Consumers assured NZ medical devices meet safety standards
Consumers may be assured that medical devices used in New Zealand meet the highest quality standards both in New Zealand and internationally, says the Medical Technology Association of New Zealand, the only national industry body representing medical technology companies in NZ.
MTANZ CEO Faye Sumner, CNZM says these quality assessments are extremely robust.
“All devices entering NZ are currently notified to Medsafe, but this will become a registration process under the proposed NZ Therapeutic Products legislation replacing the Medicines Act 1981,” says Ms Sumner.
This legislation is expected to enter Parliament in 2019 and should ensure acceptable patient safety standards while maintaining timely access to innovative technologies.
“The medical technology industry is working closely with Medsafe in relation to new requirements and legislation to ensure that a medical device being placed on the NZ market meets the highest international standards (ISO) for safety and performance.”
MTANZ’s assurance comes after the release this week of a report titled “The Implant Files” by the International Consortium of Investigative Journalists (ICIJ) and a number of media organisations.
The Advanced Medical Technology Association (AdvaMed USA) has said the report magnifies the stories of only a few individuals and overlooks the overwhelmingly positive experiences of millions of others.
AdvaMed USA says that instead of a comprehensive look at both the challenges and the achievements of an industry that touches almost every human life, these stories counterfeit the life-changing and life-saving solutions delivered to millions of people worldwide.
“Our industry constantly strives to improve our technologies and care delivery. Medical devices are the foundation of modern medicine, providing healthcare professionals the tools they rely on to improve patient care.
“Medical devices undergo extensive testing both pre and post marketing. However, surgical procedures do carry risks and our industry works very hard to minimise those risks. Adverse events are a rarity. This report has completely ignored these facts and the reality that millions of people around the world can now see, hear, walk and live normal, healthy lives as a result of life-saving and life-improving medical devices,” says Ms Sumner.
“Such sensationalised reporting is irresponsible and a gross misrepresentation of the dedicated professionals who work in our industry.”