2021

Noted (AI summary) The response acknowledges the death and outlines current NICE guidance on managing large babies and gestational diabetes, noting an ongoing trial on inducing labour for predicted macrosomia.

Noted (AI summary) NHS England notes that the concerns raised relate to the design of medical devices and fall under the remit of the MHRA, but they have worked with the British Thoracic Society and continue to work with the Faculty for Intensive Care Medicine to develop guidance on alarm systems and breathing circuits. The MHRA states that the audible alarm system in the Philips Trilogy 202 device is based on an internationally recognised standard and that there is currently no evidence to indicate a wider safety concern. They are engaging with professional organizations to explore alarm prioritisation and have requested information from a patient safety incident database.

Noted (AI summary) The Health Board reviewed nurse staffing levels which they state were adequate at the time of the incident. They have also commissioned an in-depth review of nurse staffing levels for the Emergency Department (ED) at the Grange University Hospital, and a similar review of medical staffing is also being undertaken.

Noted (AI summary) The Department acknowledges the concerns regarding the 2010 Risk Assessment Tool for Venous Thromboembolism (VTE) and refers to NICE guidelines. They note the need for further research to balance VTE risk versus bleeding risk in acute psychiatric settings and that the National Patient Safety Committee will work to identify the best route to take this forward.

Noted (AI summary) The Trust states that changes were implemented following a Serious Incident investigation. They describe using AFLOAT to assist with setting observation levels, but the final decision is based on the nurse's professional judgement.

Noted (AI summary) The MHRA will engage with the medical device safety officers (MDSO) network to raise awareness of possible incidents involving filters and encourage reporting and will write to known manufacturers of filters to ask them to conduct a review of the labelling of filter devices against the regulatory requirements, taking into consideration the findings of the inquest, and making improvements where identified. The response provides background information on HME/filters, potential issues, and proposes solutions such as standardized color coding and clearer labeling, but does not commit to any specific action. The organisations will highlight key lessons about breathing circuit filters to their membership through the Safe Anaesthesia Liaison Group’s Patient Safety Update and FICM Safety Bulletin, and have suggested that NHS Improvement undertake a formal analysis of the NRLS database to assess the frequency of incidents arising from incorrect filter use. The MHRA will work with manufacturers, other regulators, NHS England and Improvement and other stakeholders to explore the effects of actions such as reducing filter types and improving color coding, and will engage with the medical device safety officers (MDSO) network to raise awareness and improve incident reporting.