A federal recall is drawing urgent attention to a piece of equipment patients rarely see, but clinicians rely on every day: ventilator breathing circuits.
The U.S. Food and Drug Administration has labeled the action its most serious type of recall after the devices were linked to four serious injuries.
Here's what to know
As HealthExec reported, the FDA alert involves recalled Hamilton Medical coaxial breathing circuit sets used with certain Hamilton ventilators.
The problem involves an expiratory valve set that may not work properly. The defect can restrict gas flow because the valve may stick to the sealing ring, and it can appear almost immediately after ventilation begins.
The ventilator should sound an "Exhalation Obstructed" alarm if the defect blocks expiratory gas flow.
The FDA notice says the issue involves Hamilton C-1, Hamilton T-1, and Hamilton MR-1 ventilators when they are used with these coaxial breathing circuit sets and a respiratory mask.
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Hamilton announced the recall in July and said there have been no deaths linked to the defect. Still, the FDA classified it as a Class I recall because ventilator malfunction can lead to low blood oxygen and, in severe cases, organ failure or death.
More background
Ventilators are life-support devices, so even a failure in a small component can quickly become dangerous.
In this case, the concern involves how air moves during assisted breathing.
Four Hamilton Medical breathing circuit set product numbers are part of the recall: 260127, 260128, 260167, and 260168.
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The FDA said any potentially defective units should be pulled from both care areas and sales locations.
What's being done?
The recalled breathing circuit sets should not be used in patient care. Customers are being told to check inventory for matching product numbers and unique device identifiers.
Hamilton sent customers a letter with instructions for starting a return. Questions can be directed to complaints@hamiltonmedical.com or 1-800-426-6331.
Providers aware of adverse events tied to the recall should report them through the FDA's MedWatch program.
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