to the same level required of medicines.

The Ministry of Health’s Medsafe group says medical devices used in this country are up to the highest international standards and it is working towards a joint regulation system with Australia.

Faye Sumner, who heads the manufacturers group the Medical Technology Association, says Australia’s highly regulated system has had no different outcomes than have occurred in New Zealand.

“Ninety-nine percent of the products coming into New Zealand have been through rigorous audits and do meet an ISO standard,” she says.

Ms Sumner says it is not practical to increase scrutiny to the level required of medicines, and ethical considerations would prevent placebo implants from being used in a randomised control trial.