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

Clinical Specialty or Hospital Department
Clinical/Biomedical Engineering; Obstetrics and Gynecology; OR / Surgery

Device Factors
Device failure; Improper maintenance, testing, repair, or lack or failure of incoming inspection; Random component failure

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Various

Support System Failures
Error in hospital policy

Tampering and/or Sabotage
*Not stated

User Errors
*Not stated

UMDNS
Cryosurgical Units [18-051]; Cryosurgical Units, General Purpose [11-067]; Cryosurgical Units, Ophthalmic [11-068]; Forceps, Electrosurgical [11-502]; Saws, Bone, Sternal [16-718]; Tourniquets, Pneumatic [14-041]

Surgical Devices Omitted from Equipment Control Programs



Hazard [Health Devices Feb 1989;18(2):86]

Problem

ECRI has published reports on sternal saws (Health Devices 10:175, April-May 1981), pneumatic tourniquets (Health Devices 12:48, December 1982), electrosurgical forceps (Health Devices 10:256, August 1981), and cryosurgical units (Health Devices 15:332, December 1986). The common element in these reports, and in numerous other problem reports on surgical devices, is that malfunction and patient injury were caused by inadequate or nonexistent device inspection and preventive maintenance procedures. Too often, surgical equipment is omitted from the hospital's routine inspection and preventive maintenance program because the devices are reprocessed across departmental boundaries, the devices are owned by private physicians, or the need for maintenance goes unrecognized. In addition, some clinical engineering departments focus so heavily on electrical safety issues during inspections that they overlook devices without line cords.

Discussion

When personnel incorrectly assume that someone else is performing inspection and preventive maintenance procedures, performance problems or impending mechanical failures (e.g., loose screws, tubing and connector deterioration) escape detection. Such seemingly minor problems can lead to serious injury or death during surgery. Simple routine inspection and servicing can often detect these problems before they result in dangerous failures. The key, however, is to recognize that your equipment control program inventory may be incomplete.

Some devices (e.g., cryosurgical units) require that routine inspection and preventive maintenance be performed by the manufacturer. These procedures should be performed annually or as directed by the manufacturer, and they should be included on the clinical engineering inspection and preventive maintenance schedule to verify that the device is sent out for servicing at the scheduled interval.

Whenever a manufacturer or outside agency performs routine maintenance on a device, you should determine the extent of the service, as well as the need for additional inspection or maintenance. You may need to supplement a limited manufacturer maintenance procedure with a general inspection, or the device may require inspection or maintenance between manufacturer maintenance intervals. Either include these procedures on your inspection and preventive maintenance schedule, or arrange for the manufacturer to perform these additional services. If, on the other hand, the manufacturer's procedure is comprehensive and sufficiently frequent, do not duplicate effort by repeating inspections in-house (except as required for ensuring the quality of the service).

It may be impractical to include certain devices on clinical engineering's inspection schedule, or some devices may require inspections with each use (e.g., disposable devices, reusable electrosurgical forceps, endoscopes). In such cases, surgical (or central processing) personnel must be reminded that these devices require pre- or postuse inspection with each use. Personnel should be provided with specific and practical inspection instructions.

Recommendations

  1. Inventory all patient care equipment that can place patients at significant risk, regardless of who owns or maintains the equipment. This includes pneumatic-powered surgical instruments and tourniquets.
  2. Place all appropriate equipment and devices on a regular inspection and preventive maintenance schedule. The device's user or maintenance manual or the Health Devices Inspection and Preventive Maintenance Manual should specify recommended time intervals, procedures, and tests. If this information cannot be found in any of these sources, contact the manufacturer.
  3. Have the manufacturer perform periodic overhauls and maintenance procedures that cannot be performed in-house (e.g., pressure testing cryosurgical units).
  4. Disposable devices (e.g., disposable blood pressure transducers) and reusable surgical devices (e.g., electrosurgical forceps, endoscopes) should be inspected before each use. Be sure that users recognize their responsibilities and receive clear instructions.

UMDNS Terms

  • Cryosurgical Units [18-051]
  • Cryosurgical Units, General Purpose [11-067]
  • Cryosurgical Units, Ophthalmic [11-068]
  • Forceps, Electrosurgical [11-502]
  • Saws, Bone, Sternal [16-718]
  • Tourniquets, Pneumatic [14-041]

Cause of Device-Related Incident

Device factors: Device failure; Improper maintenance, testing, repair, or lack or failure of incoming inspection; Random component failure

Support system failure: Error in hospital policy

Mechanism of Injury or Death

Various


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