2015

Disputed (AI summary) The practice disagrees that too many Zopiclone pills were prescribed and argues that a special flag highlighting past overdoses would be problematic and potentially offensive. They believe their current assessment process and referral to the Crisis Response Team are adequate. The Trust undertook a Root Cause Analysis Investigation following the death, accepted the recommendations, and completed the identified actions. Assurance that changes have been embedded into clinical practice is monitored through routine audit.

Disputed (AI summary) MHRA has discussed the QA3 instructions for use with the manufacturer, advising them to review them again to ensure that they are still accurate and appropriate. MHRA contacted four other Hospital Trusts via our Medical Device Safety Officer (MDSO) network, each of which have over one hundred QA3 trolleys in use, to establish whether they have had this problem but had not reported it to MHRA. AneticAid defends the design and safety record of its QA3 trolley, arguing that no retrospective changes are needed. They suggest the issue is localised to Royal Berkshire Hospital and will continue to provide training and support to the hospital staff. Royal Berkshire NHS Trust has contracted with Anetic Aid (AA) to undertake periodic inspection and maintenance on all of its QA3 trolleys. The Trust has further updated its Clinical Engineering Checklist for AA QA3 trolleys to expressly detail the checks that must be undertaken during every inspection of a QA3 trolley.