FDA Warns Minnesota Infusion Pump Maker Over Missed Checks

The FDA’s warning letter stated that ICU Medical altered infusion pump designs in Minnesota after a recall without completing necessary regulatory approvals.

The FDA said ICU Medical has had clearance since the early 2010s for two devices but failed to submit required notifications for significant changes that could affect their safety or effectiveness, according to an April 4 warning letter.

ICU Medical manufactures the devices at a former Smiths Medical ASD facility in the Twin Cities, which it acquired in 2022. Previous recalls linked these devices to injuries and one death.

The FDA stated that post-recall device changes made them adulterated and misbranded because the modifications weren’t reviewed by the agency beforehand.

FDA Warns Company to Resolve Issues Quickly or Face Enforcement Actions

The agency urged the company to quickly resolve the issues, warning that failure to do so could lead to FDA enforcement without further notice. Such measures could include product seizures, court injunctions, or monetary penalties.

ICU purchased the Minnesota-based Smiths Medical division from Smiths Group for $2.35 billion in cash and stock in 2022, describing the move as the formation of a “leading IV therapy company.” However, in the years since, the company has dealt with multiple recalls involving its infusion pump devices.

A spokesperson for ICU Medical emphasized that patient safety and regulatory compliance remain top priorities for the company. They also noted that business operations are proceeding as normal.

“Since the acquisition of Smiths Medical, ICU Medical has invested hundreds of millions of dollars to enhance quality and service at the Minneapolis facility,” the spokesperson stated.

The FDA issued a warning letter following an inspection conducted between July 23 and August 9. The agency said ICU Medical lacks the required premarket approval or investigational device exemption for certain devices, which can take years to obtain.

The FDA stated that the company misbranded the modified devices by failing to notify the agency before advancing with broader commercialization.

FDA Clearance and Premarket Notification Concerns for ICU Medical Devices

While ICU Medical does have FDA clearance for previous versions of the two devices, the agency noted that the company did not submit a new premarket notification for substantial changes that could impact the devices’ safety or effectiveness.

The agency withheld details about the specific device modifications, citing concerns over potentially sensitive trade secrets and proprietary commercial information. However, it noted that the changes could significantly impact how infusion pumps deliver medication and trigger alarms.

The agency warned that the modifications could increase risks like under- or over-infusion, therapy delays, incomplete treatments, or false alarms, potentially leading to serious health issues such as overdoses or cardiorespiratory problems.

The FDA said ICU released updated software to address a recall on fluid delivery and false alarm issues but failed to submit the required documentation through the 510(k) process.

FDA Criticism of Inadequate Disclaimer on Device Software Review

The agency stated that including a disclaimer on the labeling indicating the device software hasn’t been reviewed by the FDA is inadequate.

An ICU spokesperson said 510(k) submissions for the two devices are currently underway and pledged to complete them within the next 90 days. They also noted that the company has secured five 510(k) clearances for its infusion systems in just over 18 months.

The spokesperson stated, ‘We commit to ensuring all Smiths Medical products comply with regulatory standards

Read the original article on: Medicalxpress

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