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The concept of safe surgery has received significantly more attention since the publication of the Institute of Medicine report in 1999. Safety issues have always attracted surgeons’ attention, but the details have frequently been left to nurses, and more recently to anesthesiologists. Surgeons have always assumed patient safety was a primary goal; however, recent findings and regulations from the Joint Commission for Accreditation of Hospitals (JCAHO) and the Occupational Safety and Health Administration (OSHA) have challenged this belief. Only recently has academic surgery addressed the issue of error prevention and causation. This monograph will address the specific safety issues of retained surgical items, wrong-site surgery, and injuries from sharp instruments, all of which affect the practicing surgeons in the operating room.

The word safety means a state of being safe: freedom from occurrence or risk of injury, danger, or loss. Error, on the other hand, is a deviation from accuracy or correctness: a mistake. The concept of error prevention attempts to lower the possibilities for human error to a minimum. The airline industry, held up as the safest, finds an accident rate of 1 per 243,309 takeoffs and the rate for near misses is 1 per 166,583. By comparison, a defect in performance occurs 1 per 2.22 patient encounters.

The idea that doctors are not only responsible for safety but can contribute to errors has been a difficult concept for medical practitioners to accept. Lister’s theory of germs was not embraced and Semelweiss ended up in an asylum when he proposed his idea that surgeons were carrying puerperal fever from patient to patient by not washing their hands. The concept that the surgeon could actually be causing the problem was anathema. When Codman suggested that surgeons should look at their results and publish them, the Boston Medical Society and the Massachusetts General Hospital rejected him and caused him to establish his own hospital.

It is consistent with this history that surgeons feel the count that nurses perform during their cases is an impediment to their surgical efficiency, and that the surgeon is not responsible for this menial task. The recent emphasis on “time out” and “boarding passes,” to identify a patient verbally and visually and identify the operative site and side, has not been embraced by the surgical community. The use of double gloving, safety needles, and scalpels and using a hands-free technique have been difficult to place into the operating room (OR) arena.

We, as a profession, are realizing that although mistakes happen, we may be able to minimize many errors in the OR and make the OR a safer place for patients, staff, and surgeons. The authors hope that this monograph will help surgeons to work in the safest environment possible and to accept their personal responsibilities, not only to perform a flawless operation or procedure, but also to participate in the team effort to protect patients, other health care personnel, and themselves from harm. A “sea change” in surgical philosophy is necessary to minimize the retention of foreign objects and to maximize the safety of all involved in the procedure. This means an attitude shift to the acceptance of rules and regulations as a protective strategy.

There are several preventable errors in the OR. Retained unintentional foreign bodies occur in 1 per 8000 to 13,000 operations and are the subject of Part 1 of this monograph. Wrong-site (wrong body part) surgeries occur more than 400 times a year and injuries to OR personnel from sharps occur in up to 15% of cases.

The rise of the incidence of human immunodeficiency virus (HIV), hepatitis B and C, and other blood-borne diseases caused the Centers for Disease Control and Prevention (CDC) to pass the Universal Precautions Act in 1987. The purpose of this and other standards by OSHA is to prevent injuries from needles, scalpels, and other sharp objects. Although injuries have decreased by 38% since 1993, the number of injuries by suture needles has increased by 27%.

There have been 137 cases of HIV or acquired immunodeficiency syndrome (AIDS) in health care workers from exposure, although few of these have involved surgeons. Hepatitis is a more significant risk to all members of the OR team.

Injuries in the OR account for 25% of all blood fluid exposures. Cuts or needle sticks may occur in up to 15% of procedures (1.7-15%), with surgeons and first assistants receiving 59% of the injuries.

Suture needle injuries are the most frequent source of injury (77%) and most (59%) occur during closure. Up to 16% of injuries occur while passing instruments hand to hand. Four strategies have been suggested to avoid sharps injuries. First, do not use sharp instruments. Use cautery not scalpel, apply tissue staplers, and use safety-tipped needles. The substitution of the safety-tipped needle significantly decreases sharp injuries at closure from 1.9 per 1000 needles to 0 per 1000. Second, use engineering sharps injury prevention devices (ESIP) to directly protect the user. “Safety scalpels” and the Suturtek 360 closure system have not been well studied but show promise for the future. Third, change work practices to minimize sharp injuries with the use of the “neutral zone” or “hands-free technique” (HFT). Although these are recommended and helpful, there are procedures that are not amendable to HFT. Stringer and colleagues reported a 59% reduction in incidents, but a randomized study of 156 cesarean sections did not show a reduction. Last, decrease the degree of the injury or contamination by using double glove techniques. Double gloving can reduce exposure by as much as 87%, yet surgeons still are resistant to donning a second pair of gloves.

The management of a health care worker who is exposed to a blood-borne infectious agent includes initiation of hepatitis B vaccines, prophylaxis with hepatitis B immune globulin, and an immediate drug regimen of 2 drugs (zidovudine and lamivudine) for 4 weeks for HIV exposure.

Wrong-side/site surgery is another area in which preventable errors should be eliminated. The term wrong-site surgery has been defined by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to mean surgery on the wrong patient, on the wrong organ, on the wrong limb, or on the wrong (eg, vertebral) level. The term is best reserved for mistakes of side or site; however, the term is inherently inflammatory and condemnatory. Removal of a cataract OS (left eye) when the consent specified and the surgeon planned to operate OD (right eye) qualifies as wrong-site surgery. Biopsy of the wrong side of the brain certainly qualifies. Extended exploration of the surgical site because additional unsuspected pathology has been encountered, on the other hand, does not.

The early 1990s saw increasing public debate about issues of quality and cost in health care. Concerns directed at hospital-based medical errors surged and wrong-site surgery received particular attention because of some well-publicized cases. In 1997, the Council on Education of the American Academy of Orthopedic Surgeons (AAOS) established a group to examine the problem. The task force examined medical liability claims filed between 1985 and 1995. Over this 10-year period, 225 orthopedic wrong-site surgery claims and 106 other surgical specialty claims had been filed. Medical liability carriers had paid an average of $48,087 to patients for wrong-site orthopedic surgery claims and an average of $76,167 to patients for wrong-site surgery in other specialty areas. As a result of this study, the AAOS recommended that surgeons, hospitals, and other health care providers collaborate to eliminate wrong-site surgery in the United States. Several procedural changes were introduced: double checking the signed consent for surgical site; having the surgeon sign or otherwise mark the operative site and side while the patient confirms the accuracy of the mark; comparing radiographs to the marked site; and additional verification of the site by the surgeons and other members of the surgical team. Adoption of these measures by orthopedists came quickly.

In August 1998, JCAHO issued a Sentinel Event Alert on wrong-site surgery based on 15 wrong-site surgery cases then on file with JCAHO. The alert was well publicized and promoted to the level of a “campaign” among OR managers. The first National Patient Safety Goals were implemented in 2003. In that year, 69 wrong-site surgeries were reported. In 2004, the Universal Protocol was implemented. In that year, 71 wrong-site surgeries were reported. In 2005, nearly 90 wrong-site surgeries were reported.

In a published summary of more than 3000 sentinel events in its database published in 2005, JCAHO ranked wrong-site surgery second in overall frequency (12.5%), exceeding perioperative complications as a group (12.3%) and medication error (11%). A recent review of the National Physicians Data Base (NPDB) identified 2217 cases of “wrong-body-part surgery” from 1900 to 2003.

The JCAHO reviewed root causes of wrong-site surgeries from 1995 to 2005. Of the 455 wrong-site surgery events reviewed, communication was identified as a root cause in nearly 80% of the events.

A recent study by the Agency for Health Care Research and Quality (AHRQ) found the rate of wrong-site surgery serious enough to qualify as a sentinel event, to require informing risk management, or likely to result in litigation in any major hospital approximately every 5 to 10 years. Retained foreign bodies, by comparison, are 10 times more likely. Most important, site-verification protocols seem to prevent approximately two thirds of the wrong-site errors.

Wrong-site surgery, like all sentinel events, has both systematic and nonsystematic causes. The systematic causes can be mitigated by protocols and universal safeguards. The nonsystematic causes may be less likely, but they are no less devastating for their improbability. Wrong-site surgery should be entirely preventable, and its causes and remedies must be studied and implemented.