Our members and their families rely on a range of medical devices to inject, infuse or which are implanted to manage symptoms of Parkinson’s, including Deep Brain Stimulation (DBS) systems and continuous medication therapies delivered by infusion pumps, such as intrajejunal levodopa (Duodopa), Fos levodopa/foscarbidopa (Vyalev) and apomorphine pumps (Apomine/Movapo) and Pen injectors (Movapo Pen and D-Mine Pen).

Further, with many new devices and delivery systems for Parkinson’s currently in development, people living with Parkinson’s will increasingly be choosing between device options, making the sharing of information about device safety, quality and performance essential to informed consent. Timely and accurate public information about the safety, quality and performance of these devices directly affects the confidence and wellbeing of the people we represent.

Question 1 — Do you agree generally to the sharing of information about medical devices included in a post-market review or investigation?

Yes.

Under the current framework, TGA can only publish information once formal regulatory action has been taken (a recall, hazard alert or ARTG suspension/cancellation). This means that where a device used by our members – for example, a DBS system, or an infusion pump, such as Duodopa, Vyalev or an apomorphine pump or pen injector – is reviewed and found non-compliant, no public record of the concern or outcome of investigation is available. Members are often aware a device has been raised as a concern (through media, clinicians or peer networks) but have no way to understand the concern or confirm the outcome.

Publishing outcomes regardless of whether regulatory action was taken would:

• Close this information gap for people relying on implanted and infused devices, where anxiety about device safety directly affects treatment decisions and quality of life
• Reduce reliance on manufacturers to answer individual enquiries about a device’s status (see Question 2)
• Build trust in the regulatory system by showing that reviews with no adverse findings are still visible, not just those that result in action
• Provide information to people during the decision-making process when there is a choice of devices to deliver a treatment.

Question 2 — What types of information should be shared?

We support publishing all four additional (currently non-public) categories proposed, for any device under review, not only where regulatory review results in action, i.e.

• Reason for the review or investigation
• Manufacturing and device information
• Findings, including positive findings where no action was required
• Review outcomes
• Complaints regarding support provided by device specific support services/patient support programs.

Additional information we recommend

1. Distinguish device faults from procedure- or technique-related complications.

   For implanted and infused devices used by our members, including DBS systems, Intra jejuneal levodopa (Duodopa), Foslevodopa/fos carbidopa (Vyalev) and apomorphine pumps (Movapo Apomine), a review finding needs to make clear whether an issue relates to the device itself, associated consumables (recharging and controllers for DBS of consumables for Apomorphine), software updates, surgical or clinical procedures or patient-specific factors. Without clear declaration of these distinctions, under-informed decisions may be made. For example, an isolated hardware issue risks being read by patients as, “this therapy is unsafe,” which could deter people from evidence-based treatment that is appropriate for them.

2. Require or encourage evidence of adequate consumer-enquiry capacity when a device is named.

   The consultation paper’s own rationale is that publication reduces the need for consumers to contact the manufacturer directly. In practice, a compliance-status entry (e.g. “Review complete – compliant with the requirements”) is unlikely to fully answer a worried patient’s question about their specific device or model and is more likely to prompt an enquiry than prevent one. For devices distributed in Australia by smaller specialty teams, which includes some newer Parkinson’s infusion therapies, a spike in enquiries following publication could outstrip existing support capacity, leaving patients without answers at the point they were told to expect transparency. This is particularly relevant when there is media surrounding a new device, leaving the patient questioning if this innovation could improve their symptom management.

   We recommend TGA either require sponsors to demonstrate adequate enquiry-handling capacity before a device is named, or publish sufficiently detailed, plain-language information that ensures patients are not forced to contact the manufacturer.

3. Extend the “intended purpose” field to flag evidence and classification strength.

   The proposal only applies once TGA has opened a formal post-market review. Devices marketed to our community on a much weaker evidence base, such as red light therapy or photobiomodulation products, often self-classified at a low risk tier or personally imported, may never trigger a review and so would never generate information under this scheme, even though they are a significant source of confusion for people seeking any credible option to manage their symptoms.

   We ask TGA to consider whether the already-public “intended purpose” information could be strengthened to indicate a device’s risk classification and evidence base, so consumers have some point of comparison even for products that fall outside the post-market review process altogether. The harm is not only financial, where these devices are perceived as an alternative rather than an adjunct, people may delay starting or discontinue approved medications and device-assisted therapies. This is a tangible and plausible risk for a progressive condition where timely treatment matters.

General comments

We strongly support the intent of this proposal. For a community managing a progressive condition like Parkinson’s, with implanted and infusion devices, published information, including confirmation that a device and associated consumables remain compliant, is a genuine reassurance tool, not just a disclosure mechanism. Being able to point our members to an authoritative, publicly available answer, rather than relying on informal information from clinicians, peer networks or the manufacturer, would meaningfully reduce anxiety and misinformation in our community.

We would welcome the opportunity to provide further input as this proposal is refined, particularly on how findings are communicated to patient groups and how consumer-facing language is tested before publication.

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