On October 3, the TGA announced a revision to the URPTG, which is accompanied by a 3 month “familiarisation period” before taking effect on 15th January 2018. We take a look at the new expectations TGA has of manufacturers and sponsors, and is a good starting point to think about the measures your company has in place in case a recall is required.
Terminology: Field Corrections vs Product Removal
Although actions can still be broadly classified as Recall or Non-recall, their subcategories are slightly different in the new version of the URPTG and the new terminology is designed to eliminate the confusion associated with the current language.
Under recall actions, the TGA has changed “recall for product correction” to “product defect correction”, which makes it at least a little clearer that this does not necessarily involve removal of the device from the field but is usually dealt with by a field service action.
TGA have also added a new subcategory “product defect alert”, which can be conducted when the discontinuation of treatment is riskier than continued use of the deficient product. This measure is appropriate when there exists no alternative product or treatment, and discontinuation of the defective product will result in interruption of patient treatment or a medicine shortage.
Regarding non-recall actions, the TGA has also clarified the language, replacing “withdrawal” and “recovery” with “quarantine” and “product withdrawal”, respectively.
Product quarantine is set to be the precursor for recall in case of a serious issue or incident with a device; it involves suspension of further supply of the device pending investigation. Product withdrawal is where a product is removed from market due to reasons unrelated to safety, quality, efficacy or presentation. For example, you may conduct a product withdrawal if you wish to remove a previous model from the market when a new model is released.
Shiny new flowcharts
To make things less painful than they have to be, the TGA has introduced a set of step by step protocols for recall, set out in flowchart form. In the newest version of the URPTG, there are two flowcharts which detail procedures for two different flavours of recall – immediate or other.
An immediate recall is appropriate when a product is an imminent or significant threat or if it is suspected that the product has been tampered with during manufacture. In this case it is critical to contact the Australian Recall Co-ordinator, who will implement and report on the agreed recall strategy and future actions.
For all recalls, the manufacturer must obtain distribution and stock status, conduct a risk analysis and decide the type, class and level of recall required. Remember that this process does not have to be confusing and arduous.
Recalls almost always have international ramifications. Regulators read each others recall databases and a recall announced in one market can quickly lead to enquiries from other regulators as to why they haven’t heard from you. If this isn’t managed proactively, the consequences can be disastrous. If you are not sure, or new to this, it is well worth taking expert advice on deciding if a recall is needed and how to manage the process.
Before implementing a recall, it is important that manufacturers have a recall and communication strategy in place. After the TGA has assessed this information, it is up to you to provide recall progress reports and the corrective and preventative actions you have taken. Based on this information, the TGA will decide if any further action is required.
What can you do to prepare?
Firstly, if you think you will conduct market action before the end of the year, stick to the current version of the URPTG but keep the new rules in the back of your mind.
Given this update in procedure and regulation, now is the time to take stock of your current internal procedures.
Don’t forget to consider things like adverse event reporting methods – how are you receiving correspondence or complaints regarding your sponsored or manufactured devices and do you capture adequate information? Have you appointed at least two personnel to implement a recall if the time comes, and have you provided their after-hours details to the TGA?
What are your plans for communicating with the regulator, your customers and the media in the event of a recall?
Taking care of these aspects now will be some of the highest value planning you ever do. Recalls happen to everyone (go read the recalls database and recognise all those household names).
As they say, it’s too late to write a disaster plan on the day after the disaster.
For more information:
Need situation specific advice about your postmarket activities? We have extensive experience in implementing recalls on behalf of manufacturers. We work with you to ensure proactive, continuing compliance and manage emerging issues to minimise disruption to your business. Let’s talk! Drop us a line at email@example.com or call our office on +61 2 9906 2984.