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Accession Number:
AD1186277
Title:
Testing the Sterility of Expired Healing Abutments to Determine Post-Expiration Date Clinical Safety
Report Date:
2022-06-16
Abstract:
Background: Surgery requires the use of myriad devices and materials, most of which have manufacturer-assigned expiration dates. For many practitioners, a sizable percentage of these materials reach their expiration dates prior to use and thus must be discarded to comply with manufacturers instructions for use. This represents a lamentable waste of limited resources and, for the authors of this article, U.S. taxpayers dollars. We analyzed the sterility of expired Biomet 3i healing abutments to help determine the safety of use beyond their expiration dates. Methods and Materials: 128 expired Biomet 3i healing abutments in their original unopened packaging that expired during the years of 2011-2019 were tested for bacterial growth. For the positive control, an unexpired healing abutment was exposed to Staphylococcus aureas ATCC 6538 at a concentration of 1 x 10 to the power of 7 CFU/mL. One unexpired healing abutment was tested for growth and used as the negative control. The healing abutments were first placed in an Enriched Thioglycollate Medium and any growth that occurred there would be subsequently subcultured on Trypticase Soy Agar with 5 percent Sheep Blood (BBL 221261) and MacConkey II Agar (BBL221270). Any bacterial growth would have been gram stained and identified using the BioMerieux Vitek 2 Compact System. Results: None (0 percent) of the expired healing abutments from 2011-2019 had bacterial growth. Conclusions: Results from this study indicate that expired Biomet 3i healing abutments (2011-2019) in their original unopened packaging remain sterile up to 8 years past their expiration dates and could reasonably be considered safe for use.
Document Type:
Conference:
Journal:
Pages:
14
File Size:
0.51MB
Contracts:
Grants:
Distribution Statement:
Approved For Public Release
