The Joint Commission cracks down on vial misuse in hospitals
Agency points to evidence linking patient harm with unsafe practices
Noting that patients are being harmed by the misuse of single-dose/single-use and multiple-dose vials, The Joint Commission (TJC) is sending a strong signal that more needs to be done to improve safety on this issue. The Oakbrook Terrace, IL-based accrediting agency has issued a Sentinel Event Alert, making it clear that health care providers need to redouble their efforts to insure that safe injection practices are being followed, thereby preventing infections from the misuse of vials.
There is clearly ample room for improvement. Citing data from the Centers for Disease Control (CDC) in Atlanta, GA, TJC reports that since 2001, at least 49 outbreaks related to the mishandling of injectable medical products have occurred. Of these, 21 outbreaks involved the transmission of hepatitis B or C and 28 outbreaks involved bacterial infections. Further, during this time period, more than 150,000 patients have had to be notified to undergo blood-borne pathogen testing because of their potential exposure to unsafe injections.
Such data may only hint at the extent of the problem. The CDC says that adverse events related to the misuse of vials are underreported, and it is difficult to trace the misuse of vials to infections. Nonetheless, TJC is clearly putting health care providers on notice that the problem requires prompt attention and diligent ongoing oversight.
Workers lack understanding
The Joint Commission cites research showing that a survey of 5,446 health care practitioners revealed significant gaps in basic infection control practices related to vial use. For example, 6% of respondents admitted to using single-dose/single use vials on multiple patients. Also, 15% reported using the same syringe to re-enter multiple-dose vials for the same patient, and of this 15%, nearly half (6.5%) reported saving vials to use on another patient. Further, of the 51 survey respondents who reported reusing a syringe to extract an additional dose from a multi-dose vial for use on another patient, about half worked in a hospital setting.1
While a significant number of infections related to vial misuse occur in pain management and cancer care clinics, many also occur in hospital settings. Oftentimes, such problems can be traced to a poor understanding of safe injection practices, according to Ruth Carrico, PhD, RN, FSHEA, CIC, associate professor, Division of Infectious Diseases, University of Louisville School Medicine, Louisville, KY. "I have never met a health care worker who wanted to hurt their patient, so from my perspective, when we have misuse, it is because people don’t know what the issues are," she says. "Many times, the problem is that they may conceptually have an understanding, but they don’t really know how to apply that concept into practice." (Also see: Guidance on the safe usage of vials, p. 88.)
For instance, Carrico notes that a health care worker in the ED may know that with a multi-dose vial you are never supposed to re-enter that vial with the same needle and syringe, but then they may work with a provider who continually re-enters a multi-dose vial for more lidocaine as he is stitching up a patient. "The health care worker may make a mental note to throw away the vial of lidocaine after the procedure, but then when the ED gets busy, he or she may not think about it, or more importantly, there may be an emphasis on cost-containment in the department," she says. "The worker may be thinking that he didn’t see any blood in the syringe and conclude [incorrectly] that therefore the vial was not contaminated."
In a busy ED, it is easy to see how an incident of this nature could happen, observes Carrico. "With the amount of activity that is occurring, people may not feel as though they have the time to do what they know is right, or they may make a judgment call that is based on poor information," she says.
There is no question that the chronic drug shortages health care organizations have been dealing with in recent years are exacerbating the problem of vial misuse, says Carrico. "There is a push to be aware of costs, but at the same time, health care organizations don’t want [staff] to be sacrificing patient safety," she says. "Under these circumstances, people will make decisions that they think make sense."
It is well understood, for example, that there is always a little bit of over-fill in single-dose vials. "If you are supposed to give 0.5 mLs of a particular medication, in that single vial there is 0.55 or even 0.6 of medicine," explains Carrico. "People learn that and think if they are supposed to give this medicine to 10 different people, they can save 0.1 mLs from each of the vials, mix them together, and then they will have an additional dose."
People who engage in this type of unsafe practice think they are doing what they are supposed to do because they are saving money for the hospital, says Carrico. "They’re trying to make sure that their technique is good with each one of those vials, but we know that all it takes is one misstep," she says.
The Joint Commission reports that such efforts to prevent waste and save money can easily backfire, resulting in adverse events that significantly drive up health care expenditures, harm patients, and generate litigation.
Public pressure to eliminate preservatives from injectable products has also contributed to the problem, says Carrico. "Unfortunately we have given weight to something where we have no data, and don’t give weight to issues where we do have data. We don’t have data about the harm of preservatives, but we do have data about the harm of contamination," she says.
Observe practice first
What steps can hospital administrators take to eliminate the misuse of vials? First, you have to know what the actual practices are in your department, advises Carrico. "I would want to observe staff to see what people are actually doing," she says. "They may say that, yes, they understand [safe injection practices], and that they are doing things right all the time. In their minds, they may be, but I would want to see firsthand what the actual practices are."
Carrico recalls how simply observing how people practice in one health care setting enabled her to identify a major safety problem. "They would use a syringe on only one patient, but they would give the patient multiple injections with the same syringe," she says, explaining that this typically occurred in cases in which patients required regular injections of pain medication. "After a first injection, you should consider a syringe to be contaminated as well as the needle, but from their perspective, they were using it on the same patient and they were saving money so everything was right."
It was clear from her observations that these health care workers needed to have a better understanding of what contamination is, and what appropriate technique is, explains Carrico. "You’ve got to be watching and observing and then you develop your plan of action," she says. "Part of it is going to be driven by what people are actually doing, so know what the actual practice is and then learn about the culture within that setting."
Unsafe injection behaviors often seep into practice over time, explains Carrico. "A lot of nursing education occurs by what I call urban legend," she says. A nurse will explain to another nurse how she was taught, and then that nurse will tweak the practice a little bit to make it relevant, she says. "After a couple of generations of this, the message has changed."
It is a sign of the times that accrediting agencies like TJC continue to see problems with injection techniques, says Carrico. "It used to be that 80% of care was in a hospital. Now probably 20% of care is in the hospital, and we see that hospitals are purchasing management arrangements with group practices, and they have arrangements with long-term care facilities," she explains. "The oversight and responsibility for accredited facilities is expanding; therefore, the responsibilities they have and the interventions they develop need to be commensurate with those responsibilities."
The Sentinel Event Alert is just recognizing the expansion of services that is under the umbrella of an accredited facility, says Carrico. But it is also a wake-up call that the status quo will not suffice. "Despite everything we have been doing, we still keep getting examples of unsafe injection practices," she says. "We should know better, but somehow [unsafe behaviors] make their way into routine practice."
- Pugliese G, et al. Injection practices among clinicians in United States health care settings. American Journal of Infection Control 2010;38(10):789-797.
- Ruth Carrico, PhD, RN, FSHEA, CIC, Associate Professor, Division of Infectious Diseases, University of Louisville School Medicine, Louisville, KY. E-mail: ruth.carrico@