2020 marks 20 years since the introduction of the pioneering BioCleanse® 20 Tissue Sterilisation Process
The BioCleanse Process is a validated, fully-automated chemical and mechanical sterilisation process that achieves a 12 log reduction of bacteria and inactivates viruses for tendon allografts without the use of irradiation.
To celebrate this milestone, here are 20 reasons to be using BioCleanse® processed tendons:
1. There have been more than 8 million BioCleanse® processed implants distributed worldwide with zero confirmed incidence of implant associated infection
2. The BioCleanse® process has been used in the tissue banking industry for 20 years
3. Grafts processed through the BioCleanse® process achieve a Sterility Assurance Level (SAL) of 10-6 without augmentation with irradiation or peracetic acid
4. More than 6,500 BioCleanse® processed tendons have been supplied by Hospital Innovations to the UK
5. The BioCleanse® process is proven to inactivate or remove all sources of infectious disease transmission without compromising the biomechanical or physiological properties of the bone or soft tissue
6. The BioCleanse® process is used to process tendon, bone and meniscus allograft
7. Since 2010, 235 UK Hospitals have successfully implanted BioCleanse® processed allografts
8. BioCleanse® processed tissue is supplied to the UK by Hospital Innovations, a company with more than 12 years of experience dealing with allograft tissue
9. One full BioCleanse® process cycle confirms a 12-log reduction of bacteria, fungi and spores and inactivation of a panel of viruses
10. All BioCleanse® processed tissue is subject to a highly effective detection system to ensure there is no contamination post-processing
11. All BioCleanse® processed grafts are swab cultured and quarantined for 14 days following processing; tissue is only released for distribution if cultures are negative after this period
12. Annually, over 600,000 BioCleanse® processed allografts are distributed to more than 50 countries worldwide
13. The BioCleanse® process was one of the first tissue-specific sterilisation processes to be introduced to the tissue banking industry
14. The BioCleanse® process is validated using the most difficult case scenario organisms; Bacillus Spores and tissue; Achilles Tendon, to achieve sterility
15. The BioCleanse® process is scientifically proven and clinically successful
16. The BioCleanse® process is a validated, low temperature, chemical sterilisation process that inactivates or removes potential contamination without the use of irradiation
17. The BioCleanse® process retains tissue biocompatibility – repeated rinses throughout the process remove debris; and final rinses remove residual chemicals leaving the tissue biocompatible as per ISO 10993
18. A 2017 review study by Roberson et al. found that when assessing tendon allograft clinical outcomes following different types of processing, BioCleanse® processed tissue produced the lowest failure rate of 5.4% when compared to irradiated and aseptically processed tissue
19. The unique mechanical pressure and vacuum oscillations allow chemicals to penetrate the entire allograft collagen matrix; addressing viruses, bacteria, fungi and spores within the tissue as well as on the surface
20. A 2016 single centre, prospective, randomised study by Arrington et al. found that there were no statistically significant differences in outcomes measures between BioCleanse® processed allograft tendons and autograft tendons when used for ACL reconstruction
Hospital Innovations Limited is a Sponsor of the National Ligament Registry