The Medical and Healthcare products Regulating Authority (MHRA) has published a response to the report of the Independent medicines and medical devices safety (IMMDS) review.
Report on Safety Review in Brief
The review is based on the principle stating that the regulatory framework should be intended to create a safe environment for patients, providing that only high-quality medicines and medical devices are made available to patients and healthcare professionals. In particular, the review describes the effectiveness of the healthcare system in the context of adverse event reporting and post-marketing surveillance. It is stated that the healthcare system should be responsive enough to ensure that all side effects associates with medicinal products in general and medical devices, in particular, are being identified and mitigated in a timely manner.
The safety review contains certain recommendations developed on the basis of the rigorous analysis of existing procedures, regulations, and reports on safety issues. With regard to the medical devices, the recommendations provided in the report include, inter alia, the following ones:
Recommendation no. 5: to establish networks of specialists centers to providing comprehensive treatment, care, and advice to the patients affected by the adverse events caused by implantable medical devices. This recommendation is based on several key points:
- The transparent and effective post-market surveillance system is vitally important to ensure the safety of implantable medical devices and mitigate the effect of adverse events associated thereto. For instance, healthcare institutions should be bound by mandatory reporting rules stating that the regulating authority should be informed about any and all adverse events and their consequences, and it is also important to set a particular timeframe for these obligations to be fulfilled.
- Medical devices with elevated risk should be subject to additional risk assessment to be performed by the authority itself – by MHRA.
- The Yellow Card system, a special platform designed for adverse event reporting, should be improved and modified. In particular, it should be supplemented with the transparent and accessible repository where the adverse event reports should be stored. The document states that openness and transparency should be a statutory requirement for adverse event reporting in the UK.
- It was identified that pre-marketing examination medical devices are subject to is less strict in comparison to one required for medicines, especially with regard to the safety and quality testing.
- It was also identified that nowadays the regulating authority actually is not involved in the process of medical devices design and development during the pre-market step, while it is recommended to increase the involvement of the MHRA in the aforementioned activities. The marketing approval process for medical devices should include several consecutive steps of assessment and evaluation. The authority should be also entitled to suspend the approval and remove the particular medical device from the register of devices allowed to be marketed in the UK in case if such a device fails to comply with the applicable safety requirements when such non-compliance has been identified at the post-marketing surveillance step.
Recommendation no. 6: the MHRA has to revise the regulations on medical devices in general and adverse event reporting regulations in particular. Such revision should be based on increasing engagement of patients and raising awareness on public protection roles. This recommendation is based on the following key points:
- All processes and procedures related to the post-market surveillance for medical devices should be rigorously revised and substantially improved through increasing the use of digital technologies and big data. The data analysis should become an important source of information related to the safety of medical devices. The authority should also improve the way it works with existing data registries.
- It is recommended to create a unified database containing information about all medical devices.
Recommendation no. 7: to create a central patient-identifiable database containing information about any and all implanted medical devices. Such a database should be available to be used for the purpose of safety monitoring and adverse event reporting. The underlying key points are the following:
- It is important to eliminate the conflict of interest existing between healthcare professionals and medical device manufacturers. At the moment, the registers of implanted medical devices are being held mostly by healthcare institutions.
- Medical device manufacturers shall duly disclose the information about all payments they make to healthcare institutions and individual healthcare professionals. Such a requirement should be set forth on a legislative level. For example, a similar requirement is provided under the US Physician Payments Sunshine Act 2010.
Additional Recommendations and Highlights
Besides the aforementioned, the safety review report contains certain additional recommendations to be implemented in order to improve the effectiveness of the medical devices regulatory framework.
For instance, it is advised to use the following definitions and approaches:
- A Registry should be defined as an organized system that continuously and consistently collects relevant data in conjunction with routine clinical care, evaluates meaningful outcomes and comprehensively covers the population defined by exposure to a particular medical device(s) at a reasonably generalized scale (e.g. national, regional, health system) with a primary aim to improve the quality of patient care.
- A database should be maintained in compliance with the general personal data protection principles outlined in the GDPR. In order to comply with the GDPR, the scope of the patient’s data kept in the database should be limited and reduced to the lowest extent possible in accordance with the intended purpose. In particular, the database should contain the following information: the NHS number of the patient, his gender, date of birth, the unique device identifier (UDI), the name and registration number of the healthcare professional who implanted the device, the date of the procedure and details about the healthcare institution.
MHRA Response to IMMDS Review Report
The MHRA has rigorously analyzed all key points outlined in the IMMDS Review report and provided a detailed response. First of all, the British medical device regulating authority explicitly stated that its activity is aimed at ensuring the highest level of patients` health protections in general and safety matters in particular.
The authority also confirms that it will evaluate all recommendations included in the report and assess the way they could be implemented in existing regulations in order to introduce necessary improvements and eliminate safety issues highlighted in the report. In particular, the MHRA intends to increase the involvement of the patients in all safety-related procedures to make communications more efficient, since it is necessary to ensure the transmission of vitally important safety information in a timely manner. The authority also intends to improve collaboration between all elements of the healthcare system.
Summarizing the information provided here above, the report on the Independent Medicines and Medical Devices Safety Review covers the most important issues related to the safety of medical devices allowed to be marketed in the UK. The document also provides specific recommendations regarding the improvement of the medical devices regulatory framework.
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