March 15, 2015

 

 FDA warns of nonsterile saline solution bags

​Training-use bags have been associated with human illnesses

Posted Feb. 25, 2015

The Food and Drug Administration is warning that bags of saline solution intended solely for simulation and training purposes may have been shipped to hospitals and clinics where they may be mistaken for sterile fluids intended for administration to patients. The contents of these training products are not sterile and should not be used in clinical patients, according to the agency.

At least 40 patients have received fluid from training bags of saline solution made by San Diego–based Wallcur and marked as “Practi-0.9% sodium chloride,” according to warnings from the FDA. At least 17 became ill, with some of those patients requiring hospitalization. In addition, one person’s death may be connected with the error.

The FDA was still testing in January to determine whether the bags could have caused the adverse events. No animals were known to have become ill.

Wallcur has issued a recall for products shipped since May 22, 2014, in 50-mL, 100-mL, 250-mL, 500-mL, and 1,000-mL sizes. All five sizes include the label “Practi-0.9% Sodium Chloride,” although other text on the bags indicates only four of the recalled sizes contain sodium chloride, and one, the 100-mL size, contains distilled water. 

Source: FDA
 

Information on the recall and photos of the Wallcur products are available here

Wallcur officials could not be reached for comment.

FDA information states that administration of fluid from the bags has been associated with fever, chills, tremors, and headache in people in at least seven states: Colorado, Florida, Georgia, Idaho, Louisiana, New York, and North Carolina. Agency officials know the bags have been sent to at least 22 states.

Brad Leissa, MD, emergency coordinator for the FDA Center for Drug Evaluation and Research, said in a Jan. 16 conference call for stakeholders in the medical professions that the agency wants help in warning health care providers about the risks to patients from training bags that were shipped but not yet used. He suggested that clinicians and staff at all health care facilities inspect all bags of fluids intended for use in patients to ensure none are labeled with the words “Wallcur,” “Practi-products,” “for clinical simulation,” or “not for use in human or animal patients.”

“We are asking that all health care professionals pay close attention to the labeling of all intravenous solution and all injectable products to ensure that they are genuine medical products suitable for administration to patients,” Dr. Leissa said.

Images provided by the FDA indicate the recalled Wallcur products come in clear bags with connections typical for fluids intended for intravenous administration.

Dr. Leissa said most of the training bags of saline solution were shipped to small outpatient human medical facilities, so the FDA was contacting stakeholder groups and state and local regulators throughout the country.

“We would like everyone to carry this alert as far and wide as possible in order to ensure that not one additional patient is exposed to the risk of being injected with these simulated products,” he said.

Michael Levy, deputy director for policy and analysis with the FDA Office of Compliance, said in the conference call that the training bags reached the mainstream drug market through “a combination of labeling and distribution practices that didn’t put adequate controls over the products.” The FDA was trying to find the best approach to remedy those labeling and distribution problems.

“We’re working with the firm to remedy that, and we’ve had sales practices of the products that did not adequately segregate the products from, you know, real, normal saline products,” he said.

The FDA indicated in January that, in addition to issuing the recall and notifying customers and distributors, Wallcur had agreed to add stickers to existing training saline bags to warn that the products are not intended for medical use. The company and FDA were still in discussions on label recommendations for all training products.

Wallcur isn’t the only company to make such training products, and the FDA plans to work with other manufacturers to ensure such incidents do not occur again, Levy said.

In late January, the FDA was still trying to find out how the training products entered the pharmaceutical supply chain and were administered to patients, agency spokesman Stephen King said. He said the FDA was working with Wallcur to “update its label to highlight the fact that these products are not sterile and should not be administered to humans or animals.”

In the recall, issued through the FDA, Wallcur officials asked that distributors and resellers ensure any materials or sites advertising Wallcur products give prominent warnings that the products are only for training purposes.

The FDA noted that supplies of normal saline have remained tight since a shortage started more than a year ago, and the agency has worked to allow temporary distribution of normal saline from alternative sources.