Australia’s Therapeutic Goods Administration has implemented new recall procedures that clarify when to quarantine products as well as how to communicate information about recalls.
The new system introduces two new types of recall actions: product defect corrections and product defect alerts. It also clarifies existing processes and explains the roles and responsibilities of the parties involved in recalls.
Under TGA regulations, there are four distinct recall actions:
Class I recalls are required when there is a “reasonable probability” that use of the device will cause serious, permanent or long-term adverse health consequences or death. Devicemakers should immediately recall products that pose an immediate and significant threat, involve actual or potential product tampering, involve human blood or blood components or radiopharmaceuticals, the agency said.
Devicemakers should issue recalls whenever there is a safety, performance issue or quality issue. These could be due to non-compliance with specified standards or legislative or manufacturing requirements.
The TGA clarified that manufacturers can undertake a non-recall action if the device meets all specifications and standards and there are no deficiencies in safety, quality, efficacy, performance or presentation. Non-recall actions include safety alerts, product notifications, quarantine and product withdrawals.
Any action should be taken by the sponsor responsible for the device and it should involve all parties that have a role in the recall. Anyone within the supply chain can identify an issue that requires either a recall or non-recall action, including:
Once a recall action is initiated, the TGA notifies key stakeholders, including state and territory health departments.
Read the notice here: www.fdanews.com/02-15-19-URPTG.pdf.