Bio-compatibility Evaluation Plan for Medical Devices

What is Bio-compatibility Evaluation?

Biocompatibility evaluation is a process of determining a device’s compatibility with a biological system (in this case, of human beings). The purpose behind performing this test is to determine overall biological safety of a medical device for human use.

Legacy Methods of Bio-compatibility Evaluation

The legacy approach for biocompatibility evaluationi can be brutalized by saying that it was executed by simply evaluating the contact type of device with a human tissue, the time taken for contact and then by picking and perform a series of test from a given list of test (Annex A of ISO 10993-1:2009). 

This approach didn’t focus enought the characterization and qualification of material used in device’s manufacturing in relation to the specific type of application and process leading to possibly unecessary animal testing on a side and eventually leaving unmitigated risks for the patients on the other side.

Latest Methods Used for Bio-compatibility Evaluation

Newly international standardized methods for biocompatibility evaluation are more robust and strongly risk based.

They require an initial risk assessment, a clarified approach to characterization of material and a detailed report regarding all the evaluations and tests performed.

The standard has evolved from a list of tests that anyone could pick up and follow, to one that now requires the evaluator to be trained and knowledgeable in biological evaluations. Due to the shift to using a risk-based approach, what used to be a straightforward document has now evolved in to a detailed and robust risk based evaluation.

This means a deeper understanding of medical device design and manufacturing along with chemical and physical properties is required to the investigator performing the assessment, leading to multiskill or mixed team requirement for execution of such investigation.

Main reference for such approach is the newly issued version of ISO 10993-1:2018. This document specifies:

— the general principles governing the biological evaluation of medical devices within a risk management process;

— the general categorization of medical devices based on the nature and duration of their contact with the body;

— the evaluation of existing relevant data from all sources;

— the identification of gaps in the available data set on the basis of a risk analysis;

— the identification of additional data sets necessary to analyse the biological safety of the medical device;

— the assessment of the biological safety of the medical device.

This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with:

— the patient’s body during intended use;

— the user’s body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).

This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.

This document also gives guidelines for the assessment of biological hazards arising from:

— risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;

— breakage of a medical device or medical device component which exposes body tissue to new or novel materials.

Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.

This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens

Main Standards and Regulations

There are standards and guidance documents used currently for biocompatibility evaluation. They main are:

Performing Biological Evaluation Plan (BEP)

Performing biocompatibility evaluation is an essential part of regulatory chain which is required if you want to place a safe medical device on the market.

TS Q&E can help companies performing Biological Evaluation Plan  (BEP) and effectively embed Biological Evaluation process inside existing QMS

TS Q&E have assisted different organizations in making biological evaluation plans and biocompatibility evaluation protocols by performing biocompatibility asessment of medical device product and related supply, manufacturing, and production processes using a risk based approach as suggested by ISO 10993 and ISO 14971.

We work with a mixed team of medical device engineers and toxicologist in order to tackle the evaluation from all different required sides.

Biological Evaluation as part of the risk management processes should be embedded inside QMS and new product development lifecycle process in order to be effective.

In this way biological risk are considered from early stage of product development and proper mitigation are embedded into requirement gathering process, allowing to select proper material and process from early stage minimizing burdens in later stage for testing and justification.

Making the biological evaluation process an embedded process will also have benefit of streamline related documentation drafting and minimize efforts concentration on the later stage of product development lifecycle when every change requires huge efforts in terms of documentation  and eventual testing repetition (example running a design change on a validated product) and therefore also economical and stuff resources in order to be executed.

We would be happy to support your company in suggesting best strategies to perfom biological evaluation planning and aswell help make sure the proper requirements are embedded inside QMS and product development lifecylce so that compliance can be assured with minimized and balances efforts.

Reach out to us today for any related question!  If you want you can also fill out the preliminary form FORM 025 – Biological Safety Evaluation Form_ENG and send it by email to info@tsquality.it.

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