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  • Ineffective medical device recalls are a patient safety scandal

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    • Patients and public, Health and care staff, Patient safety leads

    Summary

    A medical device is any piece of equipment, material or apparatus used to diagnose or treat a medical condition. When a medical device is recalled because of safety concerns, it can affect a large number of patients, often on a global scale. However, manufacturers and regulators of these devices don’t often have effective ways to ensure patients know about safety concerns, understand the risks or know what to do if their medical device is recalled.

    This blog by Kath Samson, founder of the Sling the Mesh campaign, looks at some of the issues around medical device recalls. She suggests ways that device manufacturers and regulators can improve their communication with patients and healthcare staff when a medical device is recalled.

    Content

    During an online meeting with the Patient Engagement Advisory Committee of the US Food and Drug Administration, I was struck by the huge problems that continue to exist around medical device recalls. I have been campaigning on these issues since 2015 and progress has been painfully slow. Although the meeting had a US-focus, the issues addressed are global. Medical devices travel across the world to be implanted in or used by patients - we have the technology to keep track of them and if we don’t start using it, an increasing number of patients will be harmed.

    Here are some of the issues raised in the meeting:

    Lack of global monitoring and reporting systems

    There is no robust, joined up system globally for medical device recalls. The current patchwork of local systems means that information takes a long time to disseminate, so harm continues to happen to patients who are unaware they are living with a dangerous device.

    A barcode tracking system of Unique Device Identifiers (UDI) that allows medical devices to be tracked does in theory exist, but it is not being used consistently. Manufacturers and healthcare providers need to use UDI as standard, but this is not currently happening.

    Lack of a legal and regulatory framework

    As seen in the case of the surgical mesh scandal,[1] official bodies are often reluctant to carry out retrospective audits that would reveal the scale of the problem and the harm that has been caused.

    It is also hard to understand why most medical device recalls are voluntary, meaning manufacturers have no legal obligation to ensure patients are informed. For something that poses such a risk to patients’ safety, that legal obligation needs to exist. The voluntary nature of recalls also has the effect of making safety concerns appear less serious. In reality, continued use of the device may cause significant harm. 

    There are also many medical devices still on the market with huge safety concerns that haven't even been recalled, suggesting that the threshold for recalling medical devices needs rethinking.

    ‘Equivalence’ and flaws in the approval processes

    In the current approval framework, medical devices seen as ‘equivalent’ can bypass clinical trials and other safety processes as they are seen as simply replacing an older model. In reality these devices often bear little resemblance to their predecessor and need to be separately trialled. The first vaginal mesh was approved for use on equivalence to a hernia mesh in 1996, even though it was to be used to treat a different issue in a different part of the anatomy. The hernia mesh was withdrawn in 1999, but the equivalent vaginal mesh was kept in circulation. All mesh slings date back to that first device and are still being implanted globally - they are only suspended in the UK. These devices are considered safe and not requiring a recall, but their approval was flawed in the first place. [2]

    Equivalence has resulted in huge amounts of harm and continues to present a major risk to patient safety. Its use to approve high-risk medical devices must stop, and this is something I have lobbied the MHRA about.

    Other problems with the way medical devices are approved include selective use of data to demonstrate the benefits of treatment with a particular device (known as p-hacking), inadequate patient follow-up and poor post-market surveillance.

    Lack of information for patients

    Patients are often given little or no knowledge about the actual medical device that has been implanted into their body - details such as brand names and serial numbers that would enable them to support their own safety. This means that even if patients do hear about a device recall, they won’t know whether the recall applies to them and whether they need to seek help. This lack of knowledge is a source of great anxiety for many patients, which can itself lead to further harm.

    Patients are also often unaware of the risks surrounding their medical device - both at the point of implantation or issue, and following a recall. For example, many women who were implanted with surgical mesh have received no advice about whether it is safer to have the mesh removed or leave it implanted.

    Lack of measures to remedy problems and support patients

    One of the most worrying issues is that when a device has been recalled, there is no guidance on what needs to happen next for the patients affected. If a device has been implanted, there is no official pathway for medics or patients on how to seek help and remedy harm. Patients are left feeling abandoned.

    A further concern is that patients are not always offered an equivalent solution after their device has been recalled. Medical devices are not issued without a good reason, and the health issue that warranted its use is therefore likely to return.

    Ways to improve medical device safety

    If they are willing to, manufacturers and regulators can improve patient safety by communicating with and supporting patients through medical device recalls. Here are some ways they can do this:

    • When a patient reports an issue, conduct reviews quickly. After a device has been recalled, review similar or equivalent devices to ensure they do not pose similar safety risks.
    • Use easy-to-understand language in device recalls. Involve patients meaningfully in recall processes to better understand how to communicate with different patient groups.
    • In recalls, better inform patients about risks, symptoms and what to do next so that they can support their own safety.
    • Use all available communication channels to communicate recalls with patients, including social media, text messages and email.
    • Promote and make tools for reporting side effects and adverse events, such as the Yellow Card scheme in the UK, readily available.

    These steps will help, but there are so many more systemic issues for regulators to address. I will continue to campaign for a system that takes medical devices, and the patients that use them, seriously. When a device designed to improve patients’ health causes harm, we need rigorous systems that will both enable doctors to support harmed patients and prevent similar harms happening in future.

    Further reading

    Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies - a blog by Kath Sansom

    A year on from the Cumberlege Review: Initial reflections on the Government’s response (Patient Safety Learning, 23 July 2021)

    Analysing the Cumberlege Review: Who should join the dots for patient safety? (16 July 2020)

    Transvaginal mesh timeline (Dr Carl Heneghan, 7 December 2017)

    References

    1 The Guardian, What does pelvic mesh do and why are women suing over it? – explainer (31 August 2017)
    2 BMJ Open, Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process (6 December 2017)

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    Shocking that the device companies have no legal responsibility to inform a patient when they withdraw a device from use. 

    If a car has a part that is failing in its ability to perform the companies write to you and recall the car for a check. 

    Why are humans not afforded the same standards. 

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