New cell culture laboratory to assess healthcare products
In recent years, the market for medical devices has grown significantly, whether due to technological progress within the healthcare sector, the demand for protective or diagnostic devices or the constant need to improve people’s well-being at all times.
For this reason, Regulation (EU) 2017/745 on medical devices defined which products are included and establishes essential requirements they must comply with. It also describes the assessments manufacturers must follow to ensure the conformity and safety of medical devices. According to Article 2 of this regulation, medical devices mean any medical instrument or equipment intended to be used for diagnosis, monitoring, treatment, or prevention. Among these products, we find disposable face masks and gloves, bandages, catheters, electrodes, lancets, syringes and implantable devices. Moreover, this regulation also refers to the requirements to be met in terms of patient safety, device properties, transport and storage conditions, among others. Regarding the safety of medical devices, it is important to assess their biological response. These preclinical tests are essential to obtain the CE marking of a medical device, which is indispensable for marketing in the European Union.
The risk and biocompatibility assessment of medical devices
One of the most popular standards for carrying out the biological assessment of healthcare products is, as established in Regulation (EU) 2017/745, the ISO 10993 series. Before starting with the risk assessment, it is crucial to assess the device and its application from its origin, the degree of exposure, the time of contact frequency and conditions of exposure with patients. In this sense, the standard should not be considered a battery of specific and static tests for any type of healthcare product, but a framework that allows designing the most suitable biocompatibility tests for each medical device. This means that there must be a direct relationship between manufacturers and experienced laboratories offering advice to determine the best way to comply with the biocompatibility requirements of materials under the ISO/IEC 17025 standard and the principles of good laboratory practice (GLP). This standard includes the biological tests necessary to validate a product, such as cytotoxicity (ISO 10993-5), irritation and skin sensitization (ISO 10993-10), systemic toxicity (ISO 10993-11), genotoxicity (ISO 10993-3) or interactions with blood (ISO 10993-4).
Bioassays based on cell cultures: biocompatibility assessment of medical devices
In vitro bioassays based on cell cultures have been historically used to assess the hazard of complex chemical product blends present at very low levels in the environment. They have been widely developed for toxicity assessment due to their practicality and, above all, because they are a technique that allows comparable results to in vivo results, making them a crucial battery of tests for the 3Rs (replace, reduce and refine), thus reducing the use of animal testing.
Some of the procedures described in ISO 10993 allow assessing the risks of medical devices in cell cultures to determine whether a product causes any kind of damage to cells such as cell death, DNA damage or irritation.
To participate actively in the biological assessment of healthcare products, AIMPLAS has implemented a cell culture laboratory to ensure the safety of patients, inform and advise companies in the sector, collaborate in different projects that pursue the development of medical devices of new formulation and be an additional part in the validation process of healthcare products.