Product recall arrangements
This information overviews the processes for product recalls of goods and medical consumables serviced by the HealthShare Victoria supply chain. HealthShare Victoria carries out the process and action of recalls in accordance with the guidelines established by the appropriate industry regulator.
The aim of this procedure is to mitigate risk – and increase patient safety – by ensuring roles and responsibilities around recall notifications and actions are known by those Victorian public health services serviced by the HealthShare Victoria supply chain.
HSV is not able to track goods that are not held in the HSV supply chain network, or goods once they have been delivered directly to health services. Health services will maintain responsibility for product recall requirements once they take delivery of the stock.
HSV purchasing arrangements and the product recall regulatory environment
Suppliers or sponsors and/or their wholesalers are required to identify precisely where affected goods have been distributed in the event of a product recall.
HSV’s purchasing arrangements will support an effective product recall process. These arrangements provide clarity on how HSV will support supply chain transparency and interact with sponsors’ or suppliers’ ability to meet legislative requirements for product recalls for medical consumables:
- If advised by a supplier that a product is being recalled, HSV is responsible for tracking stock items via its purchasing and ordering systems and advising our partner health services of the recall.
- HSV will provide relevant supply chain data of stock items to assist suppliers in product tracking.
- Health services will retain responsibility for managing recall arrangements for products it has received from HSV.
For more information on recalls, please see the following page:
Frequently asked questions
Who is responsible for tracking products or batches delivered to HSV’s supply chain network and then distributed to health services?
Suppliers are responsible for tracking individual products or batches of products until their delivery to one of the distribution centres within the HSV supply chain network.
In the event of a product recall, HSV and the relevant supplier will coordinate further tracking of products or batches within the HSV supply chain network.
Health services are responsible for tracking products that have been distributed to their site/s.
How can a supplier know which health service HSV has shipped the product to?
The HSV Recall Coordinator will advise the supplier. The process involves the following steps to track products being recalled:
- Recall notification is received from the Recall Health or Recall platform.
- The HSV Distribution Recall Coordinator is informed of the recall action and product locations.
- The HSV Recall Coordinator contacts partner health service Recall Coordinators to notify them of the recall and requests that they quarantine affected product.
- If the recall involves inventory product, the HSV supply chain identifies the product(s) and quarantines it.
- The HSV Recall Coordinator notifies the relevant supplier of the quarantined product location and if a return is required, the supplier collects the product from health service locations or HSV supply chain sites as applicable.
Who is responsible for coordinating health service responses, the return or disposal of recalled products, and providing credit to HSV (rather than to individual partner health services or hospital sites)?
HSV maintains financial accountability with suppliers based on orders that we raise and will credit any partner health service affected by a product recall. The relevant supplier, at HSV ’s direction, will be responsible for collecting or disposing of any recalled product from the relevant health service.
Will suppliers be able to obtain data on which health services have received products distributed from HSV’s supply chain network?
HSV may provide data on products where it can be demonstrated there is a clear need for the supplier to have the requested information. As outlined, HSV will directly transact with suppliers, who should request data directly from HSV.
Page updated 22 May 2023.