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

Clinical Specialty or Hospital Department
Cardiology / Cardiac Catheterization; CCU / ICU / NICU; Clinical/Biomedical Engineering; CSR / Materials Management; Nursing; OR / Surgery; Pediatrics

Device Factors
Device failure

Document Type
User Experience Network (UEN) reports

External Factors
*Not stated

Mechanism of Injury or Death
Misdiagnosis; Monitoring failure

Support System Failures
Improper storage

Tampering and/or Sabotage
*Not stated

User Errors
Abuse of device

UMDNS
Electrodes, Electrocardiographic, Neonatal [17-460]; Electrodes, Electrocardiographic [11-439]

Loose-Lead Alarms Resulting from Dried-Out Disposable Electrodes



User Experience Network™ [Health Devices Jul 1994;23(7):309-10]

Hospital

During apnea monitoring of pediatric patients, our hospital recently experienced numerous "loose-lead" alarms resulting from dry electrode gel. Our central supply department had been opening the manufacturer's foil pouch (i.e., primary packaging), which contains 30 pregelled electrode sets, and distributing the individual sets, which are packaged in clear polyethylene bags (i.e., secondary packaging). Despite unopened secondary packaging, the electrode gel was becoming dry enough to increase the electrode impedance, causing the loose-lead alarms.

ECRI

The drying of pregelled disposable electrodes used for ECG and apnea monitoring is commonly reported to ECRI by member hospitals. The design of many electrodes and their secondary packaging apparently permits the significant evaporation of conductive gels in less than 10 days after removal from the primary package. While some electrodes are designed to maintain their gel for up to 30 days, this may not be apparent to the clinicians using them, and hospitals may have to verify with the manufacturer whether the electrodes they are using will last this long. To reduce the likelihood of electrodes drying out before use, follow the recommendations listed below.

Recommendations

  • Open the primary packaging only as electrodes are needed. In situations where a low volume of electrodes are used, reseal the primary package, and mark its outside with the date it was opened. When possible, use an airtight container to store the opened primary package or individual electrode packets.
  • Similarly, in situations where a high volume of electrodes are used and it is necessary to remove the electrode sets from the primary package, open the primary packaging on only a several-day supply of electrodes, and store the loose electrode packets in an airtight container.

UMDNS Terms

  • Electrodes, Electrocardiographic, Neonatal [17-460]
  • Electrodes, Electrocardiographic [11-439]

Cause of Device-Related Incident

Device factor: Device failure

User error: Abuse of device

Support system failure: Improper storage

Mechanism of Injury or Death

Misdiagnosis; Monitoring failure


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