When evaluating the biocompatibility of medical devices, the obvious set of standards and guidelines to refer to are those of the ISO 10993 series. However, in the past it has been challenging to place certain medical devices such as ventilators, breathing tubes and gas-mixing stations…
Apart from the obvious answer – very carefully – the inexperienced should quickly acquaint themselves with the COSHH (Control of Substances Hazardous to Health) regulations from the Health & Safety Executive. There they will find the hierarchy of options, the first being the elimination of…
Official enthusiasm for the Threshold of Toxicological Concern (TTC) is maintained. That is the tenor of the latest EFSA draft guidance document on this important topic (http://www.efsa.europa.eu/sites/default/files/consultation/consultation/181112-d.pdf). If you have any comments to make you have until 8th January 2019 as that is when public…
Oxford Dictionary has brought joy to the hearts of toxicologists around the world – by announcing that their Word of the Year 2018, is “toxic”! We know what it means, we can spell it, and we write it a lot…but why this sudden surge in…
With hundreds of medical device companies continuously producing new, innovative technologies to improve and expand on their product ranges as well as an ever-increasing demand for these important devices, the global medical device market value is predicted to rise to $483.8 billion by 2022. But…
It has been a while, but if you recall in the previous (and first) blog in this series, we gave the potted history of the main TTC benchmarks that can used to assess an untested chemical. For any exuding a structural suspicion of genotoxicity, the…
You cannot turn the page of a newspaper these days without catching the latest worrying headline regarding the next thing that’s bad for you (which often conflicts with the previous day’s dire warnings!) – drink coffee / don’t touch caffeine, enjoy a glass of wine…
Neurodevelopmental disorders in children have increased significantly in recent years (according to the European Joint Research Centre), which adds urgency to the need to evaluate new and existing chemicals for their potential activity in this area. This is difficult when the existing OECD DNT study,…
A wide spectrum of risk assessors are enamoured of the TTC, which essentially uses a knowledge of the toxicological properties of the universe of tested chemicals to make conservative predictions of the likely toxicity of untested materials. It gives them pragmatic respite from the onward…
The effects of vaping on public health remains a newsworthy and interesting topic of discussion, with a range of views and opinions. Public Health England (PHE) is committed to reviewing the evidence regarding e-cigarette use and the effects of vaping on consumer health. PHE has…