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Biocompatibility in Respiratory Products - Help interpreting whitepaper

#11
Roland,

sorry if I was not clear enough.

Let me quote from the European MDD, Article 2:

"Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose."

This clearly implies that you have to consider operators - and yes, this involves some degree of workload, which to my experience can be limited as I intended to ppoint out previously.

HTH,

Gerhard
 
#12
This might be also of interest, taken from the blog of an ISO Technical Committee member responsible for ISO 10993 series revisions:

"Respiratory Devices - a new paradigm in biocompatibility

ISO 10993-1 does not deal well with biological evaluation of respiratory devices ? such as ventilators, masks and inhalers ? which have indirect patient contact via the gas pathway. The current approaches in Part 1 set out requirements which were really intended for indirect blood contact devices such as infusion equipment. This has resulted in regulatory expectations for testing which are infeasible such as requests to conduct extensive biological testing including implants on more than 100 separate internal components of ventilators. In a radical departure, a separate ISO Committee (ISO TC 121) is developing a new ISO 18562 for biological evaluation of respiratory devices. If accepted, these standards will remove indirect contact respiratory devices from evaluation under ISO 10993 ? and usher in a new paradigm which focuses on the composition of the delivered gas rather than the composition of the device itself. This should provide a safety assessment approach based on assessment against acceptable limits of volatile organics and particulates which is not only cheaper and simpler to perform ? but also much more robust and protective of the patient. Respiratory devices were discussed at length in Mishima and TC 194 is fully supportive of the approaches embodied in ISO 18562."

HTH,

Gerhard
 
M

milagre

#13
Dear Gerhard,

It's good to see the problem is at least being addressed currently. I really hope I can find a way to not get caught up with "requests to conduct extensive biological testing including implants on more than 100 separate internal components of ventilators". It is definitely worrisome that testing like that seems to be normal for respiratory equipment right now....

Do you have any advice for avoiding that kind of testing? It would certainly save a lot of work, and I'm not even sure if it would be in the budget if we were told to test every component separately.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#14
Dear Gerhard,

It's good to see the problem is at least being addressed currently. I really hope I can find a way to not get caught up with "requests to conduct extensive biological testing including implants on more than 100 separate internal components of ventilators". It is definitely worrisome that testing like that seems to be normal for respiratory equipment right now....

Do you have any advice for avoiding that kind of testing? It would certainly save a lot of work, and I'm not even sure if it would be in the budget if we were told to test every component separately.
Hi,

You're not required to test every component separately (even under the current paradigm), and besides there are many ways to reduce the testing burden for a given device. The requirement is "Biological Evaluation" and testing is only one avenue. Consult your accreditted test lab, they should be familiar with the above. If they have no previous experience with repsiratory devices, consider looking for another that does.

Cheers,
Ronen.
 
M

milagre

#15
Ah alright. The most incite I have gotten on specifically how to test was from the whitepaper, where they talked about creating an extraction medium with ratios of different components from the airstream as the sample to extract from. I contacted one test lab that initially said they were experienced in respiratory products, but it seems that experience may be limited to CPAP masks specifically.

Any recommendations for test labs before I go poking around?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#16
Ah alright. The most incite I have gotten on specifically how to test was from the whitepaper, where they talked about creating an extraction medium with ratios of different components from the airstream as the sample to extract from. I contacted one test lab that initially said they were experienced in respiratory products, but it seems that experience may be limited to CPAP masks specifically.

Any recommendations for test labs before I go poking around?
Hi,

Here are two I would have considered:

http://www.ul-mdt.com/

http://www.namsa.com/Services/Core-Services/Non-Clinical-Testing/Biocompatibility-Testing

Cheers,
Ronen.
 
K

kanwal

#18
In evaluating biocompatibility of a product, it is essential to understand the interactions the product and its components have with the human body of the patient, the user and others coming in contact with the device or the component.

The interactions can be either through leachates from the device or its components or particles of the device or components.

Hence the issue of biocompatibility of components would be assessed based on the ability to release leachates or particles that can be infused into the atmosphere or transferred through physical contact to which the patient or user is exposed through physical contact.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#19
:topic:

This might be also of interest, taken from the blog of an ISO Technical Committee member responsible for ISO 10993 series revisions:

"Respiratory Devices - a new paradigm in biocompatibility

ISO 10993-1 does not deal well with biological evaluation of respiratory devices – such as ventilators, masks and inhalers – which have indirect patient contact via the gas pathway. The current approaches in Part 1 set out requirements which were really intended for indirect blood contact devices such as infusion equipment. This has resulted in regulatory expectations for testing which are infeasible such as requests to conduct extensive biological testing including implants on more than 100 separate internal components of ventilators. In a radical departure, a separate ISO Committee (ISO TC 121) is developing a new ISO 18562 for biological evaluation of respiratory devices. If accepted, these standards will remove indirect contact respiratory devices from evaluation under ISO 10993 – and usher in a new paradigm which focuses on the composition of the delivered gas rather than the composition of the device itself. This should provide a safety assessment approach based on assessment against acceptable limits of volatile organics and particulates which is not only cheaper and simpler to perform – but also much more robust and protective of the patient. Respiratory devices were discussed at length in Mishima and TC 194 is fully supportive of the approaches embodied in ISO 18562."

HTH,

Gerhard
Hi all,

Does anyone out there (Marcelo?) have any inside information on the progress in developing ISO 18562, and expected release dates of the various parts? I saw on the ISO sub-committe's webpage that they are in "30.60" (comment review?) status.

Thanks!
Ronen.
 
#20
Not sure, I don´t follow ISO TC 121 work as close as I did in the past, but I´ve checked the ISO project portal and the next stage, DIS, is schedule for the beginning of 2016, and publication for the beginning of 2017.

I´ve asked a friend who is the secretary of ISO/TC 121/SC 3 for any other info.
 
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