UK: MHRA Notice On Safety-Critical Alerts

National Patient Safety Alerts

According to the official notice published by the MHRA, starting from September 17, 2020, the safety-critical alerts for medical devices requiring special actions to be performed by respective entities will be published as National Patient Safety Alerts. For this purpose, an appropriate template agreed by the National Patient Safety Alerting Committee (NaPSAC) will be used. 

The MHRA states that the National Patient Safety Alert should meet the following criteria: 

• the issue in question should be actually safety-critical (e.g. exposes the patient to the risk of disability) and thus require the responsible entity to take the necessary measures accordingly,
• the risk should be clearly described,
• the particular actions prescribed by the alert should be reasonable and appropriate, 
• the way of actions to be followed by the healthcare professionals,
• the actions prescribed by the alert should also meet the SMART criteria (specific, measurable, achievable, realistic, and timely).  

The MHRA also mentions that in case if the entity responsible for a medical device subject to the National Patient Safety Alert would fail to perform the actions set forth therein in order to mitigate the risks associated with the device, the Care Quality Commission (CQC) would be entitled to act accordingly and take regulatory measures. 

In accordance with the official notice, all healthcare institutions subscribed for safety alerts related to medical devices are also obliged to subscribe to the National Patient Safety Alerts as well. The authority states that all safety communications related to medical devices will be aligned with the NaPSAC criteria shortly in order to ensure the effectiveness of such communications. In particular, the MHRA expects that the amended format of the safety communications will allow healthcare institutions to take all necessary actions in a fast and efficient manner. It is also important to mention that besides the MHRA, the NHS England is also entitled to publish the National Patient Safety Alerts.

New Safety Alerts Concept: Key Points

Industry representatives could also find additional information regarding the National Patient Safety Alerts on a special page of the official website of the National Health Service. The information published therein covers the following points: 

• Changes and improvements to the national safety alerts,
• The impact these changes will cause to healthcare institutions (providers),
• Regulatory background for the new safety alerts system,
• National Patient Safety Alert accreditation process,
• Details about the activity of the NaPSAC, including the terms and minutes from the meetings. 

It is important to mention that the National Patient Safety Alerting Committee is a special body focused on the improvement of safety-critical communications and providing the healthcare institutions with additional assistance related to the actual implementation of the measures prescribed therein. This body is also the one responsible for the National Patient Safety Alerts. In accordance with the applicable procedures, any national bodies entitled to issue the aforementioned alerts should pass the accreditation by NaPSAC in advance. 

To assist healthcare institutions (providers) in distinguishing the National Patient Safety Alerts from any other safety-related communications, special design and logo will be applied.

Responsibilities of Healthcare Provider 

The information published by the NaPSAC also covers the aspects related to the way healthcare providers should treat the National Patient Safety Communications. According to the official notice, they should start by reviewing the internal policies and procedures regulating the way the special measures should be taken in the course of implementation of the alerts. In accordance with the requirements developed by the NaPSAC, the aforementioned actions should be performed at the level of organization rather than on the lower one (e.g. team or division) as it was allowed under the concept of the safety alerts existing before. The entity implementing the safety actions should duly document all the measures taken and keep such records as evidence. Such evidence is also required in order to enter the indication «action completed» in the Central Alerting System (CAS), a special database containing information about any and all safety alerts issued under the appropriate framework. 

According to the notice, there are two types of National Patient Safety Alerts:

1. Complex alerts – ones prescribing the healthcare provider to implement the measures requiring the actions that cannot be performed by a separate team since the intervention of the management is necessary.
2. Straightforward alerts – ones that could be actually implemented on the local level, providing that the approval of the appropriate manager is sufficient. 

CAS Officers

The document also outlines the requirements related to the obligations and responsibilities of the CAS officer – a special person appointed by the healthcare provider to receive the safety-related alerts and later to update the CAS system accordingly (by entering the information related to the actions taken by the entity). In accordance with the new requirements set forth by the National Patient Safety Alerts framework, now the CAS officer should communicate the information contained in the alert directly to the senior management for coordination of further actions instead of forwarding it to the appropriate team responsible for the matter. The actions related to updating the CAS records also require approval from the senior management. 

The CQC, a supervising body mentioned here above, will also carry out ongoing monitoring of the activity related to the National Patient Safety Alerts in order to ensure all healthcare providers receiving such alerts take all necessary actions and thus are compliant with the applicable requirements.

National Patient Safety Alerts Implementation Background 

As it is stated in the official notice, the NaPSAC determines the alerts system existing before as inefficient. In particular, they were not communicating the information about the risk associated medical devices in a way ensuring the necessary actions will be taken by healthcare providers in order to mitigate such risks. According to the comments received from the industry representatives, the main point of concern was related to the format the safety communications were provided – sometimes it was quite difficult to distinguish them from other communications. The actions prescribed by such communications sometimes were a bit unclear, so it was difficult for the healthcare provider to determine the particular actions to be performed in this regard, especially in cases related to recalls due to the safety issues. Further investigation conducted by the NHS allowed the authority to identify that the system the industry representatives employ to implement the safety actions required in the aforementioned notices is not efficient enough too. In most of the cases, the implementation issues are related to the distribution of responsibilities between separate divisions and teams (that is the issue to solved by the new approach introduced by the National Patient Safety Alerts framework that should be communicated directly to the senior management responsible for their further implementation). 

According to the information provided hereabove, the new safety communications system has been implemented in the UK. The new approach is intended to improve the effectiveness of safety-related communications and the way they are being treated by the healthcare providers.

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Sources:

https://www.gov.uk/government/news/safety-critical-alerts-have-changed-at-the-mhra–2

https://www.england.nhs.uk/patient-safety/national-patient-safety-alerting-committee/