[ascct] Next ASCCT member webinar: Medical Device Irritation Testing: An In Vitro Alternative

  • From: Kristie Sullivan <KSullivan@xxxxxxxx>
  • To: "ascct@xxxxxxxxxxxxx" <ascct@xxxxxxxxxxxxx>
  • Date: Tue, 3 Jun 2014 16:06:40 -0400

ASCCT Member Webinar: Medical Device Irritation Testing:  An In Vitro 
Alternative

When: June 24th, 2014 at 2:00 PM US ET
Presenter: Kelly Coleman, Medtronic Biomaterials Department

A modified version of the Draize rabbit test is used to evaluate the skin 
irritation potential of medical devices.  A proof of concept study was 
conducted to determine if the EpiDerm™ reconstructed human skin model (MatTek 
Corp.) could be an acceptable alternative.  A number of medical device polymers 
and adhesives were tested.  Extracts were prepared with saline and sesame oil, 
half of which were spiked with two R-38 irritants, lactic acid for saline 
extracts and heptanoic acid for the sesame oil extracts.  Tissue viability was 
assessed by MTT reduction and the proinflammatory response was assessed by 
IL-1α release.  LOAELs of 2% for lactic acid in saline and 0.7% for heptanoic 
acid in sesame oil were determined.  A cell viability reduction of     > 50% 
was indicative of skin irritation.  Cells exposed to saline extracts spiked 
with 3.25% lactic acid had significantly reduced mean cell viabilities (12.6% – 
17.2%).  Cells exposed to sesame oil extracts spiked with 1.25% heptanoic acid 
also exhibited reduced mean cell viabilities (25.5% – 41.7%).  All spiked cells 
released substantial amounts of IL‑1α (253.5 pg/ml – 387.4 pg/ml) signifying a 
proinflammatory response.  These results indicate that the EpiDerm™ model may 
be a suitable in vitro replacement for the assessment of the irritation 
potential of medical device extracts.  An ISO-sponsored round robin validation 
study is currently underway to answer this question.
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