Hazards of retained surgical instruments

Unintended retained foreign objects are the subject of a new Joint Commission Sentinel Event Alert issued October 17, 2013: Unintentional retained surgical objects. Most of the cases Med League hears about have involved objects that were left inside the patient for months or years.

Damages from retained objects after surgery

The patient leaves the operating room with a sponge, a clamp, a portion of a catehter or wire, or a towel inside. What is the impact on the patient? There can be psychological and physical damages. Sixteen deaths resulted from 772 cases reported to The Joint Commission between 2005 to 2012. We’ve heard the stories of the patient’s clamp that sets off the metal detector in the airport, but many patients find out about the presence of a retained object as a result of a medical change: infection (the biggest risk affecting nearly 50 percent of patients), a fistula (tunnel between two organs), perforation of an organ, or a bowel obstruction. Most commonly, the patient is readmitted to the hospital and has to undergo surgery to remove the retained object. 1.

Causes of retained objects after surgery

How do instruments and sponges get left behind? The highest risk is an emergency surgery – there is a nine-fold risk. With the focus on the saving the patient’s life, counts of instruments can fall by the wayside. There is a four-fold risk when there is an unplanned change in surgery based on new findings or changes in the patient’s clinical condition. Obese patients have a higher risk of instruments or sponges being lost in the body. The risk of retained instruments is doubled when more than one surgical team performs surgery at the same time. The risk also increases when there is greater blood loss during the procedure. 2. The risk also goes up when there is an abdominal surgery, a prolonged operation, and multiple staff turnovers during the operation.

Deviations

The deviations from the standard of care center around

• not having appropriate policies and procedures for prevention of retained objects, or not teaching or following the polices/procedures
• working within a rigid hierarchy where the operating room staff feel intimidated by the surgeons
• miscommunication between staff

Prevention of retained surgical instruments

There are several patient safety recommendations offered by the American College of Surgeons, The Food and Drug Administration, and the Association of Operating Room Nurses. Recommendations focus on the methods of counting and reconciling discrepancies, the types of sponges used, the need to thoroughly check the wound before closing, and the documentation of counts. (Med League has provided experts on several retained sponge and instrument cases. It is our experience that surgical counts are ALWAYS recorded as correct in these cases.) The use of surgical sponges embedded with radiofrequency chips makes retained sponges easier to locate.

The Centers for Medicare and Medicaid Services took a stand on this problem by announcing it is no longer provided reimbursement for care necessitated by the retained surgical instruments.

Implications for attorneys and legal nurse consultants

These are difficult cases to defend – retained instruments and sponges during emergency procedures are the most easily defensible cases. Analysis of damages centers around the effects on the patient from the retained instrument or sponge, which can be considerable. During discovery, obtain procedures for surgical counts. Determine if an incident report was completed. Get statements or depose healthcare providers in the operating room at the time.

• Were the packages of sponges counted before the surgery to verify the number printed on the outside of the package was correct?
• Did the surgeon dismiss the incorrect count without re-exploring the wound?
• Did the nursing staff accept the incorrect count?
• Was there any sign of breakage of devices after they were removed from the patient?
• Were non-x-ray detectable sponges used?
• Were counts performed in an audible manner?
• When was the count performed in relation to closing the wound?
• Did the radiologist versus the surgeon read the x-ray when the count was incorrect?

Have the expert witnesses carefully evaluate the circumstances in comparison to the reasonably prudent, versus the superior standard of care. For example, while radiofrequency sponges are a wonderful innovation, their use is not the standard of care as of now.

References
1.    ECRI Institute, Sponge, sharp and instrument counts, Healthcare Risk Control Risk Analysis, Vol. 4, Surgery and Anesthesia, 5, November 2004
2.    Gawande, A. et al, Risk factors for retained instruments and sponges after surgery, New England Journal of Medicine, Vol. 248, No. 3, January 16, 2003, 229-235

Med League provides medical expert witnesses with expertise in evaluating operating room malpractice cases. Call us for assistance.