1. 2012;15;E573-E614Assessment of Infection Control Practices for Interventional Techniques: A Best Evidence Synthesis of Safe Injection Practices and Use of Single-Dose Medication Vials
   Health Policy Review
   Bradley W. Wargo, DO, Standiford Helm II, MD, Ramsin M. Benyamin, MD, David L. Caraway, MD, Frank J.E. Falco, MD, Laxmaiah Manchikanti, MD, Hans Hansen, MD, Allan T. Parr, MD, Joshua A. Hirsch, MD, and Vijay Singh, MD.

BACKGROUND:  It is universally accepted that transmission of bloodborne pathogens during health care procedures continues to occur because of the use of unsafe and improper injection, infusion, and medication administration practices by health care professionals in various clinical settings. This resulted in development of multiple guidelines based on case reports; however, these case reports are confounded by multiple factors without causal relationship to a single factor. Even then, single-dose vials used for multiple patients have been singled out and became the focus of infection control policies resulting in inordinate expenses for practices without improving patient safety. The cost of implementation of single dose vial policy in Interventional Pain Management for drugs alone may cost $750 million, whereas with single use radional gloves may exceed $1 billion per year.

STUDY DESIGN: Best evidence synthesis.

OBJECTIVE: To critically appraise and synthesize the literature on infection control practices for interventional techniques, including safe injection and medication vial utilization.

METHODS: The available literature on infection control practices was reviewed. Due to the nature of the studies involved, with the majority being case reports, and a few prospective evaluations, quality assessment and clinical relevance criteria were not applied.

Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 through June 2012, literature from the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and manual searches of the bibliographies of known primary and review articles.

OUTCOME MEASURES: The primary outcome measure was correlating infection to a breach of standards in infection control practices. The secondary objective was to assess the contribution of single-dose vials independently for infection.

RESULTS: A total of 60 reports met inclusion criteria, with 16 reports related to pain management and other procedures, of which 9 reports were attributed to issues related to interventional techniques.

Based on an estimated 37 infections occurring during 200 million interventional techniques from 1997 through 2011, the rate of infection is speculated to be one infection for every 5 million interventional pain management procedures. However, if 10 times more infections are estimated, the infection rate appears to be one infection for every 500,000 interventional pain management procedures.

The evidence is good for infection related to a breach of infection control practices. There is good evidence that contamination of multi-dose or single-dose vials can contribute to infection.

There was poor evidence that the use of single-dose vials on multiple patients with appropriate infection control practices cause infection in interventional pain management.

LIMITATIONS: The limitations of this comprehensive best evidence synthesis include the paucity of literature and dependence of governmental agencies on their literature without applying Institute of Medicine (IOM) criteria for guideline synthesis.

CONCLUSION: There is good evidence that any breach of sterile practice may result in serious and life threatening infections. There is poor evidence for single-dose vials as a sole factor causing infections when used in multiple patients in interventional pain management settings.