Dräger hit with another Class I recall over possible contaminants in pediatric ventilators

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来源: FierceBiotech

Rather than constituting a request that all Carina ventilators be returned to Dräger, this recall instead serves as a correction notice: The company is instructing healthcare providers to stop using the devices to provide breathing support to children, though they can continue to be used for adult patients at higher minute volumes.

For the fourth time this year, German devicemaker Dräger’s portfolio of respiratory devices is the target of a recall deemed Class I by the FDA.

This time around, the agency has homed in on the company’s Carina sub-acute care ventilator. Though Dräger discontinued production of the Carina devices in 2019—about a decade after they were first cleared by the FDA—they’re still used in hospitals to provide either partial or full breathing assistance to both pediatric and adult patients.

According to a recall notice the regulator published Wednesday, in recent tests of the ventilators, Dräger discovered that contaminants could potentially enter the device’s airpath at higher-than-acceptable levels for children. Exposure to those contaminants could lead to toxic reactions or even death, the FDA noted, though the company hasn’t yet received any complaints associated with the issue.

The recall spans more than 11,600 ventilators, according to its entry in the FDA’s recall database. They were distributed over the span of more than a decade, from March of 2009 through this year.

In a letter (PDF) sent to healthcare providers in June, Dräger described how it had been running routine tests of the durability of the polyether polyurethane (PE-PUR) foam used to muffle sound in the devices.

Though they concluded that the foam wasn’t at risk of breaking down or decaying over periods of up to 15 years, the company did find that it could release 1,3-Dichloropropan-2-ol—which the FDA describes as “a potential carcinogen”—into the airpath in dangerously high quantities when the ventilators are used continuously for more than 30 days in pediatric patients.

The contaminant’s levels remained below acceptable thresholds, however, when the ventilator was programmed to higher minute volumes for adult patients.

In the letter, Dräger noted that along with a lack of complaints related to the issue, human studies have so far proven “no carcinogenic effect” associated with the higher quantities of 1,3-Dichloropropan-2-ol. The company concluded, “Our risk assessment reveals only a low risk of additional cancer cases by comparison with the general cancer risk.”

With those findings in mind, rather than constituting a request that all Carina ventilators be returned to Dräger, the recall instead serves as a correction notice: The company is instructing healthcare providers to stop using the devices to provide breathing support to children, though they can continue to be used for adult patients at higher minute volumes.

Those recommendations will stand until Dräger has updated all affected ventilators still in use. Per the letter, it plans to remove the noise-reducing PE-PUR foam from the devices and replace it with a “newly designed blower cover.” The company is expecting to have the new piece available in the early days of the fourth quarter of this year, and the repair process will be conducted free of charge.

Once the ventilators have been updated with the new blower cover, clinicians will be able to resume using them as before.

“We apologize in advance for any inconvenience caused by this measure. We consider this a necessary measure to increase patient safety,” the company wrote in closing.

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