Claims
- 1. A method of verifying a sterility of a medical implant, the method comprising the steps of:
(a) receiving at least one sterilized medical implant from a group of sterilized medical implants produced by a manufacturer; (b) performing, on said at least one medical implant, a procedure chosen from the group consisting of confocal microscopy, scanning electron microscopy, atomic force microscopy, adding an antibody-tagged fluorescent probe, respirometry, and equivalent visualization techniques to produce test results; (c) analyzing said test results for the presence of bacterial biofilm; (d) if said test results indicate no evidence of bacterial biofilm, validating the sterility of the manufacturing process for said group of medical implant; (e) if said test results indicate evidence of bacterial biofilm, providing information regarding said test results to the manufacturer for correction of the manufacturing process.
- 2. The method of claim 1, wherein step (b) comprises performing confocal microscopy and step (c) comprises visually identifying any biofilm or bacterial colonies in an image produced by said confocal microscopy.
- 3. The method of claim 2, further comprising applying a live/dead stain to the implant prior to performing confocal microscopy.
- 4. The method of claim 1, wherein step (b) comprises adding an antibody-tagged fluorescent probe and step (c) comprises visually identifying a developed color.
- 5. The method of claim 1, wherein step (b) comprises performing scanning electron microscopy and step (c) comprises visually identifying a biofilm or bacterial colony in an image produced by said scanning electron microscopy.
- 6. The method of claim 5, further comprising applying a sputter coating prior to said scanning electron microscopy.
- 7. The method of claim 1, wherein step (b) comprises performing respirometry and step (c) comprises detecting an increase in carbon dioxide or methane.
- 8. The method of claim 1, wherein step (e) comprises identifying a location where a biofilm has been found.
- 9. The method of claim 1, wherein step (e) comprises identifying a predominant bacteria found in said biofilm.
- 10. The method of claim 1, wherein step (e) comprises identifying a manufacturing process likely to have caused said biofilm.
- 11. A method of testing a removed medical implant for the presence of a biofilm, the comprising the steps of:
(a) receiving a medical implant that has been removed from a patient; (b) performing, on said medical implant, a procedure chosen from the group consisting of confocal microscopy, scanning electron microscopy, atomic force microscopy, adding an antibody-tagged fluorescent probe, respirometry, and equivalent visualization techniques to produce test results; (c) analyzing said test results for the presence of bacterial biofilm; (d) if said test results indicate no evidence of bacterial biofilm, certifying a lack of biofilm; and (e) if said test results indicate evidence of bacterial biofilm, providing information regarding said test results.
- 12. The method of claim 11, wherein step (b) comprises confocal microscopy and step (c) comprises visually identifying a biofilm or bacterial colony in an image produced by said confocal microscopy.
- 13. The method of claim 11, further comprising applying a live/dead stain to the implant prior to performing confocal microscopy.
- 14. The method of claim 11, wherein step (b) comprises adding an antibody-tagged fluorescent probe and step (c) comprises detecting a developed color.
- 15. The method of claim 11, wherein step (b) comprises scanning electron microscopy and step (c) comprises visually identifying a biofilm or bacterial colony in an image produced by said scanning electron microscopy.
- 16. The method of claim 11, wherein step (b) comprises respirometry and step (c) comprises detecting an increase in carbon dioxide or methane.
- 17. The method of claim 11, wherein step (e) comprises identifying a location where a biofilm has been found.
- 18. The method of claim 11, wherein step (e) comprises identifying a predominant bacteria found in said biofilm.
Parent Case Info
[0001] This application claims priority from provisional application 60/365,331, filed Mar. 18, 2002.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60365331 |
Mar 2002 |
US |