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Medical device makers have been rushing to add AI to their products. While proponents say the new technology will revolutionize medicine, regulators are receiving a rising number of claims of patient injuries. This Reuters Special Report investigates some of the hazards associated with AI-enabled medical devices, including errors in a navigation system integrated into a medical device used in ENT surgery, AI software used for prenatal ultrasound scans that misidentified fetal body parts and AI assisted heart monitors that failed to recognise abnormal rhythms.  Issues with the capacity of the U.S. Food and Drug Administration (FDA) to review the flood of new AI-enabled medical devices are also raised, as well as concerns that the FDA's traditional approach to regulating medical devices may no longer be fit for purpose.

This article highlights three questions tabled in the House of Commons relating to the Yellow Card Scheme, the system for recording adverse incidents with medicines and medical devices in the UK. Yellow Card Scheme The Yellow Card Scheme is intended to support the Medicines and Healthcare products Regulatory Agency (MHRA) monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those who use them.[1] Reports can be made for all medicines, including: side effects (also known as adverse drug reactions or ADRs) medical device adverse incidents defective medicines (those that are not of an acceptable quality) counterfeit or fake medicines or medical devices safety concerns for e-cigarettes or their refill containers (e-liquids). IMMDS Review and incident reporting Published on the 8 July 2020, the Independent Medicines and Medical Devices Safety (IMMDS) Review, led by Baroness Julia Cumberlege, highlighted the need to improve incident reporting in healthcare, specifically in regards to medicines and medical devices.[2] The Review examined the response of the healthcare system in England to the harmful side effects of three medical interventions: hormone pregnancy tests, sodium valproate and pelvic mesh implants. These interventions have resulted in a truly shocking degree of avoidable harm to patients over a period of decades. One area of particular concern that the Review raised related to the Yellow Scheme, highlighting the need for reform of this system, stating that: it needs to be more user-friendly and accessible that the system was hampered by a lack of awareness among both the public and healthcare professionals. More broadly, the Review recommended that the MHRA needed to revise its approach in relation to adverse event reporting and do more to ensure that it engages with patients and their outcomes. The Government accepted this recommendation in its response to the Review.[3] Questions in the House of Commons Below are details of three written questions tabled by Emma Hardy MP concerning the Yellow Card Scheme. All three questions were answered by Will Quince MP, Minister of State (Minister for Health and Secondary Care). Awareness Question: To ask the Secretary of State for Health and Social Care, what assessment he has made of the level of awareness of (a) health professionals and (b) the general public of the Adverse Events Yellow Card System; and what steps is he taking to increase awareness of that system among those groups. Answer: The Medicines and Healthcare products Regulatory Agency (MHRA) recognises the importance of both public and healthcare professional understanding of, and access to the MHRA Yellow Card scheme, so that they can promptly report any concerns they have about the safety of healthcare products. The MHRA monitors the number of reports it receives from members of the public and healthcare professionals and strives to keep improving understanding and awareness of the reporting system. The MHRA continually works to encourage reporting of any safety concerns to the Yellow Card scheme and help improve the safe use of medicines and medical devices for everyone. A sharp increase in reporting, mainly from patients, has been seen due to better awareness of the scheme following significant communications activity at the start of the COVID-19 vaccination campaign.[4] Data collection Question: To ask the Secretary of State for Health and Social Care, what assessment he has made of the (a) level and (b) adequacy of data collected by (i) mandatory and (ii) voluntary reporting of adverse clinical events by health professionals before the introduction of the Yellow Card reporting system in England compared to that now collected via the Yellow Card system. Answer: The Medicines and Healthcare products Regulatory Agency (MHRA) has reviewed other international mandatory and non-mandatory reporting systems for healthcare professionals and found limited evidence that making reporting mandatory increases the ability to detect safety signals. Very few international mandatory reporting systems have a better reporting rate or a more successful system for detecting safety signals than the United Kingdom. In both medicines and devices legislation there are requirements for manufacturers to report, but there is no legal obligation for healthcare organisations. However, there are professional body standards and guidelines that make reporting a gold standard for healthcare professionals. The MHRA continues to work with partners across the healthcare system to promote and encourage use of the Yellow Card scheme to help detect safety issues. The MHRA has reviewed global approaches to mandatory reporting in other regulatory systems and continues to consider the approach in the UK as we work to improve reporting capability and functionality through systems.[5] Data analysis Question: To ask the Secretary of State for Health and Social Care, which body has responsibility for analysing data collected by the Adverse Events Yellow Card system; and what assessment has he made of the potential merits of collating this data on a publicly accessible database. Answer: The Medicines and Healthcare products Regulatory Agency (MHRA) collects and analyses the data received through the Yellow Card Scheme, and publishes data on medicines and COVID-19 vaccines in a searchable database on the Yellow Card website for transparency purposes. As outlined in the Yellow Card Privacy Policy, the MHRA has responsibilities under both the UK General Data Protection Regulation and the Data Protection Act 2018 to protect confidential data and personal data pertaining to individuals. The content and format of the data is currently being enhanced in line with patient and healthcare professional feedback and will be expanded to include medical devices in due course. The data provided will continue to be aligned to the MHRA’s legal responsibilities to data subjects.[6] References MHRA, Welcome to the Yellow Card reporting site, Last Accessed 6 June 2023. The IMMDS Review, First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review, 8 July 2020. Department of Health and Social Care (DHSC), Government response to the report of the Independent Medicines and Medical Devices Safety Review, 21 July 2021. House of Commons, Yellow Card Scheme, UIN 186945, tabled on 25 May 2023. House of Commons, Yellow Card Scheme, UIN 186944, tabled on 25 May 2023. House of Commons, Yellow Card Scheme, UIN 186946, tabled on 25 May 2023. Related reading A year on from the Cumberlege Review: Initial reflections on the Government’s response (Patient Safety Learning, 23 July 2021) Response to the Select Committee report on the Independent Medicines and Medical Devices Safety Review (Patient Safety Learning, 20 January 2023) Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies (Kath Sansom, 15 April 2021)

The Yellow Card Scheme helps the Medicines and Healthcare products Regulatory Agency (MHRA) monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those who use them. On the Yellow Card Scheme website you can report a suspected incident or problem.  Reports can be made for all medicines including: side effects (also known as adverse drug reactions or ADRs) medical device adverse incidents defective medicines (those that are not of an acceptable quality) counterfeit or fake medicines or medical devices safety concerns for e-cigarettes or their refill containers (e-liquids).

Toolkit to improve safety for mechanically ventilated patients helps hospitals in the US make care safer for mechanically ventilated patients in intensive care units (ICUs). ICU staff can use the toolkit to reduce complications for patients on ventilators.

This pledge card, produced by the Health Innovation Network, is designed to promote urinary catheter safety and good practice and, in turn, preventing infection. This initiative was part of catheter care awareness week. This pledge card could be used in numerous settings.

This survey for health and care staff looks at how quickly staff are aware of alarms emitted by bedside monitoring equipment in single patient rooms, and their ability to respond. Doors to single patient rooms are often kept shut for long periods of time for reasons of privacy, dignity and (at the moment especially) infection control. With the UK Government targeting a growth in the proportion of NHS hospital rooms which have a single bed, is this a risk to the health and wellbeing of patients? This is not a specific issue where data is collected, so an online survey has been created to gather feedback and opinions. This online survey takes five minutes to complete and will contribute to understanding of this potential patient safety risk. Prevention of Future Death reports have been issued on this subject, but without data it is difficult to identify if this is a specific problem, and if it is, how a big a problem.

As part of my quality improvement study at university, I developed and introduced an oxygen reference card that was shown to improve newly qualified clinical staffs' knowledge and confidence when using an oxygen cylinder. The project's literature review captured that clinical staff may not have the memory recall to support them in clinical practice and, therefore, a lack of embedded knowledge, which could compromise care. It is paramount that users of oxygen cylinders have the knowledge to understand how to use a cylinder safely and to understand how to assess the remedial gas in the cylinder to support oxygen administration. The study found that there is minimal training accessed to support staffs' knowledge and skill foundations for using cylinders. The outcome of the study recommended that there needs to be better support for clinical staff to use cylinders within their pre/post training to be able to using the device correctly. Introducing a oxygen reference card that they could keep on them whilst at work is a useful tool to support decision-making when using the cylinder. You can download the card from the attachment below. Both NAMDET – National Association of Medical Device Educators and Trainers and Northumbria Healthcare Facilities Management - NHS FOUNDATION supported the QI project.

The objective of this review is to contribute to the development of the GMC's policy in this area. Given the GMC’s role as a regulator of individual healthcare professionals (i.e. doctors) this study focuses on the types of requirements and standards applicable to or having implications for healthcare practitioners, rather than the regulation of healthcare providers (e.g. hospitals, surgeries etc.) or healthcare systems as a whole.   This article is aimed at doctors who are practising with telemedicine and would need to understand the guidance and regulation.