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
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
*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
[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