What’s New in the Patient Safety World

December 2017



·       A Fix for OR Foot Traffic?

·       Speech Recognition Still Not Up to Snuff

·       Study Confirms Safety of Restrictive Transfusion Policy

·       ECRI’s Top 10 Health Technology Hazards for 2018




A Fix for OR Foot Traffic?



In several of our columns we’ve warned that long surgical duration has the potential to increase surgery-related infections and that excessive OR traffic and opening of OR doors is likely a major factor. In our March 10, 2009 Patient Safety Tip of the Week “Prolonged Surgical Duration and Time Awareness” we noted a study (Lynch 2009) that suggested increased foot traffic may be factor related to prolonged procedures that increases the likelihood of surgical site infections. Then in our January 2010 What's New in the Patient Safety World column “Operative Duration and Infection” we discussed another study (Proctor et al 2010) that looked at a large database of general surgical procedures and demonstrated a linear relationship between duration of surgery and infectious complications. This relationship persisted even after adjustment for a variety of other risk factors for perioperative infections. The unadjusted infectious complication rate increased by 2.5% per half hour. Hospital length of stay (LOS) also increased geometrically by 6% per half hour. We again speculated that increased foot traffic may be another factor related to prolonged procedures that increases the likelihood of surgical site infections as suggested by Lynch et al. And our December 30, 2014 Patient Safety Tip of the Week “Data Accumulates on Impact of Long Surgical Duration” cited several other studies in which surgical infections were one of several complications related to prolonged surgery.


Then in our November 24, 2015 Patient Safety Tip of the Week “Door Opening and Foot Traffic in the OR” we discussed a study from Johns Hopkins that formally studied how often OR doors are opened during joint arthroplasty surgeries and the impact on OR air flow (Mears 2015). The researchers measured how often and for how long OR doors were opened during 191 hip and knee arthroplasty procedures. They also measured air pressures in the OR and adjacent corridors. They found that, on average, OR doors were open 9.5 minutes per case and the average time between door openings was 2.5 minutes. As you’d expect the number and duration of door openings correlated with the length of surgery. In 77 of the 191 cases positive pressure within the OR was defeated. The implications are obvious. While they found only one surgical infection in the 191 cases, the effects of the door opening on OR pressure and air flow theoretically would predispose to surgical infections. OR’s have positive pressure to avoid flow of air and airborne pathogens from nonsterile adjacent areas.


Finally, our July 26, 2016 Patient Safety Tip of the WeekConfirmed: Keep Your OR Doors Closed” highlighted a study that actually demonstrated that a program to reduce unnecessary door openings may reduce surgery-related infections (Camus 2016). A Canadian hospital did a manual count of door openings during total joint replacement operations and revision procedures. They counted between 42 and 70 door openings per operation from incision time to joint capsule closure time. Operations averaged 75 minutes. Reasons for entering and exiting the OR during operations included retrieving charts, instruments, or equipment, and taking a break. Next their CUSP (Comprehensive Unit-Based Program) team brainstormed and came up with key changes, including stopping all traffic in and out of the OR between total joint capsule opening and closure, communicating by phone, and increasing the use of templates to identify implant size prior to each operation. They also put a sign on the OR door reminding staff to minimize traffic and asking them to record why they are entering the OR during an operation. Subsequent traffic audits taken every six months indicated an amazing reduction in OR traffic from between 42 and 70 door openings to 3.2 door openings per case. They felt this intervention may have contributed to a decrease in orthopedic SSIs from 2.8 percent to 2.1 percent.


Now yet another study looked at the impact of an audible alarm on reducing OR foot traffic during total joint arthroplasties (Eskildsen 2017). Researchers placed an audible alarm on the substerile operating room door that sounded continuously when the door was ajar. This resulted in a significant difference in the overall mean door openings per minute between the period with no alarm and with an alarm. Prior to the door alarm, the substerile door was opened a mean of 88.12 times per case, or 0.53 times per minute. After the door alarm was installed, door openings decreased to a mean of 69.46 times per surgery, or 0.42 times per minute. However, this effect slowly decreased over the time of the intervention.


The percentage of time the door was left ajar per case also decreased significantly with the alarm. Prior to the intervention the door remained open for a mean of 14.45 minutes per case, or 8.65% of overall surgical time. After the door alarm was installed the mean duration of time that the door remained open decreased to 10.81 minutes per surgery, or 6.63% of the overall surgical time.


Unfortunately, the study was not large enough to determine whether the reduced door opening had an impact on surgical infection rates. But the findings certainly suggest that this may be one way to reduce such infections.


So while the idea of using an alarm or our prior suggestion of using an “On the Air” sign similar to that used in television or radio studios may help alert staff to the fact that excess foot traffic into and out of the OR are undesirable, neither is a forcing function. Forcing functions are much better interventions. One quasi-forcing function we’ve suggested is keeping a log where staff are required to log in every time they leave and enter the OR for each case, similar to what was done in the Canadian study (Camus 2016).  Of course, there will be blowback from many of your staff that this might be time consuming. It need not be. How many of you have an electronic device like an Amazon Echo or a Google Home Assistant and say something like “Alexa, add paper towels to my grocery list.”? Alexa creates a grocery list and adds paper towels to it. You could do the same with such a device in your substerile OR area and, when the OR door alarm sounds, require the person entering the OR to say something like “Alexa, this is surgical tech Yvonne Jones entering the OR with new equipment” and Alexa could add the name of the staff member and the reason to the log created when the case began. Voila! It took years before we learned about barcoding from our supermarkets and applied it to healthcare. It’s time we take a lesson from our hi-tech kitchens!


And, of course, the potential benefit of such a system is not just on surgical infections. We’d anticipate that the number of distractions and interruptions would likely decrease with decreased movement in and out of the OR. And analysis of the log entries should help identify ways to improve OR efficiency. For example, the log entries might identify the need for a certain supply or piece of equipment to be present prior to the cases. So we’d suggest you make review of the log part of your postop debriefing. You are doing debriefings after every case, aren’t you?




Our prior columns focusing on surgical OR foot traffic and door opening:







Lynch RJ, Englesbe MJ, Sturm L, et al. Measurement of Foot Traffic in the Operating Room: Implications for Infection Control. American Journal of Medical Quality 2009; 24: 45-52




Procter LD, Davenport DL, Bernard AC, Zwischenberger JB. General Surgical Operative Duration Is Associated with Increased Risk-Adjusted Infectious Complication Rates and Length of Hospital Stay, Journal of the Amercican College of Surgeons 2010; 210: 60-65




Mears SC, Blanding R, Belkoff SM. Door Opening Affects Operating Room Pressure During Joint Arthroplasty. Orthopedics 2015; 38(11): e991-e994




Camus S. Operating Room Traffic Monitoring Improves Patient Safety. Abstract session presentation at the 2016 American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP®) Conference. July 18, 2016 as reported in ACS (American College of Surgeons). Minimizing Operating Room Traffic May Improve Patient Safety by Lowering Rates of Surgical Site Infections. ACS Press Release July 18, 2016




Eskildsen SM, Moskal PT, Laux J, Del Gaizo DJ. The Effect of a Door Alarm on Operating Room Traffic During Total Joint Arthroplasty. Orthopedics 2017; 40(6): e1081-e1085






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Speech Recognition Still Not Up to Snuff



It’s been quite a while since we discussed errors related to speech recognition (see our October 4, 2011 Patient Safety Tip of the Week “Radiology Report Errors and Speech Recognition Software”). We certainly thought by now the technology had improved considerably and that errors related to speech recognition software would have diminished.


But a new study (Hodgson 2017) compared the efficiency and safety of using speech recognition assisted clinical documentation within an electronic health record (EHR) system with use of keyboard and mouse in an emergency department setting. 35 ED clinicians were randomly allocated to clinical documentation tasks using speech recognition or keyboard and mouse on a commercial EHR system


The researchers found that mean task completion times were 18.11% slower overall when using speech recognition compared to keyboard and mouse. For simple tasks speech recognition was 16.95% slower and for complex tasks 18.40% slower. Increased errors were observed with use of speech recognition (138 vs. 32 total errors, 75 vs. 9 errors for simple tasks, and 63 vs. 23 errors for complex tasks). Interestingly, interruptions did not significantly affect task completion times or error rates for either modality.


The authors felt that some of the observed increase in errors may be due to suboptimal speech recognition to EHR integration and workflow. They concluded that improving system integration and workflow, as well as speech recognition accuracy and user-focused error correction strategies, may improve SR performance.


Bottom line: we still have a long way to go before speech recognition software can improve both efficiency and patient safety. Lots of promise but still too many glitches.








Hodgson T, Magrabi F, Coiera E. Efficiency and safety of speech recognition for documentation in the electronic health record. Journal of the American Medical Informatics Association 2017; 24960; 1127-1133






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Study Confirms Safety of Restrictive Transfusion Policy



We’ve done numerous columns on the benefits and safety of more restrictive transfusion policies. Most studies comparing restrictive vs. liberal transfusion policies have been conducted in patients undergoing non-cardiac surgery. The question has been unanswered in patients undergoing cardiac surgery. Until now, that is. The recently completed Transfusion Requirements in Cardiac Surgery (TRICS) III trial demonstrated that even for those patients undergoing cardiac surgery who are at moderate-to-high risk for death a restrictive transfusion strategy is noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis (Mazer 2017).


Patients were randomized to either a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward).


Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group. The percentage of patients who had a primary composite outcome event was 11.4% in the restrictive-threshold group, as compared with 12.5% in the liberal-threshold group.


So the restricted transfusion strategy was as good as a more liberal one from a patient safety perspective and resulted in far fewer transfusions. This should answer that last unanswered question. It is clear that a restrictive transfusion strategy is safe and effective in all types of surgical patients, even those undergoing cardiac surgery.


Also timely in this regard are recommendations from researchers at Johns Hopkins for a patient blood management program to promote high-value care and reduce unnecessary transfusions (Sadana 2017). They note that 3 recommendations summarize evidence-based RBC transfusion practices, derived from the AABB clinical practice guidelines and Choosing Wisely aims:

  1. RBC transfusion is not indicated in hemodynamically stable adult hospitalized patients with a Hb level of 7 g/dl or more. This population includes critically ill patients.
  2. RBC transfusion is not indicated in patients undergoing orthopedic or cardiac surgery or in patients with underlying cardiovascular disease with a Hb level of 8 g/dl or more.
  3. Single-unit RBC transfusions followed by reassessment should be the standard of care for patients who are hemodynamically stable and not actively bleeding.


They offer the following blueprint for a patient blood management program:

Step 1: Organization and Support

Step 2: Transfusion Guidelines

Step 3: Education and Clinical Decision Support

Step 4: Data Dashboards, Audits, and Reports

Step 5: Other Blood Conservation Methods


They note the importance of multidisciplinary representation from multiple departments (medicine, surgery, pediatrics, blood bank/transfusion medicine, anesthesiology, critical care, nursing, pharmacy, quality/safety, and IT) for developing buy-in and ensuring compliance. The initiative should be adequately funded, with the savings from blood resource utilization justifying the funding. The guidelines can include blood products other than just RBC’s (eg. plasma, platelets, etc.). Education should be targeted but supplemented by clinical decision support (CDS) in the EMR. The CDS alerts should include reasons for bypassing alerts (eg. active bleeding). Data with feedback should include peer-to-peer comparisons. Each clinical service should have a champion or leader who reviews the reports and provides feedback to service members. Other blood conservation methods include treating anemia before surgery, using antifibrinolytic medications, autologous blood salvage, preoperative autologous blood donation, avoiding excessive phlebotomy, etc.


While transfusions may be lifesaving, they also have several potential harms and downsides. An effective blood transfusion management program is essential for patient safety and will likely produce considerable financial savings for every hospital or ambulatory surgery center.



Prior columns on potential detrimental effects related to red blood cell transfusions:







Mazer CD, Whitlock RP, Fergusson DA, et al. for the TRICS Investigators and Perioperative Anesthesia Clinical Trials Group. Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. NEJM 2017; November 12, 2017




Sadana D, Pratzer A, Scher LJ, et al. Promoting High-Value Practice by Reducing Unnecessary Transfusions With a Patient Blood Management Program. JAMA Intern Med 2017; Published online November 20, 2017






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ECRI’s Top 10 Health Technology Hazards for 2018



ECRI Institute has released its annual Top 10 list for health technology hazards for 2018 (ECRI 2017). They are:


  1. Cybersecurity threats in health care delivery and patient endangerment
  2. Endoscope reprocessing
  3. Bed and stretcher mattress contamination
  4. Secondary alarm notification systems
  5. Medical device cleaning methods
  6. Electrosurgical electrode pencil handling
  7. Digital imaging tools to control radiation
  8. Bar-coded medication system workarounds
  9. Networked medical devices and information systems
  10. Enteral feeding tubing erroneously connected to patient lines

Most of these have been on ECRI’s lists at some time in the past. But the cybersecurity issue really vaulted to the top of the list this year after hospital systems ground to a halt after ransomware attacks. HealthLeaders Media (Pecci 2017)  noted six points for leadership to consider from Juuso Leinonen, senior project engineer for ECRI Institute's Health Devices Group:

  1. Define organization-specific goals to improve security and develop a practical plan.
  2. Prioritize resource allocation, including money and people power.
  3. Conduct real-life exercises and drills that consider overall organizational response and what the clinical workflow would be in the case of an attack (including the chance of reverting to a paper workflow).
  4. Create a complete and detailed inventory of assets that are connected to the hospital networks.
  5. Involve everyone in the organization, which can be as small as reminding everyone not to click on suspicious emails.
  6. Institute a plan for identifying when software updates are available, confirming whether a device can be safely updated, and applying the updates in a timely manner.


Again on this year’s list is the one regarding secondary alarm notification systems. You’ll recall in our February 9, 2016 Patient Safety Tip of the Week “It was just a matter of time…” we described a case in which the alarm notification went out to a healthcare worker who was not assigned to that patient rather than to the correct person.


Electrosurgical electrode pencil handling also made this year’s list. Proper use of safety holsters for active-electrode pencils is critical to avoid inadvertent activation of ESU pencils. We’ve done numerous columns on the role of electrocautery devices causing both surgical fires and iatrogenic burns. Our September 5, 2017 Patient Safety Tip of the Week “Another Iatrogenic Burn” discussed in detail issues related to electrocautery devices.



We’ll let you read about these and all the others in the ECRI document itself. You can download ECRI Institute’s Top 10 Health Technology Hazards for 2018 for free at the ECRI site.






ECRI Institute. Top 10 Health Technology Hazards for 2018. ECRI Institute. November 2017




Pecci AW. 6 Things Healthcare Execs Should Do to Prepare for Cyber Threats. HealthLeaders Media 2017; November 21, 2017






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Print “December 2017 What's New in the Patient Safety World (full column)

Print “December 2017 A Fix for OR Foot Traffic?

Print “December 2017 Study Confirms Safety of Restrictive Transfusion Policy

Print “December 2017 Speech Recognition Still Not Up to Snuff

Print “December 2017 ECRI’s Top 10 Health Technology Hazards for 2018





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