Federal health investigators indicate that Baxter Healthcare Corporation sold its SIGMA Spectrum Infusion Pump to the public without first getting the medical device approved for sale by the FDA.
In a warning letter sent to Baxter earlier this month, the FDA said that the company did not go through the proper process to get the SIGMA Spectrum Infusion Pump with Master Drug Library sold on the market and did not tell the FDA they were selling it.
Without an approved application from the FDA or an approved application for investigational device exemption in place, Baxter violated provisions of the Federal Food, Drug, and Cosmetic Act; a violation that can result in serious consequences.
An infusion pump is a small medical device which delivers medication to the body. Different types of pumps can deliver drugs intravenously, subcutaneously or through an epidural infusion. The pumps are often worn by Type 1 diabetics to deliver insulin as needed. Infusion pumps may also be used in a hospital setting to delivery different drugs, including chemotherapy, antibiotics and anesthesia.
By failing to properly notify the FDA it planned to commercially distribute the Sigma infusion pump, the New York Based company misbranded the product. The FDA outlined in the April 1 letter that any devices “intended for use in the diagnosis of disease or other conditions, or in the cure mitigation treatment or prevention of diseases, or to affect the structure or any function of the body” must be approved by the agency first.
The FDA has requested that Baxter respond to the notification within 15 days, outlining specific steps they will take to correct the violations and prevent the violations from occurring again. If the company plans to continue to sell the infusion pump to the public, they will need to submit a premarket application, which the FDA will evaluate to deem whether the product can been legally marketed.
Failure to comply with the notice and correct the violations may result in regulatory action by the FDA, which can include seizure, injunction, and monetary penalties.
In recent years, concern regarding infusion pumps problems has been heightened nationwide, resulting in the FDA issuing a draft guidance in 2010, which was designed to increase the quality and safety of products sent to market.
The draft guidance required manufacturers to undergo more risk assessments before gaining premarket approval for new or modified devices. The protocol was issued to prevent situations like the violation by Baxter.
During advisory meetings at the time, the FDA revealed there have been more than 56,000 adverse event reports concerning infusion pumps, resulting in 87 pump recalls and nearly 500 deaths.