FDA warns epidural needle maker International Medical Development

The FDA today published a warning letter it sent to epidural and anesthesia needle maker International Medical Development over issues with it marketing its Gertie Marx needles outside its indication and quality control issues related to manufacturing. International Medical Development’s Gertie Marx needles are cleared for “the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter in adults,” according to the FDA. The federal watchdog said the company is marketing the needles for lumbar puncture, myelogram and pediatric use, which it said the company lacks clearance or approval for. The agency referenced 4 cases in which International Medical Development’s website, promotional material and outer packaging mis-represented their indicated uses, referring to the devices as “needles for Lumbar Punctures,” “an invaluable tool for . . . pediatric anesthesiologists and neurologists,” and other pediatric and lumbar uses. The FDA also knocked International Medical Development on its manufacturing quality control systems, noting 5 specific areas where the company was failing to meet the agency’s requirements. International Medical Development was hit for failing to establish and maintain procedures to control non-conforming products. The agency said the company had “failed to document any nonconforming product” but said 9 device history records reviewed by...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Business/Financial News Food & Drug Administration (FDA) Regulatory/Compliance International Medical Development Source Type: news