Product recall arrangements

This information overviews Therapeutic Goods Administration (TGA) processes for product recalls of medical consumables delivered to HealthShare Victoria’s (HSV’s) Distribution Centre.

HSV’s warehouse management system will support TGA’s product recall requirements and enable product tracking – including batch and stock number information – for stock items held within our Distribution Centre system inventory and non-stock (imprest) items ordered by HSV as required for a health service and cross-docked at the HSV Distribution Centre. It also incorporates bulk stock that transits through the Distribution Centre out to health services.

HSV is not able to track goods that are not in stock, 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 bulk product purchasing arrangements and the product recall regulatory environment

The TGA requires suppliers or sponsors and/or their wholesalers to identify precisely where affected goods have been distributed – including where bulk purchasing arrangements are in place – in the event of a product recall.

The TGA has developed a process to assist state and territory coordinators in managing goods affected by product recalls within their jurisdictions.

HSV’s bulk purchasing arrangements will support an effective product recall process in line with TGA objectives. 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 covered by the TGA 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.

Frequently asked questions

Who is responsible for tracking products or batches delivered to HSV’s Distribution Centre and then distributed to health services?

Suppliers are responsible for tracking individual products or batches of products to their delivery to HSV’s Distribution Centre.

In the event of a product recall, HSV and the relevant supplier will coordinate further tracking of products or batches within the HSV Distribution Centre.

Health services are responsible for tracking products that have been distributed to their site/s.

How can a supplier know which health service the HSV Distribution Centre has shipped the product to?

HSV relies on advice from a supplier, the TGA or online communication platform Recall Health – which uses secure electronic processes for real-time product recall and withdrawal management within the healthcare sector – that a product recall action is underway. Once confirmed, HSV will track supply within our system, rather than requiring suppliers – who may not have access to relevant supply chain data to assist in tracking – to do this on our behalf.

The process involves the following steps to track products being recalled:

  1. Recall notification is received from the supplier, Recall Health or the TGA.
  2. HSV Distribution Centre Clinical Product Advisor (CPA) is informed of the recall action and product locations.
  3. CPA contacts partner health service ward locations to notify them of the recall and requests that they quarantine affected product.
  4. If the recall involves inventory product, the Distribution Centre identifies the product(s) and quarantines it.
  5. CPA notifies the relevant supplier of the quarantined product location and the supplier collects the product from health service locations or Distribution Centre as applicable.
  6. HSV will credit health services or replace product it has distributed when that product has been recalled, so long as the supplier has provided the product to the HSV Distribution Centre and notified HSV of the recall.

How does HSV’s bulk purchasing via the Distribution Centre interact with Recall Health and the requirement to use Recall Health?

When a supplier delivers to HSV’s Distribution Centre, that is the location to which the supplier tracks the item. HSV  will track stock items within the Distribution Centre system, and then partner health services are responsible for tracking products that have been distributed to their site/s.

Who is responsible for coordinating health service responses, the return or disposal of recalled products, and providing credit to HSV’s Distribution Centre (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 or RMH’s direction, will be responsible for collecting or disposing of any recalled product from the relevant health service.

Should the recall procedure have provision for the TGA to advise that supplier responsibility in a product recall transfers to the purchaser?

HSV is responsible for notifying locations and customers (i.e. partner health services and partner hospital sites) of recalled products that have been supplied to them from HSV’s Distribution Centre. It is HSV’s responsibility to provide this information to the relevant supplier.

The TGA will consider this point from a national regulatory perspective. For more information, please see information about recall procedures on the TGA’s website.

Will suppliers be able to obtain data on which health services have received products distributed from HSV’s Distribution Centre?

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.