A new ISMP Canada Safety Bulletin (ISMP Canada 2018) reminds us to never use a syringe for a topical product. That’s because the topical product might be accidentally injected into a patient if it is in a syringe. While parenteral injection of almost any topical product could lead to devastating consequences, the ISMP Canada bulletin focuses on chlorhexidine.
The Safety Bulletin prompts our recall of devastating injuries resulting from inadvertent parenteral injection of chlorhexidine. Most of us remember an unfortunate case a decade ago where a patient was inadvertently given intraarterially the antiseptic skin prep solution, chlorhexidine, instead of contrast media (ISMP 2004). That resulted in a leg amputation, followed by a stroke and multiple organ failure and, ultimately, death. In that case there were two unlabeled basins containing clear solutions that looked alike. So, it was not surprising that such accidents might occur.
We discussed this issue in detail in our June 23, 2015 Patient Safety Tip of the Week “Again! Mistaking Antiseptic Solution for Radiographic Contrast”. The National Health Service in England issued an alert following three incidents involving inadvertent injection of skin antiseptic solutions since 2012, and one additional near miss (NHS 2015). Two incidents involved severe harm from confusion between 2% chlorhexidine and x-ray contrast media in circumstances where both substances were in unlabeled basins. The near miss also involved confusion between chlorhexidine and x-ray contrast material despite the fact the two solutions were on different tables. The other incident involved flushing a renal dialysis line with chlorhexidine rather than saline. These cases occurred despite two previous alerts from the National Patient Safety Agency in the UK (NPSA 2007, NPSA 2010).
A common scenario for such serious incidents is where chlorhexidine solution and a solution intended for injection (e.g., a local anesthetic or an injectable medical dye) are poured into open, unlabeled bowls in the operating room or angiography suite. Someone then draws up the incorrect solution into a syringe and administers the solution parenterally. The error probably occurs more often with clear, rather than tinted, chlorhexidine solutions. Note that the switch in antiseptics from a brown povidone-iodine solution to a clear chlorhexidine solution likely played a role in some of these incidents, such as the one described in the 2004 ISMP alert.
One patient safety blog (patientsafe blog) has catalogued incidents related to accidental misuse of chlorhexidine. These include not only cases of accidental intravenous injection of chlorhexidine but also cases where it was injected epidurally, or into the eye or a joint space, and cases where it was given orally to patients. There’s even been an incident involving a buccal injection during a dental procedure (Hiremath 2016).
A root cause analysis of an epidural incident (O’Connor 2012) was also informative. A 32 y.o. woman was to receive an epidural block during labor. The anesthetist mistakenly injected 8 ml of an alcoholic solution of chlorhexidine, The patient developed paralysis and hydrocephalus. Chlorhexidine and saline, both clear liquids, were in two identical metal containers in the anesthetist’s work space. Staff had decanted the solutions into the unlabeled containers. Apparently, previous chlorhexidine solutions had been slightly colored but the facility had recently switched to a new preparation that was lighter in color. Saline was apparently usually used in a syringe that was used to help the anesthetist know when the needle was in the epidural space. But the anesthetist had the wrong solution in the syringe and injected chlorhexidine into the epidural space.
The regional Department of Health subsequently recommended removal of the skin antiseptic preparation and associated swabs after the skin is prepped. It also recommended that when a nurse or midwife was required to prepare a medication dose for administration by a provider in a sterile set-up, there needs to be a double check by the provider prior to administration. Some hospitals, in response, apparently switched to povidone-iodine skin prep, though questions persist about the relative antiseptic capabilities of povidone-iodine vs. chlorhexidine. Physical separation of antiseptic solutions from the epidural sterile tray has also been used.
Incidents involving injection of the wrong substance when two look-alike substances are in proximity and are unlabeled have occurred in multiple venues (angiography suites, cath labs, dialysis units, hospital OR’s, ambulatory surgery centers, and others). Most hospitals have really focused on enforcing the “no unlabeled syringes” and “no unlabeled solutions in basins” in the OR. But it may be that those other areas (radiology suites, cath labs, dialysis units, etc.) may be even more vulnerable to such incidents. And don’t forget bedside procedures. They are probably even more prone to such mistakes. Clear, colorless skin antiseptics might be easily confused with substances intended for spinal injection or injection into other body cavities.
In our June 23, 2015 Patient Safety Tip of the Week “Again! Mistaking Antiseptic Solution for Radiographic Contrast” we noted some of the human factors that may contribute to such incidents. There’s always that tendency to think “I know what’s in that basin” and “there will only be one basin”. Then another basin shows up with a substance similar in appearance, often unbeknownst to the person who will actually be injecting.
There’s also a tendency to keep the skin antiseptics around “just in case we might need them”. Once you’ve prepped the skin, the antiseptic agent should be removed from the sterile field (and even adjacent stands). There is usually easy access to these in most venues if you really do need them again so there is little reason to “keep them around just in case you might need them again”. And remember that the alcohol-based antiseptics are also flammable so you especially don’t want them sitting around where they might get ignited by a heat source during a procedure.
We previously noted the steps recommended by ISMP in that 2004 Alert (ISMP 2004):
And we added these recommendations:
Now ISMP Canada adds the following recommendations regarding chlorhexidine products:
· Ensure that products are in ready-to-use formats. Chlorhexidine-impregnated swabs should be the only form of chlorhexidine available for skin disinfection in the procedure area, where available.
· If chlorhexidine solution must be used (e.g., because swabs are unavailable), only procure formulations that are tinted with a visually distinct dye (to provide a visual cue that the liquid is not to be injected). Avoid supplying a clear chlorhexidine solution that could be mistaken for a product intended for parenteral administration. Be sure to check that the patient is not allergic to the dye used in the product.
Though the ISMP Canada Safety Bulletin focuses on chlorhexidine, it notes similar issues with use of topical epinephrine in the operating room and, theoretically, almost any topical medication could be involved in similar incidents. So, ISMP Canada adds the following general recommendations to mitigate the risk of inadvertent injection of topical products:
· Do not use a syringe to draw up, hold, or apply a solution intended for topical use. Topical medications should only be administered with a distinct topical applicator.
· Develop separate, easily differentiated processes for the storage, preparation, and handling of medications intended for topical application and those intended for parenteral injection.
· Ensure that the word “TOPICAL” appears on the label of any container used to hold a solution intended for topical application.
· Perform skin preparation before introducing equipment and injectable solutions to the sterile procedure area. This ensures that skin preparation solutions, such as chlorhexidine, can be removed and kept separate from injectable solutions used during procedures.
· Label every syringe and container with its contents. Sterile preprinted labels are available to facilitate labelling in sterile areas, including operating rooms.
· Discard any unlabeled syringes and containers.
The Joint Commission, of course, requires that all basins, syringes, and other containers in the sterile field be appropriately labeled. Moreover, when any such liquid is to be injected into a patient there should be a verification that the agent is the one intended for injection.
Much like the concentrated potassium chloride situation years ago, we are putting our healthcare workers in jeopardy of making a mistake by making available containers of chlorhexidine in multiple venues. There is actually little reason for that. Applicators are available for skin preparation with chlorhexidine and you should not ever need to pour chlorhexidine solution into any type of container. (But don’t forget that chlorhexidine in alcohol solutions is highly flammable and the appropriate size applicator may be needed in some circumstances. See our January 10, 2017 Patient Safety Tip of the Week “The 26-ml Applicator Strikes Again!”.)
The best way to get your staff’s attention to vulnerabilities to relatively rare incidents is to tell a story. So go ahead and show them the YouTube video Gina’s Story, the full story of a woman who lost her leg after chlorhexidine was inadvertently injected instead of contrast during an angiogram in 2013.
ISMP Canada. Do Not Use a Syringe for a Topical Product – A Focus on Chlorhexidine Disinfectant Solutions. ISMP Canada Safety Bulletin 2018; 18(9): 1-3 November 21, 2018
ISMP (Institute for Safe Medication Practices). Loud wake-up call: Unlabeled containers lead to patient's death. ISMP Medication Safety Alert! Acute Care Edition. December 2, 2004
NHS (National Health Service) England. Patient Safety Alert NHS/PSA/W/2015/005. Stage One: Warning. Risk of death or severe harm due to inadvertent injection of skin preparation solution. May 26, 2015
National Patient Safety Agency. Promoting safer use of injectable medicines. Patient Safety Alert 20, 2007
National Patient Safety Agency. Injectable medicines in theatres. Signal 1162, 2010;
patientsafe. Accidental Chlorhexidine Injections. Patientsafe (blog) accessed November 24, 2018
Hiremath H, Agarwal RS, Patni P, Chauhan S. Accidental injection of 2% chlorhexidine gluconate instead of an anesthetic agent: A case report. J Conserv Dent 2016; 19(1): 106-108
O’Connor M. Responsiveness to the Chlorhexidine Epidural Tragedy: A Mental Block? J Law Med 2012; 19(3): 436-443
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