Intra-Operative Waste in Spine Surgery: Incidence, Cost, and
Effectiveness of an Educational Program
Alex Soroceanu MD CM MPH
Elena Canacari RN 2
Eric Brown2
Adam Robinson 2
Kevin J. McGuire MD MS 3
1
(1) Department of Orthopaedic Surgery
Dalhousie University, Queen Elizabeth II Health Sciences Center
Halifax (NS), Canada
(2) Beth Israel Deaconess Medical Center
Boston, MA, USA
(3) Department of Orthopaedic Surgery
Beth Israel Deaconess Medical Center
Boston, MA, USA
Correspondence and Reprints:
Kevin J. McGuire MD MS
Beth Israel Deaconess Medical Center
Stoneman 10
330 Brookline Ave.
Boston, MA
02215
kjmcguir@bidmc.harvard.edu
Phone: (617) 667-8900
ABSTRACT
Study Design: Prospective observational study.
Objective: This study aims to quantify the incidence of intra-operative
waste in spine surgery, and to examine the efficacy of an educational
program directed at surgeons to induce a reduction in the intra-operative
waste.
Summary of background data: Each year, over 600 000 surgical
interventions are performed on the spine in the United States. Spine
procedures are associated with high costs. Implants are a main contributor
of these costs. Intra-operative waste further exacerbates the high cost of
surgery. The incidence and cost of intra-operative waste has not yet been
studied in the context of spine surgery.
Methods: Data was collected during a 25-month period from one academic
medical center (15 months observational period, 10 months post
awareness program).The total number of spine procedures, and the
incidence of intra-operative waste were recorded prospectively. Other
variables recorded included the type of product wasted, cost associated
with the product or implant wasted, and reason for the waste. Statistical
analysis was performed with STATA (v11.0), using z-tests of proportion, ttests, and analysis of variance.
Results: Intra-operative waste occurred in 20.2% of the procedures prior to
the educational program and in 10.3% of the procedures after the
implementation of the program (p<0.0001). Monthly costs associated with
surgical waste were, on average $17680,29 prior to the awareness
intervention, and $5876.87 afterwards (p=0.0006). Prior to the intervention,
surgical waste represented 4.3% of total operative spine budget.
After the
awareness program this proportion decrease to an average of 1.2% (p=0.003).
Conclusions: Intraoperative waste in spine surgery exacerbates the already
costly procedures. Extrapolation of this data to the national level leads to an
annual estimate of $126,722,000.00 attributable to intra-operative spine
waste. A simple educational program proved to be and continues to be
effective in making surgeons aware of the import of their choices and the
costs related to surgical waste.
Key Words: Spine surgery, intra-operative waste, implant waste, cost.
MINI ABSTRACT
A prospective observational study is presented. This study looks at incidence of
intra-operative waste in spine surgery, and evaluates the effectiveness of a
surgeon awareness program in decreasing associated costs.
INTRODUCTION
It is estimated that, each year, over 600,000 surgical interventions are
performed on the spine in the United States. (1) The volume of spine fusions has
already increased at a higher rate than other orthopaedic procedures such as
arthroplasty, and is expected to continue to do so. (2, 3) The rate of spinal
fusions increased by 250% from 1990-2003. (4-6)
Explanations include an
increase in the prevalence of disease; patients’ changing expectations and
preferences; development and application of new technologies; physician
workforce; reimbursement patterns; economic forces; and scientific uncertainty.
(7,8)
The increase in the rate of spine surgery is not the whole story. Enigmatic
regional variations persist. (7,8) According to Weinstein et al there remained an
8-fold variation in regional rates of lumbar discectomy and laminectomy in
Medicare enrollees in 2002 and 2003. For lumbar fusion, nearly a 20-fold range
existed.
This represented the largest coefficient of variation seen with any
surgical procedure.(8) These variations may reflect professional and patient
uncertainty regarding the appropriate indications for spine surgery, resulting in
differing thresholds for surgical intervention. (9,10)
Even the increases in the rate and the variation, however, do not tell the
complete story. Costs have increased. Medicare spending for inpatient back
surgery more than doubled over the decade as the spending for lumbar fusion
increased more than 500%. In 1992, lumbar fusion represented 14% of total
spending for back surgery; by 2003, lumbar fusion accounted for 47% of
spending.(8 )
Part of these costs is waste. Intra-operative “waste” -defined by previous
authors as products prepared but not used during surgery which can not be then
utilized on a different patient- further contributes to the high cost of spine surgery.
(11) Prior studies have demonstrated that surgical implant waste is a factor
influencing cost in arthroplasty and, to a lesser degree, orthopaedic trauma.
(11,12) According to these studies, implant waste occurred in 2% of arthroplasty
procedures, which translated to an estimated national annualized cost of
$36,000,000.00. In orthopedic trauma implant waste occurred in 0.6% of surgical
cases. These studies identified implant waste as a potential new area of focus to
reduce costs related to orthopaedic care.
These studies identified surgeon
decisions as being the most common determinant of implant waste; therefore it
was hypothesized that they would be a key part of any strategy aimed at
decreasing implant waste.
To our knowledge, the incidence of intra-operative waste has never been
studied in the context of spine surgery. First, this study aims to quantify the
incidence of intra-operative waste in spine surgery. A secondary goal of our
study is to examine the efficacy of an awareness program directed at surgeons in
decreasing costs associated with intra-operative waste.
METHODS
Data was collected during a 25-month period (October 2007 to November
2009) from one center. For the purposes of the study, all products recorded as
“wasted” were prospectively recorded during. As previously described in the
literature, an item was considered wasted when it was prepared or opened
during a case, but was ultimately not used or implanted, and could not be
subsequently used or implanted in a different patient. Surgical waste was further
categorized as: (1) surgical implants, (2) bone grafts and substitutes, and (3)
other waste. Other waste included items such as drapes, gowns, gloves,
sponges, sutures, and drains. Each item wasted was further categorized based
on the reason for the waste. Reasons for the waste included: (1) surgeons’
change of mind, (2) equipment failure / technical difficulties, (3) opened by
mistake, (4) contamination, (5) case cancellation, and (6) other.
After an initial observation period of 15 months, an educational program
was put in place. As part of the program, all spine surgeons and operating room
staff were made aware of what constituted intra-operative waste. Surgeons were
also presented with the data of costs associated with surgical waste, both on an
institutional and an individual level monthly without anonymity. Data was
collected for an additional 10 months after the intervention.
Statistical analysis was performed with STATA (v11.0), to compare the
incidence in implant waste pre and post surgeon awareness program. We used ttests, z-tests, and analysis of variance as deemed appropriate. A p-value of less
than 0.05 was considered significant.
RESULTS
Incidence of waste during pre-intervention period
During the initial observation period, a total of 1304 spine procedures were
performed. Throughout that time, intra-operative waste occurred in 263 cases
(20.2%). This corresponded to a total number of 739 items wasted over the
course of 15 months, amounting to a total of $275,356.00.
Surgical implants, accounted for only 42% of the number of items wasted.
However, the surgical implants accounted for a cost burden of $234,868 or
85.3% of the cost of all waste during the initial time-frame. (Table 1) There was a
statistically significant difference in the average cost per item wasted between
surgical implants, bone grafts and substitutes, and other waste. (Table 2) The
average cost per item was $752.78, $1093.77, and $73.31 (p<0.001) for each
group respectively. Multiple comparison analysis showed that the difference
between other waste and implants (p<0.0001), and between other waste and
bone grafts & substitutes (p<0.0001) accounted for the statistical significance.
“Contamination” and “surgeon’s change of mind” accounted for the
majority of the wasted items (26.9%, and 44% respectively). (Table 3) These
difference were statistically significant (p<0.001). (Table 4) As seen in the table,
the two causes associated with the highest cost per wasted item were
“equipment failure” ($676.02 / item), and “surgeon’s change of mind” ($670,16 /
item). This could be explained by the fact that items wasted for these two
reasons were primarily surgical implants, which as shown are more costly than
other types of waste.
Comparison of surgical waste pre and post intervention
Figure 1 compares incidence of cases with surgical waste before and after
the surgeon awareness program. Intra-operative waste occurred in 20.2% of the
procedures prior to implementation of the program and in 10.3% of the
procedures afterwards. This difference is statistically significant (p<0.0001).
Figure 2 shows difference in mean monthly cost related to waste before
and after the program. Prior to the intervention, an average of $17600.29
(annualized cost of $211203.48) were incurred as a result of intra-operative
waste. Following the intervention, the monthly average fell to $5876.29
(annualized cost of $70515.58). The difference between the two groups was
statistically significant (p=0.0006).
Similarly, Figure 3 shows the mean monthly cost related to intra-operative
waste as a proportion of the mean monthly total operating room budget
pertaining to spine surgery. Prior to the intervention, surgical waste represented
4.24% of total operative spine budget. After the surgeon and staff awareness
program this proportion decrease to an average of 1.20% (p=0.003).
Figure 4 shows that the post intervention proportion of implants wasted
compared to all items wasted significantly decreased. While prior to the
intervention 44.11% of items wasted were implants, this number was reduced to
24.48%. The decrease was statistically significant (p<0.0001). Similarly, as seen
in Figure 5, the number of items wasted because of the surgeon’s change of
mind decreased from 42.20% to 24.10%. This change was also statistically
significant (p<0.0001).
DISCUSSION
This study tried to compute the occurrence of intra-operative waste in
spine surgery, and to evaluate the effectiveness of a surgeon-directed
awareness program. To our knowledge, our study is the first to address this
problem. According to our results, the incidence of spine cases during which
surgical waste occurs was 20.2%. Therefore, intra-operative waste during spine
surgery is, according to our study, ten times more frequent than the rate of
implant waste associated with arthroplasty in the published literature. Prior to the
educational intervention, the annualized cost related to surgical waste was
$211203.48. Extrapolation of our data to the national level leads to an annual
estimate of $126,722,000 attributable to intra-operative waste, which makes it a
non-negligible factor in the cost of spine surgery.
Further analysis of our results showed that the most common reason for
waste was “Surgeon changed mind” and further that this was the main driver of
the cost burden. Surgical implants were the type of item associated with a higher
cost per item wasted. The awareness program was successful in decreasing the
cost burden associated with intra-operative waste by 66%. We achieved these
results by decreasing the proportion of implants wasted, and decreasing the
incidence of surgeons’ change of mind.
There are limitations of this study. The categories for reason for waste are
broad and ill defined.
As part of continued efforts to control waste, these
categories are being refined. The definition of a wasted implant also remains illdefined and varies from institution to institution. Importantly, as part of this study
a consensus was reached by a multidisciplinary group as to what defined a
wasted implant with buy in from the surgeons and staff.
This study is the first to demonstrate that surgical waste is an important
cost in spine surgery, and that a simple awareness program may be effective.
TABLE 1: Distribution of waste during pre-intervention by category.
TABLE 2 : Average cost (standard deviation and frequency) by waste category
TABLE 3 : Reasons for waste during pre-intervention period
TABLE 4 : Average cost by cause for waste
FIGURE 1 : Comparison of the incidence of cases with surgical waste before and
after the awareness program.
FIGURE 2 : The difference in mean monthly cost related to waste before and
after the awareness program.
FIGURE 3 : The difference in mean monthly cost related to waste as a proportion
of the mean monthly total operating room budget pertaining to spine before and
after the awareness program.
p=0.0003
0.05
0.04
0.03
0.02
0.01
0.00
Pre
Post
.
FIGURE 4 : The difference in the proportion of implants wasted compared to all
waste before and after the awareness program.
.
FIGURE 5 : The difference in the proportion of waste occurring because of
surgeon’s change of mind before and after the awareness program.
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