Revised: 29 August 2013

Safety Information

Reporting of Incidents involving Active Implantable Devices and their Accessories

Wellington
19 March 2008

Reporting of Incidents involving Active Implantable Devices and their Accessories

Medsafe, the New Zealand Safety Authority for Medicines and Medical Devices, wishes to remind clinicians, and hospitals, of the need to report the details of any adverse events arising from the use of active implantable medical devices to the manufacturers of these devices and to Medsafe.

Manufacturers of medical devices are required to operate design and manufacture quality system by regulators of medical devices, such as Medsafe. These systems require users to report on the performance of products to manufacturers. Reports on the ease of implantation of a device, its safety and efficacy, and the longevity of the device are used by manufacturers to inform their Correction and Preventative Action Programs (CAPA) and to make improvements to the device.

Medsafe encourages clinicians to supply information to the manufacturers of devices describing where and when their products are implanted or explanted, and to report all problems that occur with the device. Where a device has been explanted due to a fault or difficulties with its operation, Medsafe recommends that the device be returned to the manufacturer for analysis so that the cause of the fault may be accurately determined.

Medsafe regards the reporting of incidents involving active implantable medical devices, and their accessories, to the equipment manufacturer as a best practice requirement and requests clinicians to cooperate in this reporting system.

For queries regarding medical device safety please contact us at devices@health.govt.nz

Yours sincerely,

Stewart Jessamine
Group Manager
Medsafe