NHS England and the Medicines and Healthcare products Regulatory Agency (MHRA) have today jointly issued two patient safety alerts to help healthcare providers increase incident reporting for medication errors and medical devices. The alerts instruct providers to take specific steps that will improve data report quality; and will see the establishment of national networks to maximise learning and provide guidance on minimising harm relating to these two incident types.

The patient safety alerts call on large healthcare provider organisations across a range of healthcare sectors, along with healthcare commissioners, to identify named leaders in both medication and medical device safety roles. These leaders will be supported by two new national networks for medication and medical device safety. The networks will improve communication and feedback on reported safety issues, and enable safer practice to be discussed and shared through webinars, online forums, conferences and workshops.

Smaller healthcare provider organisations should continue to report medication and device incidents, take action to improve medication and device safety locally and work with local safety champions.

This joint work responds to a number of strategic drivers including recommendations by Sir Robert Francis QC and Professor Don Berwick on patient safety and a review by Earl Howe into MHRA’s handling of the PIP breast implant fraud.  All recommended taking steps to maximise the quality and quantity of adverse incident reports from healthcare organisations.

This new guidance has been developed by NHS England and MHRA after extensive engagement with stakeholders across England. Dr David Cousins, Senior Head of Safe Medication Practice and Medical Devices at NHS England, said: “More than 500 stakeholders including staff in the NHS provider, community pharmacy, independent sector and commissioner organisations, took part in the engagement exercise, with respondents overwhelmingly indicating a strong support for these alerts.”

“There are many staff who are already working on medicine and device safety and others who would like to do more. This new guidance clarifies roles and key contacts for medication and medical device safety to enable better exchange of information between local and national levels, to enable more effective action to improve patient safety.”

Dr Mike Durkin, NHS England Director of Patient Safety, said: “Issuing these two alerts and the development of local support systems for safety issues surrounding medicines and devices signifies a step change in how we approach patient safety. Once the medicines safety officers and medical device safety officers have been identified by the organisations required to act on the alerts, these individuals and the newly formed networks will enormously increase our ability to improve safety by broadening our reach and establishing channels for sharing and feedback.  We are also working in partnership with the pharmaceutical and devices industries through the Association of the British Pharmaceutical Industry (ABPI) and Association of British Healthcare Industries (ABHI) as part of the work of NHS England’s Industry Council, which will be a catalyst for this exciting and innovative approach to spread and adopt good practice.”

John Wilkinson, Director of Medical Devices, MHRA, said: “This is a significant step forward for both organisations showing our commitment to develop new ways to help improve patient safety. These joint patient safety alerts have been devised after considerable feedback from stakeholders highlighting the importance and the need for simplifying reporting and improving learning. We see this as a great initiative to work with partners in healthcare organisations to increase the number of and detail within reports in order to improve medical device safety. New integrated reporting routes will help to drive these improvements. Manufacturers will also benefit from the initiative as they will obtain improved safety information on their products and will have support in acting upon their field safety notices.”

Director of Vigilance and Risk Management of Medicines (VRMM) at the MHRA, Dr June Raine, said: “Our priority is the safety of patients and this collaboration will strengthen the reporting and learning from medication errors and device incidents.  It will increase the quality and quantity of medication error reports and with our Yellow Card Scheme for reporting suspected adverse drug reactions it will allow us to maximise learning and minimise harm in clinical practice.  Named safety officers and the new safety networks will be key to success, enabling better exchange of information and encouraging reporting both at local and national level.  This will lead to improvement in patient safety and the safer use of medicines and devices.”

You can view the full alerts and supporting information via the links below:

Medication error

• Patient safety alert on improving medication error incident reporting and learning.
• Supporting information for patient safety alert on improving medication error incident reporting and learning.
• Word version of the medication safety officer contact form.

Medical devices

• Patient safety alert on improving medical device incident reporting and learning.
• Supporting information* for patient safety alert on improving medical device incident reporting and learning.

* Improving medical device incident reporting and learning alert was amended on 1 Apr 2014 to reflect changes to adverse incident report figures in appendix B and a revised link to the EU directive on medical devices.