Cause of Device-Related Incident
Device factors

Clinical Specialty or Hospital Department
Obstetrics and Gynecology; OR / Surgery; Orthopedics; Radiology / Ultrasound / Nuclear Med.

Device Factors
Design / labeling error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Infection; Particulates

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
*Not stated

UMDNS
Sponges [13-695]; Sponges, X-ray Detectable [13-705]

X-Ray Detectable Surgical Sponges



Hazard [Health Devices Dec 1980;10(2):52]

Problem

Member hospitals have reported an inability to radiographically detect sponges labeled as "X-Ray Detectable" or "Radiopaque" following loss in patients during surgery. The problem is most acute with small sponges used in surgery of the head and spine, since their presence is frequently masked by nearby bone.

Discussion

These surgical sponges can be as small as ¼-inch square. They are manufactured with either a small radiopaque insert (typically a thin flexible strip about 2 mm wide) sewn or melted into the material, or they are impregnated with a radiopaque substance such as barium sulfate. While the insert tends to be more radiopaque than barium sulfate impregnation, it represents a smaller target to locate.

The sponges can be readily detected if radiographed through tissue such as muscle or fat that is less dense than the radiopaque insert. However, if the x-rays must also pass through denser tissue such as bone, it is likely that the sponge will be masked and difficult or impossible to detect with a single radiographic view. Since the loss of these small sponges is uncommon, their detection by radiography is not a routine procedure and the limits of their radiopacity may not be widely known.

Standards activities, underway for several years, are seeking to define a required level of radiopacity and develop a standardized test method specifying exposure limits, film type, aluminum mask thickness, and radiograph viewing conditions. At present, manufacturers typically have proprietary guidelines for radiopacity of their products. Until such time that standards are promulgated, the label of "X-Ray Detectable" or "Radiopaque" on surgical sponges should be viewed as relative, rather than absolute, descriptions. While these sponges may contain an x-ray detectable element, their detection is highly dependent on their location with respect to bone and the radiographic technique and equipment used. Larger sponges used in general surgery typically have a large radiopaque strip or ring attached and are more easily detected.

Detection of small radiopaque surgical sponges lost in patients may require several radiographic views of the area thought to contain the sponge. Various exposures may also be required. Such studies can frequently be performed in the operating room with mobile equipment without removing the patient from the table.

If radiographic detection in the operating room is unsuccessful but the presence of the sponge in the patient is still suspected, further radiographic studies employing laminagraphy or computerized tomographic scanning may be indicated. However, such studies cannot usually be performed in the operating room due to the location of the necessary equipment and must be completed postoperatively. Fluoroscopy does not have adequate resolution to detect these small sponges and is not recommended.

Manufacturers of these sponges have been hesitant to provide specific recommendations on how to best radiograph their sponges, preferring to leave this judgment to the radiologist. If, however, you have repeated problems in detecting a certain brand of sponges, contact the manufacturer for guidance and please also notify ECRI of such problems.

Recommendations

  1. When radiography is required during surgery to locate a small sponge suspected of being in the patient, the most skilled radiological personnel and best portable equipment available should be used. Utilizing the best available resources in these situations will minimize both the additional time the patient is under anesthesia and his exposure to ionizing radiation since fewer radiographs will probably be required.
  2. An initial radiograph of the suspect area of the sponge should be taken and developed. If this is unsuccessful in detecting the sponge, several radiographic views of the suspect area may be indicated (possibly at various exposures). If considerable time is likely to be spent taking additional views, it is necessary to consider the patient's condition and ability to safely withstand further anesthesia.
  3. Postoperatively, further radiographic studies employing laminagraphy or computerized tomographic scanning may be indicated.
  4. Radiology departments should be aware of the limited radiopacity of small surgical sponges labeled "X-Ray Detectable" or "Radiopaque." In addition, they should develop appropriate search techniques for their institutions that consider the availability and condition of portable radiographic equipment, location and performance of x-ray film processors that may be stationed near the operating rooms, and personnel most capable of effectively performing this type of radiographic study.

UMDNS Terms

  • Sponges [13-695]
  • Sponges, X-ray Detectable [13-705]

Cause of Device-Related Incident

 Device factor: Design error/labeling error

Mechanisms of Injury or Death

Infection; Particulates


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