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Laurence  
#1 Posted : 08 December 2010 09:40:25(UTC)
Rank: New forum user
Laurence

One of the theatres here is looking at carrying out a new procedure using 4% Formaldehyde. A graft is to be taken from the patient, soaked in Formaldehyde for 12 minutes then re-attached. Normally all specimens are decanted in a controlled environment using a fume cabinet in the theatre complex but using 10% Formaldehyde. The 12 minute soaking time is crucial and any delay with the graft (i.e. taking it down to the room with the fume cabinet and finding other staff using the room), so the surgeon is insistant that the Formaldehyde is kept in the theatre during the procedure, the air change in the theatre is 25 AC/hr. I am waiting for a COSSH assessment from Sypol, hopefully later today, but I believe it just may say like the MSDS that adequate ventilation and PPE should be initiated. My initial risk assessment is reccommending that the container with the Formaldehyde should kept closed until the graft is applied, closed for the 12 minutes then opened/closed again, I believe this is sufficient. The other risks of spillage, fire etc will be suitably controlled. Has anybody got further advice before I go ahead with the assessment. Cheers in advance.
MB1  
#2 Posted : 08 December 2010 10:34:48(UTC)
Rank: Super forum user
MB1

Hi Laurence, Not my expertise, although have you considered a system to identify anyone who may be already sensitised to formaldehyde? Few in number and you are obviously looking at measures to reduce exposure. Additionally the air exchange in OT's are pretty good too!
chris.packham  
#3 Posted : 08 December 2010 10:55:21(UTC)
Rank: Super forum user
chris.packham

I am intrigued (alarmed?). You are rightly concerned about inhalation exposure, but I would also be very concerned about skin exposure. Formaldehyde is an extremely potent skin sensitiser, so appropriate precautions will need to be taken to avoid skin contact. Presumably the skin tissue will be handled using forceps, but it there is any possibility of skin contact, perhaps when manipulating the tissue in situ, then appropriate PPE will be needed. This will mean a single-use nitrile glove in the category III class. (Most of the single-use sterile nitrile gloves will probably be category I). Also bear in mind that permeation breakthrough will occur fairly quickly following intial contact (even after the contact has stopped permeation continues), so it may be necessary to ensure that the gloves are changed immediately after the application of the tissue to the patient. Note that patch testing for formaldehyde is carried out at just 1% in water. I wonder if those proposing this procedure have considered the potential effect on the patient of applying a formaldehyde soaked piece of skin long term. Chris
teh_boy  
#4 Posted : 08 December 2010 14:28:13(UTC)
Rank: Super forum user
teh_boy

Hi laurence I don't really have an answer but thought throw in my initial thoughts. First - take note of what Chris says, he is the god of all things skin. As for the inhalation risk it will be possible to calculate (or should I say guesstimate) concentrations in the air. If you know temperature you can work out evaporation rate, as know air change you can see generally what levels might be reached and if they breach the WEL. there are also modles to work out concs in zones around the source but it all starts to get a bit Mathy (is that word?) Note that this will not account for someone with their head over the open container tho I have no idea how much a soln 'fumes' but as you suggest covering it will limit exposure. can you consider use of and LEV system within the theatre or even a mini fumehood / filter system?
chris.packham  
#5 Posted : 08 December 2010 19:30:35(UTC)
Rank: Super forum user
chris.packham

Laurence Just out of interest I copied your posting to a very good friend of mine who I work closely with and who happens to be one of the leading consultant dermatologists in Germany. Here is his response regarding the use of formaldehyde as you have indicated: === "Hilarious: it's toxic, it's carcinogenic it's highly allergenic - seems a(n) (un)practical joke to me." === All I can say is that if your organisation persists in continuing with the proposed procedure expect some pretty hefty compensation claims from patients sensitised to the formaldehyde, plus possibly a prosecution due to the organisation having deliberately exposed the patient to a substance known to be harmful. Chris
martinw  
#6 Posted : 08 December 2010 19:56:58(UTC)
Rank: Super forum user
martinw

Laurence what is being grafted? Formaldehyde being the nasty stuff that it is, even when it is formalin, you would have to be rinsing it pretty well before it goes back to a patient. 4% is the same concentration used at the theatres where I am too. Just interested. Martin
andybz  
#7 Posted : 08 December 2010 20:10:44(UTC)
Rank: Super forum user
andybz

Is it not the case that lots of substances used in medicine are toxic? I'd guess some are carcinogenic (e.g. radiation, which is used to treat cancer). And I certainly know lots of people can be allergic to medicine. Not sure who is playing the 'hilarious' joke.
chris.packham  
#8 Posted : 08 December 2010 22:17:53(UTC)
Rank: Super forum user
chris.packham

Just one or two points to ponder on. Patch testing is used to determine whether a person is already sensitised to a particular substance. In patch testing the suspected chemical is applied in diluted form to the back for a period of 48 hours. As in doing so a risk of actual sensitisation by the test exists it is important to dilute to a level where this is extremely unlikely, but where the concentration is still sufficient to elicit a reaction if someone is already sensitised. For Formaldehyde this has been determined by experience and consensus among a body of eminent dermatologists as 1%. If I now take the description in the original posting at face value, it is proposed to apply a skin patch to the person for an extended period (presumably considerably longer that 48 hours) which has been soaked in formaldehyde at a concentration of 4%. As already stated, patch testing is carried out at just 1%. Even worse, this skin patch would not be placed on the outside of viable skin, but presumably on an area of the body where the skin is either damaged or where the outer (barrier) layer (stratum corneum) has been completely removed. Given that damaged skin is more prone to sensitisation and that there is nothing to prevent the sensitiser from reaching cells in the immune system, there has to be a very high probability of active sensitisation. Of course, this is taking the posting at face value. It may be that there are elements of the operation that have not been included or that those involved have found some way of removing the formaldehyde from the skin graft. Chris
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