Toxicological risk assessment of a disinfecting agent in a syringe medical device

Client

A global medical device manufacturer.

Background

The client manufactures a product which is used as part of a syringe line medical device. The connection set-up has the potential to introduce a disinfectant chemical into the line and be injected into patients.

Project goals

Bibra was asked to conduct a Toxicological Risk Assessment (TRA) in compliance with ISO 10993-17 to assess the health risk posed to patients (adults and children, including neonates) exposed to the chemical intravenously.

Approach and outcome

Chemical ingress testing was conducted on the device and related products. From the results of the analyses, worst-case patient exposures were estimated. In accordance with ISO 10993-17, Estimated Exposure Dose (EED) values were calculated for each patient subgroup from the reported concentrations. 

Comprehensive literature searches were conducted using bibra’s in-house databank (TRACE) alongside the ITER database, focusing on Expert Group reports and opinions. Data were collected on key hazard endpoints, including genotoxicity and carcinogenicity, acute and repeated-dose toxicity, and reproductive/developmental toxicity, while Absorption, Distribution, Metabolism and Excretion (ADME) insights were also considered. Subacute Tolerable Intakes (TIs) were derived based on ISO 10993-17 guidance and Expert Group evaluations, where available, and were compared with the EED values in order to estimate Margin of Safety (MoS) figures.

The available evidence indicated that the chemical is not mutagenic and was therefore assessed as a threshold toxicant. Three subacute TI values were calculated after accounting for the various sources of uncertainty (e.g. cross-route extrapolation from the key oral/inhalation studies), and the corresponding MoS values were generally reassuring. The more conservative TI values indicated the possibility of health risks for neonates under the specified use scenario. However, consideration of the conservative nature of the exposure scenario did not suggest a significant concern. 

The result

Overall, it was deemed that the assessed exposure would not seem likely to pose an unacceptable risk to any subgroup.

Why bibra?

• An extensive in-house database TRACE enables comprehensive literature searching 
• All of our senior team are UK and European Toxicologists 
• Bibra has been providing expert, industry-leading toxicology consulting for the medical device industry for decades, and we have established ourselves as authorities in this area 

Learn more about our work in medical device toxicology

There are over half a million medical devices available on the UK and European markets, covering everything from in vitro diagnostic devices, surgical instruments and implants to contact lenses and wheelchairs. With recent regulatory changes – the introduction of the UKCA mark in Great Britain and the Medical Devices Regulation coming into force in Europe – companies are faced with a daunting task to ensure continuing compliance. Thanks to our extensive expertise in medical device toxicology, and close partnerships with analytical and testing laboratories and regulatory experts, we are the ideal partner for assessing the safety of your medical devices. Get in touch if we can help you!