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Through the fog: ISO 10993-1:2018 explained

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Medical Plastics News editor Laura Hughes sat down with Beau Rollins, global director of quality services for ConvaTec, to better understand ISO 10993-1:2018 and learn about how medical device manufacturers can ensure compliance with regulatory requirements.

1. Put simply, what is ISO 10993-1:2018?

If I had to summarize the new ISO 10993-1:2018 in just a couple words, it would be “risk based evaluation.” 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.

2. What are the main changes manufacturers need to be aware of for ISO 10993-1:2018?

The most noticeable change is to Annex A. Other key changes are new device exposure categories, emphasis on the requirements of the author for the biological evaluation, and on material and chemical characterization.

Additionally, a new category, transitory, has been introduced to allow for devices like needles and lancets that are in contact for less than one minute, to be evaluated and accepted without testing unless they use coatings or lubricants that could be left behind. The terminology for ‘permanent’ device has also now changed to ‘long-term’ – combatting a misconception that only permanent implants belonged in that category.

3. Do you have any tips for helping manufacturers comply with ISO 10993-1:2018?

For FDA submissions that are new or complex, do a pre-sub. Ensure that your biological evaluation protocol is in line with their expectations and identified risks. For EU regulators, we’re on the precipice of European Medical Device Regulations (EUMDR) which will change the European tech files, but if you are in doubt, talk to your regulatory body and propose a change review to allow them to look over your plan (like a pre-sub), but be warned, with MDR and new requirements, many regulatory bodies can take six months or more to do this. If you want to go straight to submission, I recommend finding a good consultant who understands these changes and a laboratory that understands the analytical requirements that are coming out hopefully later this year in the new 10993-18.

4. What do these changes mean for the manufacturers of medical devices?

For most, it’s probably a new approach for your biological evaluations, a new employee or consultant to perform or review the evaluation, and a new test that is not cheap. The analytical testing can be used to mitigate the risks for various toxicities and therefore can mitigate those costs for higher risk devices, but for the low risk devices, this is a new test and expense that adds to the approval hurdles. I think it’s fair to say that most manufactures are not set up for this level of baseline evaluation.

In industry, we are also seeing regulatory bodies and governments rejecting biological evaluations due to the authors or reviewers not carrying sufficient experience or education to perform these evaluations. In the past most organizations had these evaluations performed by research and development engineers, quality engineers, sterilization engineers, or even regulatory specialists, and now if their curriculum vitaes do not reflect the necessary skills or competency, their biological evaluations are being rejected. To combat this, manufacturers are bringing on biocompatibility skilled individuals to conduct reviews. The struggle organizations are finding is that since there is not a certification or course established to accredit individuals for biocompatibility, the supply of experts out there is rather thin.

5. What do you believe are the current biocompatibility challenges facing medical device manufacturers?

In one word, resources, which leads to a supply and demand issue. We are deficient on the information available from our suppliers, and the laboratories (particularly the extractables and leachables sector) are dealing with new methods and a shortage of scientists/equipment which leads to capacity constraints. The methods and requirements are not detailed in standards or have been generally established so that the results we receive vary (this was recently proven in an inter-lab comparison performed by J&J and presented at SOT) and are extremely expensive.

The biocompatibility field has developed into being a full time, specialized position and with MDR here, most companies find themselves lacking the biocompatibility systems and specialists. Even many of the consulting firms out there are struggling to provide competent biocompatibility consultants.

6. How can you and other leaders in the industry help medical device manufacturers to better understand these regulatory requirements?

There has been a noticeable increase and push for biocompatibility specific conferences around the globe where ISO members and industry experts can present changes and explain the standards and various ways to assess the biocompatibility of a device.

I will be speaking in Chicago at the biocompatibility conference in October and San Diego at the Q1 productions conference in December. There is also a NAMSA sponsored biocompatibility conference in Minneapolis this year and Nelson laboratories generally holds biocompatibility specific discussions at the various medical device tradeshows and webinars. There are opportunities out there for the readers to attend and learn more.

Beau Rollins
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