Cause of Device-Related Incident
Device factors; Support system failures; User errors

Clinical Specialty or Hospital Department
CCU / ICU / NICU; Clinical/Biomedical Engineering; CSR / Materials Management; Nursery; Obstetrics and Gynecology; OR / Surgery; Pediatrics

Device Factors
Design / labeling error; Improper maintenance, testing, repair, or lack or failure of incoming inspection; Improper modification

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Hemorrhage; Mechanical (puncture, perforate, lacerate, break, cut, tear, nick, crush)

Support System Failures
Lack or failure of incoming and pre-use inspections

Tampering and/or Sabotage
*Not stated

User Errors
Failure to perform pre-use inspection; Failure to read label

UMDNS
Clamps, Circumcision [10-869]

Routine Inspection Needed for Scissors-Type Circumcision Clamps



Hazard [Health Devices Mar 1999;28(3):115-6]

Problem

ECRI’s ongoing surveillance of incidents involving scissors-type circumcision clamps has revealed that the gap between the clamps’ jaws when they are fully open may increase due to damage, faulty repair, or extended wear. This is particularly hazardous for infants, since it can allow more than just the foreskin to be pulled into the gap, potentially contributing to injury to the glans penis during circumcision.

Discussion

The scissors-type circumcision clamp, which was invented more than 60 years ago, consists of two hinged jaws. One face of the clamp is flat, and the other is concave. The clamp’s jaws can be held closed with a cam-lever-bar assembly attached to the end opposite the hinge.

Scissors-type circumcision clamps are currently available in two sizes, infant and adult. The gap distance of the infant-sized clamp allows only the infant’s foreskin to be pulled into the opening; it tends to exclude the glans penis. If this gap widens, however, the glans could be pulled in unnoticed along with the foreskin and could be partially amputated during circumcision. Most scissors-type circumcision clamps are robust, and actual wear leading to gap enlargement probably takes many years. Nonetheless, clamp damage, modification, or faulty repair may enlarge the gap distance. If left unnoticed, the enlarged gap distance may prove hazardous, especially with the infant-sized clamps.

Because of the seriousness of the injuries these devices can inflict, ECRI recommends that, in addition to incoming, routine, and pre-use inspections, circumcision clamps undergo acceptance inspection following any repair, modification, or overhaul. (Note that, while this type of clamp can be repaired, most suppliers believe that it is often better to discard the worn device and purchase a new one.) Unfortunately, these clamps do not typically have unique identifiers on them, and each unit will need to be engraved with a hospital equipment control number to facilitate management. Until data is available to support a different frequency of inspection, ECRI recommends inspecting and documenting the size of the gap every 12 months.

These inspections can also help address another problem involving circumcision clamps. In a 1995 Hazard Report, ECRI noted several incidents in which an adult-sized clamp was being used when part of an infant’s glans penis was amputated along with the foreskin ("Amputations with Use of Adult-Size Scissors-Type Circumcision Clamps on Infants," Health Devices 24[7], July 1995). These incidents brought to light the fact that physicians could inadvertently use the adult-sized clamps if they were not marked or labeled to indicate their size. (The adult- and infant-sized scissors-type clamps are similar in appearance.) The adult-sized clamp opening—like infant-sized clamps with widened gaps—can allow an infant’s glans penis to be pulled in along with the foreskin. In this earlier report, we recommended measuring and appropriately marking the clamps’ size and informing users of the risks involved when adult-sized clamps are used on infants. Periodic inspections of these clamps will help ensure that they are appropriately labeled.

Recommendations

  1. Locate all scissors-type circumcision clamps and ensure that they receive routine inspection and acceptance testing. In most cases, it will be necessary to assign an equipment control number to each clamp. The control number will need to be engraved on the clamp; a standard electrical engraver can be used to mark the units.
  2. Inspect the circumcision clamps and measure the gap distance every 12 months, more or less, depending on the frequency of use of the clamp. Document the inspection results. The gap, when measured at the end of the clamp, should be 1.5 to 2.5 mm for infant-sized clamps and 3.0 to 5.0 mm for adult-sized clamps. See the figure for the location of the measurement.
  3. Remove from service any scissors-type circumcision clamp with an excessive gap distance. Such units should be either discarded or returned to the supplier or a servicer for repair.
  4. Refer to the recommendations published in our July 1995 Hazard Report for adding size labels to circumcision clamps.

UMDNS Term

Clamps, Circumcision [10-869]

Cause of Device-Related Incident

Device factors: Labeling error; Improper maintenance, testing, repair, or lack or failure of incoming inspection; Improper modification

User errors: Failure to perform pre-use inspection; Failure to read label

Support system failure: Lack or failure of incoming and pre-use inspections

Mechanism of Injury or Death

Hemorrhage; Mechanical


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