NZ Medical Device Recalls Remind Medical Device Suppliers to be Prepared
New Zealand (NZ)’s regulatory body for therapeutic goods, Medsafe, have issued a reminder to medical device suppliers to ensure they are suitability prepared for a recall should an adverse event occur with a supplied device. Medsafe advise, recall actions are serious matters. They are also not isolated matters. Between 1-Jul-2012 and 30-Jun-2013 Medsafe was advised of 705 medical device market actions, resulting in 101 recalls, 173 corrective actions, and 25 alerts. The balance of actions related to devices where the affected lots/batches/versions were not supplied in New Zealand, or where the device itself had not been supplied in NZ.
Medical devices supplied in NZ must be listed on the Medsafe medical device database, Web Assisted Notification of Devices (WAND), established by the Medicines (Database of Medical Devices) Regulations 2003 which came into force on 1 January 2004. Organisations supplying medical devices in NZ must have a supporting post market surveillance system which monitors devices once on the market in NZ and facilitates traceability, adverse event reporting and recall where required.
Medsafe reminded medical device suppliers to do the following:
- Be Prepared
- Recall actions can occur at any time. Make sure your organisation has a plan detailing how your respond to a recall action, what needs to be done, who needs to do what, and when it has to be done by.
- These procedures make up what is often termed, a post market surveillance system.
- Inform Medsafe (the Regulator)
- Any recall action relating to a medicine or medical device should be conducted in consultation with Medsafe, Ministry of Health. The guidance issued by Medsafe states, “An agent must immediately consult the Ministry of Health when there is reason to consider that a product recall may be required.” If the New Zealand sponsor is not the initiator of the correspondence, then representatives of the New Zealand sponsor need to be copied in to all correspondence with Medsafe.
- Advise your customers
- Information about a recall action needs to be communicated clearly and concisely, avoiding “marketing speak”, so that customers know how to correctly identify affected product and what needs to be done should they have affected product.
- Report on progress
- Recall actions are concluded when all actions relating to the issue with the affected product have been resolved, the root cause identified, and corrective and preventative action (CAPA) has been implemented to prevent a recurrence of the issue. All of this information needs to be communicated to Medsafe in a timely manner.
Information about recall actions conducted in New Zealand is published to the Medsafe On-line Recalls Database at the link below;
Does your organisation have a post market surveillance system which assists you to monitor your devices on the market place, identify and comply with adverse event reporting requirements, and follow appropriate procedures for recall? KD&A can provide your organisation which a system designed to meet your specific needs and the regulatory requirements in both NZ and Australia. Contact KD&A for a quotation, or visit our Post Market Surveillance page.