Reporting a Defect
Reporting Faulty Medical Devices
Report even if you consider the fault is isolated
Communications network established with hospitals
Reporting form
Medsafe wants to receive reports of faulty medical devices from doctors, pharmacists and other health professionals. Defects such as incorrect labelling, faulty packaging, foreign material in a device or a device not working as expected should be reported.
Medical devices are defined in the Medicines Act 1981 and can range from condoms to complex electronic equipment. Other examples include implantable devices, diagnostic and monitoring equipment and disposable equipment such as syringes, wound dressings and gloves.
Report even if you consider the fault is isolated
It is easy to question the worth of reporting what you think is an isolated fault, but if Medsafe receives a number of similar reports then the fault becomes more significant. Medsafe will investigate the problem with the local distributor and, if necessary, contact overseas regulatory agencies to ascertain whether they have received reports about the device.
Communications network established with hospitals
A communications network between hospitals and Medsafe has been established so that information on medical device issues can quickly be disseminated. As well, the network encourages hospital staff to report any device problems they have. The general manager of each hospital has nominated a contact person with Medsafe so hospital doctors can either report faulty devices via that person, or directly to Medsafe.
Reporting Form
A Microsoft Word reporting form (3,352KB), common to New Zealand and Australia, should be used to report suspected defects to medical devices. Initially the form requires downloading to your computer. Return the completed form to Medsafe by post, fax or e-mail. Contact details are on the form.
As the form was developed and printed prior to the launch of Medsafe, it contains the Ministry of Health logo. The form will contain Medsafe's logo when it is reprinted.
Further information on reporting faulty medical devices contact the Compliance Team at Medsafe.