2020

Disputed (AI summary) HSIB has made changes to its investigation methodology and processes to enable them to share early learning with Trusts following the investigation into Theo’s death. The Healthcare Safety Investigation Branch (HSIB) disputes the coroner's concerns, stating they provided opportunities for safety information to be shared and acted upon, and that inaccuracies were not due to their error. HSIB maintains its investigation was conducted in line with statutory directions. Surrey & Sussex Healthcare NHS Trust increased midwifery staffing, instituted daily staff allocation reviews, improved CTG monitoring and interpretation via training and audits, and recruited a Senior Lead Midwife. These actions led to an 'Outstanding' CQC rating in January 2019.

Disputed (AI summary) The British Standards Institution (BSI) expresses its sympathy but states that it is not a regulatory or enforcement body and therefore cannot take action to prevent a reoccurrence. BSI states it would not be able to create a compulsory scheme to augment or replace that of ADIPS. Rundles disputes the coroner's concerns, arguing that their role as an inspection body does not extend to ensuring operators use equipment safely. They claim it is dangerous to divert responsibility from operators to inspection bodies. HSE has written to the Amusement Safety Device Council to remind them of their obligations and intends to publish additional guidance on the design, operation, and inspection of sealed inflatable devices, which is currently being drafted in consultation with representatives of the amusement industry.

Disputed (AI summary) Resuscitation Council UK disagrees with recommending defibrillators start in automatic mode, arguing manual mode results in greater chance of return of spontaneous circulation and supports the remedial actions taken by LAS. London Ambulance Service investigated the incident and found that Paramedic A did not recognise that Mr Marin was in ventricular fibrillation. LAS has updated guidance, provided human factors training, and provided focused training to solo first responders and are exploring devices to switch to AED mode automatically; they are undertaking thematic analysis and Trust wide learning following the incident. The Association of Ambulance Chief Executives (AACE) acknowledges the need for prompt defibrillation and issued revised guidance in June 2019 advocating for the use of automatic mode by solo responders. However, it is not AACE's responsibility to recommend which defibrillator device an ambulance service should purchase. The Department of Health and Social Care acknowledges the concerns regarding defibrillator default settings, but states that factory settings must cover a wide range of applications and individual ambulance services are responsible for future procurement. MHRA has not received similar reports and the National Clinical Director considers the current default mode acceptable, though this will be kept under review. Stryker argues that the coroner's concerns about the LP15 device defaulting to manual mode are inaccurate, as the device can be configured to power on in either automatic or manual defibrillation mode based on the health system's clinical protocols, therefore no action will be taken.