Brian Marks

Tamara Finkelstein 
Chief Operating Officer 

Richmond House  
79 Whitehall 
London 
SW1A 2NS 

Mr J Pollard 
Senior Coroner 
Coroner’s Court 
1 Mount Tabor Street 
Stockport 
SK1 3AG 

29 April 2015 

Dear Mr Pollard  

Thank you for your letter following the inquest into the death of Brian Marks. 

I  was  very  sorry  to  hear  of  Mr  Marks’  death  and  wish  to  extend  my  sincere  condolences  to  his 
family. 

You explain that Mr Marks had Motor Neuron Disease and was fed and given medication via a PEJ 
(Percutaneous  Endoscopic  Jejunostomy)  tube. During  a  stay  in  hospital  Mr  Marks’  feeding  tube 
appeared to malfunction.   

The nurse who tried to replace the PEJ tube mistakenly believed that it was a PEG (Percutaneous 
Endoscopic Gastrostomy) tube. Whilst the two tubes are similar in appearance, the procedures for 
using  them  are  very  different.  The  PEJ  tube  could  not  be  replaced  because  of  the  error  and  Mr 
Marks had then to be fed and medicated intravenously. The best protection against error of this kind 
is to ensure that the clinician concerned is fully aware of what he or she is doing. Regrettably, that 
does not appear to have happened in this case.  

You have noted that the PEG and PEJ tubes are very similar in appearance and there is therefore a 
risk of confusion. You heard from witnesses at the inquest that a simple colour coding system could 
be implemented so that the tubes (including when in situ) could be immediately differentiated.   

We  have  discussed  your  report  with  NHS  England  and  the  Medicines  and  Healthcare  Products 
Regulatory Agency (MHRA).  

Both  organisations  agree  that  feeding  tubes  look  very  similar  and  can  therefore  be  confused  with 
one  another,  potentially  putting  the  patient  at  risk.  However,  the  solution  might  not  be  as 
straightforward as it first appears.  

There is a wide range of feeding tubes available, beyond PEJ/PEG, and the terminology used may 
not  always  be  clear  to  practitioners.  Further  types  of  tubes  are  in  use  for  purposes  other  than 
feeding.    These  tubes  may  also  be  used  in  different  anatomical  sites  -  for  example,  Percutaneous 
Endoscopic Sigmoid Colostomy (PEC) tubes are inserted into the colon and used for irrigation or 
anchoring the bowel.  

 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 Some tubes are licenced for use both in the stomach or small bowel. The position where the tube 
exits the body on the patient’s abdomen does not automatically indicate where the tube is located 
within the gastrointestinal tract.  

This means that even after correctly identifying the tube it would not be possible to reliably identify 
its position or function in the gastrointestinal tract.  

Your suggestion of introducing a colour coding scheme has already been considered.  Some experts 
in  the  field  believe  a  suitable  scheme  could  be  helpful,  although  influencing  manufacturers  to 
change  design  to  ensure  easier  visual  distinction  of  their  product  is  not  always  straightforward. 
Manufacturers  cannot  be  compelled  to  make  such  changes  where  these  are  not  part  of 
internationally required design standards.  

Medical products traded in the European Economic Area (EEA) are assessed before being placed on 
the  market.  To  obtain  the  CE  mark  demonstrating  approval  for  use,  manufacturers  must 
demonstrate  that  their  product  conforms  to  the  relevant  essential  requirements  of  the  Medical 
Devices Directive 93/42/EC, and does not compromise the safety of the patient or user when used 
as  intended. This  includes  ensuring  that  risks  from  foreseeable  misuse  have  been  assessed  and 
adequate controls implemented. The Directive does not however stipulate the control measures to 
be adopted. It may therefore be difficult to persuade manufacturers to make specific changes to their 
devices for only a single country in the current global market.   

There are other potential problems in introducing the proposed colour coding. Many enteral feeding 
catheters (for feeding directly into the stomach, duodenum or jejunum) already use a colour code on 
the  connector  to  indicate  the  diameter  of  the  catheter.  If  further  colour  coding  for  PEG  and  PEJ 
tubes were to be implemented, this might provide scope for even more confusion.   

Colour coding itself also causes problems for users with colour blindness or deficiencies in colour 
perception. For these people, colour coding may not help them to distinguish between devices and 
can therefore introduce new hazards.  

There  is  also  the  likelihood  that  the  colours  introduced  would  not  be  specific  to  one  group  of 
devices, so that a reliance on colour coding could  also introduce the  potential  for misconnections 
between  different  tubes.  This  issue  was  reported  in  the  recently  published  U.S.  Food  and  Drug 
Administration  (FDA)  guidance  document,  ‘Reduce  –  and  Report  –  Enteral  Feeding  Tube 
Misconnections’.  

This guidance advises that users ‘shouldn’t rely on colour coding to prevent misconnection because 
colours aren’t always consistent or specific to device groups’. The full document is available at:  

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm
234440.htm 

A similar message was contained in an earlier Joint Commission Alert in 2006. Issue 36 of the Joint 
Commission’s Sentinel Event Alert in 2006 stated that colour coding ‘can lead users to rely on the 
colour  coding  rather  than  assuring  a  clear  understanding  of  which  tubes  and  catheters  are 
connected correctly to which body inlets.’  

The full document is available from the following web address: 

http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misconnections%E2%80%
94a_persistent_and_potentially_deadly_occurrence/ 

 
 
 
 
 
 
 
 
 
 
 
 Although  the  introduction  of  further  colour  coding  might  not  be  the  solution  you  had  hoped  for 
there are other steps that are being taken to minimise the risk of such confusion in future.  

Many  manufacturers  use  harmonised  standards  where  they  exist  for  a  particular  device  because 
there  is  an  assumption  that  products  meeting  these  standards  conform  to  the  requirements  of  the 
Medical Devices Directive 93/42/EC.  

MHRA will bring the issue of tube misidentification to the attention of the Standards Committees 
(European  Committee 
for 
Standardisation - ISO) to consider if this issue should be addressed in the relevant standard. If this 
issue  were  to  be  included,  it  would  help  to  bring  about  beneficial  changes  to  the  products  by 
manufacturers. 

for  Standardisation  –  CEN  and 

International  Organisation 

MHRA publishes a document called Managing Medical Devices, providing guidance on factors to 
consider before purchase to help Trusts with this process. MHRA confirms its intention to include 
the risk of misidentification of similar devices in the next revision of this guide.  

In addition, individual NHS Trusts can already take steps to minimise such risks. An opportunity 
arises during the procurement phase for devices, when NHS Trusts consider the usability of devices 
and  whether  the  particular  devices  used  within  their  healthcare  organisation  could  be  confused. 
Devices that have a lower risk of confusion should be identified and purchased. NHS Trusts should 
also  consider  further  training  of  staff  and  development  of  local  policies  and  documentation  in 
minimising the risk to patients.  

Lastly, I can confirm that NHS England is committed to working with other stakeholders, including 
the  MHRA,  on  solutions  to  the  risks  you  have  identified  in  your  report.  They  will  keep  you 
informed of progress.  

I hope that this response is helpful and I am grateful to you for bringing the circumstances of Mr 
Marks’ death to my attention. 

Yours sincerely 

TAMARA FINKELSTEIN