[ascct] Fwd: Next ASCCT member webinar: Medical Device Irritation Testing: An In Vitro Alternative
- From: Kristie Sullivan <KSullivan@xxxxxxxx>
- To: "ascct@xxxxxxxxxxxxx" <ascct@xxxxxxxxxxxxx>
- Date: Wed, 18 Jun 2014 17:28:26 -0400
Reminder!
https://global.gotomeeting.com/meeting/join/600873733
Begin forwarded message:
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.
1. Please join my meeting.
https://global.gotomeeting.com/meeting/join/600873733
2. Use your microphone and speakers (VoIP) - a headset is recommended. Or, call
in using your telephone.
United States: +1 (213) 289-0016
Access Code: 600-873-733
Audio PIN: Shown after joining the meeting
Meeting ID:600-873-733
GoToMeeting
Online-Meetings made easy
Other related posts:
- » [ascct] Fwd: Next ASCCT member webinar: Medical Device Irritation Testing: An In Vitro Alternative - Kristie Sullivan
