Ajit's  summary :

Only  licensed product available  with 2% Chlorhexidine & 70% alcohol for skin prep is  Chloraprep

MHRA  &  RCS  advise using only  licensed products . Trust is  therefore liable to be sued if  you use an unlicensed product.

 

Pink  solutions  in the  same concentrations are available  but are  un -licensed  &  have the added  risk of  pooling & catching fire ( apparently almost colourless  flame)

Adding  dye  adds  to the problem of not being licensed.

 

If  a  risk  assessment  is  done & clinicians , infection control, theatres etc agree  to  use  an unlicensed product our  trust  advises that  all patients  are  informed & this  is  noted  on the consent forms  to reduce litigation.

 

Alternative suggestion in the  forum is to  use :

Solution of  your  choice for prep but use  chloraprep  for the incision site. 


 

Dear all 


Our trust is being very forceful in introducing this product against clinicians desire

The issues are;

It is the only 'licensed' preparation of 2% chlorhexidine
The MHRA and RCS have released statement that only licensed products should be used
There is only one company manufacturing a licensed product at 20x the cost.
Some of the surgeons find the applicators difficult to use in extremities.

Has this been 'forced upon' anyone else?

regards

Steve Hepple
______________________________________________________________________________________________________________________________

 

 

In Leicester we had exactly the same pressure 18 months ago.  We reached a compromise whereby we could do an initial wider field prep of choice (mostly iodine based) with the mini Chloraprep used for the incision site.  Generally happy with this approach.

Richard A Power FRCSEd(Orth)

Consultant Orthopaedic Surgeon
Clinical Director Musculoskeletal and Specialist Surgery


________________________________________________________________________________________________________
Great and useful feedback so far, it seems however that most people have previously rejected or reluctantly agreed to use these on 'infection control' grounds. That is not the argument being used at present, but rather that this is the only licensed 2% chlorhexidene product. There is no infection control evidence behind it but the MHRA and RCS have issued a statement saying all trusts should use a licensed product and it is therefore our rusts fear that they will be contravening an MHRA edict rather than any clinical benefit. 
 
The following link may illuminate some of the tactics of the company marketing chloraprep - FIFAesque in the allegations of bribery behind the scenes in USA
 
Steve Hepple 
Consultant Orthopaedic Surgeon
Clinical Director Musculo-skeletal
North Bristol NHS Trust

From: orthodirectors@yahoogroups.com [orthodirectors@yahoogroups.com]
Sent: 16 June 2015 11:20
To: orthodirectors@yahoogroups.com
Subject: Re: [SPAM] [orthodirectors] RE: Chloraprep
  
Dear all, 
We had a similar "push" to use Chloraprep in wolverhampton a couple of years ago. We went through all the same arguments: 
Evidence is only from general survey patients, and only with application to flat surfaces. 
The sticks are VERY expensive, and we felt there was an increased chance of de sterilising the surgeon, coz they are too short, 
We were forced to take part in a "trial" organised by gen surgery in our hospital. Poor science, using historical controls, but it showed no change in superficial wound infection rates.... (No appreciation from gen  surg that deep infection rates are the most important!!...). 
Final outcome is that the hospital quietly dropped the sticks!
 
Adrian Simons

Sent from my iPhone

On 16 Jun 2015, at 11:06, 
ridgey@doctors.net.uk [orthodirectors] <orthodirectors@yahoogroups.com> wrote:
  
*FROM MEMORY*
I am unsure if the evidence is as strong as we are led to believe. I think it arises from a large trial published in the NEJM some years ago. 
However not one Orthopaedic Patient was recruited to that trial.
The applicators for Chlrorhexidene were touted at the Dublin BOA / IOA congress and all thought they were savagely expensive. A brief discussion occured subsequently in this forum and most were against.
We objected to the transparency of the standard liquid and add a dye to it which costs around £3:50 for copious amounts!
We have been instructed to move accross to the Pads.
Jeremy rRdge Dewsbury  
 
 
On 16-06-2015 10:40, 'FARNDON MARK (RCD) ORTHOPAEDIC CONSULTANT' mark.farndon@hdft.nhs.uk [orthodirectors] wrote:
  
[Attachment(s) from FARNDON MARK (RCD) ORTHOPAEDIC CONSULTANT included below]
Indeed.
We use tartrazine colourant for extremities as you can see where you've been, we find it much easier to assess the peripheral perfusion than if the livid pink has been used.

The colour in either case is added to a fresh bottle of alcoholic chlorhexidine.

I find the prep sticks a pain even for knees, so use 'yellow' for everything.


Mark.


On 16 Jun 2015, at 10:33, Steve Hepple 
steve.hepple@nbt.nhs.uk<mailto:steve.hepple@nbt.nhs.uk> [orthodirectors] <orthodirectors@yahoogroups.com<mailto:orthodirectors@yahoogroups.com>> wrote:

Cefin


As I understand the pink staining prep is 'made on site' i.e. it is clear chlorexidene that has a dye added but he nurses when the bottle is opened. We mainly use the pink hydrex too at present.


regards


Steve Hepple

Consultant Orthopaedic Surgeon

Clinical Director Musculo-skeletal

North Bristol NHS Trust