Revised: 1 July 2014
Medical Devices
Glossary of Terms
Understand the language of medical devices. To comply with the Act and the Regulations it is necessary to understand what is meant by key words and phrases.
| Term | Relating to | Definition |
|---|---|---|
| Acknowledgement form | Corrective action | A form accompanying a corrective action notice for the customer/user to complete and return to the sponsor to confirm receipt of the notice. In a recall situation this form should also be used by the customer to indicate the number of units of affected product they hold, or have under their control. |
| Affected product | Corrective action | A defined grouping of product that is impacted by a corrective action. The sub-set may be defined by lot/batch number, date of manufacture, expiry date, date of distribution, serial number range, or by some other suitable means. |
| ARTG Number | WAND | Australian Register of Therapeutic Goods Number This is the reference given to a device for which marketing approval has been granted by the Australian Therapeutic Goods Administration (TGA). For sponsors supplying devices in both New Zealand and Australia there is an optional field in the WAND device notification form where this number may be recorded. |
| CAPA | Corrective action | Corrective and Preventative Action Action taken by the manufacturer to correct an issue, and/or to prevent such an issue from recurring. |
| Corrective action | Corrective action | Collective term used to refer to all post market actions taken in response to a safety matter. This includes, but is not limited to; recalls, product corrections, safety alerts, hazard alerts, advisories, and field safety notices. |
| Corrective action notice | Corrective action | Generic term used to refer to any recall, product correction, alert, advisory or field safety notice issued in response to a safety issue. |
| Destruction certificate | Corrective action | Document issued by the operator of a secure landfill or medical
waste destruction facility to confirm the receipt and destruction
of goods. Destruction certificates are requested by Medsafe as confirmation that recalled goods have been destroyed safely. |
| Field safety corrective action (FSCA) | Corrective action | A field safety corrective action (FSCA) is action taken by a
sponsor of a medical device to reduce a risk of death or serious
deterioration in the state of health associated with the use of
a medical device. Possible actions include:
|
| GMDN Code | WAND | The Global Medical Device Nomenclature (GMDN) code is an international
system used to describe medical devices. A GMDN code is a 5-digit
number that references a text description of the device. GMDN codes
are selected by the manufacturer to describe its devices. Information
about a GMDN code for a particular device should be obtained from
the manufacturer. The GMDN Agency manages the coding system. |
| Hazard alert | Corrective action | Information issued to healthcare professionals about implanted
medical devices concerning a safety related condition pertaining
to that device. This information may describe situations to be aware
of or advise of potential complications that have arisen since the
device was implanted. Note - a hazard alert may also be issued in conjunction with a notice recalling all unimplanted devices. |
| Intended Purpose | WAND | The intended purpose of a medical device is the purpose for
which the manufacturer of the device intends it to be used. The
description of the intended purpose of the device should be provided
by the manufacturer of the device. The intended purpose should be
clearly stated in 1-2 sentences. For example; "Nasal splints to reduce or prevent adhesions between the septum and lateral nasal wall", instead of "Nasal splints for nose."
|
| Product correction | Corrective action | Notice issued by the sponsor to advise customers and users that a modification, correction, or upgrade relating to the device is required. Product corrective actions include, but are not limited to; software upgrades (for safety reasons), structural modifications, changes in labelling or instructions for use, replacement of componentry, adjustment of specifications, and recalibration. |
| Quarantine | Corrective action | The storage of affected product so that it is prevented from being accessed or used during a corrective action. For sponsors this includes the storage of non-distributed affected product as well as returned affected product. For users this is the storage of affected product before it is collected or returned to the supplier. |
| Recall | Corrective action | The removal from the market of a specified grouping of medical devices for safety reasons. The sub-set may be defined by lot/batch number, date of manufacture, expiry date, date of distribution, serial number range, or any other identifiable means. |
| Safety alert | Corrective action |
|
| Sponsor | WAND | The New Zealand entity - exporter, importer or local manufacturer
- responsible for the medical device. Definition of a Sponsor |
| Sponsor's Own Reference | WAND | A free text field to be used by the sponsor to identify the
device(s) being notified to the WAND database. High risk devices (class III and AIMD) must be uniquely identified in the field; for example, "Heavenly Lifetime Defibrillator Lead, Model 1313". Medsafe recommends all notifications incorporate a description of the device that includes the brand and description for ease of identification. For example; "Tonka Large Scale Trucks" instead of "Trucks". |
| TGA | WAND | The Australian Therapeutic Goods Administration The federal Australian regulator for medicines, medical devices, and other therapeutic products. |
| Therapeutic Purpose | WAND | For a product to be a medical device it must have a therapeutic
purpose. A product may also be regulated as a medical device or
a medicine if the manufacturer or sponsor claims or implies a therapeutic
purpose for its product. The definition of therapeutic purpose is
contained within Section 4 of the Medicines Act 1981. Understanding Therapeutic Purpose |
| URP | Corrective action | Uniform Recall Procedure The short name for the "Uniform Recall Procedure for Medicines and Medical Devices". The guidance document issued by Medsafe outlining the procedure to be followed when conducting a corrective action in New Zealand. |
| WAND Administrator | WAND | The person nominated by a sponsor to be its first point of contact
with Medsafe regarding the WAND database. The WAND Administrator is responsible for the sponsor's WAND access. Any communication sent by Medsafe via WAND will be sent to the WAND Administrator email address. Update the WAND Administrator Details Form (Word 51 KB, 4 pages) |
