• A new national scanning system for surgical implants should be introduced by the Department of Health and Social Care
  • HSIB identified fatigue as a factor in a surgical never event which resulted in a “lapse in attention”
  • Recommendations aimed at national regulators include better labelling and new verification processes

A new national system of scanning prosthetic implants before they are put into patients should be created by the government, the Healthcare Safety Investigation Branch has said.

In its first national investigation report since being set up in April last year, HSIB said such a system if used in operating theatres could prevent wrong prostheses being used.

It made the recommendation after an incident where a 62-year-old man had two incompatible prostheses implanted during a total hip replacement. The mistake was only picked up days after the surgery, when information was entered into the National Joint Registry database.

HSIB said there were on average 52 wrong implant or prosthesis never events a year with the latest data showing 65 in the year to March 2018, which it said suggested “a national, systemic issue”.

It has made a number of safety recommendations aimed at NHS Improvement, the Department of Health and Social Care and other national bodies.

These include:

  • The DHSC should commission and introduce a basic barcode scanning system in theatres to identify incompatible prostheses before they are implanted in patients.
  • The DHSC should expand the remit of the working group looking at the Scan4Safety programme to include alerts about wrong prostheses.
  • NHS Improvement should change standards on prosthesis verification to include surgeons reading out loud details of the label, boxes of prostheses being shown together, and details of required equipment stored away from the theatre being written down and confirmed with the surgeon.
  • The British Standards Institute should change existing labels on products to make them easier to read.
  • The National Joint Registry should change the alerts its system produces when data is entered suggesting wrong implants have been used.

HSIB also made a “safety observation” that the existing National Reporting and Learning System does not require the inclusion of human factors and environmental conditions which investigators said would be “beneficial for future developments”.

As part of the investigation, HSIB reviewed records, interviewed staff, observed surgery in other settings, carried out a literature review of scientific studies and consulted human factors experts.

The patient, John Hampton, was also involved in the process and consulted on the findings.

As part of its investigation, HSIB identified tiredness and fatigue by one nurse as well as noise in the operating theatre as potential factors that were at play in what it described as “a lapse in memory or a slip in attention”. Poor labelling and variation in practice were also risks to repeat mistakes.

The investigation found the nurse who collected the implants had taken one from the wrong cupboard and she did not know why. All members of the team checked the size and expiry date but not the manufacturer.

The report identified fatigue as a possible factor saying: “The nurse recalled feeling tired on the day of Mr Hampton’s surgery, having returned the night before from a two-day course. She explained she had slept badly.”

The nurse had worked 59 hours in the previous seven days as a result of voluntary overtime, which was “well in excess of her contracted working week of 37.5 hours”.

The investigators also identified noise in the operating theatres as a potential issue citing observations of noise levels at 64 to 72 decibels, exceeding the World Health Organisation recommendations of 30 decibels. The noise was often a mixture of ventilation systems, equipment alarms and monitors, and music.

Melanie Ottewill, lead investigator, told HSJ that investigators visited Denmark which uses a scanning system that could be used in the UK. She said: “It identifies the wrong prosthesis before it is put into the patient whereas at the moment in this country it is only identified after the event.

“What caused this was a slip in attention of a group of staff. We will never know exactly what happened and we were interviewing staff a number of weeks after the incident but we do know the wrong prosthesis was collected. When the checking process went on other staff did not pick that up.

“At the moment, the process to prevent it is people checking each other. A scanning system would alert staff right there in theatre before the procedure.”

Each of the organisations responsible for the recommendations now has 90 days to respond.

HSIB demands national implant reform in first report