Product related deaths

Noted (AI summary) The Department acknowledges concerns about the availability of suicide methods online and outlines actions to reduce suicide rates through the Suicide Prevention Strategy for England, including reducing access to the means of suicide and working with online retailers of harmful substances.

Noted (AI summary) East London NHS Foundation Trust clarifies that responsibility for environmental risk assessments following the patient's discharge from hospital would lie with the Reablement Team, which falls within the remit of the London Borough of Tower Hamlets. However, they will discuss the case within their regular team meetings. East End Homes states that the smoke alarms were of an appropriate standard, properly installed, maintained, and operated when activated. They believe that residents do not expect domestic alarms to be monitored externally, and they offer general guidance on fire safety. The GP practice will ensure the multi-disciplinary team and Social Services are made aware of concerns raised about the adequacy or safety of a patient's home environment. Clinicians can prompt the Care Navigator or Social Worker at the monthly Integrated Care Multidisciplinary Meeting to ensure that appropriate fire safety checks are implemented.

Noted (AI summary) Byron has rectified the lack of records kept of on-job training immediately and each employee will now have records kept, and are investing in a market leading training system called "Flow" which is launched in the business from November where every employee will have their own personal training modules and records. BSACI will write to the chair of the FSA to advocate for funding for the UK Fatal Anaphylaxis Registry (UKFAR), which they are exploring closer working with to ensure its sustainability. National Trading Standards states that food safety and allergen regulation is outside their remit, which focuses on regional or national issues like complex consumer fraud. They note the Food Standards Agency is responsible for allergen legislation and policy. The FSA plans to develop an online reporting system and improve data sharing for allergic reactions, including those not resulting in death, to enable timely identification of trends and action by local authorities. DHSC will work to increase information prevalence on anaphylactic deaths and will support the FSA's reporting platform.

Noted (AI summary) The Department has passed concerns about a nursing pillow lacking proper safety warnings to the Office for Product Safety and Standards (OPSS) for investigation and potential action with Local Authority Trading Standards. The Department clarifies that nursing pillows aren't medical devices and directs safety regulation concerns to the Department for Business, Energy and Industrial Strategy. They highlight existing guidance and resources from health visitors, midwives, Public Health England, the Lullaby Trust, Start4Life, and NHS Choices regarding safe sleeping and SIDS prevention.

Noted (AI summary) The MHRA reviewed the SUSAR report and determined that the symptoms were in line with the known safety profile for nivolumab, and no further action is required for participants in nivolumab clinical trials. They also stated that conflict of interest lies outside the remit of MHRA for clinical trials.

Noted (AI summary) Imperial College London's Toxicology Unit acknowledges the difficulties in accurately analyzing and detecting NPSs due to their changing nature, lack of standards and pharmacological data, and states that no action is proposed. Alere Forensics describes its ongoing efforts to improve the analysis and detection of new psychoactive substances (NPS), including developing novel screening techniques, working with universities to obtain reference materials, and providing training to stakeholders. The Psychopharmacology, Drug Misuse and Novel Psychoactive Substances Research Unit at the University of Hertfordshire is engaged in research to identify NPS and provide updated clinical guidelines, including using computational models to identify potential compounds before they appear on the market.

Noted (AI summary) M&S expresses condolences and states that the Gown was compliant with all legal requirements. M&S goes significantly beyond the legal requirements in its flammability testing of adult dressing gowns.

Noted (AI summary) Takeda believes the existing patient information leaflet adequately addresses the issue of damaged patches, and they have requested a review to determine if changes are needed; the MHRA also reviewed product information for fentanyl patches in April 2015.

Noted (AI summary) The Department for Business Innovation and Skills acknowledges concerns about clothing flammability but states that most clothing is flammable and reducing it would require flame retardants with their own risks. They don't believe there's sufficient evidence to extend flammability requirements to other types of clothing but will keep the issue under review.

Noted (AI summary) The Department of Health acknowledges the concerns raised about helium gas and suicide, noting ongoing discussions with partners but without specific outcomes to report. They highlight the need to balance helium availability with safety and reference Samaritans' media guidelines.