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

Clinical Specialty or Hospital Department
CCU / ICU / NICU; Clinical/Biomedical Engineering; Emergency Medicine; Nursing; OR / Surgery

Device Factors
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
Failure to deliver therapy

Support System Failures
Failure to train and / or credential

Tampering and/or Sabotage
*Not stated

User Errors
Accidental spill; Failure to perform pre-use inspection; Failure to read label; Incorrect clinical use

UMDNS
Defibrillator/Monitors [11-129]; Defibrillator/Monitors, Line Powered [15-029]; Defibrillators, Battery Powered [11-134]; Defibrillators, Line Powered [11-137]

User Error and Defibrillator Discharge Failures



Hazard [Health Devices Dec 1986;15(12):340-2]

Problem

Many incidents have been reported involving failure of the defibrillator of battery-powered defibrillator/monitors to discharge during cardiac emergency responses. Most of the affected units were being used to provide external emergency defibrillation for ER, CCU, or ICU patients at the time of the failures; in one instance, the discharge failure occurred during open-heart surgery when internal defibrillator paddles were needed to restore the heart to normal rhythm. No serious patient injury resulted in any of these incidents, and no resuscitation attempt had to be aborted. At least seven of the discharge failures were due to user error.

While the reported incidents involved battery-powered units, unexpected failure of any type of defibrillator to discharge places additional stress on the members of the advanced life-support team, requires the immediate availability and use of a backup unit to resume and complete the resuscitation attempt, and causes delay that could increase the risk of irreversible injury or death.

Discussion

Battery-powered defibrillator/monitors are designed primarily to reverse ventricular fibrillation or overcome cardiac arrest and restore normal heart rhythm. When not in active use, they are frequently stored on top of a crash cart or adjacent to critical care treatment areas so that their batteries can be recharged and the units kept in a state of readiness.

At least seven of the reported discharge failures were caused by user error (e.g., inadequate knowledge of proper device operation, fluids spilled into the unit, incorrect placement of the defibrillator chassis into its charger base, dirty paddles, loose internal defibrillator paddle cable connector). In some cases, inconsistent operational checks by clinical users, poor or delayed reporting of operational problems to clinical engineering or other service personnel, or poor preventive maintenance also contributed to the failures. Manufacturers have informed us that user errors remain a common factor in many defibrillator discharge failures and encourage users to report difficulties in using their devices so that units can be made simpler, safer, and more reliable. Manufacturers are usually responsive to user feedback and often redesign or modify poorly functioning units.

Although periodic inspection and preventive maintenance procedures performed by clinical engineering personnel will uncover some problems, frequent user checks will help keep any type of defibrillator in good working order. We divide user checks into two categories:

  1. Quick visual inspections should be performed by users at least daily and after each use of the device to ensure that units are available and ready for use; all necessary supplies should be accessible and in good condition.
  2. Users should confirm once a week that the defibrillator is functioning by setting it at a low energy (e.g., 50 J) and then firing the external paddles into a test load provided with the unit or into a defibrillator analyzer. To assist users in completing these checks, we have provided a poster that itemizes steps for users to follow to reduce user error when operating these devices.

Because there is little margin for error when operating these life-support devices, we strongly urge all users to be aware of the risk of error and the impact that such error can have on the success of a resuscitation attempt, especially when a particular defibrillator is otherwise fully operational.

User errors can often be addressed by simple device modifications if ECRI and manufacturers are aware of them and how frequently they occur. Clinical and bioengineering personnel state that they are sometimes reluctant to report defibrillator/monitor problems to ECRI and the device manufacturer because if a hospital fails to take action on a user error with a life-support device, and that same error recurs, the hospital's liability may be greater. We urge users to promptly report any problem with a defibrillator or a defibrillator/monitor, regardless of its cause, to clinical engineering or other service personnel, who can then inform the hospital risk manager, the device manufacturer, and ECRI (ECRI maintains the confidentiality of its reports). The faster the problem is reported within the healthcare facility, the quicker the affected unit can be evaluated, repaired, and returned to service, and the quicker the manufacturer or ECRI can recommend use or device modifications to reduce the likelihood of patient injury or device failure.

One major factor involved in reducing user error is the training and retraining of advanced life-support teams and other clinical personnel in the proper operation, inspection, and maintenance of defibrillators and defibrillator/monitors. One of the key statements regarding the accreditation decision-making process of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) emphasizes that "where appropriate, the hospital has a program designed to assure that patient care equipment, whether electrically or nonelectrically powered, performs properly and safely, and that individuals are trained to operate the equipment they use in the performance of prescribed duties."(1)

We find that many manufacturers provide operator's manuals with their units that can easily be used as training guides. Some manuals also contain suggested procedures and intervals for user and clinical engineering inspections. Some manufacturers will make audiovisual aids (e.g., slides, tapes, videocassettes) and/or trainers available on request to enhance a hospital's training/retraining programs. Revised Standards and Guidelines for CPR and Emergency Cardiac Care and other training materials are available from the American Heart Association.(2) The types of user error that commonly contribute to defibrillator discharge failure, including those referenced in this article, may also be identified and resolved by strengthening in-service education of nurses and house staff and by scheduling meetings between clinical users and engineering personnel as the need arises.

Recommendations

  1. Alert users of battery-powered defibrillator/monitors and other defibrillators to this report. Users should perform a visual inspection of any such units in the health care facility daily and after each cardiac resuscitation. Refer to the daily inspection procedure included by manufacturers in their operator's manuals for a particular defibrillator/monitor. Use ECRI's poster as a guideline in remaining familiar with the unit you may be called upon to use.
  2. Perform the weekly operational discharge test by setting the defibrillator or defibrillator/monitor to a low energy setting (e.g., 50 J, or other values as recommended by the device manufacturer) to ensure that a unit is in good working order. More frequent discharge tests may be performed only if recommended by the manufacturer. Infrequent users of defibrillators or defibrillator/monitors (e.g., one resuscitation attempt every three weeks) should perform the weekly operational discharge test as a refresher on the correct operation of the unit they are expected to use in an emergency.
  3. If a battery-powered defibrillator/monitor fails to discharge when needed, or if it or any other type defibrillator unit fails the daily visual inspection or the weekly operational test, promptly report the failure or problem to clinical engineering or other appropriate service personnel so that they can notify the hospital risk manager, the device manufacturer, and ECRI. In this way, technical advice can be obtained, if needed, and the affected unit returned to service as soon as possible. Review the "Isolated Incident" articles (Health Devices Dec 1986;15[12]) that summarize failure to discharge in defibrillator/monitors made by three different manufacturers, and try to report the reason you believe that discharge did not occur, as explained in the preface to these articles.
  4. To reduce the stress normally associated with making cardiac emergency responses and to reduce the likelihood of user error as a factor in discharge failures in any type of defibrillator, periodically review the effectiveness of defibrillator training and retraining programs currently in use in your facility. Be aware that JCAHO now considers such training programs to be one of the key factors in its accreditation decision-making process. Consult the device manufacturer and the American Heart Association about audiovisual aids and/or trainers available on request by your nursing education or cardiology departments. Schedule meetings between clinical users and engineering personnel, as needed, to identify and resolve common user errors that may be contributing to defibrillator or defibrillator/monitor discharge failures.

Notes

  1. Joint Commission on Accreditation of Hospitals. Standard PL.9: Patient care equipment. Accreditation manual for hospitals, 1987. Chicago: JCAHO, 1986:199-200.
  2. JAMA 1986; 255(21):2905-92.

UMDNS Terms

  • Defibrillator/Monitors [11-129]
  • Defibrillator/Monitors, Line Powered [15-029]
  • Defibrillators, Battery Powered [11-134]
  • Defibrillators, Line Powered [11-137]

Cause of Device-Related Incident

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

User errors: Accidental spill; Failure to perform pre-use inspection; Failure to read label; Incorrect clinical use

Support system failure: Failure to train and/or credential

Mechanism of Injury or Death

Failure to deliver therapy


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