Outbreaks of infection after interventional pain
procedures are even rarer than single infections. Indeed,there has only been 1 prior reported outbreak in theliterature. Civen et al34 reported on 10 patients who
developed Serratia marcescens infection after undergoing
atrogenic infection is a rare but potentially catastrophic
epidural injection using betamethasone that had been
improperly compounded at a community pharmacy. Five
Although the incidence is unknown, examination of the
of the patients developed meningitis resulting in 3 deaths,
American Society of Anesthesiologists (ASA) closed
and the other 5 patients developed epidural abscesses.
claims database from the years 1970 to 1999 revealed
That report highlighted the fact that compounded
that infections accounted for 13% of all closed claims
medications are not a risk free alternative to commercially
arising from chronic pain procedures and for 21% of all
available product. In fact, a Food and Drug Administra-
epidural steroid-related complications.1 Overall, infection
tion (FDA) survey of 12 compounding pharmacies
was cited as the third most common complication leading
throughout the United States found that 10 of 29 sampled
products failed at least 1 standard quality test.35
Infection has been reported after interlaminar
Although a second report of an infection outbreak is
epidural steroid injection,2–20 transforaminal epidural
ascribed to a ‘‘pain remediation clinic,’’ it was actually the
steroid injection or selective spinal nerve injection,21,22
result of a nurse anesthetist reusing a common needle and
zygapophysial injection,23–27 stellate ganglion injection,28
syringe to administer intravenous sedation and was not
sacroiliac joint injection,29 epidural lysis of adhesions,30
attributable to the intervention itself.36
and discography.31,32 Most of these reports involved an
In this issue of The Clinical Journal of Pain, Cohen
isolated case wherein 1 patient became infected. The
et al37 report an outbreak of S. marcescens in an
presumed route was a breach in sterility leading to a
outpatient pain clinic. In total, there were 5 culture
single infection and the most common organisms were
confirmed cases and 2 presumptive cases over a 4-week
Staphylococcus aureus or Staphylococcus epidermidis.
period. Five patients (4 confirmed and 1 presumptive) had
Serious sequelae from infection after an interven-
procedures over a 4-day period; the remaining 2 cases had
tional procedure have been reported, including sepsis,
procedures performed approximately 2 weeks prior. Five
meningitis, epidural abscess, osteomyelitis, and death.2
patients underwent selective spinal nerve block, 1 patient
Analysis of the literature found that the median time from
underwent an epidural lysis of adhesions procedure, and 1
procedure to appearance of symptoms was 7 days;
patient had a discogram. Although no patient died, the
however, some patients presented substantially later.2 The
resulting infections were serious, including sepsis, menin-
most common presenting symptom has been shown to be
increasing axial or radicular pain, and improved outcomes
Cohen and his associates thoroughly investigated
are correlated with early diagnosis and treatment.2,8,33
the potential sources of the outbreak, performing an
Several risk factors for iatrogenic infection after an
observational study of the clinic’s infection control
interventional procedure have been cited in literature
procedures, and performing microbiologic and environ-
reviews, including medication or disease-related immune
mental investigations. They observed that single use vials,
compromise (patients with diabetes, metastatic cancer,
including saline and contrast, were used over a several-
day period on multiple patients and were not refrigerated.
and patients taking chronic oral steroids). A history of
A common needle and syringe were also used to access
recent, recurrent, or prior iatrogenic infection was also
multiple medications during a procedure.
cited, as was older age and the injection of a depot
They additionally performed a case-control study
using unmatched controls that did not develop infectionto look at potential risk factors. Their analysis identified
Received for publication February 26, 2008; accepted February 28, 2008.
several potential risk factors, including exposure to
From the Department of Anesthesiology, University of Washington,
contrast agent, procedures involving the epidural space
or intervertebral disc, use of a larger volume of contrast,
Reprints: Ray M. Baker, MD, University of Washington, Seattle, WA
and procedures performed over a defined 4-day period at
Copyright r 2008 by Lippincott Williams & Wilkins
the outpatient pain clinic in question.
Clin J Pain Volume 24, Number 5, June 2008
Clin J Pain Volume 24, Number 5, June 2008
Cohen reports that either normal saline or contrast
Gastmeier,48 after a hospital-based prevalence study on
could be implicated in the outbreak given that both
bacterial contamination of MDVs, advise against using a
involved reusing a single-use medication repeatedly over
filtered ‘‘mini-spike’’ that allows for multiple uses through
several days. Saline usage was not recorded, making
a common port. He noted contamination of a filtered
further analysis difficult. Although not conclusive, Cohen
spike in his study and warned against a false sense of
does present a convincing case for the causative vehicle
security leading to improper handling of the vials.
being iohexol. Experimental inoculation of the iohexol
In terms of practical advice, Cohen correctly
(Omnipaque 240) contrast medium determined that it was
identifies proper infection control techniques that mini-
capable of growing S. marcescens at room temperature.
mize the risk of infection. These include hand washing,
This is further supported by 2 other case reports of
avoiding the use of acrylic or artificial nails, observance of
nosocomial infection from contrast agents.38,39
strict aseptic technique, proper barrier precautions, the
Several issues arise from Cohen’s study that are
prompt use of open trays and supplies, and the cleansing
pertinent to the safe performance of interventional pain
of procedure areas and equipment with a hospital grade
procedures—some a matter of common sense, others less
antiseptic. He additionally advocates for thorough
intuitive. First, it is important to distinguish between
patient education, and in particular, for discussing signs
single-use, multiple-dose, and multiple-use medications.
and symptoms that would alert the patient to the presence
Single-use medications are preservative free and the vials
are ideally meant to be accessed only once. Multiple-dose
However, an outbreak still occurred in the clinic in
preparations contain preservatives that inhibit bacterial
question, despite utilization of these infection control
growth and are meant to be accessed multiple times over
techniques. Which brings us to the crux of the matter—
many days. There are no standards for how long a
the handling of multiple-use medications. The clinic
multiple-dose medication can be safely used. Finally, a
personnel reused a single-dose vial of contrast over a
multiple-use medication is a single-dose medication that is
several day period, and they accessed multiple medica-
tions using a common needle and syringe. Optimally, a
Cohen correctly points out that fresh needles and
single-dose vial should only be used once and only for a
syringes should be used to access each medication, except
single patient.49 Notwithstanding, the vials are expensive
in the setting where the medications are discarded after
and are often not priced by volume. Thus, a 10 mL vial
each case. Thus, a single syringe and needle combination
can be just as costly as a 50 mL vial. Given the reduced
can be used to access iohexol and then reused to draw up
reimbursements for interventional pain procedures and
xylocaine from a single-dose vial as long as the xylocaine
the push for cost-efficient care, a case can be made for
vial is discarded after the procedure and that the
safely reusing a single-dose medication.
medication is used on only 1 patient. However, that same
If a practitioner chooses to reuse a single-dose
syringe or needle should not be used with a reusable
medication, there must be strict safeguards in place to
medication, whether or not it is in a multiple-dose vial
minimize the risk of infection. These include using the
medication for a limited number of patients and for a
MDVs although less likely to support bacterial
single day only, cleansing the stopper thoroughly between
growth, are not infection proof. Preservatives added to
uses with isopropyl alcohol or another suitable antimi-
MDVs are not expected to eliminate all microorganisms
crobial, refrigeration of the vial between cases if there is a
that might be introduced during repeated use.40,41 In fact,
time gap between consecutive cases, and discarding the
the USP criteria for the antimicrobial effectiveness of
vial if any breach in sterility is suspected. Of course, the
preservatives used in multiple-dose formulations require
previously noted general safeguards are also implemen-
only a standard reduction of viable bacteria by day 7.42
ted, including using a needle or syringe on only 1 patient,
Additionally, there have been numerous case reports of
and using the same needle and syringe on only 1 vial,
infection outbreaks with MDVs, including a S. aureus
unless that vial is discarded after the procedure.
outbreak arising from a MDV of lidocaine.43 Paradoxi-
In the end, the cost savings of using a single-dose
cally, a possible contributing factor cited in that outbreak
medication in a multiple-use fashion must be weighed
was refrigeration of the vial between uses. The preserva-
against the risk. Unless proper safety measures can be
tive used was later shown to be less active at refrigerated
assured and unless the cost of the medication warrants its
temperatures,44–47 and the manufacturer’s recommenda-
multiple-use, a single-use medication should be used only
tion was to store the vial at room temperature. This serves
once and then discarded. One serious infection quickly
as a reminder that each medication contains a unique
erases any cost savings to the patient, the provider, or the
combination of preservatives and each must be used and
stored according to the manufacturer’s instructions.
In addition to assuming that a MDV medication
will make up for poor infection control habits, practi-
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