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From Assessment to Planning. Injection Safety Assessments coordinated by WHO/Vaccines and Biologicals in the Eastern Mediterranean Region Carsten Mantel, MD, MPH WHO STC. WHO/V&B/VAM Assessment of Injection Safety. WHO/V&B Tool C: Rationale, Objectives, Methods
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From Assessment to Planning Injection Safety Assessments coordinated by WHO/Vaccines and Biologicals in the Eastern Mediterranean Region Carsten Mantel, MD, MPH WHO STC
WHO/V&B/VAM Assessment of Injection Safety • WHO/V&B Tool C: • Rationale, Objectives, Methods • Experience from 22 country assessments 2000-2002 • WHO/EMR: • Regional Injection Safety Assessment • Regional Injection Safety Strategy • Regional Injection Safety Plan of Action
Unsafe disposal Reuse of equipment Unsafe collection Injection Safety: Critical Issues • The risk to the recipient • Re-use of syringes or needles • Use of non-sterile equipment • Risk to the health care worker • Inappropriate waste collection • Risk to the community • Inappropriate waste disposal
Assessment of Injection Safety: Tool C Rationale • Describes injection practices in a standardised and representative way • Identifies detailed problems in injection practices • Identifies local issues to design effective, efficient interventions • Provides baseline information and indicators for monitoring progress
Assessment of Injection Safety: Tool C Objectives • To determine if a facility meets necessary requirements for staff competence, equipment, supplies, and waste disposal. • To assess if injections are administered according to recommended best practices. • To identify the unsafe practices that may lead to infections and that should be targeted by interventions. • To estimate the proportion of health-care facilities where injection practices are safe.
Assessment of Injection Safety:Tool C Methods • Standardized and representative method to allow for: • Measuring and documenting progress • Comparison across countries • Simple/structured and flexible (2-3 weeks) • To be adjusted to country needs (other issues at health facility can be looked at simultaneously) • Need to link with change plan of action.
Assessment of Injection Safety: Tool C Development • Collaboration between SIGN, BASICS and WHO/V&B • Ohio State University: • Statistical advice on sampling strategy • Computer simulation studies of sampling design
Assessment of Injection Safety: Tool C Sampling • Cross-sectional observational study • Two-stage cluster sampling with probability proportional to size of population • 8 districts randomly selected • 10 health care facilities visited in each district • Representative of the country • With around 10% precision of the estimate
Assessment of Injection Safety:Tool C Data Collection • Observation of supplies: • Type and number of syringes and needles • Number of safety boxes, sharps containers • Type of waste disposal • Observation of injections: • Immunisation and curative departments • Interview of healthcare workers: • With injection provider • With the supervisor of the centre
Assessment of Injection Safety: Tool C Data Analysis • Data Entry in Epi Info • Data Analysis in Epi Info and e.g. Stata: • Calculation of means and proportions • Calculation of 95% confidence intervals (binomial) • Cluster sampling design taken into account
Tool C Injection Safety Assessments 2000-2002 Burkina Faso, Chad, Djibuti, Egypt, Eritrea, Ethiopia, Gambia, Guinea, Honduras, Kyrgyzstan, Morocco, Nepal, Niger, Oman, Pakistan, Paraguay, Syria, Sudan, Tunesia, Yemen, Zambia, Zimbabwe Assessments done Assessments planned
Results: Injection Equipment 20 country reports available as of June 2002 • Sterilizable equipment in majority of facilities 8/20 • AD-syringes for all immunizations 2/20 • Disposable equipment for curative injections 20/20
Results: Risk to Injection Recipients • 100% use of sterile equipment for all observed injections: 4/18 countries • 100% use of sterile equipment for all observed immunization injections: 9/17 countries
Results: Risk to Injection Recipients Countries using disposable equipment (n=12): • In 9 countries 100% of immunizations are safe Countries using sterilizable equipment (n=8): • In 1 country 100% of immunizations are safe • In all facilities leaking sterilizers, no regular use of time-steam-temperature spots
Results: Risk to Injection Recipients Relative Risk for safe immunization injections for countries using disposable equipment v.s countries using sterilizable equipment OR 14.0 (95% CI: 1.3 - 156)
Results: Risk to the Health Care Worker • Use of safety-boxes 0 - 89% • No sharps in open containers 5 - 66% • No two-hands recapping 29 - 84% • No needle-stick injuries in the last 12 month 21 -82% • Mean number of needle sticks per person and year 1 - 9
Results: Risk to the Community • No sharps in the surroundings 7 - 91% • Open burning or unsupervised dumping of sharps waste 18 - 64% • Health care waste policy 0 - 9%
Discrepancy between IS policy and actual findings (Country 1) • Country policy: Use of disposable injection equipment • 84% of the injections are given with sterilizables • Sterilizers without leaks only in 84%, only in 23% spare parts and in 7% TST spots available to register sterility
Discrepancy between IS policy and actual findings (Country 2) • Country policy: Use of sterilizable injection equipment for immunizations • Only 4% of health facilities in the country are using sterilizable equipment • Clients are purchasing the injection material locally
WHO Eastern Mediterranean Region 23 countries with 482 Mio. total population (2000)
WHO/EMR: Injection Safety Situation • Standardised assessments performed in 9/23 countries representing 65% of EMR population • Additional data used: • WHO/UNICEF Joint Reporting Forms on vaccine-preventable diseases • SIGN reports • ATT reports • GAVI applications re: injection safety • Expert knowledge (Delphi estimates) of national EPI managers • Published scientific papers (Egypt, Pakistan)
WHO/EMR: Injection Safety Assessments Palestine Bahrain Covering 65% of EMR population
WHO/EMR: Risk to Injection Recipients Proportions weighted by population figures
WHO/EMR: Immunization Safety 2002 Palestine Bahrain > 95% safe injections 91- 95% safe injections 81- 90% safe injections 71- 80% safe injections 70% safe injections
WHO/EMR: Equipment and Supplies Proportions weighted by population figures
WHO/EMR: AD Injection Equipment Palestine Bahrain At least partially available for 51% of EMR population
WHO/EMR: Risk to Health Care Workers Data from 7 countries - weighted by population figures
WHO/EMR: Safety Boxes Palestine Bahrain At least partially available for 93% of EMR population
WHO/EMR: Risk to Health Care Workers Proportions weighted by population figures
WHO/EMR: Risk to the Community Proportion weighted by population figures
WHO/EMR: Sharps Waste Disposal Proportions weighted by population figures
WHO/EMR: Summary Estimates Weighted Proportion • Risk to Recipients (EPI and curative): • Non-sterile injections 34% • Risk to Health Care Workers: • Sharps in open containers 71% • Two-hands re-capping 60% • Needle-stick injuries (admitted) 50% • Risk to the Community: • Unsafe sharps waste disposal 85%
Pakistan Summary Estimates %95% CI • Risk to Patients: • Non-sterile injections 64% (54 - 73) • Risk to Health Care Workers: • Sharps in open containers 92% (85 - 96) • Two-hands re-capping 83% (71 - 92) • Needle-stick injuries (admitted) 46% (33 - 60) • Risk to the Community: • Unsafe sharps waste disposal 94% (86 - 98)
Planning or „Quality“ Cycle Benchmarking Evaluation Assessment Monitoring Planning Implementation
WHO/EMR Regional Injection Safety Goals • Ensure the safety of all immunization injections in all member countries. • Extend successful injection safety strategies and activities to other parts of health care services.
WHO/EMR: Regional Injection Safety Targets All countries of the EMR will ... • have reliable baseline data on injection safety by the end of 2003. • have declared their political commitment to injection safety and have developed national policies, guidelines and plans of action on injection safety by the end of 2003. • have sustained public information and communication activities and behaviour change strategies to increase injection safety by the end of 2005.
WHO/EMR: Regional Injection Safety Targets All countries of the EMR will ... • have strengthened their management capacity and improved human resources development in all issues related to injection safety by the end of 2004. • have assured that no reuse of injection equipment occurs at any time and that safe injection equipment and safety boxes are supplied “bundled” with all vaccines by the end of 2004.
WHO/EMR:Regional Injection Safety Targets All countries of the EMR will ... • have assured the safe collection, treatment and destruction of sharps waste by the end of 2005. • have a regular reporting system and the capacity to supervise, monitor and evaluate injection safety programmes by the end of 2005. • have extended successful injection safety strategies and activities from immunization services to other parts of the health care services by the end of 2005.
WHO/EMR:Regional Injection Safety Plan of Action • Eight main activities according to established targets • Additional resource requirements 2002-2005: for regional-level activities: 655,000 USD for country-level activities: 805,000 USD
WHO/EMR: Regional Injection Safety Milestones and Indicators • Milestones set for 2003 - 2005 • Measurable indicators (input, process, outcome) suggested for regional and country level
Acknowledgements • Dr. Julia Fitzner, WHO/V&B/VAM • Dr. Phillipe Duclos, WHO/V&B/VAM • Dr. Ezzedine Mohsnie, WHO/EMRO • Dr. Yvan Hutin, WHO/BCT • All collaborators, counterparts in Ministries of Health, field workers, health facility staff, patients and vaccinees