The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 87, Issue 10

Scientific Articles | October 01, 2005

Sterility of Surgical Site Marking

Geoffrey Cronen, MD¹; Vytautas Ringus, MD¹; Gavin Sigle, MS IV¹; Jaiyoung Ryu, MD¹

¹ Department of Orthopaedics, West Virginia University, P.O. Box 9196, Health Sciences Center, Morgantown, WV 26506-9196. E-mail address for G. Cronen: wvubonehead@yahoo.com

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The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

A commentary is available with the electronic versions of this article, on our web site () and on our quarterly CD-ROM (call our subscription department, at 781-449-9780, to order the CD-ROM).

Investigation performed at the Department of Orthopaedics, West Virginia University, Morgantown, West Virginia

The Journal of Bone and Joint Surgery, Incorporated

J Bone Joint Surg Am, 2005 Oct 01;87(10):2193-2195. doi: 10.2106/JBJS.E.00293

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Abstract

Background: Over the past decade, wrong-site surgery has been a popular topic of discussion, not only in medical and legal journals but also in the mainstream press. Marking of the surgical site according to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Universal Protocol was implemented at our institution to help reduce the number of wrong-site operations. In this study, we determined whether marking of the site affected the sterility of the surgical field.

Methods: The study included twenty volunteers. The right forearm was used as the experimental (marked) arm and the left forearm, as the control arm. The experimental forearms were marked with a surgical marker as described by the protocol. Both upper extremities were then sterilized from the antecubital fossa to the phalanges with a 7.5% povidone-iodine scrub followed by the application of a 10% povidone-iodine paint. Swabs were used to obtain samples from the experimental and control arms as well as from the marker and were sent for microbiological culture and analysis.

Results: No growth was seen in the cultures of the swabs used on the experimental or control arms or on the marking pens.

Conclusions: Preoperative marking of surgical sites in accordance with the JCAHO Universal Protocol did not affect the sterility of the surgical field, a finding that provides support for the safety of surgical site marking.

Figures in this Article

Over the past decade, wrong-site surgery has been a popular topic of discussion in medical and legal journals as well as in the mainstream press. The issue has become prominent in the current literature because of profound patient, social, professional, and medicolegal consequences. Although controversial^1,2, a report by the Institute of Medicine estimated that 44,000 to 98,000 Americans die each year from preventable medical errors rather than from the admitting diagnosis³. The estimated annual cost to United States taxpayers is approximately $9 billion³. In 1994, the Canadian Orthopaedic Association instituted an educational program intended to prevent wrong-site surgery by recommending that the incision site be marked with an indelible marker. As a result, the number of cases of wrong-site surgery declined from thirteen in 1994 to five in 2000⁴. A 2001 poll of 167 randomly selected Canadian orthopaedists showed that 52% of them always marked their surgical site, despite the lack of a mandatory universal protocol for identification of the surgical site prior to operations⁴.

In an effort to address the issue of surgical site marking, the American Academy of Orthopaedic Surgeons (AAOS) instituted a voluntary "Sign Your Site" campaign⁵ in 1997. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) established a Universal Protocol in 1998 to prevent wrong-site surgery and its consequent complications⁶. The Universal Protocol includes the patient's verbal verification of the surgical site, active discussion of the procedure with the patient, marking of the surgical site by the physician or another specified health-care proxy using permanent marker that can withstand the local sterilization procedure, use of a verification checklist or pertinent documents and images, and oral verification of the site by the surgical team in the operating room during a "time out."⁷ This protocol has introduced new variables, particularly the application of a potentially nonsterile chemical marking substance, to the operative field.

The aim of this study was to determine whether the sterility of the surgical field was affected by the use of a permanent-ink marker for identification of the intended surgical site. Our hypothesis was that there would be no difference between the results of standard bacterial cultures of specimens taken from the marked and analogous unmarked areas.

Materials and Methods

Materials and Methods | Results | Discussion | Acknowledgements | References

After we obtained approval for the study from our institutional review board, twenty randomly selected volunteers were recruited from our locale to participate in this study. After they had provided written informed consent, one site (the anterior antebrachial skin) on the right upper extremity, which was chosen as the experimental arm, was marked according to the JCAHO recommendation⁸ with a 2 × 5-cm YES with use of a standard surgical site marker (Kendall-LTP, Chicopee, Massachusetts). The same marker was used on all of the subjects and was not considered sterile prior to the study. Both forearms were then prepared in the standard preoperative fashion with a 7.5% povidone-iodine scrub followed by a 10% povidone-iodine paint and allowed to dry in room air for ten minutes. This process created sterile areas from the elbow to the distal phalanges that were identical to those prepared for the operating theater.

Sterility Assessment

The prepared, marked areas and the contralateral, unmarked areas were then sampled with use of standard Kendall sterile bacterial swabs (Becton Dickinson Laboratories, Franklin Lakes, New Jersey), and the swabs were placed into 16 × 125-mm sterile culture test tubes in a standardized sterile fashion. The samples were obtained from areas of skin directly over the markings which, having been placed by an indelible marker, were minimally altered by the sterilization process. Samples were also taken from analogous sites (as could best be identified) on the contralateral forearm. In addition, a direct sample was taken from the permanent marker in a sterile fashion. The specimens were then sent to the hospital microbiology laboratory for routine culture.

The swabs were placed on chocolate, blood, and Mac-Conkey aerobic agar plates and were observed for seventy-two hours. A culture was deemed to be positive when any bacterial growth was noted on the agar plate. Routine bacteriological investigation at our institution includes a gram stain and cultures for gram-negative rods and gram-positive organisms, with a specific focus on Staphylococcus, Streptococcus, and Enterococcus species. This regimen allows reporting of up to three gram-positive species. Agar dishes containing more than three gram-positive species are reported to be "mixed." We did not test for anaerobes in this series. If colonies formed, the species were identified, the colony size was estimated, and antibiotic sensitivities were determined.

Statistical Analysis

The proportions of positive cultures were compared between the experimental and control groups. Our study had an 80% power to detect a difference of =5% in the infection rates between the two groups. With a 95% confidence interval set, the likelihood of bacterial colonization could be as high as 8.8%. Our study protocol indicated that if positive cultures were identified, an independent t test would be used to compare colony sizes between the two groups. Statistical tests were to be two-tailed and conducted with use of JMP Statistical Discovery Software (version 5.1.1; SAS Institute, Cary, North Carolina) and a Type-I error rate of 0.05 (p).

Results

Materials and Methods | Results | Discussion | Acknowledgements | References

The results of twenty cultures of the swabs used on each of the experimental and control arms as well as on the permanent marker were available. Thus, there was a total of forty-one culture results. After three days of culture, as dictated by the hospital protocol, there was no growth in any culture of specimens obtained from the control or experimental arms or from the marking pen. Because all cultures were negative, no more statistical analyses were conducted.

Discussion

Materials and Methods | Results | Discussion | Acknowledgements | References

Monitoring of sentinel events by JCAHO revealed that 278 incidents of wrong-site surgery were reported from January 1995 through September 2003⁹. Thirty-five percent of those incidents involved orthopaedics⁹. In another review, JCAHO identified 126 cases of wrong-site, wrong-person, or wrong-procedure surgery as of December 2001, and 41% of the cases were related to orthopaedics¹⁰. As of January 2004, wrong-site surgery was the third highest sentinel event, accounting for more than 12% of all sentinel events reviewed by the Joint Commission since 1995⁹. JCAHO continues to receive five to eight reports of wrong-site surgery per month⁷.

Several other authors have addressed this problem. In a poll of 1560 active members of the American Society for Surgery of the Hand, Meinberg and Stern found that 16% had prepared to operate on the wrong site but had corrected the error prior to incision and 21% had performed wrong-site surgery at least once¹¹. The overall incidence of wrong-site surgery was one per every 27,686 procedures performed¹¹.

Wong estimated that at least one in five orthopaedists will have an occurrence of wrong-site surgery in his or her career⁹. Watson et al. reviewed claims against an orthopaedic training program and found that operations at the wrong anatomic site, improper use of equipment, and missed or delayed diagnosis were all reasons for a favorable decision regarding the claim for the plaintiff¹². DiGiovanni et al. implicated non-compliance of the patient as a factor in wrong-site surgery, finding that only 59% of patients complied with instructions to mark NO on the uninvolved extremity¹³. The Physician Insurers Association of America reported 213 paid claims, with an average indemnity payment of $54,800, for suits involving wrong-site surgery between 1985 and 1997⁸.

It is hoped that the marking of surgical sites, which is currently done with ink in a nonsterile fashion, will not affect the sterility of the surgical field. The present study showed the prevalence of laboratory-detected microbacterial growth to be 0% in cultures of specimens obtained from prepared marked and unmarked surgical sites.

Some potential limitations of our study include the observation of the laboratory cultures for only seventy-two hours. If some slow-growing flora were present, they may not have been detected in the allotted time frame. However, that is unlikely as most bacteria colonizing the skin grow rather quickly. It is also possible that the media used were inappropriate for the growth of colonies of certain bacteria. Although this remains a concern, most epidermal flora routinely thrive in the agar solutions that we used. In a series of eight infections that developed following office-based face-lifts and augmentation mammoplasties, the causative organism was found to be an acid-fast bacillus, Mycobacterium chelonae, that had been delivered through contaminated gentian-violet ink used to mark the skin prior to incision¹⁴. Ultimately, only rarer species, such as Mycobacterium chelonae, require special culture dishes or more time to be identified. However, special circumstances would be required for those bacteria to become a surgical wound issue. This, combined with the rigorous sterile preparation of the extremities, makes it highly unlikely that these more obscure pathogens would be of common clinical importance.

As more institutions implement the JCAHO Universal Protocol⁶, it is hoped that the incidence of wrong-site surgery will be significantly reduced. Cooperation among physicians, operating room staff, and pre-operating room staff will greatly facilitate the implementation and efficiency of procedures for marking surgical sites. Recently, there have been clarifications of some of the points of the Universal Protocol; these include: (1) the surgical site is to be marked by the surgeon or a "credentialed provider" (which includes residents or fellows or licensed physician assistants); (2) the actual surgical site should be marked (reproducibly); (3) an X should not be used (as it may be imprinted on other sites in a mirror fashion); (4) patient cooperation should be garnered (this does not preclude use of mild sedatives) and, when appropriate, may include the family; and (5) an indelible marker must be used⁹.

Only time will tell if the JCAHO's current recommendations will have a noteworthy impact on the incidence of wrong-site surgery. It is believed that institutions that have implemented the process of repeated confirmation, involving not only hospital staff but also the patients, may already have diminished the rate of wrong-site surgery. Our results should encourage physicians to be less concerned regarding the deleterious side effects of signing sites and more proficient in confirming them preoperatively, for both the patient's benefit and their own. ?

Acknowledgements

Materials and Methods | Results | Discussion | Acknowledgements | References

Note: The authors thank Nina Clovis and Suzanne Smith for their technical assistance with this study.

References

Materials and Methods | Results | Discussion | Acknowledgements | References

Leape LL. Institute of Medicine medical error figures are not exaggerated. JAMA.2000;284: 95-7.28495 2000 [PubMed][CrossRef]

McDonald CJ, Weiner M, Hui SL. Deaths due to medical errors are exaggerated in Institute of Medicine report. JAMA.2000;284: 93-5.28493 2000 [PubMed][CrossRef]

Kohn LT, Corrigan JM, Donaldson MS, editors. To err is human: building a safer health system. Committee on Quality of Health Care in America, Institute of Medicine. Washington, DC: National Academy Press; 2000. 2000

Furey A, Stone C, Martin R. Preoperative signing of the incision site in orthopaedic surgery in Canada. J Bone Joint Surg Am.2002;84: 1066-8.841066 2002 [CrossRef]

American Academy of Orthopaedic Surgeons Council on Education. Report of the Task Force on Wrong-Site Surgery. Rosemont, IL: American Academy of Orthopaedic Surgeons; 1998. .
www.aaos.org/wordhtml/meded/tasksite.htm

Joint Commission on Accreditation of Healthcare Organizations. Universal protocol for preventing wrong site, wrong procedure, wrong person surgery. .
www.jcaho.org/accredited+organizations/patient+safety/universal+protocol/wss_universal+protocol.htm

Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alert. 1998; Issue 6. 1998

OK plan to end wrong-site surgeries. AAOS Bulletin. 1997;45:.
www.aaos.org/wordhtml/bulletin/oct97/wrong.htm

Wong DA. Surgical site marking comes of age. AAOS Bulletin. 2004;52: .
www.aaos.org/wordhtml/bulletin/apr04/feature1.htm

Joint Commission on Accreditation of Healthcare Organizations. Sentinel Event Alert. 2001; Issue 4. 2001

Meinberg EG, Stern PJ. Incidence of wrong-site surgery among hand surgeons. J Bone Joint Surg Am.2003;85: 193-7.85193 2003 [PubMed]

Watson E, Byington M, Groff H, Trombly S, Schaffer JL. Risk management and medical malpractice in orthopaedic surgery. Read at the Annual Meeting of the American Academy of Orthopaedic Surgeons; 1999 Feb 4-8; Anaheim, CA. 1999

DiGiovanni CW, Kang L, Manuel J. Patient compliance in avoiding wrong-site surgery. J Bone Joint Surg Am.2003;85: 815-9.85815 2003

Safranek TJ, Jarvis WR, Carson LA, Cusick LB, Bland LA, Swenson JM, Silcox VA. Mycobacterium chelonae wound infections after plastic surgery employing contaminated gentian violet skin-marking solution. N Engl J Med.1987;317: 197-201.317197 1987 [PubMed][CrossRef]

Topics

accreditation ; agar ; ink ; joint commission on accreditation of healthcare organizations ; operating room ; povidone-iodine ; safety ; infection ; arm ; forearm

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Geoffrey A. Cronen, M.D.

Posted on April 11, 2006

Dr. Cronen responds to Dr. Maripuri

West Virginia University, Morgantown, WV 26506

While we wholeheartedly agree with Dr. Maripuri that pens used to mark surgical sites should be discarded after a single use, the reality, as pointed out, is different. Our study used a single marking pen identical to those found in the surgical preoperative holding area. It had been commandeered from our musculoskeletal research laboratory where it had been used for many months prior to its use in this study. Therefore, we believe that this effectively simulates the aforementioned "real world" condition.

Although many surgeons do not mark directly over their surgical site, there are a few instances where incisions may necessarily cross these sites. The first is commonly seen among plastic surgeons who preoperatively outline their incisions in an effort to produce a symmetric, aesthetic result. Their procedures routinely take them directly through these marks. As another example, certain procedures require prepping either the entire extremity or, during the case, it is found that the incision needs to be expanded. In either instance, the surgical site marking may find its way into the surgical field or be incised.

Lastly, a power analysis was done evaluating the number of patients needed to obtain a significant result. The number of 20 was determined to have an appropriate Beta statistic to validate our results - especially considering that our findings were of no growth on all specimens.

While we appreciate your well thought out critique of this study, we feel that the reasons stated above invalidate any concerns you may have.

Subramanyam n Maripuri

Posted on January 12, 2006

IS SURGICAL SITE MARKING REALLY SAFE?

University Hospital of Wales, Dept. Trauma & Orthopaedics, Cardiff, UK

To The Editor:

Surgical Site Marking is essential to avoid wrong site operations, and the idea of ensuring that the marked site is sterile is beyond dispute. However, there were certain limitations of this study.

First, the methodology of this study did not mimic the real practice on wards, where the same marker pen may be used to mark an infected case and then a clean case by two different surgeons (unknowingly), which is not an unusual practice.

Second, this study was conducted on only twenty volunteers. With such a small study group, the evidence is not enough to conclude that surgical site marking is safe.

I would like to highlight a few points: first, the marker pens used to mark infected cases should be discarded immediately to prevent their inadvertent use on clean cases; second, since many surgeons prefer to avoid marking directly over the surgical site(in contradistinction to JCAHO protocol) to avoid possible contamination of the surgical site, the mark should be placed apart from the surgical site and point to it with an arrow and the mark should be draped out of surgical field.

Surgical site marking should not be considered entirely safe until unless it has been proven by a large randomised control study.

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Geoffrey Cronen, Vytautas Ringus, Gavin Sigle, Jaiyoung Ryu; Sterility of Surgical Site Marking. The Journal of Bone & Joint Surgery. 2005 Oct;87(10):2193-2195.

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