Low temperature vaporized hydrogen peroxide sterilization of 3D printed devices
Abstract Background Low temperature vaporized hydrogen peroxide sterilization (VH2O2) is used in hospitals today to sterilize reusable medical devices. VH2O2 sterilized 3D printed materials were evaluated for sterilization, biocompatibility and material compatibility. Materials & methods Test ar...
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | 3D Printing in Medicine |
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| Online Access: | https://doi.org/10.1186/s41205-024-00206-1 |
| _version_ | 1797275825336221696 |
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| author | Randal Eveland Kathleen Antloga Ashley Meyer Lori Tuscano |
| author_facet | Randal Eveland Kathleen Antloga Ashley Meyer Lori Tuscano |
| author_sort | Randal Eveland |
| collection | DOAJ |
| description | Abstract Background Low temperature vaporized hydrogen peroxide sterilization (VH2O2) is used in hospitals today to sterilize reusable medical devices. VH2O2 sterilized 3D printed materials were evaluated for sterilization, biocompatibility and material compatibility. Materials & methods Test articles were printed at Formlabs with BioMed Clear™ and BioMed Amber™, and at Stratasys with MED610™, MED615™ and MED620™. Sterilization, biocompatibility and material compatibility studies with 3D printed materials were conducted after VH2O2 sterilization in V-PRO™ Sterilizers. The overkill method was used to evaluate sterilization in a ½ cycle. Biocompatibility testing evaluated the processed materials as limited contact (< 24-hours) surface or externally communicating devices. Material compatibility after VH2O2 sterilization (material strength and dimensionality) was evaluated via ASTM methods and dimensional analysis. Results 3D printed devices, within a specific design window, were sterile after VH2O2 ½ cycles. After multiple cycle exposure, the materials were not cytotoxic, not sensitizing, not an irritant, not a systemic toxin, not pyrogenic and were hemo-compatible. Material compatibility via ASTM testing and dimensionality evaluations did not indicate any significant changes to the 3D printed materials after VH2O2 sterilization. Conclusion Low temperature vaporized hydrogen peroxide sterilization is demonstrated as a suitable method to sterilize 3D printed devices. The results are a subset of the data used in a regulatory submission with the US FDA to support claims for sterilization of 3D printed devices with specified materials, printers, and device design 1. |
| first_indexed | 2024-03-07T15:19:35Z |
| format | Article |
| id | doaj.art-09973925fde14cd19231ff3fde6d8fa8 |
| institution | Directory Open Access Journal |
| issn | 2365-6271 |
| language | English |
| last_indexed | 2024-03-07T15:19:35Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | 3D Printing in Medicine |
| spelling | doaj.art-09973925fde14cd19231ff3fde6d8fa82024-03-05T17:44:05ZengBMC3D Printing in Medicine2365-62712024-02-0110111010.1186/s41205-024-00206-1Low temperature vaporized hydrogen peroxide sterilization of 3D printed devicesRandal Eveland0Kathleen Antloga1Ashley Meyer2Lori Tuscano3STERISSTERISSTERISSTERISAbstract Background Low temperature vaporized hydrogen peroxide sterilization (VH2O2) is used in hospitals today to sterilize reusable medical devices. VH2O2 sterilized 3D printed materials were evaluated for sterilization, biocompatibility and material compatibility. Materials & methods Test articles were printed at Formlabs with BioMed Clear™ and BioMed Amber™, and at Stratasys with MED610™, MED615™ and MED620™. Sterilization, biocompatibility and material compatibility studies with 3D printed materials were conducted after VH2O2 sterilization in V-PRO™ Sterilizers. The overkill method was used to evaluate sterilization in a ½ cycle. Biocompatibility testing evaluated the processed materials as limited contact (< 24-hours) surface or externally communicating devices. Material compatibility after VH2O2 sterilization (material strength and dimensionality) was evaluated via ASTM methods and dimensional analysis. Results 3D printed devices, within a specific design window, were sterile after VH2O2 ½ cycles. After multiple cycle exposure, the materials were not cytotoxic, not sensitizing, not an irritant, not a systemic toxin, not pyrogenic and were hemo-compatible. Material compatibility via ASTM testing and dimensionality evaluations did not indicate any significant changes to the 3D printed materials after VH2O2 sterilization. Conclusion Low temperature vaporized hydrogen peroxide sterilization is demonstrated as a suitable method to sterilize 3D printed devices. The results are a subset of the data used in a regulatory submission with the US FDA to support claims for sterilization of 3D printed devices with specified materials, printers, and device design 1.https://doi.org/10.1186/s41205-024-00206-13D printingSterilizationVaporized hydrogen peroxide |
| spellingShingle | Randal Eveland Kathleen Antloga Ashley Meyer Lori Tuscano Low temperature vaporized hydrogen peroxide sterilization of 3D printed devices 3D Printing in Medicine 3D printing Sterilization Vaporized hydrogen peroxide |
| title | Low temperature vaporized hydrogen peroxide sterilization of 3D printed devices |
| title_full | Low temperature vaporized hydrogen peroxide sterilization of 3D printed devices |
| title_fullStr | Low temperature vaporized hydrogen peroxide sterilization of 3D printed devices |
| title_full_unstemmed | Low temperature vaporized hydrogen peroxide sterilization of 3D printed devices |
| title_short | Low temperature vaporized hydrogen peroxide sterilization of 3D printed devices |
| title_sort | low temperature vaporized hydrogen peroxide sterilization of 3d printed devices |
| topic | 3D printing Sterilization Vaporized hydrogen peroxide |
| url | https://doi.org/10.1186/s41205-024-00206-1 |
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