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15 July 2020 - R&Q experts discuss "First Do No Harm - The report of the Independent Medicines and Medical Devices Safety Review."
Last week, The Independent Medicines and Medical Devices Safety Review (IMMDSReview), chaired by Baroness Julia Cumberlege, released an extensive report highlighting numerous examples of situations when the grievances of patients regarding complications with medical devices and pharmaceuticals were routinely disregarded. Consequently, patients and their families suffered enormously due to faulty processes and a fragmented system.
In the report, "First Do No Harm - The report of the Independent Medicines and Medical Devices Safety Review" (Access the report here) using gathered evidence from patients, clinicians, academics, regulators, and manufacturers the publishing committee cites the failure of their healthcare system to listen to and advocate for patients. In the opening letter, Baroness Cumberlege discusses the inspiration for the report:
“We have found that the healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers – is disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’etre. It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially. Indeed, over these two years we have found ourselves in the position of recommending, encouraging and urging the system to take action that should have been taken long ago.”
These systematic deficiencies alone are key examples of why Post-Market Surveillance activities are crucial to any medical device, combination product, and IVD manufacturer. Though the report is not exhaustive in how patients have been harmed in poorly monitored devices, it successfully paints the picture of a healthcare system that is slow to respond to the feedback of patients. These examples are a catalyst to drive much-needed policy changes, not only in the United Kingdom but also in the European Union (EU) and the United States.
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Subsequently, the report recommends several policy changes including the creation of a registry for all implanted devices and redress system for patients harmed by medicines or medical devices:
“The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that. This is why one of our principal recommendations is the appointment of an independent Patient Safety Commissioner, a person of standing who sits outside the healthcare system, accountable to Parliament through the Health and Social Care Select Committee. The Commissioner would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, encourages and requires the system to act. This person would be the golden thread, tying the disjointed system together in the interests of those who matter most.”
Whether or not these policy recommendations are enacted, the report does highlight the need for Post-Market Surveillance of medical devices. We can see through the various examples provided that it is vital for medical device manufacturers to follow and respond to safety signals. Although the EU Medical Device Regulation (MDR) defines the tools manufacturers need to comply, it requires careful analysis and acting on the data when it becomes apparent there is patient dissatisfaction. Therefore, with the proper implementation of Post-Market Clinical Follow-up (PMCF) reports, Periodic Safety Update Reports (PSUR), and Clinical Evaluation Reports (CER), manufacturers can use the early warning system to identify and act on those safety signals, with the ultimate goal of Doing No Harm.
>> Click here for free webinar: RAPS Webcast - Strategies for Successful PMCF Planning and Execution
>> Click here for blog: Q&A - Post-Market Surveillance Requirements of the EU MDR from RAPS Webcast
Having trouble understanding and interpreting all the new post-market surveillance requirements? R&Q has answers and is available to help you keep your devices safe and effective... and your business grow. Our dedicated (and highly qualified/proficient) team stays on top of the newest regulations, industry trends, and uses our industry connections to grasp what our competition might not. Learn more about how we can help here.
Source:
The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege. First Do No Harm The report of the Independent Medicines and Medical Devices Safety Review. Published 8 July 2020. Accessed 13 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf
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