Publications by authors named "T Rollins"
To ensure patient safety, medical device manufacturers are required by the Food and Drug Administration and other regulatory bodies to perform biocompatibility evaluations on their devices per standards, such as the AAMI-approved ISO 10993-1:2018 (ANSI/AAMI/ISO 10993-1:2018).However, some of these biological tests (e.g.
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- The ISO 10993 standards promote using validated in vitro methods over animal testing for biocompatibility of medical devices.
- A round robin study tested in vitro reconstructed human epidermis (RhE) assays as alternatives to rabbit skin irritation tests, with RhE successfully identifying strong irritants but raising questions about accuracy compared to traditional tests.
- Follow-up studies confirmed that RhE models yield results comparable to the more sensitive intracutaneous rabbit test, supporting their use as acceptable replacements for assessing the irritant potential of medical devices.
Round robin study to evaluate the reconstructed human epidermis (RhE) model as an in vitro skin irritation test for detection of irritant activity in medical device extracts.
Toxicol In Vitro
August 2018
Responders such as firefighters and emergency medical technicians who respond to farm emergencies often face complex and unknown environments. They may encounter hazards such as fuels, solvents, pesticides, caustics, and exploding gas storage cylinders. Responders may be unaware of dirt roads within the farm that can expedite their arrival at critical sites or snow-covered manure pits that act as hidden hazards.
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