TGA Puts New Recall Procedures Into Effect

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:

• A recall removes the device permanently from the market or from use when there are deficiencies or potential deficiencies in safety, quality or performance;
• A product defect correction is undertaken to correct a specific or potential deficiency and includes repair, modification, adjustment, relabeling or risk mitigation until a permanent correction is made;
• A hazard alert is issued for an implanted device with a deficiency or potential deficiency related to safety, quality, performance or efficacy when implanted devices cannot be recalled;
• A product defect alert allows for informed continued use of a defective but critical product and describes precautionary actions that clinicians or patients may take to mitigate risk.

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:

• The manufacturer (through the implementation of their quality management system);
• The Australian sponsor through adverse event reports or complaints;
• The TGA through its post-marketing monitoring and compliance activities;
• Other regulators that notify the TGA through international collaborative activities; and
• Third-party auditors or inspections by regulators.

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.