Cause of Device-Related Incident
*Not stated

Clinical Specialty or Hospital Department
Clinical/Biomedical Engineering; OR / Surgery

Device Factors
*Not stated

Document Type
User Experience Network (UEN) reports

External Factors
*Not stated

Mechanism of Injury or Death
Burn (electrical, thermal, chemical)

Support System Failures
*Not stated

Tampering and/or Sabotage
*Not stated

User Errors
*Not stated

UMDNS
Electrosurgical Units [11-490]

Are Spark-Gap Electrosurgical Units Safe to Use?



User Experience Network™ [Health Devices Jul 1995;24(7):293]

Hospital

We have decided to replace our spark-gap electrosurgical units (ESUs) with a newer technology. However, one of our surgeons refuses to use the newer ESUs for urology procedures because he states that they are not as effective as the spark-gap units. Does ECRI have any advice regarding this issue?

ECRI

The outdated spark-gap units have been largely superseded by solid-state devices. Although the solid-state units initially available did not perform as well as spark-gap ESUs during demanding surgical procedures (e.g., open-heart surgery, transurethral resections), they have been improved and are now effective in all surgical procedures. Today, because they decrease the risk of patient burns, they are safer to use than the spark-gap ESUs. (We previously addressed this issue in 1987; see References.) Many of the solid-state units have integral return electrode contact-quality monitors that help to prevent patient burns, whereas most spark-gap units do not have this monitoring capability. We therefore recommend that you encourage your surgeons to try the newer and safer technology. Most will find solid-state devices to be acceptable. However, allowing surgeons who prefer using spark-gap units to continue to use them would likely be safer for patients than forcing them to use a device that they believe to be unacceptable.

If the surgeons in your institution continue to use the spark-gap ESU, we recommend that you ensure that they are clearly aware of the safety risks associated with continued use of these devices. In addition, it may be prudent for your hospital to obtain signed documentation from these surgeons stating that they are aware of the safety risks involved and explaining their rationale for continued use of an older technology.

References

Association for the Advancement of Medical Instrumentation (AAMI)/American National Standards Institute (ANSI). Standard for Electrosurgical Devices. ANSI/AAMI HF18-1993.

ECRI. The Bovie CSV: Still accepted? [Consultants Corner]. Health Devices 1987 Sep-Oct; 6(9-10):340-1.

UMDNS Term

Electrosurgical Units [11-490]

Mechanism of Injury or Death

Burn 


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