DEHP and BPA containing medical devices attestation form, Health Canada

somashekar

Staff member
Super Moderator
#1
Helloo everyone.
I have received an attestation form from Health Canada for signoff and return. along with some information about the DEHP not exceeding 0.1% in the plastic parts (PVC) and similarly not being a derivative from BPA in the medical devices we make.
We make patient monitors and sensor cables which have plastic parts in them. These are supplied from various vendors.
Can anyone here with Health Canada experience about this aspect throw more light about what tests were conducted and how this 0.1% was confirmed before attesting and returning this form to Medical devices bureau. Not being an expert in chemicals and plastics, I am stuck .... :confused:
 
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Ajit Basrur

Staff member
Admin
#2
Helloo everyone.
I have received an attestation form from Health Canada for signoff and return. along with some information about the DEHP not exceeding 0.1% in the plastic parts (PVC) and similarly not being a derivative from BPA in the medical devices we make.
We make patient monitors and sensor cables which have plastic parts in them. These are supplied from various vendors.
Can anyone here with Health Canada experience about this aspect throw more light about what tests were conducted and how this 0.1% was confirmed before attesting and returning this form to Medical devices bureau. Not being an expert in chemicals and plastics, I am stuck .... :confused:
Thats true - refer this Health Canada

Btw, DEHP and BHA stand for di(2-ethylhexyl)phthalate and bisphenol A (BPA) and is step towards going GREEN

My approach to the absence of BPA and DEHP would be to get a declaration from the plastic parts supplier as ma first step and then to test your plastic parts for the absence of DEHP and BPA. There are lot of laboratories who do this testing.
 
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M

MIREGMGR

#3
Heh. We've responded to perhaps a hundred such info requests at this point, from various customers. :)

A short course in the applicable chemisty, which perhaps may allow you to avoid having rather expensive testing done:

Most flexible PVC formulations are flexibilized by means of the presence in their formulation of 30% to 45% of a blend of plasticizers. The most common type of plasticizer in vinyl formulations that are created to be minimum- to moderate-cost is phthalates. The most commonly used phthalate in formulations that are intended to operate across "normal" human-environment temperature ranges is DEHP. My guess is that >99% of flexible vinyl products are based on phthalate plasticizers.

Some materials, usually much higher cost with special properties, use other plasticizer types. We also use a family of proprietary flexible vinyl coatings that are based on a polymeric plasticizer type, and contain no DEHP. But, materials like those are definitely the exception.

If you make products containing flexible vinyl and you don't have some reason to be relatively sure that their formulation is unique/special/different, it's safe to assume that the answer to the Health Canada DEHP question is "yes". Otherwise it's "no".

Of course, if your cable insulation is an unknown flexible plastic, you may be stuck. But it'd be nice to think that your suppliers at the least could tell you the basic plastic type, i.e. vinyl, an olefinic elastomer, silicone, or otherwise.

BPA is a fundamental chemical constituent of two types of plastics: polycarbonates, and (conventional) epoxies. These are both rigid materials, not likely to be used in a cable insulation system but quite possibly found in connectors. BPA is not normally a part of any other plastic type.

Per the above, you may have available to you enough technical knowledge of the plastic materials used in parts provided to you to know the basic resin type. If there is any polycarbonate or epoxy in your product, the answer to the Health Canada BPA question is "yes". Otherwise it's safe to answer "no".
 
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G

gholland

#4
There are a couple issues with DEHP in medical products.

First is that even if your product is made with, say, a TOTM plasticizer (a common one that we use in our PVC applications that is non-DEHP) is that unless your supplier is careful you run the risk of cross contamination. You can specify a non-DEHP plasticizer all day long but a typical extruder will run DEHP and TOTM plasticizers on the same machine and you will get DEHP into your product. You must make special arrangements with your supplier for line clearance and cleaning the machine, or in our case our supplier has a dedicated extrusion line for non-DEHP parts.

If you have PVC in your product and you do not specify a non-DEHP plasticizer it is almost certain you have DEHP in your product and will fail the requirement. As miregmgr states it is less expensive than a non-DEHP plasticizer.

TOTM makes the parts more expensive but it is not uncommon. If you produce disposable medical products with PVC components you are using a non-DEHP PVC or you will be soon. Most extrusion houses that supply medical parts are familiar with other plasticizer options but you have to be specific and require them.

As Miregmgr states if you don't have PVC in your product you can safely claim you comply with the DEHP requirement. I have no experience with BPA.

You can ask a test lab to run a test for DEHP on your product... most likely they will use a Gas Chromotography procedure, basically you use a leechate to see what comes out of your product and then analyze it. It will run a few thousand dollars and cost a couple weeks of time for the test. It is a common enough test, contact someone like Nelson labs and they are familiar with it.

:2cents:
 
M

MIREGMGR

#5
Our belief so far is that (in the volumes we buy, anyway), it would be possible to comply with the Health Canada <=0.1% DEHP requirement with plasticized vinyl run on a well managed but mixed-production line. We are not doing this, but we've considered it.

A 0.0% content would be impossible to achieve. Cross-contamination to a small degree is unavoidable, of course. My understanding is that most medical personnel have body phthalate (mostly DEHP) percentages in the tens or hundreds of PPB range...certainly not zero.

If you produce disposable medical products with PVC components you are using a non-DEHP PVC or you will be soon.
For the EU market, anyway, and perhaps Canada. We don't think the FDA is going there, anytime soon anyway. We make enough product that we can offer separate versions for different markets.

So far our EU customers prefer to buy the PVC versions, because of cost.
 

somashekar

Staff member
Super Moderator
#6
Thanks for all your updates ... :agree:
With my supplier stating that the DEHP in the cables he supplies us is under 1000 PPM and with all your tech stuff about the DEHP, I am more confident now to handle this. Thanks for your alerts on cross contamination. This will help in more better part specification as well as provide inputs to discuss with supplier on the proper usage of the moulding machines ....
:thanx:
 
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