TRUEresult Blood Glucose System

A considerable number of employees have contacted me with regard to a new, smaller blood sugar testing device that has appeared on our emergency vehicles. The majority of employees have voiced their concerns that the TRUEresult system is not suitable for use by healthcare professionals based upon what is written on the accompanying poster. I have viewed the poster and the reference appears to apply just to the lancet, which we will not be using. However there are other issues which I have become aware of and these have been notified to management in line with best practices.

Whenever the management intend to introduce changes to the workplace, practices, procedures or equipment, there is a requirement to consult with the health & safety representatives elected to represent the employees that will be affected by these proposed changes. This consultation does not appear to have taken place and so the appearance of the new device was unexpected. The Trust has stated that staffside had been involved with the procurement and evaluation of the new equipment but this is not the case. Unison have not been involved in the processes.

I have been informed that the reason for changing devices is because “The company no longer make the discs containing the test strips”. I have sent an email to Bayer to find out if this is because the test strips were no longer financially viable, unpopular or if there were other reasons.

There is an obligation on the part of the Trust to ensure that all employees are trained in the safe use of any new equipment before it is introduced. Where there is the potential for injury to employees or to the public, when the equipment is used, ‘Best Practices’ would include a formal assessment of the individuals at the end of the training to ensure that they have fully understood how to use the equipment in the safest manner and what, if any, pitfalls to be aware of. I have been informed that a Formal Assessment Form, to be used at the end of training in the TRUEresult system was created on 11 November 2014, but despite this, there had been no forward planning to ensure qualified clinicians currently out on the road were trained and assessed in the four months since last November.

This failure to train employees before introducing the equipment means that employees are carrying equipment which they are expected to use but have not been trained to do so.  In an attempt establish if there were any obstacles that would hinder or prevent our employees from using the TRUEresult blood glucose system, I obtained a copy of the Owner’s Manual. It took 45 minutes to read the Owner’s Manual and become aware that there were just causes for concern.

The TRUEresult Owner’s Manual informs the reader of the need to read the Owner’s Booklet and all product “Instructions For Use” before using the system.

Page 2 states that the system is used for self-testing.

Page 3 instructs the user to perform Control Tests before performing a blood glucose test for the first time.

Page 4 gives the following information:

IMPORTANT HEALTH and SAFETY INFORMATION

The TRUEresult twist Blood Glucose Monitoring System is for one person use ONLYDO NOT share your meter with anyone, including your family members. DO NOT use on more than one person. ALL parts of the TRUEresult twist Blood Glucose Monitoring System could carry blood-borne pathogens after use, even after cleaning and disinfection.

Reuse of devices labelled for single-use may result in product contamination and patient infection.

This information provided by the manufacturer is a clear message that the TRUEresult system is specifically for one person only and should not be used on more than one person.

Page 13 states “Control Solution Level (1,2 or3) Testing at least 2 levels of Control Solution is recommended.

Page 17 states Control Test

The Control Test checks that the system is working correctly and testing technique is good. Use ONLY TRUEresult Control Solution to perform Control Tests. Perform Control Tests:

  • For practice before using the system for the first time
  • When opening a new vial of test strips
  • If a Test Strip vial has been left opened or in extreme heat, cold or humidity
  • If results seem unusually high or low

Performing control Tests with more than one level of Control Solution is recommended to ensure that the system is working properly. The Level of test solution are in the following ranges:

  • Level 1:                     1.7 to 3.4 mmol/L
  • Level 2:                     4.8 to 6.5 mmol/L
  • Level 3:                     13.7 to 18.6 mmol/L

If the test result falls within its range on the solution bottle label, it can be used for testing blood.

If the test result does not fall within the range on the solution bottle label, repeat the test using a new test strip.

If the test result is still outside the range after a second test, the system should not be used.

Based upon the above information it becomes obvious that:

  • Employees must undergo training and assessment in the safe use of the TRUEresult monitoring system before using it on a patient
  • Training should be carried out by a suitably qualified instructor / assessor
  • The TRUEresult system is clearly intended for single person use only
  • The TRUEresult system should not be used on more than one person

Incidents such as this could be avoided if the Trust had consulted with the Unison Health & Safety Team during the preliminary stages to ensure that new equipment is suitable for use, robust and that employees are trained in its safe use before it is introduced into service. I will endeavour to keep you updated.

Jeff Pittman

East of England Ambulance Unison 20106

Branch Health & Safety officer