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Anaesthetists are Concerned about Safety in the Operating Theatre

Patient Safety is, or should be, the number one priority for anaesthetists and theatre staff alike. In 2009 the SALG Report was circulated to all anaesthetists and others involved in patient safety.

 

Twelfth-century Byzantine manuscript showing the oath written in the form of a cross.

SAFETY IN TIVA, SEDATION, PCA, MRI, ICU APPLICATIONS

"I will apply dietetic measures for the benefit of the sick according to my ability and judgment; I will keep them from harm and injustice."

- extract from the Hippocratic Oath

This comprehensive report highlighted many of the 'incidents' that have occured in operating theatres concerning:

  • Disconnection of cannulae,
  • Patient Awareness,
  • Leaking Valves,
  • Mismatching of anaesthetic drug contents with specific lines,
  • leaking lines(due to poor manufacturing process) etc.

In total there were 18 reported incidents concerning the above problems, and this is only the proverbial 'tip of the ice berg'! Following is an extract from the SALG-2009 Report:

Data from the RLS was searched from March 2008 to 15 June 2009. 89 incidents were found and all were reviewed.49 were found to be relevant. Key issues identified were as follows:
  • Non-availability of appropriate pumps – ten incidents; in two cases this was because the pumps had not been charged
  • Problems with pumps during TIVA – 11 incidents; in one case the TIVA technique was abandoned; in eight cases the problems were noted immediately and the pump either changed or managed differently; in one case it was only noted at the end of the surgery that the pump had not delivered the appropriate amounts of agent.
  • Two reports were of syringes being 'switched' with one relating to wrong labelling (Propofol and Remifentanil) and one where a 1% solution was used instead of 2%.
  • Three cases were reported where lines had been pulled out in error and one where the cannula had 'tissued'.
  • One case reported where anaesthetist was not familiar with technique.
  • Three cases of potential awareness were reported but with no problems with TIVA being identified.
  • 18 cases reported problems with the intravenous line:
  • Three related to Y connectors.
  • Three related to 3-way taps.
  • Other incidents include, kinking of lines, blocking of line, luer lock leaks and other leaks from lines, assumed fixed valves in lines becoming disconnected."

When opening, say, a typical 3 Way TIVA set, the anaesthetist firstly has to trust the integrity of the sets he chooses to use. Secondly it is his or her responsibility to constantly monitor the patient on all parameters and still trust that the set is functioning as it should. Nearly always, the 3 way TIVA set does the job intended and, so it should. It should not kink in any area, have an underperforming distal valve, or be able to disconnect from the cannula or leak from poorly connected joints. These safety issues can be seen on a simple MHRA search over the last few years.

It has been clearly identified that more must be done to improve patient safety per se. A massive amount of research has gone into TIVA-TCI pump technology with sophisticated and well tried drug algorithims for propofol, remifentanil etc. Very little attention has been given, though, to to the overall safety of the administration set.


Safety Issues in TIVA administration

Leading and expert anaesthetists have determined that the following safety issues should be addressed with all types of total intravenous anaesthesia administration sets:

Red End Caps:

To be easily seen, should the cap migrate into the patient's breathing circuit. Download 'Project Orcadian' DOH (Department of Heath) 2004 for a full overview of this and other safety concerns.

Adjustable Line Fixation:

So that the cannula is always protected from disconnection. Not a piece of IV dressing or surgical tape, but proper placement in the chosen area.

Colour Coded Drug Labels:

These to conform with AAGBI guidelines. Eliminates the risk of a drug mismatch.

High Flow Distal Valve:

The highest specification valve should be used and always give the anaesthetist the option, at any time, to infuse adequate volumetric support up the rate limiting factor of a 14g cannula > 280mls/min.

Eye Protection:

Anaesthetists agree that non-traumatic eye protection should be used and to keep patients' eyes closed without trauma at the end of the case.

Distal Line Safety:

It is considered not enough to simply have a 'plastic bridge' to stop the all important distal section from kinking. It should also be 'tamper proof'! It is, unfortunately, the case that many TIVA and PCA sets can kink when stress is applied to them.This makes the risk of an unintended drug bolus all the more likely. For example, in the case of remifentanil, a sudden drug bolus can cause respiratory depression and is clearly avoided if the end section of the set is completely protected.

A TIVA administration set with added safety features

3-way TIVA set

Comparison of 3 Way TIVA-TCI Multiple IV Sets

Full patient safety is now demanded by the NHS and private sector and in sophisticated Export markets. What desiderata should those responsible for purchasing 3 Way TIVA-TCI sets be looking for?

  • Safety
  • Product Excellence
  • Price

For the purposes of this comparison (in the most widely used clinical area) I have excluded 2-Way & 4-Way TIVA Sets and those with a *detachable peripheral iv 2/3 way connector.

*Receiving wards/ICU etc will have their own preference for the iv connector.


Physical Comparison of 3 Way TIVA-TCI Multiple IV Sets

Red End Caps Cannula Protection Non-Distal Kinking Drug Tags Eye protection
FANNIN YES NO NO NO NO
CAREFUSION NO NO NO NO NO
MEDIPLUS YES NO NO NO NO
GLOBAL MEDICAL YES YES YES YES YES
AMS NO NO NO NO NO
VYGON NO NO NO NO NO
B. BRAUN NO NO NO NO NO

The suppliers listed are the main ones operating in the market, there might be others. The Safety Features listed have been asked for by leading anaesthetists and safety advisors. Of course there are others

salg report 2009

  • SALG | AAGBI
    This important report highlights the cases that have been reported in terms of patient safety during TIVA-TCI procedures.Worth reading is-Project Orcadian-2004 (Dept of Health/UK) and Article in the AfPP (Association for Peri-Operative Practice).

Conclusion

I urge you to obtain all of the currently available 3 Way TIVA-TCI sets and compare against each other side by side at your next Audit Meeting. Consider the clinical implications and benefits for your Trust (including reducing the risk of litigation) or private group.

As clinicians, the Hippocratic Oath should be a constant guide, keeping the patient's well-being and safety uppermost in their decisions and actions.


 

Source:
Safe Anaesthesia Liaison Group

 

 

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About The Operating Theatre Journal

The Operating Theatre Journal, OTJ, is published monthly and distributed to every hospital operating theatre department in the UK. The distribution includes both the National Health Service and the Private Sector.

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