IRIC case studies

Your incident report may lead to changes in the manufacturing process or the publication of a safety alert. See the following case studies.

Case study 1: Adverse incident report leading to changes in the manufacturing process

Speciality: Cardiac surgery

Equipment: Anaesthetic breathing circuit with integral monitoring line

Incident: The anaesthetic machine detected inappropriate concentrations of anaesthesia and oxygen being delivered to the patient during surgery. It was thought that a crack in the medical device may have been caused by the over-tightening of the luer connection by the anaesthetist.

Investigation and Findings: The two medical devices were returned to the manufacturer for investigation. A crack was found in the luer connector of both products and the circuits failed the manufacturer’s testing for leakage. A review of the production records for the specific lot number revealed cracks had occurred during the production process and suspected some cracks were not obvious during the sorting process. Checks of the manufacturer’s post-market surveillance database revealed that the two incidents were isolated cases and no further reports for the affected lot number were received.

Outcomes:

• The manufacturer identified the cause in the manufacturing process.
• Additional ‘monitoring line leakage’ testing was implemented during production to prevent cracked breathing circuits leaving the factory.

Case study 2: Adverse incident report leading to a publication of a Safety Action Notice

Service: Physiotherapy / Rehabilitation

Equipment: Manual wheelchair and wheelchair weighing scales

Incident: A wheelchair user sustained a head injury following a rearward tip when using a wheelchair weighing scale

Investigation and Findings: The wheelchair had not been re-assessed for safety and stability after the user’s recent lower limb amputation which changed the wheelchair’s centre of gravity. Also, the wheelchair user reversed down the weigh scale ramp further reducing wheelchair stability. Anti-tip levers designed to reduce tipping incidents had been removed from the wheelchair. Additionally, the wheelchair weighing scale had been accessed without the assistance of an attendant.

Shared Learning:

A Safety Action Notice was published recommending:

• patients undergoing lower limb amputation should be routinely referred to their wheelchair centre for re-assessment to check wheelchair safety and stability.
• information, in the form of signage, on the correct use of scales should be easily accessible for staff and patients to read.
• the wheelchair weighing scales risk assessment should consider location and orientation to restrict unsupervised access and to discourage reversing on or off the scales.

Case study 3: Adverse incident report leading to changes in the manufacturing process

Speciality: Maternity - labour ward

Equipment: Umbilical cord clamp

Incident: The umbilical cord clamps caused the partial shearing of the umbilical cord resulting in haemorrhaging on two separate occasions.

Investigation and Findings: The batch of unused clamps was returned to the manufacturer for investigation in order to determine the root cause of failure. Microscopy revealed the presence of some flashes of plastic material from the moulding process along the closing area surface with a height of 0.1 - 0.2 mm. Excess material from the injection moulding process leaked between two surfaces of the mould resulting in 0.1 - 0.2mm protruding plastic on the clamping area.

Shared Learning:

• The manufacturer identified the cause in the manufacturing process and improved the injection moulding process.
• In 2020 the manufacturer issued a Field Safety Notice to it customers initiating a product recall on two specific batches of umbilical cord clamps to prevent similar incidents of harm reoccurring.

Case study 4: Adverse incident leading to a publication of a safety information message

Speciality: Local Authority Health and Safety Team

Equipment: Emollient cream

Incident: Scottish Fire and Rescue Service (SFRS) investigated a local fire incident and advised the local authority of fire risks involved with paraffin based emollient cream build up in fabrics. The local authority raised the issue with IRIC as a safety concern.

Investigation and Findings: Paraffin based emollients are moisturising treatments applied directly to the skin and can build up over time on fabrics (such as clothing or bedding) and can cause them to catch fire more easily. Emollient creams are classed as medicines and do not come under IRIC’s remit. Medicines and Healthcare products Regulatory Agency (MHRA) previously issued advice about this issue through medicine channels. However, IRIC re-assessed the issue since it had been raised by the local authority and concluded that the problem also impacts on the management of equipment such as dressings and mattresses which do come under IRIC’s remit. IRIC assessed that stakeholders involved in the use and management of medical equipment may not be aware of this issue and would benefit from being aware of the problem.

Shared Learning:

IRIC worked with the National Fire Safety Advisor to produce a Safety Information Message highlighting the MHRA guidance to its stakeholder network. Follow up guidance was produced by IRIC a year later to support a national campaign to raise awareness of the fire risk and precautions that need to be taken when using skin creams.

Recommendations included:

• Avoid smoking whilst wearing clothing or a bandage that has been in contact with skin creams.
• Change and wash clothes and bedding frequently to reduce build-up of skin cream.
• Tell your healthcare professional if you normally smoke.