MEDICAL DEVICES

Biological evaluation of medical devices is a complex process that represents a part of the overall development of a medical device. It consists in the review and evaluation of existing data and the selection of additional tests to guarantee the safety of the product.

Galileo Research can drive the nonclinical development of your medical device, planning the biological evaluation within the framework of ISO 10993 standards and delivering all the pertaining documents for regulatory purposes.

Galileo Research provides the medical device industry with customised biocompatibility service according to ISO 10993 standard requirements and in compliance with GLP.

The following tests can be conducted in our laboratories according to ISO 10993-1, OECD and GLP standards.

OUR TESTS

The genotoxicity test battery includes:

  • test for gene mutation in bacteria (OECD 471), which can be adequately modified on the basis of the medical device under evaluation, for example using a device extract as test item, prepared according to ISO 10993-12. Five strains of Salmonella Thyphimurium are used
  • in vitro test for evaluation of chromosomal damage in mammalian cells (OECD 473). Chinese Hamster Ovary (CHO) or Chinese Hamster lung (V79) cells are generally used.
  • in vitro mouse lymphoma tk assay (OECD 490), modified for medical devices
  • in vitro mammalian cell micronucleous test to assess chromosomal damage and aneugenicity (OECD 487).

If any test gives positive results, in vivo follow-up testing shall be considered on the basis of the most appropriate end-point identified by the in vitro test.

  • micronucleous test in rodents (OECD 474) is the most appropriate.

Effects on the first and second generation are assessed, in accordance to OECD 414, OECD 415, OECD 416 and OECD 421, taking into consideration the applicability to medical devices (route of application, extraction, exposure).

According to nature of test item one or more of the following tests can be chosen:

  • extract test
  • direct contact test
  • indirect contact test.

Cytotoxicity can be measured by different methods that address different end-points:

  • cell damage
  • cell growth
  • cell metabolism

Established cell lines from recognised repositories are suggested. Guidelines and publications suggest the use of cell lines and experimental conditions that better reflect the clinical use of the product, thus other cell lines maybe used to better simulate the conditions under which the device will be used.

Implant studies are used to assess the local pathological effects on living tissues, as well as duration of the implant. Rodents are used in our facility.

Our scientists can help the customers to design an expanded study plan that includes the evaluation of both local and systemic effects to address the end-points of single- and repeated-dose toxicity studies.

The following route of application can be managed at our facility: intraarticular, intramuscular, intradermal, subcutaneous, intraosseous.

The in vitro skin irritation test with the Reconstructed Human Epidermidis (RHE) model can predict acute skin irritation of device extracts prepared according to ISO10993-12.

Sensitization tests estimate the potential for contact sensitization by medical devices and their extracts.

The test method available at Galileo Research is the Local Lymph Node Assay (LLNA) that is internationally accepted as an alternative to the Guinea Pig Maximization test, in view of animal welfare considerations.

Galileo Research is able to plan and conduct in vitro or in vivo studies specifically designed for your device, developing models that take into account all processes that influence biodegradation (biochemical, mechanical,…), and also measuring leachables and degradation products.

Absorbable medical devices that are intended to be implanted for longer than 30 days and can release potentially toxic substances during body contact, have to undergo specifically designed degradation studies. The assessment of degradation should consider the anatomical location and the biological environment. In vitro test systems that simulate the conditions of the clinical application should be developed and scientifically justified.

Galileo Research is able to plan and conduct in vitro or in vivo studies specifically designed for your device, developing models that take into account all processes that influence biodegradation (biochemical, mechanical,…), and also measuring leachables and degradation products.

Systemic toxicity studies are used to estimate the potential dangerous effects of the device when leachables and degradation products are absorbed systemically after single or repeated exposures (acute, subacute, subchronic, chronic toxicities). Protocol design for systemic toxicity studies is a critical phase and, according to ISO standards, it can be expanded in order to include implantation study and to determine systemic and local effects.

Toxicokinetic evaluations to determine the presence of leachables, degradation products and their metabolites can also be included in such protocols. Analytical methods have to be validated within the study plan.

Assessment of immunosuppression and/or immunostimulation can be included in the same studies, to get the first non-functional indications of such effects. More specific immune function assays can then be applied.

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