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Inspection report

Date of Inspection: 25 January 2012
Date of Publication: 24 February 2012
Inspection Report published 24 February 2012 PDF

People should be safe from harm from unsafe or unsuitable equipment (outcome 11)

Meeting this standard

We checked that people who use this service

  • Are not at risk of harm from unsafe or unsuitable equipment (medical and non-medical equipment, furnishings or fittings).
  • Benefit from equipment that is comfortable and meets their needs.

How this check was done

Our judgement

Equipment was regularly monitored to ensure it was safe and working effectively. Processes were in place to ensure that patients were not put at risk from unsafe or unsuitable equipment.

Overall, we found that BMI The Garden Hospital was meeting this essential standard.

User experience

On this occasion we did not speak to patients about this outcome area.

Other evidence

Senior managers told us that all medical devices and implants used at the hospital were approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and were marked accordingly. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. The provider was aware that a number of patients had undergone breast enhancement surgery at the hospital between 2007 and 2010 using implants that were now withdrawn from use. As soon as an alert was received from the MHRA about the safety of the implants in 2010 they had been quarantined and not used again.

There were contracts in place for the servicing of equipment including that used in the operating theatres and checks were carried out on a regular basis. This ensured that medical equipment was maintained in a safe condition. We saw that regular checks of medical gases and operating theatre lights had taken place and were recorded.

Decontamination of instruments took place at another BMI Healthcare Limited facility. Any concerns about decontamination were highlighted immediately and action had been taken to improve practices. We saw that records were kept of all sterile instruments used during surgery. This enabled the tracking and tracing of instruments if decontamination concerns were later identified.

We saw that medical products were stored safely in a cupboard in the theatre area. We saw a number of breast implants in sealed boxes. These were within the expiry date for the product and were not of the type that had been withdrawn from use because of safety concerns.

Any safety alerts received from the MHRA or equipment manufacturers were disseminated to the appropriate staff and products were withdrawn immediately when required. Examples were provided of when this had happened. All medical devices purchased needed to be approved by the MHRA.

We saw emergency equipment was easily accessible to staff in the theatre area. An emergency airway kit was kept in the lift in case this was needed by patients returning to the ward after surgery. Emergency equipment had undergone regular checks to ensure it was fully functioning when needed.