Incidence and Awareness of Near Miss And Retained Surgical Sharps: A National Survey

Introduction. A retained surgical sharp (RSS) is a never-event and defined as a lost sharp (needle, blade, 2 instrument, guidewire, metal fragment) that is not recovered prior to the patient leaving the operating 3 room. A near-miss sharp (NMS) is an intraoperative event where there is a lost surgical sharp that is 4 recovered prior to the patient leaving the operating room. With underreporting of such incidents, it is 5 unrealistic to expect aggressive development of new prevention and detection strategies. Moreover, 6 awareness about the issue of near miss or retained surgical sharps remains limited. The aim of this large- 7 scale national survey-based study was to estimate the incidence of these events and to identify the 8 challenges surrounding the use of surgical sharps in daily practice. 9 Methods. An IRB approved and anonymous national survey composed of eleven questions was 10 distributed electronically to operating room team members across the United States. There were 447 11 survey responses, in which 411 were used for further analysis. 36 responses were removed due to 12 incomplete respondent data. The 411 were then categorized by group to include 94 (22.9%) from 13 anesthesiologist, 132 (32.1%) from resident/fellow/attending surgeon and 185 (45%) from surgical nurse 14 and technologist. 15 Overall, most each group reported sharp over year.

The idea of safe practice in Patient Safety Culture (PSC) has been an important aspect for 2 advancement in health care since its introduction in the Institute of Medicine report "To Err is 3 Human" 1 . PSC embodies properties in patient care guidelines and processes that are crucial for 4 preventing adverse events in health care. Organizational properties for PSC extend beyond the

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A retained surgical sharp (RSS) is a never-event and is defined as a lost sharp (needle, 12 blade, instrument, guidewire, metal fragment) that is not recovered prior to the patient leaving 13 the operating room. This must be reported to the hospital incident committee as well as to the 14 patient. In certain cases, this is discovered in the post anesthesia recovery unit (PACU) during a 15 routine x-ray. In other cases, the RSS is uncovered when the patient has an acute or chronic 16 complication from the retained foreign body. There are also several cases of RSS being found 17 incidentally, sometimes years later, during routine imaging for an unrelated condition [5][6][7][8] . 18 A near-miss sharp (NMS) is an intraoperative event where there is a lost surgical sharp 19 that is recovered prior to the patient leaving the operating room. A common example of a NMS 20 is when a needle is lost inside the patient or in transition between the surgeon and the surgical 21 assistant. In some cases, this is not recognized until the surgical count is incorrect at the end of 22 the procedure, prompting the difficult question of whether the lost sharp could be retained inside 23 the patient. Surgical teams will go to great lengths to recover any lost sharp given the increased 24 risk to the patient, which can be a time-consuming and costly event.

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Both NMS and RSS events are difficult to quantify and their reporting to the Joint 26 Commission (JC) is voluntary, so that underreporting remains a reasonable concern. Moreover,

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NMS are even less likely to be voluntarily reported as the problem was rectified prior to the 28 patient leaving the OR and therefore the degree of risk to the patient (and provider/hospital) has 29 been significantly reduced. Furthermore, there is no easy or efficient way to report near-30 miss/never events directly to the JC and any reporting to one's own administration typically 31 results in significant paperwork, legal counsel and quality control measures -further reducing the 1 likelihood of self-reported events. With underreporting of such incidents, it is unrealistic to 2 expect aggressive development of new prevention and detection strategies. Moreover, awareness 3 about the issue of near miss or retained surgical sharps remains limited. 4 The aim of this large-scale national survey-based study was to estimate the incidence of 5 these events and to identify the challenges surrounding the use of surgical sharps in daily 6 surgical practice.  To increase the number of respondents, additional emails were sent to online member registries. 16 Approximately 2,650 emails were sent resulting in an additional 250 responses (9.4% response 17 rate).

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The survey was anonymous. Participants were asked to answer three demographic 24 questions as well as eight questions related to their personal perception of NMS and RSS 25 (Figure 1). Demographic questions were asked with care to ensure no identifiable information 26 was obtained and therefore unable to be traced back to a specific respondent or institution.

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Perception questions 4-6 and 11 were designed to understand the incidence of various sharp 28 events (e.g. lost, retained, miscounted). Questions 7 and 10 were dedicated to understanding time 29 spent managing sharps and questions 8 and 9 were dedicated to understanding the use x-ray and 30 its effectiveness.  To further our understanding of the discordance between groups, surgeons were 10 compared to a combined group of anesthesiologist, nurses and technologist, and a binomial 11 logistic regression was performed to assess the likelihood that the following events were reported 12 by surgeons:   21 Respondent demographics are presented in Table 1. By role, the median ranked value for   26 The distribution of ranked response scores was significantly different between the three 27 groups in question 4, 5, 6, 8, 11 but similar in questions 7, 9 and 10. Pairwise comparison 28 revealed statistically significant differences in median scores between the surgeon and 29 anesthesiologist groups, and surgeon and nurse/technologist groups in most of questions, but not 30 between the anesthesiologist and nurse/technologist groups ( Table 2).  1 When evaluating the incidence of lost sharps over the last year (question #4), there was 2 an association between the respondent's role and the number of reported lost sharps. Overall, 3 most of each respondent group reported 1-5 lost sharp events over the last year (91.7% of 4 surgeons, 75.5% of anesthesiologists and 80.5% of nurses/technologists) (Figure 2a). 5 Questions 5 revealed the incidence of miscounted sharps in the last year (Figure 2b). 6 Significant discordance was found between the surgeon and anesthesiologist group regarding 7 how often they believe miscounts "never" happen. Here, roughly 20% of surgeons believed they    22 Discordance was found in the perception of how frequently portable x-ray was used to 23 aid in the recovery of lost sharps (question #8, Figure 5a). Here, more than half (56.8%) of 24 surgeons report using x-ray 100% of the time when managing a lost sharp whereas 25 anesthesiologists and nurses/technologists believe it is closer to 1/3 of the time. Agreement was 26 found between all three groups when describing the effectiveness of x-ray and believed to be 27 between 26-50% effective in identifying a lost sharp. Additionally, roughly 38% of each group 28 reported that it is never effective or effective only 1-10% of the time (Figure 5b).  30 Time added to the OR due to x-ray was found to be similar between the three respondent 1 groups at 31-40min. Additionally, 21-30 minutes was reported as the median rank for time spent 2 searching for a lost sharp.  4 The binomial logistic regression performed was statistically significant, with p values of  To our knowledge, this is the first anonymous survey conducted to estimate the degree of 13 NMS and RSS events. Several key ideas were illustrated by the survey responses, including 14 incidence within the last year, incidence per number of surgical cases, surgical team agreement, 15 and surgical team discordance. 16 While most literature estimates a retained foreign body event to occur once out of every 17 1,000 to 18,000 surgeries (with poor delineation between a sharps vs other foreign bodies) 9-11 , 18 our data suggest a higher incidence of 2.7 events per 10,000 surgeries (roughly 1 event per every 19 3,800 surgeries). This further supports the concern for the underreporting of RSS. Additionally, 20 respondents experience 2.7-4.3 lost sharp events each year (4.3 -anesthesiologist, 2.7 -surgeons, 21 3.9 -nurses/technologists) with an average incidence of 4.4 lost sharp events per every 1,000 22 surgeries. The underreported nature of NMS and RSS may be attributed to the challenges 23 associated with reporting and concern for negative repercussions on the provider or surgical 24 team.

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In addition to underreporting, the survey demonstrates significant discordance between were found to be 2.95 times more likely to report zero lost events in the last year. Additionally, 3 surgeons were found to be 2.5 times more likely to report 100% of all lost sharps recovered 4 before the completion of the surgery. Consistent with the previously mentioned odds ratios, the 5 surgeon group was half as likely to report miscounting of sharps in >2% of surgeries. This may 6 be because the surgeons are not directly involved in the instrument counting process thereby 7 increasing their recall bias. Together these odds ratios support the conclusion that surgeons are 8 less likely to perceive that a sharp has been lost and more likely to perceive that all lost sharps 9 have been recovered, suggesting a larger recall bias as compared to the rest of the operative 10 team.

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With each lost/retained sharp event there are significant implications on the health 12 system, which encompasses the patient, provider, and hospital. Patient implications include 13 additional exposure to radiation as well as the prolonged anesthesia time and increased risk for 14 iatrogenic damage during search and recovery. Prolonged operative time has been significantly 15 associated with increased risk for infection and additional post-surgical complications as well as 16 prolonged hospital length of stay 12-14 . As such, investigating risks to the patient was a focal point 17 of this study.

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Agreement was found between all three groups of respondents when evaluating the 19 amount of time added to the OR as a result of manually searching for a lost sharp (21-30min) as 20 well as by the time added to the OR when obtaining an x-ray (31-40min). This concordance 21 suggests that each lost sharp event may result in up to 70min of added OR time. 22 The survey results also highlighted the need for improved technologies in identifying 23 RSS, as 69.1% of anesthesiologists, 63.6% of surgeons, and 51.9% of nurses/technologists said 24 that an x-ray is 1-50% effective, with approximately 38% of each group reporting that it is never 25 effective or effective only 1-10% of the time. Prior studies have evaluated the effectiveness of x-26 ray in identifying lost sharps, and more specifically the effectiveness at identifying needles. They 27 note needle size should act as a key determining factor when deciding on whether an x-ray 28 should be obtained to aid in needle recovery, quoting poor effectiveness in needles <17mm 15 .

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When evaluating the prolonged operative time associated with the use of x-ray (31-40min) as 30 well as the cost of the x-ray and radiation exposure to the patient, x-ray appears to be a costly 1 and ineffective method of identifying RSS.

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The hospital is also subject to negative consequences in the setting of a RSS as costs 18 associated with resulting complications are not reimbursable, with the average cost per patient 19 ranging from 70,000-200,000 18,19 . In the case of a settlement, costs to the hospital can range 20 from 2 to 5 million dollars even with a positive patient outcome 19 .

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A team-based approach is paramount to reducing the barriers to reporting these events 22 and is appropriate given that over 90% of retained items are due to a team/system-based 23 error 20,21 . Here we see a significant degree of discordance between the different members of the 24 operative team providing initial evidence that OR staff may perceive the frequency of lost, 25 miscounted and retained surgical sharps differently. This hints at a lack of communication 26 regarding these sentinel events creating opportunity for undue patient harm [22][23][24] . By creating an 27 environment of transparency and a standardized reporting system, helpful discussions of ways to 28 prevent retained surgical sharps in the future could be had between all members of the team and 29 reduce the risks to the patient, physician, and hospital [22][23][24] .

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The estimated value of incidence would be a limitation of present study. The incidence 1 value was derived by taking the median value of each response term which was originally in a 2 range, and this may result in a relatively inaccurate value to present the mean scores and 3 interpretation of the differences between groups. While more granular detail regarding 4 respondent demographics or the type of sharp that was lost/retained/miscounted could have been 5 collected, and therefore act as a study limitation, we aimed to keep the survey short to increase 6 the number of responses. Additionally, while team discordance is suggested by this study, 7 respondents were not necessarily from the same surgical team and therefore the effectiveness of 8 any one surgical team's communication cannot be derived from this study. a. Use of X-ray b. Effectiveness of X-ray