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January 15, 2026
Approximately 5 minutes
TGA Post-Market Review of Ventilators, CPAP, and BiPAP Devices
TGA Post-Market Review of Ventilators, CPAP, and BiPAP Devices
1. Background and Initiation
The Therapeutic Goods Administration (TGA) initiated a post-market review of ventilator, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) devices included in the Australian Register of Therapeutic Goods (ARTG). This review was prompted by risks identified in polyester-based polyurethane (PE-PUR) foam used as soundproofing in devices supplied by Philips Electronics Australia Ltd. The aim is to ensure these devices meet the Essential Principles and are safe over their service life. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-ventilator-cpap-and-bipap-devices
The review covers continuous and non-continuous ventilators, acute care ventilators, ambulatory ventilators, CPAP devices, and BiPAP devices.
2. Devices Under Scope
The devices assist patient breathing:
- Ventilators push air (or air with oxygen) into the lungs and remove carbon dioxide, used non-invasively or invasively in hospitals or homes.
- CPAP devices deliver continuous positive pressure via a mask to treat obstructive sleep apnoea at home.
- BiPAP devices provide two pressure levels for inhalation and exhalation to treat central sleep apnoea and other lung conditions, primarily non-invasively. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-ventilator-cpap-and-bipap-devices
All such devices in the ARTG are included in the review.
3. Identified Safety Concerns
Concerns focus on PE-PUR foam degradation, which may lead to deterioration in device performance and unnecessary health risks during normal use. For other devices containing foam, the review assesses material degradation and long-term safety. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-ventilator-cpap-and-bipap-devices
Specific risks include potential health impacts from foam particles or volatile organic compounds.
4. Sponsor Requirements and Responses
Sponsors were requested to provide information on soundproofing materials, risk assessments, mitigation strategies, and evidence of long-term safety. For non-Philips devices with PE-PUR foam or other foams in the breathing gas pathway, submissions are under review. Philips has fulfilled conditions of inclusion (COI) by providing information on corrected devices, which is currently under TGA assessment. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-ventilator-cpap-and-bipap-devices
5. Regulatory Outcomes
The review is ongoing. Actions against Philips include Federal Court proceedings for alleged unlawful supply of non-compliant devices, ten infringement notices for delayed reporting, and COI on affected ARTG entries for timely recall and remediation. Lists of unaffected devices, devices with PE-PUR foam, and devices with other foams are published and updated. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-ventilator-cpap-and-bipap-devices
Regulatory decisions are based on individual device merit.
6. Guidance for Users and Healthcare Professionals
Users of Philips devices should consult the TGA's Philips recall webpage and register their device with Philips. Consumers should discuss concerns with healthcare practitioners. Patients and professionals are encouraged to report adverse events via the TGA's Incident Reporting and Investigation Scheme (IRIS). Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-ventilator-cpap-and-bipap-devices
7. Current Status and Expert Input
The review continues with updates as available. A Ventilator Expert Working Group (VEWG) considered information from July 2021 to April 2023 and concluded its work. All COI on devices can be viewed on the ARTG certificate. Source: https://www.tga.gov.au/products/medical-devices/monitoring-and-compliance/medical-device-post-market-reviews/post-market-review-ventilator-cpap-and-bipap-devices
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