Welcome to the Hoodin RAQA Deep Dive Sessions recordings and resources page! In this edition, we'll explore insights from our webinar: Catch Me If You Can: The Hide 'n Seek of Biocompatibility with expert Marina Daineko, special attention is now on biocompatibility,
Theme: "Catch Me If You Can: The Hide 'n Seek of Biocompatibility"
Expert speaker: Marina Daineko
Further down this page, you'll find a summary, Q&A, Marina’s presentation, and other useful resources and assets.
Watch the recorded full version of the webinar
🎙️ Speaker: Marina Daineko
📚 Theme: Catch Me If You Can: The Hide 'n Seek of Biocompatibility
🗓️ When: Aug 15, 2pm CET
⏱️ Duration: 61 minutes
Webinar Summary:
Marina highlights the risks associated with medical devices, such as potential irritation from thermometers, which could lead to recalls, complaints, and reputational damage. To mitigate these risks, Marina advocates for leveraging post-market information to enhance devices and ensure business continuity. She outlines a systematic approach for biocompatibility evaluation, stressing the importance of collecting, analyzing, and documenting post-market data. Marina concludes by underscoring the necessity of updating the Biological Evaluation Report to reflect this information, thereby ensuring ongoing biological device safety and regulatory compliance.
The webinar covered key aspects of biological evaluation and risk management for medical devices:
ISO 10993-1: Biological Evaluation is conducted within a total life cycle. Draft of ISO 10993-1 focuses even more on gathering and analyzing patient feedback and other post market information relevant to biological safety.
Step-by-step approach to work with post market data:
Collect post market data
Assess the data related to biocompatibility
Update the Biological Evaluation Report with your assessment and conclusion about biological safety
Early Biological Evaluations: Encouragement for startups to conduct biological safety evaluations early in the design phase to identify potential biological concerns.
Device-Specific Queries: Addressed queries related to standards for specific devices, such as breathing gas pathways and dental products.
PMS information: Use information e.g. about regulations update (CLP (CMR list), REACH (ED list)), adverse events to the competitor’s device and to your device to evaluate the impact on biological safety of your device.
Hoodin Tool: Available at Hoodin.com with a 14-day free trial and expert sessions for tailored compliance solutions.
Decode the data: Use a risk based approach when working with post market information. If you need further assistance, contact Intrinsic Medical Group,
Q&A´s:
In Step 2C, what could potentially be tested beyond ISO 10993? Is there any standard or guidance to leverage?
Additional tests could include e.g. chemical characterization and toxicological risk assessment based on specific product applications and identified biological hazards. Standards like ISO 18562 for breathing gas pathways or IEC 62366 for usability engineering might be relevant.
Could you explain more about the Hoodin application?
Hoodin is a software tool that automates post-market surveillance, media monitoring, and reporting for regulatory compliance.
What other sources besides Hoodin can you use?
Hoodin is not a source but a SaaS platform that provides surveillance and vigilance intelligence, and provides you with the right sources for your life science products. Includes regulatory updates, literature reviews, clinical databases, adverse event reporting etc. More info you can find at: www.hoodin.com
Could you elaborate on the design examination of Class III and IIB devices?
The medical device classification as per MDR differs from classification as per ISO 10993-1. If we are talking about biocompatibility, we need to consider 1) type of body contact 2) duration of body contact. We need to pick the relevant biological endpoints to the specific device. Table A.1 of ISO 10993-1 can help with it.
Is a Toxicological Assessment mandatory to perform? If yes, what steps need to be followed to strengthen the Biological Evaluation Report (CFR’s)?
It depends on the device as well as available information to it. It might be required. Steps may include chemical characterization, leachables/extractables test and Toxicological Risk Assessment. The conclusion shall be documented in the Biological Evaluation Report (BER) following ISO 10993-1 and relevant CFR guidelines. P.S. chemical and physical characterization is mandatory for each medical device under biological evaluation (see Section 6.1 of ISO 10993-1:2018).
How do we evaluate the biosafety of nano-materials? Is there any suggested evaluation model that the authority currently recognizes?Evaluating biosafety involves assessing particle size, distribution, and potential for toxicity. The FDA and ISO/TR 10993-22 provide guidance on nano-material evaluation models.
When can you use ISO 14971 and ISO 10993-1 together?These standards must be used together.. Biocompatibility evaluation is part of risk management activities. Draft of ISO 10993-1 provides even more focus on risk management in biological evaluation process.
Which company provides the Hoodin tool? Could you share a link where I can access it?Hoodin is provided by Hoodin AB. More information can be accessed on their official website: Hoodin.com and Free Trial at: https://app.hoodin.com/sign-up
May I know what you usually advise for startup or SME edtech companies for starting their biological evaluation plan? There's a perception that one can achieve compliance by ticking the boxes based on Table A.1 of ISO 10993-1.Start as early as possible with a risk-based approach rather than merely ticking boxes. Gather all the data. Ensure the biological evaluation plan is robust, tailored to your device, and includes justification for chosen tests.
For breathing gas pathways, may I know if ISO 18562 Part 1 can be claimed equivalent to ISO 10993-18 & ISO 10993-17, or is it carried out differently?ISO 18562 is specifically designed for breathing gas pathways and includes different requirements compared to ISO 10993-18/17, which focus on chemical characterization and toxicological risk assessment. It's an additional standard, you need to follow ISO 10993-1 anyway :)
What are the endpoints needed to evaluate for a skull implant that is placed inside intact dura mater?Evaluate big three (cytotoxicity, sensitization, irritation) as well as long-term implant effects like chronic toxicity and carcinogenicity. For all biological endpoints that shall be addressed, check Table A.1 of ISO 10993-1:2018.
Is there a specific categorization for dental products regarding biological compatibility?Dental products are categorized under ISO 7405 for biocompatibility, with specific considerations for material types and contact duration. The devices shall comply with ISO 10993-1:2018 requirements.
How much biocompatibility evaluation is required for IVDs (ISO 7405:2018)?Generally, IVDs require biocompatibility evaluation under ISO 10993-1, depending on the contact duration and material composition.
IVD compliance: There was a push for healthcare workers having contact as well. I have found it’s more about documenting what the product is made of.Documenting material composition and its safety, especially for substances of concern, is crucial for IVD compliance.
For non-long-term implants or implant devices applied for less than 30 days, is it acceptable to perform material characterization (worst-case leaching evaluation, extractable/leachable study, and toxicological assessment) to complete the biocompatibility evaluation?
It’s a tricky question as the available data shall be reviewed. Performing material characterization and a toxicological assessment can be sufficient for biocompatibility evaluation if the study addresses all relevant risks. All the biological endpoints shall be evaluated and this assessment shall be documented. Don’t forget to perform gap analysis to make sure there are no gaps.
We recently went through this in IVDR. It was a risk-based approach to document the substances of concern, animal origin, etc., then we added gloves as a risk mitigation measure.The risk-based approach involves documenting materials of concern and adding protective measures like gloves where necessary.
Is it possible that the ISO 10993 series also applies to AI/ML as medical devices?
No. ISO 10993-1 states that the biological evaluation is required for the medical devices that have direct or indirect contact with the patient’s body during intended use and the user’s body if the medical device is intended for protection. AI/ML devices might require additional considerations under IEC 62304 for software lifecycle processes.
How’s your experience with the acceptance of in vitro methods of irritation for US FDA and EU MDR submissions?In vitro methods are increasingly accepted, especially in the EU, but the FDA may require further justification or complementary in vivo data.
Is there any test available to measure residues from hydrogen peroxide sterilization?ISO 22441:2022 provides guidelines for testing residues from hydrogen peroxide sterilization.
Do we need to justify the CMR-ED concern if it’s below the threshold limit in devices with limited contact?Justification is required even if below threshold limits, by assessing the overall risk and potential exposure. While the MDR focuses more on labeling requirement, we need to assess biological safety of the material in the Biological Evaluation Report.
How do we justify using small animal sample sizes according to the new standard 10993-2, given that all in vivo tests have already been conducted?
Justify using small sample sizes by referencing the scientific validity of the data and demonstrating that it meets statistical and regulatory requirements. Review existing data (chemical / physical characterization, previous testing results, post market information).
Contact Expert Speaker:
Marina Daineko - https://www.linkedin.com/in/marinadaineko/
Company.: https://www.intrinsicmedicalgroup.com
"If you need specialized support with biocompatibility, IMG is here to help. Let's partner to ensure your medical device is safe and compliant."
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