We did our own analysis of the CDC data they used to draw their incorrect conclusions.
"The CDC developed guidelines for the use of single dose contrast vials that fail to take into account costs of their recommendations, practicality of their recommendations, whether their recommendations would curtail or eliminate beneficial treatments, or whether their recommendations might actually cause more harm. Therefore the key questions the CDC uses in their development of guidelines in this case focused only on risks and not of benefits of a treatment, a position that is contrary to nearly all other medical guideline development. The CDC openly admits this to be the case:
Concerns have been raised about whether these guidelines and related policies contribute to drug shortages and increased medical costs to healthcare providers. CDC recognizes the problem of drug shortages; however, such shortages are a result of manufacturing, shipping, and other issues unrelated to the above guidelines. CDC s priority is protecting patients from harm. From the CDC document Protect Patients Against Preventable Harm from Improper Use of Single-Dose/Single-Use Vials
http://www.cdc.gov/injectionsafety/cdcposition-singleusevial.html
The recommendations based on the guidelines are therefore flawed, and there was no benefit/risk cost analysis performed since the CDC did not analyze the large numbers of injections being performed everyday with multiple uses of single dose vials. Nor did the CDC recognize that many patients would simply not be able to receive injections in an outpatient office setting given the very high cost of single dose vials that would make such injections financially unviable, nor did they factor in the economic cost of lost patient-years of work and the increase in pain and suffering that would result in the absence of such injections.
Furthermore, the CDC was dealing with a relatively small number of infections (compared with the millions of injections performed yearly) due to a multitude of errors in practice that the CDC ultimately attributed solely to the reuse of single dose vials rather than to other known factors of contamination. For instance, in the CDC investigations, the reuse of syringes, reuse of needles, improper skin decontamination, and inadequate hand hygiene were factors in the 16 investigations by the CDC. The number exposed to infection in these 16 studies cited (
http://www.cdc.gov/HAI/settings/outpatient/outbreaks-patient-notifications.html) is approximately 75,000. Of these, 96% were associated with the reuse of syringes (double dipping), a known common source of infection. Rather than focus on the processes that led to the infection exposures, the CDC used the single dose vial as a scapegoat for all infection exposures. Reuse of syringes or needles in any setting, whether single use vials, multidose vials, or accessing IV sites has a known increased risk for infection. The CDC did not comment on the use of good practices that would eliminate such contamination when reusing single dose vials such as adequate decontamination of the stopper when re-accessing the vials, use of an unused needle and syringe for every access of these vials, avoidance of adding any diluent to the vials, etc. The Pain Society simply reflects in its policy that there are logical and proven methodologies towards harm reduction by focusing on the processes of infection control rather than eliminating the common practice of reuse of single dose vials costing up to $50 each. We do not dispute that the single use of single dose vials is the optimal method to eliminate iatrogenic contamination, however by using the infection control processes outlined by the Pain Society that have been used for decades by physicians that have not had outbreaks of clusters of infections, an alternative is presented to the recommendations of the CDC that are practical and permit the continued access of care that would be eliminated if CDC recommendations were followed. However, if single dose vial cost of contrast material drops significantly, then the use of single dose vials could be employed.
Finally, CDC recommendations are just that: recommendations. The CDC has no regulatory or enforcement function. From the CDC website: Is CDC a regulatory agency? CDC is not a regulatory or enforcement agency and does not make policy decisions. CDC conducts science-based investigations, research, and public health surveillance (tracking) both nationally and internationally when there is an outbreak (large number of cases) of disease.
http://www.cdc.gov/cdc-info/inquiries.html
None of this serves to diminish the value of the work of the CDC, nor our appreciation of the difficulties of epidemiological investigation, but instead demonstrates the CDC examines risk in the absence of benefit. The CDC is focused solely on harm elimination rather than balancing the continued availability of important pain relieving therapies or the negative effect of CDC recommendations might have such as forcing physicians to engage in potentially risky practices of interventional pain procedures without the use of contrast.
