Question about biocompatiblity of medical device - Contacts with patient skin

L

luloo117117

#1
One medical device contacts with patient skin during the treatment. So the medical device testing lab, Intertek, request biocompatibility evidence, but they did not provide any further information about what kind of evidences are good enough. Who can provide some idea what should we do to provide evidence. (There are two parts will contact patient skin: one is glass, another is plastic)

Leon
 
Elsmar Forum Sponsor

GStough

Staff member
Super Moderator
#2
One medical device contacts with patient skin during the treatment. So the medical device testing lab, Intertek, request biocompatibility evidence, but they did not provide any further information about what kind of evidences are good enough. Who can provide some idea what should we do to provide evidence. (There are two parts will contact patient skin: one is glass, another is plastic)

Leon
There may be some ASTM standards for this out there somewhere, but I don't know right off-hand what they are....Have you looked on ASTM's web site? It might be a good place to start...

Hope this helps...:bigwave:
 
M

MIREGMGR

#3
If you were inquiring in regard to FDA expectations, you would want to consult FDA Guidance Memorandum G95-1 at http://www.fda.gov/cdrh/g951.html. Its three attachments define the FDA's starting-point expectations for biocompatibility determinations.

Each specified test refers to procedural requirements of an ISO 10993 section. Normally such testing is done by an appropriately certified third-party lab. For FDA qualifications, such testing normally should be done per FDA Good Laboratory Practices.

Those FDA requirements include several tests that are in addition to the basic requirements defined in ISO 10993-1's Annex B, Tables 1 and 2, and Figure B-1. The latter requirements would govern if the device is to be distributed only in markets where FDA requirements do not apply.
 
S

SteveK

#4
When I worked in the pharmaceutical industry we had to have on file (Drug Master File) USP data (items were marketed in the USA) for polymer items such as drug containers, drug contact components, metered dose inhalers (MDIs - the plastic shroud) etc - I think we went for class V or VI.

The United States Pharmacopeia (USP) XIX biological tests are designed to
provide information on potential biological effects of polymer materials. There are six different classes, I to VI, depending on performance in biological tests. The higher the material class, the more severe and stringent are the tests.

We used third party labs.

Hope this helps.
 
M

MIREGMGR

#5
From an FDA perspective, the material-qualification requirements for pharma packaging/administration systems are based on a separate regulatory section than the biocompatibility requirements for devices. Within the FDA's regulatory scope, there also is a third material-qualification basis, for food packaging.

Qualification of a material per one of these three regulatory bases, does not qualify it for either of the others. The systems are independent, and the tests are not substitutable.

In past years, this was less clearly defined. Back in the late 70s, for instance, evidence that a plastic material to be used in a device was Class VI qualified (which at that time was just a certificate from the resin vendor saying that it was not contaminated, basically) plus maybe a Draize test was all that was needed to establish biocompatibility for a 510(k), even for an invasive device.

I don't have the specific 21CFR sections immediately at hand for requirements for pharma-packaging/administration systems and food packaging. If someone else doesn't post them first, I'll try to post them here later today.
 
M

MIREGMGR

#6
Food-contact material qualifications for polymeric materials are per 21 CFR 177, as a starting point.

Since multiple regulatory frameworks apply to pharma packaging/administration-system material qualifications, it's preferable to start with "Guidance for Industry: Container and Closure Systems" (http://www.fda.gov/cder/guidance/1714fnl.htm#ATTACHMENT A), which summarizes the boundaries between the various regulations.

Medical device material qualifications are as defined above.
 
A

Axelgaarder

#7
We also deal with med. devices that contact the skin. Take a look at the ISO 10993-1:2003 requirement: Bio evaluation of med devices. It gives a chart on page 7 of the requirement that shows what tests for what bio effect based on contact duration. We end up sending our product out for bio certification at NAMSA.

Hope this helps!
:bigwave:
Peggy
Regulatory Supervisor
California
 
A

Axelgaarder

#9
Yes. They have a fairly new program where if you get the tests and report done for the three tests (irritation,cytox, sensitivity) they give you a certificate showing all three are done and passed. (Each report/test costs, and the cert is a separate charge.) But it then is available for customers, rather than sending the report.
 
T

twarden

#10
Try the USP testing for biocompatability - I recommend the use of the agar overlay cell culture option - if you need further information, please contact me. I have been involved with biocompatability testing over the years.
 
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