Use of Recycled Material In New Device Builds

From the Q&A on a webinar I conducted on Device changes and the 510(k):

Answer to reprocessing / recycling:

1. Reprocessing is the taking of a used single use device and disinfecting, testing, repairing, cleaning, repackaging / relabeling and resterilizing  that SUD for reuse.  Usually done by a 3rd party reprocessor under the reprocessor's 510(k) to allow that;

2. Recycling could be the incorporation of used material in a new build.  I used the example of plastic regrind, but it could be corrugate shipper's using recycled cardboard, or recycled metal used in a part / component, etc. In such instances the company would have to make decisions based on patient risk (ISO 14971:2019), and V&V against the part specification. If the part using recycled raw material meets spec, then it should meet CGMPs. Use of regrind and recycled corrugate are accepted in the device industry - final decision here is based on cost, cost of the regrind / corrugate, vs cost of additional testing / monitoring, if an issue. 

What are other companies doing?  The "c" in CGMP.   

Risks:

o  Unknown provinence / history of the recycled material; missing "documentation" needs to be addressed by filling in the gaps with new documentation based on data;

o Unknown number of times the recycled material has had a portion of it recycled:  

o  The introduction of extra material / particulate during handling / introduction of recycled material and cleanness of the recycled stock; e.g., black specs, other particulate / scrap; 

o Potential weakness of the resulting part using recycled material, compared to part using virgin material; caused by the extra processing and particulate introduction, et al;

Use of recycled subassemblies: I would tend to question its usage at all as that gets into the definition of a new vs used device.   

Also check with your legal department, e.g.,   How would this use affect the outcome of a jury trial involving the malfunction of a device having recycled materials.

See FDA Guidance on use of recycled material in food contact applications:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-use-recycled-plastics-food-packaging-chemistry-considerations

I couldn't find any specific device information on the FDA's website on the above. 

Another follow-on point:

Rework of a failed / non-conforming new part / component is addressed the CGMPs, requiring dispositioning per SOP and usually by a Material Review Board, defined in a rework Work Order, supported by test / verification data if necessary, and reviewed/approved by Engineering, maybe R&D / others, and QA

-- jel@jelincoln.com