Information for Medical Device Suppliers
Glossary of Corrective Action Terms
Understand the language of recalls and corrective actions. The glossary provides definitions for the key words used when describing or conducting corrective actions.
|Acknowledgement Form||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||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.|
|CAPA||Corrective and Preventative Action
Action taken by the manufacturer to correct an issue, and/or to prevent such an issue from recurring.
|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||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||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)||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
Return of a medical device to the sponsor
Advice given by manufacturer or sponsor regarding the use of the device (e.g. where the device is no longer on the market or has been withdrawn but could still possibly be in use e.g. implants)
|Hazard Alert||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.
|Product Correction||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||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||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||Notice issued by the sponsor to emphasise to users a safety related condition that may occur given a particular set of circumstances that has been highlighted in the device's instructions for use. (Note that new information, warnings, or instructions should be advised via a product correction notice.)|
|URP||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.
Page last updated 10 May 2011