Atrium Medical products - US consent decree on manufacturing facility

The TGA is aware of regulatory action undertaken by the US Food and Drug Administration (FDA) in relation to the Maquet manufacturing facility in Hudson, New Hampshire, USA. However, Atrium Medical products that have been manufactured in that facility are not currently being removed, recalled or subject to other related corrective actions in Australia. Atrium Medical is a subsidiary of Maquet.

The TGA is also aware that some Australian hospitals have been informed of the consent decree entered into by Maquet and the FDA and that this may have resulted in some confusion.

The consent decree relates to FDA concerns about the Maquet facility's quality management system. It does not require that devices manufactured in the facility be removed or recalled from the market in the US.

While the standards expected of medical device manufacturers are generally uniform across regulators, different regulatory frameworks can result in different compliance actions being required in different countries.

The TGA has conducted its own inspection of the quality management system in Maquet's Hudson facility to assess the safety implications for Australian patients.

The TGA's investigation has not revealed any problems that would warrant regulatory action at this time, but rather found that the manufacturer has taken appropriate and acceptable steps to address identified issues.

A follow-up inspection will be undertaken by the TGA to confirm ongoing compliance with the applicable Australian standards.

The TGA will continue to monitor the safety and performance of the devices manufactured by Maquet, and will take appropriate regulatory action if a safety concern becomes apparent. In accordance with its usual procedures, the TGA will also continue to liaise closely with the FDA and other international regulators on this and similar issues.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.