VialAcquiredHAIs Health Care Associated Infections A Risk Management Analysis

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Vial-Acquired-HAIs (Health Care Associated
Infections) A Risk Management Analysis

• Capstone Presentation
• December 2009
• Karen Weiss, M.D.
• Capstone Supervisor and
• Faculty Advisor
• Dr Sydney Dy

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Definitions

• Healthcare Associated Infection (HAI)
• Acquired during the course of treatment for other
  conditions within a healthcare setting
• http//www.cdc.gov/ncidod/dhqp/
  healthDis.html
• Vial-acquired HAI
• Type of HAI, improper aseptic technique
• Vial, Single-Dose
• Single unit of a parenteral drug product.
• Vial, Multi-Dose
• More than one dose of the drug product. FDA
  Data Standards Manual

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HAIs Public Health Impact http//www.ahrq.gov/
qual/haiflyer.htm

• 1.7 million HAIs annually
• 100,00 deaths
• 30 million dollars
• Vial-acquired HAI
• Sometimes requires notification of at risk
  patients
• May involve thousands of people
• Additional financial, psychological cost

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Adapted from Managing Risks from Medical Product
Use Creating a Risk Management Framework. Report
to the FDA Commissioner from the Task Force on
Risk Management.
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Identify/characterize risk

• Sources literature, meta-
  analyses, expert opinion
• 25 reports reviewed
• One or more nosocomial infections
• Two unsafe practices, but no infections
  documented
• Botulinum toxin
• Insulin
• Two reports were not vials
• Insulin pen
• Saline in bags

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Identify the issue
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(No Transcript)
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Risk Quantification

• Latency between exposure and
  infection, link to HAI not made
• Asymptomatic cases never come
  to medical attention
• Infections not always reported
• Problems with case definition
• 20-30 of HCV infections, no source identified
• Verbaaan et al. Inf. Control and Hosp Epidem.
  2983-5, 2008

Significant under-reporting
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Examples of failure in aseptic technique. From
http//www.who.int/injection_safety
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Another example
MMWR May 16, 2008
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Failure in aseptic technique root cause
analysis
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Identify, analyze options
Budnitz et al Pharmaco.and Drug Safety 16 2007
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Select the strategy (ies)

• Eliminate (national level) multi-dose vials
• FDA banned inhalers that use chlorofluorocarbons
  (CFCs) in mid-90s
• Precedence
• Multi-dose vials banned - sporadic, at
  local/institutional level
• Will not eliminate the problem
• Unsafe practices with single dose vials
• Develop oversight/standards
• Concurrent education/outreach e.g.,
• One and Only campaign

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Steps in rulemaking
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Evaluate the results

• Monitor vial-acquired outbreaks
• Passive Surveillance
• Prospective Studies?
• Verbaaan et al. Inf. Control and Hosp Epidem.
  2983-5, 2008
• Surveys
• Assess compliance
• Cost analyses
• Vial pricing, Cost/dose,

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Engage Partners
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Summary

• Risk management model a useful tool to assess
  vial-acquired HAIs
• Root causes multifactorial
• Knowledge gaps
• Financial
• Oversight
• Potential solutions systems based
• Engineering modifications single dose vials
• Education/outreach e.g. One and Only
• Enforcement standards, infection control,
  oversight in ambulatory facilities

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Summary contd

• Risk model calls for
• Stakeholders/partners in all steps
• Process to measure effectiveness of intervention
• Iterative process