NHS Fife acknowledges and agrees with the importance of regular and timely review of policy statements and aims to review policies within the timescales set out. New policies will be subject to a review date of no more than one year from the date of first issue.
Reviewed policies will have a review date set that is relevant to the content (advised by the author) but will be no longer than three years.
If a policy is past its review date, then the content will remain extant until such time as the policy review is complete and the new version published.
1.1 This Policy reflects the responsibilities of the Board to meet the duty of care to staff, patients, visitors and to the organisation itself. This Policy sets out the requirements to maintain patient and staff safety where information identifying potential risk is received by NHS Fife from various external bodies, agencies or via internally generated alerts related to medical devices or equipment, should these be identified locally.
1.2 Such information is disseminated throughout the organisation in the form of hazard and safety notices and alerts, and this Policy summarises the practical arrangements in place to manage the receipt, dissemination and implementation of all such notices and alerts received by the Board from external sources. The External alerts excluded from this policy, are detailed at Section 3.3 below.
1.3 The principles and processes described in this document are in keeping with the Scottish Government CEL 43 (2009), issued in October 2009, and Addendum CEL 43 (2009), dating from November 2013. Reference has also been made to ‘Managing Medical Devices: Guidance for Health and Social Care Organisations’, issued by the Medicines and Healthcare Products Regulatory Agency in January 2021.
2.1 This Policy is applicable to all staff within NHS Fife.
2.2 All staff who receive notice of an alert under this Policy have a duty to read such notices, to disseminate the notice appropriately within their own area of responsibility and to take all actions required in relation to managing the specific risk identified.
3.1 ‘Hazard and Safety Notice’ is a generic term that covers a number of different types of alerts issued by a number of external bodies. The majority are distributed within the organisation by the Corporate Governance & Board Administration team. A generic email address (email@example.com) has been established as a central point of contact for both external and internal users in relation to alerts and notices.
3.2 The most common types of notices received by the Board from external sources are listed below (though these categories are not exhaustive):
• MHRA Device Safety Information (MDSIs) – These notices are issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) and, on occasion, Health Facilities Scotland (HFS) and contain important advice on patient-related equipment and devices. Also referred to as national Patient Safety Alerts (NatPSA) following recent changes by MHRA (see further descriptors below).
• Estates and Facilities Notices (EFNs) – These notices are issued by Health Facilities Scotland (HFS), and include important advice on estates and facilities equipment such as engineering plant and installed services.
• Product Recall Notifications (PRNs) – These notices are issued by NHS National Services (Scotland) National Procurement.
• Safety Action Notices (SANs) – These notices are a Scotland-only format mostly used to produce Scottish versions of national patient safety alerts that are published in England by NHS Improvement.
• Customer Alert Notices (CANs) – These notices are issued by NHS National Services (Scotland) National Distribution Centre (NDC), to bring to the attention of customers any issues with products following advice from manufacturers and/or complaints to NDC.
• Field Safety Notices (FSNs) – FSNs are issued directly by manufacturers when they become aware of a safety-related issue due to a problem with a particular product. FSNs are often sent some weeks in advance of a corresponding MDA. FSNs can be received anywhere in the organisation or require a proactive search for products used within NHS Fife. An example is a FSN relating to implanted devices such as pacemakers. Manufacturers tend to send out multiple copies of these and look for a customer acknowledgement slip from each recipient.
• Safety Information Message (SIMs) – These messages are issued by the NSS Incident Reporting & Investigation Centre (IRIC).
• National Patient Safety Alerts (NatPSA – UKHSA) – These alerts are issued by the UK Health Security Agency.
• National Patient Safety Alerts (NatPSA – NHSI) – These alerts are issued by NHS Improvement (NSI).
• National Patient Safety Alerts (NatPSA- NHSPS) – These alerts are issued by NHS England.
3.3 This Policy does not relate to the processing of the following alerts and/or notices listed below, which are presently handled by other departments than the Corporate Governance & Board Administration team:
• Product / component recalls or safety advice received from the Scottish National Blood Transfusion Service.
• Public Health Alerts issued by Health Protection Scotland.
• Medicine alerts or drug safety information issued by the Chief Medical Officer Directorate, Pharmacy and Medicines Division, of the Scottish Government.
3.4 The Corporate Governance & Board Administration department are responsible for the administration and initial dissemination of all notices received into the organisation from external agencies. Additionally, a proactive search of the following websites is regularly undertaken by the department’s administrative staff to ensure all active and new alerts have been appropriately received and logged:
3.5 Information on product recalls is also received into the organisation via an email subscription to the NHSScotland Procurement Community Knowledge Hub mailing list.
3.6 Whilst the completion of the ‘Response’ section on the Datix alert record is required of some recipients, all recipients of Datix Safety Alert emails have a responsibility to read the notification they have received and to take action as appropriate.
3.7 To ensure that distribution lists (or recipient lists) remain up-to-date, local managers must inform the Datix administrators of changes to the current distribution lists, e.g. as a result of staff starters and leavers.
4. OPERATIONAL SYSTEM
4.1 All safety notices and alerts, including medical device alerts and patient safety notices (see descriptions in 3.2 above), are distributed by Corporate Services administrative staff through the Datix system, which enables any action required to be tracked and recorded.
4.2 The process below explains how alerts are distributed and cascaded throughout NHS Fife to appropriate contacts:
• An alert is received into the organisation or identified during a proactive search of key websites (see 3.1 and 3.4 above).
• Where possible, prior to distribution to large groups of staff, alerts are first triaged. In particular those alerts relating to medical devices and product recalls are triaged as below:
- If the alert is related to equipment (for instance, a medical device or estates and facilities equipment etc.), the Incidents and Alerts Officer will first assess the alert and give advice as to the potentially relevant department/s that should be notified.
- If the alert is procurement-related (i.e. product recalls or Customer Alert Notices), it will be sent direct to the Procurement Department to action with potentially relevant department/s as they see fit.
• The alert is entered into Datix by Corporate Governance & Board Administration administrative staff for distribution.
• The alert is logged and a copy attached to the Datix record.
• The alert is distributed by email via Datix using standardised types of distribution lists. Distribution is either:
- ‘For action by’ (a response is required and followed up if not received)
- ‘For information only’ (no response required but the alert can be forwarded to colleagues).
• The email template sent from Datix includes notification on whether the recipient is required to respond to the sender or whether they have been sent the alert for information only.
• Those sent the alert ‘For action by’ will be required to:
- Respond within the Datix system to confirm appropriate action to mitigate the risk has been taken.
- Forward the alert to relevant colleagues and monitor responses.
For convenience, a step-by-step guide to the forwarding process is attached to every alert in Datix.
Alerts can be forwarded to colleagues possessing a Datix user account directly via the Datix safety alert record by those receiving them via the ‘For Action by’ distribution list. ,
Alternatively, the alert can be downloaded from the record and sent via email, particularly for those staff without access to Datix. In these circumstances the original sender is still required to confirm actions taken back to the System administrator.
4.3 In the case of alerts sent to colleagues ‘For action by’, the responses will be returned through Datix to the System administrator and can be subsequently reported on for compliance purposes.
4.4 Alerts can be cascaded to other colleagues within the organisation as required– the system will alert senders if the intended recipient has already received the alert via another source, thus minimising duplication where possible. A list of all recipients is also included at the foot of each alerts record page in Datix.
4.5 Responses will be monitored and reminders sent out as required following a standard timeframe highlighting unactioned alerts. Reminders to those recipients that fail to complete the response section as required will be issued by administrators within the Corporate Governance & Board Administration team and will be based on the ‘deadline for action’ date contained in each alert.
4.6 A ‘Not applicable’ option is available to use as a response where the recipient finds this necessary.
4.7 Governance of this Policy will be achieved through:
• Periodic audits of the above procedure by the Risk Management team;
• Periodic reviews within operational areas, should any compliance issues be identified;
• Quarterly reporting to the Medical Devices Group, which has route of escalation to the Clinical Governance Oversight Group;
• Annual reporting to the Executive Directors’ Group, on an exception basis; and
• Audits of the process on an ‘as requested’ basis by Internal Auditors.
5. ADDITIONAL INFORMATION
5.1 The initial distribution is the key to the process being successful and for responses to the alert email to be adequately monitored.
5.2 Anyone receiving an alert ‘For information only’ is still able to forward on to other colleagues ‘For action by’ if they wish (and vice versa).
5.3 The Distribution lists ‘For information only’ and ‘For action by’ should include contingencies for when key ‘distributors’ are not at work, via a ‘whom failing’ option.
5.4 GPs and Community Pharmacies do not have access to Datix, thus alerts requiring action by these groups will be sent using email. However responses can still be logged in Datix if required providing the sender has access to the Datix Safety Alerts record.
6. RISK MANAGEMENT
6.1 The key risk involved in the implementation of this policy is:-
• lack of awareness of managers and staff about the process for distributing, and responsibilities for responding to and actioning alerts, resulting in non-compliance with the recommendations contained within the alerts and a resulting inability of staff to implement these to ensure the delivery of safe and effective care and the health and safety of staff.
6.2 This key risk, along with any others related to the management of external alerts, are addressed through the robust implementation of this Policy led by the Medical Director and regularly monitored by the NHS Fife Medical Devices Group and the Clinical Governance Oversight Group.
7. RELATED DOCUMENTS
7.1 The completed EQIA Form for this Policy is given at Appendix 1.
The Scottish Government CEL 43 (2009) Safety of Health, Social Care, Estates and Facilities Equipment: NHS Board and Local Authority Responsibilities, October 2009
The Scottish Government Addendum to CEL 43 (2009) Safety of Health, Social Care, Estates and Facilities Equipment: NHS Board and Local Authority Responsibilities, November 2013
MHRA, Managing Medical Devices: Guidance for Health and Social Care Organisations, January 2021