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

Clinical Specialty or Hospital Department
Cardiology / Cardiac Catheterization; CCU / ICU / NICU; Home Healthcare; Nursing; Pulmonary / Respiratory Therapy

Device Factors
*Not stated

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Suffocation

Support System Failures
Error in hospital policy; Use of inappropriate devices

Tampering and/or Sabotage
*Not stated

User Errors
Inappropriate reliance on an automated feature

UMDNS
Ventilators [15-613]

Leaving Ventilator-Dependent Patients Unattended



Hazard [Health Devices Apr 1986;15(4):102-3]

Problem

ECRI has always recommended that ventilator-dependent patients never be left unattended. These patients cannot breathe spontaneously for substantial periods of time and cannot manually ventilate themselves. In the past, ventilator-dependent patients have been in special care units, where constant attention was available. Recently, however, medically stable patients (e.g., spinal cord injury patients) have been moved to other hospital rooms or even to home care.

Non-ICU areas cannot provide constant medical attention, and ventilator patients may be subjected to a smaller staff-to-patient ratio. If these patients are left unattended without proper ventilation monitoring and remote alarms, inadequate ventilation (due to ventilator failure or breathing-circuit disconnections) may go undetected, resulting in serious patient injury or death. We are concerned that adequate ventilation monitoring and remote alarms are not being used for ventilator-dependent patients in non-ICU areas.

Discussion

Critical care ventilators have high- and low-pressure and exhaled-volume monitors with alarms. Both pressure and exhaled-volume alarms are needed to properly detect inadequate ventilation due to tubing disconnections, leaks, failure of the ventilator to cycle, and failures of the exhalation valve. Low-pressure alarms may be misled by back pressures generated by partial occlusions or leaks. Filters and humidifiers can also generate back pressure, making it essential that ventilation pressure is not sensed upstream of these devices, such as within the ventilator.

Exhaled-volume monitors are not affected by back pressures and are superior to pressure monitors for detecting disconnections and leaks. However, low-pressure monitors are still needed to detect failures of the exhalation valve, which some exhaled-volume monitors cannot do. High-pressure alarms are essential for warning of decreases in patient compliance and dangerously high ventilation pressures.

Lower-cost portable ventilators, which would otherwise be adequate for home care or medically stable patients, often lack good pressure alarms, and none are equipped with exhaled-volume monitors. This is partly due to reimbursement policies of many third-party payers, which tend to cover only the lowest-cost ventilators and alarms available. In many instances, portable ventilators are the devices used for non-ICU and home care ventilator-dependent patients.

Many critical care ventilators and all portable ventilators, except the Life Products LP6, lack alarms that can be seen or heard at a distance (i.e., outside the patient's room). This is also true for stand-alone pressure and exhaled-volume alarms. The technology to provide exhaled-volume monitors and remote alarms is not complex, yet it is not being universally applied to ventilators.

We believe it is inconsistent and unacceptable to use inferior alarm systems with ventilators for patients who are left unattended, while ICU patients, who are attended, are properly monitored. Many home care ventilator-dependent patients are in a similar situation, but are even less well attended. Manufacturers should explore various remote warning systems to meet varying home and hospital care needs (e.g., interfacing with nurse-call emergency systems, wireless alarm systems that require no installation). We urge manufacturers to provide portable ventilators that are easy to use, cost effective, and equipped with effective, integral exhaled-volume alarms and remote indicators. We also call on appropriate third-party payers to reimburse hospitals/patients for ventilators that include these improved alarms.

ECRI maintains that ventilator-dependent patients should never be left unattended. We realize, however, that a trend is developing in the opposite direction, in many cases forced by economic conditions. All ventilators that may be used on ventilator-dependent patients (whether located in the ICU, general care areas, or at home) should be equipped with reliable pressure and exhaled-volume monitors with alarms. Until ventilators with integral, reliable alarms are available, users may need to add these alarms, especially to portable ventilators used outside special care areas. If a ventilator-dependent patient must be left without someone in direct attendance, then staff must always be where they can hear and rapidly respond to alarms. This may require installation of remote alarm indicators.

In most instances, hospitals and home care providers using currently available equipment will have to assemble their own remote alarm systems. One possibility is to set up the alarms to turn on a flashing light and an audible alarm outside the patient's room while alerting the nurses' station. In addition, many nurse-call systems with emergency indicators may be interfaced with certain ventilation monitors. Assistance may be needed from the ventilator and/or alarm manufacturer if modifications are required to provide an interface with nurse-call systems.

Recommendations

  1. Alert health care providers responsible for non-ICU ventilator-dependent patients, including home care patients, to this report and the report on hazards and recalls of home care equipment.
  2. Use proper low- and high-pressure alarms in addition to an exhaled-volume monitor with ventilator-dependent patients. If someone cannot be in attendance, you should also use an appropriate remote alarm system, and the patient should be situated close to attending staff (e.g., in the room closest to a staffed nurses' station).

UMDNS Term

Ventilators [15-613]

Cause of Device-Related Incident

User error: Improper reliance on an automated feature

Support system failures: Error in hospital policy; Use of inappropriate devices

Mechanism of Injury or Death

Suffocation


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