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

Clinical Specialty or Hospital Department
Anesthesia; CCU / ICU / NICU; CSR / Materials Management; Nursing; Pulmonary / Respiratory Therapy

Device Factors
Design / labeling error; Manufacturing error

Document Type
Hazard Reports

External Factors
*Not stated

Mechanism of Injury or Death
Barotrauma; Suffocation

Support System Failures
Lack or failure of incoming and pre-use inspections

Tampering and/or Sabotage
*Not stated

User Errors
Device misassembly; Failure to perform pre-use inspection

UMDNS
Resuscitators, Pulmonary, Manual [13-367]; Resuscitators, Pulmonary, Manual, Disposable [17-592]; Resuscitators, Pulmonary, Manual, Reusable [17-591]

Reprocessing and Inspection of Manual Pulmonary Resuscitators



Hazard [Health Devices Nov 1987;16(11):378-9]

Problem

A clinical emergency is not the occasion for discovering that a manual resuscitator is not functioning properly. It's too late. We have received two reports of failure to ventilate patients due to resuscitator malfunction: one due to a missing valve component and the other due to a valve component from a different unit that became wedged in the inlet valve of a resuscitation bag, causing it to malfunction.

Discussion

Although a manual resuscitator is not a complex device, it is crucial for life support and may be the only such device that is readily available. Critical time may be lost in attempting to use the ventilator with a defective resuscitator, recognizing the malfunction, and attempting to correct the problem or obtain another unit. This loss of time may distract staff attention and result in a failed resuscitation attempt. Although mouth-to-mouth resuscitation is always available, it may not be performed because of the fear of infection (see "An Alternative to Mouth-to-Mouth Breathing," below).

When a resuscitator is made available, the user must be able to assume that it was clean and in proper working order when it was placed in a protective bag or kit and declared ready for use: There is no time for pre-use testing in an emergency. Such a guarantee is difficult to achieve by many central sterile departments because their employees, although able to verify sterility, cannot certify that all of the different kinds of equipment they process functions properly.

The first step in correcting the problem is for manufacturers to use designs that do not permit misassembly or possible loss of critical small parts (such as valve parts). The second step is to ensure that the small parts are held in place while they are cleaned and disinfected so that they cannot be lost or combined with a different resuscitator during reassembly. Most current resuscitators satisfy these requirements, but older units may not.

Recommendations

  1. Place all parts of a single resuscitator in a closed mesh bag for cleaning and disinfection. This will keep them together for rapid assembly while preventing parts from being lost or small parts from other equipment from becoming trapped in resuscitator components.
  2. Resuscitators should be inspected and tested after reassembly by someone who can certify their operation before they are sealed in a clean bag. Using sterile technique in handling resuscitators once they are disinfected is not necessary.

An Alternative to Mouth-to-Mouth Breathing

Manual resuscitators have been available for many years and are an important part of advanced life support following basic mouth-to-mouth ventilation by the first person on the scene. However, with the reluctance if not the refusal of many rescuers to perform mouth-to-mouth resuscitation, immediate ventilation may not be started. Only seldom is a manual resuscitator immediately available, and valuable time can be lost in starting ventilation.

The void is being filled by mouth-to-mask devices that are entering the market in increasing numbers. The typical unit consists of a mouthpiece and a mask with an intermediate valve to direct the exhaled breath away from the inhalation path. It may also have a filter to further isolate the rescuer from the patient; however, clinical studies have not yet generated data to demonstrate whether these devices prevent the transmission of viruses to the user.

These single-use units are inexpensive and can be distributed throughout all rooms and other areas of a hospital or carried routinely by nurses. Thus, they can be immediately available. Training should be no more difficult than for the mouth-to-mouth procedure because the rescuer can use both hands to position the patient's head to maintain the airway and seal the mask. (This step has been one of the more difficult parts of learning to use a manual resuscitator and one of the reasons its use is reserved for advanced life support by trained personnel.)

We recommend that hospitals use these mouth-to-mask devices to allow rapid initiation of artificial respiration, while allaying staff fears about infectious diseases.

UMDNS Terms

  • Resuscitators, Pulmonary, Manual [13-367]
  • Resuscitators, Pulmonary, Manual, Disposable [17-592]
  • Resuscitators, Pulmonary, Manual, Reusable [17-591]

Cause of Device-Related Incident

Device factors: Design/labeling error; Manufacturing error

User errors: Device misassembly; Failure to perform pre-use inspection

Support system failure: Lack or failure of incoming or pre-use inspections

Mechanism of Injury or Death

Barotrauma; Suffocation


[Home]    [About]    [Help]    [Site Map]
Copyright © 2017 ECRI
All rights reserved
www.ecri.org