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Endoscopies, blood-borne viruses and blood donors: time to move on from precaution
Veronica C Hoad1, George Serhan1, Clive R Seed1
1Clinical Services and Research, Australian Red Cross Lifeblood, Perth, Australia.
Insights
Blood donation deferrals for endoscopy procedures in Australia are unnecessary. A study found zero blood-borne viruses (BBVs) in donors post-endoscopy, confirming blood safety and leading to policy change.
Area of Science:
- Transfusion Medicine
- Infectious Disease Epidemiology
- Public Health Policy
Background:
- Current Australian blood donation regulations mandate a 4-month deferral after endoscopic procedures involving polyp removal or biopsy.
- This policy is based on Council of Europe directives and aims to mitigate risks of blood-borne virus (BBV) transmission.
Purpose of the Study:
- To assess the incidence of HIV, hepatitis B, and C in blood donors following endoscopic procedures.
- To evaluate the associated risk to blood safety and inform policy regarding deferral periods.
Main Methods:
- Analysis of 16,283 blood donors with endoscopy deferrals between 2013-2017, including pre- and post-donation BBV testing.
- Comparison with a standard blood donor cohort to determine BBV incidence.
- Risk modeling to estimate residual risk of unrestricted post-endoscopy donation.
Main Results:
- Zero incidence of BBVs (HIV, hepatitis B, C) was observed in donors post-endoscopy (95% CI 0-0.000105).
- The upper confidence limit for BBV incidence was 10.5 per 100,000 donations.
- Residual risk remained negligible even under worst-case scenarios, with total positive donations from repeat donors at 1.87 per 100,000.
Conclusions:
- The 4-month BBV endoscopy deferral is not required to ensure blood safety in Australia.
- Data supported a successful exemption request to regulators, leading to policy change implemented in April 2020.
Background And Objectives:
Based on the Council of Europe directive which dictates regulatory requirements in Australia, blood donors are currently deferred from donating for 4 months after an endoscopic procedure if either polyps were removed or a biopsy sample was taken. We aimed to assess the incidence of blood-borne viruses (BBVs) (HIV, hepatitis B and C) in blood donors who donated after an endoscopic procedure and evaluate the risk to blood safety through risk modelling.
Materials And Methods:
Donors from 1/1/2013 to 31/12/2017 with an endoscopy deferral on their blood donor file with pre- and post-BBV testing were analysed to determine an incidence of BBVs using standard methods. The standard blood donor cohort was used as a comparator group. Using the incidence of endoscopies and BBV risk, the total residual risk estimate of allowing donors to return postendoscopy without restriction was calculated.
Results:
The incidence of a BBV postendoscopy in this large cohort of 16,283 where testing has been confirmed postendoscopy was zero (95% CI 0-0·000105). The upper confidence interval of the zero events is 10·5 per 100 000 donations. Total positive donations from 2017 repeat donors were 1·87 per 100 000 (95% CI 0·0000117-0·0000277). Sensitivity analysis demonstrated that the residual risk remained negligible under realistic worst-case scenarios.
Conclusion:
A BBV endoscopy deferral is not required for blood safety in Australia. The presented data has enabled us to submit a request for an exemption to our regulator, which has been approved and the policy change subsequently implemented by Lifeblood on 4/4/2020.
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