Patient Safety Tip
of the Week
December
4, 2018
Don’t Use Syringes for Topical Products
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).
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):
- Develop and
implement policies and procedures for safe labeling of medications and
solutions used in all settings where procedures might be done.
- Make labeling easy
by purchasing sterile markers, blank labels, and preprinted labels prepared
by the facility or commercially available that can be opened onto the
sterile field during all procedures. (ISMP had also recommended preprinted
labels for all anticipated medications and solutions for a case but we are
always concerned that having multiple labels increases the risk the wrong
label might be affixed to the wrong substance).
- Require labels on
all medications, medication containers (e.g., syringes, medicine cups,
basins), or other solutions on and off the sterile field, even if there is
only one medication or solution involved
- Require labels on
all solutions, chemicals, and reagents (e.g., formalin, saline, Lugol's solution, radiocontrast media, etc.) that are
used in the units where procedures might be done.
- Differentiate look-alike products (eg. tall man lettering, highlight/circle
the distinguishing information on the label, etc.) When possible, purchase
skin antiseptic products in prepackaged swabs or sponges to clearly
differentiate them from medications or other solutions and eliminate the
risk of accidental injection.
- Label only one at a time.
- Verify all labels and medications/solutions. Verbally confirm the product name,
strength and dosage form between the scrub person and circulating nurse
and when passing it to the physician or person performing the procedure.
- Keep all original
medication/solution containers in the room for reference until the
procedure is concluded.
- Re-verify with relief staff. Shift changes, temporary or permanent, are vulnerable periods and
the handoffs should include verification of all medications/substances and
their labels on the sterile field.
- Discard unlabeled medications. Don't assume that you know what is contained in an unlabeled
syringe, cup, or basin. Discard any unlabeled solution or medication found
in the procedural area (including the sterile field) and report the event
as a hazardous condition. Nothing should leave the hand unless it is
labeled.
- Audit or do walk
rounds in all areas doing procedures to ensure compliance with these
policies and practices. You really need to risk assess injectable medicine
procedures and products and practices in all clinical areas.
- Stories, not
statistics. Stories about tragic mixups remain
one of the best ways to ingrain safety concerns in all staff.
And we added these recommendations:
- Once you’ve prepped
the skin, the antiseptic agent should be removed from the sterile field
(and even adjacent stands).
- Areas that use
saline (or other substance) to “flush” lines or fill balloons might be
especially at risk and the flushing substance needs to be carefully
labeled and identified.
- If you supply blank
sterile labels, make sure you supply a sterile pen
so those labels can be appropriately labeled
- Pay careful
attention to the risks not just in the OR but in other areas and don’t
forget bedside procedures may be vulnerable
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.
References:
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
https://www.ismp-canada.org/download/safetyBulletins/2018/ISMPCSB2018-i9-Chlorhexidine.pdf
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
https://www.ismp.org/resources/loud-wake-call-unlabeled-containers-lead-patients-death
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
http://www.england.nhs.uk/wp-content/uploads/2015/05/psa-skin-prep-solutions-may15.pdf
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;
http://www.nrls.npsa.nhs.uk/resources/?entryid45=66753
patientsafe. Accidental Chlorhexidine Injections. Patientsafe (blog) accessed November 24, 2018
https://patientsafe.wordpress.com/accidental-chlorhexidine-injections/
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
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4760004/
O’Connor M. Responsiveness to the Chlorhexidine Epidural Tragedy: A Mental Block? J Law Med 2012; 19(3): 436-443
https://patientsafe.files.wordpress.com/2015/11/chlorhexidine-mental-block.pdf
https://www.youtube.com/watch?v=IJfoLvLLoFo&feature=youtu.be
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