The TGA states
The TGA is seeking comments from interested parties on the applicability and usefulness of the content contained in the draft regulatory guidance and information materials. The guidance is intended to assist industry understand and comply with their responsibilities to ensure that medical devices are cyber secure.
The guidance will also contain information to assist users (including those in health care settings) with managing cyber security matters related to the use of medical devices. ... The purpose of the consultation is to seek stakeholder feedback on the proposed guidance and information materials which have been prepared to assist industry understand and comply with their responsibilities to ensure that medical devices are cyber secure under the Therapeutic Goods Act 1989 as well as in accordance with the ‘Essential Principles’, as set out in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002.
Feedback from the medical device cyber security public consultation and webinar, and targeted stakeholder interviews has informed the development of this guidance.
Connectivity and digitisation of medical device technologies may help improve or increase device functionality. However, the connection of devices to networks or the internet exposes devices to increased cyber vulnerabilities that can potentially lead to unacceptable risk of harm to patients. A large number of Class II, Class III and Active Implantable medical devices on the ARTG include electronic components with embedded software, have a software accessory or are a software device. This is a growing area of interest as more health care systems and patients rely on medical devices that are 'connectable'. There is also significant innovation and fast moving technological advancements in software development underpinning more personalised medical devices.The announcement coincides with the TGA's strange response to problems with breast implants, ie they are apparently fine to use if they are 'in stock' - something that raises concerns about potential harms and the TGA's disregard of public communication.
The ABC yesterday reported
Breast implants deemed unsafe in Europe will continued to be used in Australia, according to local health authorities. "From now on, these medical devices can no longer be marketed in France and in Europe and [we have asked] Allergan to recall products in stock at all health facilities," a statement from the National Security Agency of Medicines and Health Products said.
In response, the Australian regulator, the Therapeutic Goods Administration (TGA), said no new textured implants made by Allergan would be allowed to be used here, but that would NOT stop existing implants on shelves from being used.As a law academic I do wonder why there isn't a comprehensive recall of what's on the 'shelf' if concerns are so serious that imports are prohibited.
The ABC report goes on
The French announcement came in the wake of a probe by the International Consortium of Investigative Journalists (ICIJ), including the ABC, which highlighted significant flaws with the way medical devices were approved for use in patients and monitored once on the market.
Textured implants are used in about 90 per cent of Australian breast augmentations and the Allergan brand is the most popular among surgeons. An estimated 40,000 breast surgeries take place in Australia each year.
A spokesman for the TGA said it was working with Allergan and French regulators to determine the "most appropriate course of action in Australia".We should expect the TGA to proactively 'work with' the community rather than merely the vendor of a health product that - on the face of it - is sufficiently problematical to incur a ban. Regulatory scholars will recall the belated TGA response to substantive problems with pelvic mesh and PIP (Poly Implant Prosthese) implants.
