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DRAFT: Uniform Recall Procedure for Therapeutic Goods

Consultation document

27 October 2015

Book pagination

Step 6 - Analysing the type, class and level of recall

Note: This information is part of the Consultation: Revised edition of the Uniform Recall Procedure for Therapeutic Goods

Once you have determined that you need to conduct a safety-related recall, inform the TGA promptly (see Step 9).

You can skip this step and go to Step 7 if you know the proposed action type, proposed classification and proposed level of recall action.

Types of recall actions

Possible types of recall action are:

In some situations, you may wish to conduct a non-recall action.

Use your risk assessment to propose the action category type. If the TGA disagrees with your proposed action category, we will explain why and suggest an alternative.

Recall

Conduct a recall to remove products permanently from the market or from use when there are deficiencies or potential deficiencies in safety, quality, efficacy, performance or presentation.

Recalls include:

  • Removal from supply or use of products with inherent design or manufacturing defects
  • Requests to check and return products found to be defective sent to:
    • pharmacists
    • hospitals
    • pathology laboratories
    • fractionators
    • operating and research facilities
    • biomedical engineers
    • others.

Recalls do not include:

  • removal of time-expired products
  • removal of appropriate numbers of products for testing to determine whether there are deficiencies relating to quality, safety, efficacy, performance or presentation.

Product defect correction

A product defect correction is undertaken to correct a specific or potential deficiency.

In some instances, the product can continue to be used if there is robust mitigation in place until permanent correction has been implemented.

Product defect correction includes:

  • the repair, modification, adjustment or re-labelling of therapeutic goods for reasons relating to deficiencies in the quality, safety, efficacy, performance or presentation
  • corrections involving a product's expiry date
  • updates or changes to any accessories, operating instructions or software.

The corrective action may take place at any agreed location, including:

  • the user's premises (field correction)
  • any other agreed location.

Product defect correction does not include removal of individual products for:

  • repair in the event of an incidental malfunction or failure as a result of normal wear and tear or lack of good maintenance
  • appropriate preventative maintenance
  • modification due to technical improvements (that does not relate to quality, safety, efficacy, performance or presentation).

Hazard alert (implanted medical devices and biologicals)

A hazard alert is issued for an implanted good with a deficiency or potential deficiency relating to its safety, quality, performance or efficacy because implanted products (medical devices or biologicals) cannot be recalled.

Hazard alerts consist of:

  • precautionary information for health professionals, including advice on:
    • situations to be aware of
    • potential complications
  • advice about on-going management of affected patients.

A hazard alert may be issued in conjunction with a recall notice for affected products that have not been implanted.

Product defect alert

Discontinuation of treatment is sometimes riskier than continued use of the deficient product. This occurs for critical therapeutic products for which there is no alternative product or for which a recall action will result in interruption of patient treatment or a medicine shortage.

Product defect alerts:

  • raise awareness of the concerns about safety, quality, efficacy or performance
  • describe actions that clinicians or patients may take to mitigate risks due to product deficiencies.

A product defect alert may later be followed by a recall once unaffected or alternative products become available.

Non-recall actions

Not all issues require recall actions. You can conduct a non-recall action if:

  • the therapeutic products meet all specifications and standards

and

  • there are no deficiencies in safety, quality, efficacy, performance or presentation.

If the product does not meet all specifications and therapeutic indications, then you should be conducting a recall action.

Before you undertake a non-recall action:

  • fill out the form Notifying recall actions of therapeutic goods or email the TGA
  • include a copy of your proposed communication for the TGA to review.

The TGA recommends you wait for its review before continuing with your non-recall action to avoid the need to undertake further market action.

Safety alert

Safety alerts are issued to provide information on safe use of products in certain situations where, although meeting all specifications and therapeutic indications, its use could present an unreasonable risk of harm if certain specified precautions are not followed.

A safety alert is generally for reiterating specific precautions or instructions regarding use of the products.

Send the TGA copies of the final signed version of the safety alert and we will:

Depending on the circumstances, the TGA may also:

  • notify others, possibly alerting the public through our website
  • ask you to provide progress reports in Step 12
  • review the market action in Step 13.

Product notification

A product notification provides information about a product in a situation that is unlikely to involve significant adverse health consequences.

Quarantine

A quarantine action suspends further supply pending investigation of an issue or incident. The outcome of the investigation will determine whether further actions are required.

Product withdrawal

A product withdrawal is used to withdraw products for reasons that are not related to safety, quality, efficacy, performance or presentation. For example, removing a previous model when a new model has been released.

The risk based classification of recall actions

The TGA classifies recalls into three risk classes to convey the seriousness of the deficiency and the degree of risk involved.

Unlike the classes used for medical devices and biologicals, a Class I recall is the most serious. Class I and Class II are urgent, safety-related recalls. Class III recalls relate to the lowest risk cases and are not considered as urgent.

  • Class I recall - a situation in which there is a reasonable probability that the use of, or exposure to, a deficient product will cause serious adverse health consequences or death.
  • Class II recall - a situation in which use of, or exposure to, a deficient product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
  • Class III recall - a situation in which use of, or exposure to, the deficient product is not likely to cause adverse health consequences.

For further information, see examples of Class I, Class II and Class III recalls.

Level of recall action

The action level (or depth) describes who will be notified of the recall action.

Determining the level

The TGA needs to agree on a number of aspects of the recall strategy, including the type, class and level of recall action (see Step 10). To determine the level consider the following:

  • the channels by which the product has been distributed
  • the extent to which distribution has taken place
  • the potential harm to a user as a result of the issue
  • the likelihood of the issue occurring
  • the ability of the consumer, health professional or caregiver to identify the issue
  • whether the product is outside the manufacturer's specifications
  • the availability of an alternative product, or the risk associated with not providing treatment if an alternative product is not available:

The four levels

There are four levels of recall action.

Sometimes, the scope can be narrowed to particular groups within the level. For example, for some retail level actions you do not need to contact supermarkets and health food stores.

Wholesale level

Wholesale level includes:

  • medicine and device wholesalers, who are third parties holding product for distribution to retailers or other organisations
  • state and territory purchasing authorities.
Hospital level

Hospital level includes:

  • wholesale level
  • hospitals
  • nursing homes, hostels and other healthcare institutions
  • clinical investigators and the institutions in which clinical investigations are performed
  • hospital pharmacies, blood banks, pathology laboratories, operating facilities, fractionators, human tissue banks, other hospital departments
  • ambulance services including the Royal Flying Doctor Service.
Retail level

Retail level includes:

  • hospital and wholesale levels
  • retail pharmacists
  • dentists
  • general practitioners
  • other retail outlets such as supermarkets and health food stores.
Consumer level

Consumer level includes:

  • retail, hospital and wholesale levels
  • patients and other consumers.

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