Regulatory
found. Though regulators can issue a recall order if they think a company is being too slow to act. Regulators will then oversee the recall itself, though it’s the manufacturer’s responsibility to implement it. For example, in the US, the Food and Drug Administration (FDA) determines whether the recall has been rolled out effectively and when it can be terminated. Often, regulators will help spread information about the recall, too, though in practice, the process is opaque and inconsistent – in large part due to failures in collecting, sharing and making decisions based on data in a timely manner.
In June 2011, a report by the United States Government Accountability Office (GAO) noted that the FDA does not routinely analyse recall data, and that their process for overseeing recalls was unclear. For instance, they didn’t have any established criteria for assessing whether a company had removed the faulty devices sufficiently. Further, issues with medical devices are under-reported while data collecting systems are inefficient and lack transparency, reports a 2022 paper in the British Medical Journal (BMJ). Perhaps the most high-profile case of late was the 2021–2023 recall of Philips Respironics’ CPAP and CBAP machines, where patients were found to be breathing in harmful foam. Despite thousands of reports being filed detailing problems with the device, both the company and regulator have come under fire for being slow to act – all while patients who were unaware of the issues continued to use the machines. With recalls on the rise – from 2012 to 2022, there was a 125% increase in medical device recalls in the US, with the number of recalls within the most serious classification hitting a 15-year high – what might change to improve the process?
Better information flow
“Recalls can be massively complex,” says Stephen Gilbert, professor of medical device regulatory science at EKFZ Digital Health, part of the Faculty of Medicine of the TU Dresden. As exemplified by the Philips Respironics case, there are serious issues with how manufacturers report recalls, and how that information is accessed. Here, Gilbert believes that a better system would involve sharing information on device performance and quality between medical practitioners, patients, manufacturers and regulators. Indeed, the BMJ paper mentioned earlier describes concerns about ineffective data collection systems and the poor quality of information collected. But how to improve the information flow? Gilbert is optimistic that digital avenues hold part of the
answer, especially if a device can directly upload information to a publicly available database. If everyone from regulators to journalists and other stakeholders could access this, it prevents complete reliance on the manufacturer to report an issue with a device. There’s no excuse here, he explains, as if we have access to AI, we should be able to readily report live information from medical devices. In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) might point to the Yellow Card app, whereby anyone can report issues to a regulator. But Gilbert believes this just doesn’t work as intended. “It’s definitely not on the patient interface, doctors are immensely busy,” he says. “[Reporting] this way doesn’t happen that often.” And it’s not just reporting into databases that Gilbert believes holds the answer, but making the databases themselves more accessible. For instance, the US has a database on device issues, but in Europe such data can be harder to access. “It’s about information in the public domain so the authorities know their homework is being marked in public,” he says.
In the case of the Philips Respironics issue, Gilbert believes a recall resolution might have been reached much quicker if it were more widely seen that “these patients are telling their doctors they’re breathing in foam”. The rise of wearables and digital interfaces, where a device is connected to an app or central database, could potentially transform how incidents are reported.
More efficient systems
Gilbert believes that the emergence of AI and digitised systems could also improve outcomes by driving data-sharing efficiencies – in part because the information from devices can be more readily transmitted to larger systems. Trends in performance
Medical Device Developments /
www.medicaldevice-developments.com 15
FDA recall processes have faced criticism for being slow and opaque – better data sharing and transparency could help. protect patients.
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