What The Emerging Literature Reveals About Infection Control, Multi-Dose Vials And Surgical Centers

Warren S. Joseph DPM FIDSA

I know that this title seems like I am tying in a number of fairly diverse topics but hear me out on this one. I was browsing through USA Today while sitting in an airplane recently and came across a story titled "Safety Breaches at Surgery Centers". That in and of itself was interesting enough to me but upon reading the story, I learned that, “A federal study finds many same day surgery centers — where patients get such things as foot operations (my emphasis added) and pain injections — have serious problems with infection control.”

This short piece in the paper was reporting on the results of a study published in the June 9, 2010 issue of the Journal of the American Medical Association (JAMA). In the study entitled “Infection Control Assessment of Ambulatory Surgical Centers,” Schaefer and colleagues assessed ambulatory surgical centers in three states, specifically looking at hand hygiene, injection safety, medication handling, equipment reprocessing, environmental cleaning and handling of blood glucose monitoring equipment.1 Despite the centers’ employees knowing that they were being observed, 67.6 percent had at least one lapse.

Also of interest was the breakdown on numbers and types of procedures.1 Almost a full one-third of all the procedures performed at these surgi-centers were classified as “podiatry.” I did not find where the study differentiated lapses in infection control by types of procedure and, unlike the USA Today piece, the JAMA article did not specifically single out “foot operations.”

The reason for me reporting on this study, besides the public relations nightmare from the USA Today piece, is that I know many podiatric physicians have a financial interest in an ambulatory surgical center. All I can do is plead with you to maintain the absolute highest level of vigilance in your infection control practices. This will come back and “bite” you if you do not. After a report like this in a journal like JAMA, you know that more regulations are not far behind.

What You Should Know About Multi-Dose Medication Vials

Along the same vein, I sit on my hospital’s infection prevention and control committee. At our most recent meeting, the RN infection control coordinator passed out a position paper from the Association for Professionals in Infection Control and Epidemiology (APIC) on safe injection practices.2

Why I found this particularly pertinent to what we do in lower extremity practice is that it discusses the use of multi-dose medication vials. I have personally reviewed a few malpractice cases of doctors being sued for allegedly causing infection by using these vials. Apparently, there is some controversy about how long one of these vials can be used. The United States Pharmacopeia (USP) requires that a multi-dose vial must be disposed of 28 days after the initial stopper penetration unless the product insert states otherwise. The Centers for Disease Control and Prevention (CDC), however, takes the stance that one can use the bottle until the manufacturer’s expiration date or if there are concerns about its sterility.

Taking these different opinions into account, the APIC Guidelines suggest “… adhering to strict aseptic technique when accessing the vial, using a new sterile needle and a new sterile syringe for every access, removing all access devices from the vial, storing the vial in a clean protected location according to the manufacturer’s directions, and ensuring that any vial whose sterility may be compromised is immediately discarded.”

I rather like one of the APIC’s other suggestions: “Use multi-dose medication vials for a single patient whenever possible … Infection transmission risk is reduced when multi-dose vials are dedicated to a single patient.” While this may not be economically viable and is not currently the “standard of care,” this may be the best advice to protect your patient and yourself.


1. Schaefer MK, Jhung M, Dahl M, et al. Infection control assessment of ambulatory surgical centers. JAMA 2010; 303(22):2273-9.

2. Dolan SA, Felizardo G, Barnes S, et al. APIC position paper: Safe injection, infusion and medication vial practices in health care. Am J Infect Control 2010; 38(3):167-72.

Editor’s note: This blog originally appeared at www.leinfections.com/ and has been adapted with permission from Warren Joseph, DPM, FIDSA, and Data Trace Publishing Company. For more information about the Handbook of Lower Extremity Infections, visit www.leinfections.com/ .

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