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Unintended Retention of a Foreign Object After Surgery

Patients should never have to suffer the accompanying pain, risk of death and required additional surgery that must take place when surgical items are left inside their bodies from a previous surgery or procedure.

Leaving a foreign object inside a patient is considered a Never Event, a term first introduced in 2001 by the National Quality Forum, in reference to particularly shocking medical errors that should never occur. This type of incident is one of 28 identified Never Events.

Medical Definition: Retained Surgical Items is now the medical term for the problem of surgical items being inadvertently left in various body spaces after an operation. Surgical items are the tools and materials that are used in medical procedures. Retained surgical items are a surgical patient safety problem.

How often it occurs: It has been estimated that 1,500 to 2,000 Retained Surgical Items incidents occur each year in the United States.

In Florida, surgery to remove foreign objects from a surgical procedure is one of 10 patient safety incidents that are tracked quarterly by the state’s Risk Management Patient Safety Program. The list includes death, brain damage, wrong site surgery, wrong patient surgery and others. There were 101 surgeries to remove foreign objects from a surgical procedure performed in hospitals and surgery centers in 2010, up from the 95 in 2009 and down from the 118 reported in 2008. The quarterly reports break down the incidents that occur at hospitals and ambulatory surgery centers.

The most common items left behind include sponges and towels, instruments and sharps, and device fragments, including pieces of wire or tubes according to U. S. Food and Drug Administration.

The consequences of retained surgical tools include injury, death, repeated surgery, and unnecessary excess monetary cost.

Why it occurs: While many believe that the amount of blood lost in a surgery or the changing of nurses during the surgery would influence the risk of losing something, studies do not support this. Human factors such as exhaustion, lack of tools necessary to aid in producing an accurate count, and a chaotic environment all help to increase the risk of forgetting a tool. These factors cannot be controlled and surgeons must learn to mitigate them.

Inaccurate counts are a main reason why tools can be left behind. Many cases of a retained instrument originally reported a correct sponge count when the patient was released. An inaccurate count can occur when nurses are deprived of sleep, when the operation is particularly difficult, long, and mentally draining, when the operation is an emergency, or when there are unforeseen changes in the procedure.


Based on an Emergency Care Research Institute (ECRI) Institute study that examined insurance company closed-claims data from 1985 to 2001, patient deaths due to retained surgical objects were rare. More common adverse outcomes included:

• readmission to hospital or prolonged length of stay (59% of cases),
• second surgery to remove retained object (69%),
• sepsis or infection (nearly 50%),
• fistula or small-bowel obstruction (15%), and
• visceral perforation (7%).

Only 6% of retained instruments were discovered within one day of surgery, while discovery around the 21st day after surgery was more common. However, some retained objects were not discovered until many months or even years later.

The Cost: The costs to remove a retained foreign body can run up to $50,000 per case, making it a costly human oversight and, more importantly, a most risky circumstance for patients. Today, healthcare facilities must absorb the direct cost of objects retained during surgery because these occurrences are considered "preventable conditions" for which the Centers for Medicaid & Medicare Services won't pay.

Preventing Errors: Each licensed medical facility in Florida is required to adopt a patient safety plan to comply with state law. Each facility must appoint a patient safety officer and a patient safety committee, which shall include at least one person who is neither employed by nor practicing in the facility, for the purpose of promoting the health and safety of patients, reviewing and evaluating the quality of patient safety measures used by the facility, and assisting in the implementation of the facility patient safety plan.

In order to improve the system and reduce the number of accidents, some hospitals require four counts of sponges and instruments. The first count happens when the instruments are being set up and the sponges unwrapped. The next count is required right before surgery begins, another count as closure begins, and finally a count during skin closure. This is a general guideline and there are different count methods according to different hospitals.

While careful counting could prevent some mistakes, counting carries its own risks. Sometimes the patient must be worked on immediately, leaving no time to count the instruments to be used beforehand. Another risk of counting after is having to leave the patient under anesthesia longer. In addition, counting may not be entirely beneficial as counting is prone to human error and the majority of the cases happen under a reported correct count.

A new technique is a “bar coded sponge management system” reasoning that technological error is smaller than human error. Each surgical instrument has a bar code placed on it and nurses pass the items through a hand scanner. The bar code allows each sponge to be identified, resulting in little to no room for error.

The American College of Surgeons provides guidelines that recommend:

• standardized counting procedures for sponges, sharps, instruments,
• methodical wound exploration before closure,
• use of X-ray detectable items within the surgical wound,
• effective communication among perioperative team members, and
• thorough documentation of surgical counts:
• documentation of actions taken when discrepancies occur,
• documentation when counts are waived.

Regarding device fragments, the U.S. Food and Drug Administration recommends:

• Inspect devices prior to use for damage during shipment or storage that might increase the likelihood of fragmentation during a procedure.
• Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation.

Recommendations by Association of Operative Registered Nurses related to counts include:

• Use radiopaque (X-ray detectable) sponges and towels within surgical wounds.
• Radiopaque sponges should not be cut because of embedded indicators.
• Audible counting by two healthcare workers including at least one RN.
• Timing of counts — baseline, after any updates such as when instruments are added, at change of staff, at start of wound closure, and at end of procedure for all layers of tissue closure.
• Location of count: from surgical site to Mayo stand to discarded items, in same standardized sequence.
• Specify responsible team member(s).
• Count prepackaged sponges and instrument sets:
• Counts printed on outside of package should be verified before use.
• Preprinted count sheets to match standardized instrument sets are useful.
• Effective reconciling of any count discrepancy:
• Notify surgeon, perhaps delay wound closure.
• Thoroughly search OR environment and wound.
• Consider portable X-ray scanner.
• Consider reading of X-ray by radiologist instead of by surgeon.
• Safe disposal of sponges and sharps, according to OSHA guidelines.
• Document counts.

For more on patient safety issues, see the library of articles by Daytona Beach medical malpractice attorney.




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