"Medical Grade" polymers
Submitted by Diane Rutherford on Tue, 01/06/2009 - 4:11pm
I am new to the forums, so this may have been asked and answered before, but I have seen a recent trend and am hoping for some input from those with more experience on this topic.
I work for a medical device manufacturer. We have always used polymers that are classified (by the manufacturer) as "Medical Grade". In the past, these materials had references to having met the requirements of USP Class VI on the technical data sheet. For a material we have been using for many years, that statement has now been removed. I have also seen "FDA Compliance" which generally seems to indicate food contact approval.
So, what is required for a material manufacturer to label a material as "Medical Grade"? Is there an industry standard or some other standard to which this claim must measure up? Are there additional requirements to stating USP Class VI compliance other than the biocompatibility tests listed in the USP - such as frequency of testing (each lot or annually), notification to users of changes in material formulation or process or raw material supplier, etc.??
Thank you in advance!
Comments
Material supplier Advertising claims vs OEM 510K compliance
I was the materials approval manager for Baxter for a number of years and a manufacturer of materials for the medical device manufactures for another 10. "Medical grade" is a loose definition, not a industry standard. The FDA has specific required testing over and above the USP tests based on the various types of devices. These are to be run on materials which have undergone the processing done in the manufacture of the devices including: molding, cleaning, and sterilization, which can not be done by the raw material suppliers. It is the responsibility of the medical device manufacturer to run (or contract for these test to be run) and the results submitted by that manufacturer, when he submits his IND or 510K to the FDA for approval. Retesting should be conducted at least every five years and kept in the manufacturer's files for potential review by the FDA, if they desire.
As a material supplier, we needed to file a materials sheet with the FDA stating our generic formula and the tests that we do on a lot by lot basis to assure we remained in compliance with the CGMP to assure our material was not contaminated. This master materials file number was given to each buyer for inclusion in his 510K filings.
US -FDA approvals vs European approvals
The US FDA does not and will not provide a list of materials that have been approved by them as in compliance with any of their 6 qualification grades. The Class 6 is the highest grade approval and required the medical device manufacturer to provide the test results of the class 6 USP tests. The USP calls out the chemical and biological tests that must be conducted to meet that qualification. Class 6 requires implantation tests. You do not need to conduct tests to this level if you are just going to use the material for a short term or just wet surface contact exposure. Specifying everything to meet class 6 is over testing and not required. However, anything that passes class 6 is automatically approved for any lower usages. That is why some material suppliers actually test their materials at an independent biological laboratory to the class 6 specifications. The device manufacturer can submit to the FDA with their 510K submission the test results that were furnished to him by the material supplier but should also submit duplicate testing of the material as it would be processed and sterilized by him in the final product to be completely valid. The medical device manufacturer should also include the Drug master file (DMF) number from the material supplier. The manufacturer must submit the formula for each of its materials to the FDA to obtain an DMF number.
Europe and Japan have entirely different protocols which are mostly based on chemical tests rather than the US Biological animal and cell culture tests.
Medical Grade Polymers
Being a manufacturer of plastic components used in the manufacturing of medical devices, i face the same problems.
The buzz words/terms are "FDA class 6 approved" or "USP 6" material. Recently, the clients are also aksing for REACH and RoHS. It is getting a LOT of documentation...!
I wish there was a link on the internet where were we could find ALL the grades of Plastic materials that are USP class 6 certified and can be used for making components. All we do (as a manufacturer) is to provide a Certificate to say the part was made of so-and-so grade.
Bader
bader@medmolds.com
Medical Grade Polymers
I know this thread was started quite a while ago, but I am just now joining SPE and noticed the question posed. While I do not know of any master list of materials that are compiled for UPS Class 6 or ISO 10993(the newest standard), I do represent LyondellBasell in many of their European offerings. The Purell branding from LBI designates that the materials are UPS Class 6, European Pharmacopia and in most cases ISO 10993 compliant.
Other features include long term consistency of formulation, no change unless mandated or 24 months notice given to customer base, 24 month guarantee of supply, back up plant concept and single sourced raw material supply.
This value of this concept is catching on in Europe and in the US with the numerous incidents of product rationalization we have seen in recent history causing serious issues and expense to device manufacturers. Perhaps other resin producers will feel some pressure to offer similar guarantees on the "medical" products that they offer.
Phil
Medical grade plactics
Plastic compounds, as a material, are not FDA approved. A particular plastic is tested by the OEM per the FDA requirements for that device. This might be USP class IV for implantable devices. These test also include leachables requirements. The supplier must supply a Drug Master File (DMF)to the FDA listing the formula and any testing they have done and (FDA gives it a flie number)you can reference this file number when you file your 510K. A supplier that states the material is "medical grade" most likely means they have only included known non-toxic FDA approved or "approvable" ingredients in the formula. They should also have their facility approved to manufacture FDA materials and have their facility CGMP or ISO certified. It is up to the device manufacturer to retest the final product to assure the material remains non-toxic after processing. The FDA can inspect your facility to make sure you are in compliance with CGMP and that you have a retesting program in place. If you work for a large OEM device manufacturer, talk to your FDA Regulatory Compliance Officer and he should be able to show you the program you have in place in your company