Consultation: Improved sharing of information about medical devices | Proposed amendments relating to transparency of disruptions to supply of a medical device

We consulted on a proposal to improve transparency of information sharing about medical device supply disruptions. This consultation was only in relation to sharing information we hold and not to require stakeholders to provide information to us. The consultation sought feedback on:

• whether the TGA should release information about actual or anticipated disruptions,
• who that information should be shared with,
• what types of information would be most useful, and
• whether sponsors should be given an opportunity to comment before information is released.

View the public Consultation Document. 

We thank all stakeholders who participated in this consultation.

Participation

We received 48 submissions in response to the consultation from the following stakeholder groups:

• Consumers
• Health professionals, societies, and colleges
• Government entities
• Industry stakeholders.

Overall stakeholder support

Respondents broadly supported greater transparency about medical device supply disruptions, particularly where information sharing would support patient safety, informed decision making, contingency planning and procurement, and would improve public confidence in the health system and the regulator.  

Many respondents outside industry preferred public release, while industry stakeholders generally supported the intent but raised concerns about confidentiality, administrative burden, reputational impacts, and the risk of unintended consequences if information is released without appropriate controls.

Across the consultation, there was strong support for a risk-based and tiered approach to information sharing. This approach is intended to balance transparency and timely communication with the need to manage confidentiality, accuracy and proportionality.

We considered feedback from the public consultation alongside additional targeted engagements with representatives from industry, state and territory health departments, private hospitals and the Public Health Laboratory Network. This helped us better understand stakeholder views and refine the proposed risk-based and tiered approach.

We will now work to implement changes to the way in which we share information about medical device supply disruptions and shortages. This includes developing a legal instrument to support the release of information and publishing guidance material to improve transparency about disruptions to the supply of medical devices.

We will publish further updates on the TGA website as this work progresses.