The Maryland Department of Health and Mental Hygiene (DHMH) announced on October 4, 2016 that it was issuing a recommendation that any healthcare facilities, providers or anyone else who has received Nurse Assist prepackaged, three-, five- and 10-milliliter syringes of saline flush immediately discontinue using and sequester these saline products until further notice.
The DHMH announced that it, in coordination with other state and federal agencies, is investigating a possible link between Nurse Assist pre-filled saline flushes and the development of Burkholderia cepacia bloodstream infections. The issue in Maryland was first identified after a cluster of patients developed Burkholderia cepacia bloodstream infections while receiving intravenous care using these prepackaged saline flushes from Nurse Assist. The DHMH stated that several other states also have identified possible links between the injection of this product and the development of bloodstream infections.
In Maryland, eleven patients, none of whom have died, have been identified as developing Burkholderia cepacia after the Nurse Assist saline flushes were used during their medical treatment.
Also on October 4, 2016, Nurse Assist announced its voluntary recall of its IV flush syringes, stating in a press release, “Nurse Assist, Inc. announced today that it is voluntarily recalling all unexpired lots of I.V. Flush Syringes due to a potential link to Burkholderia cepacia bloodstream infections with the product. According to the U.S. Centers for Disease Control and Prevention (CDC), the effects of Burkholderia cepacia on people “vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.” If a patient is having symptoms, contact your health care provider. Since patient safety is of utmost importance, all unexpired lots of these products are being recalled until a thorough investigation can be completed … The lots being recalled were distributed to customers and distributors between 02/16/16 and 09/30/16 … Nurse Assist is actively investigating the possible link to the infections with the Food and Drug Administration, the U.S. Centers for Disease Control, and various state health departments to ensure that the products are safe for their intended use. Until an investigation can be completed, Nurse Assist urges all healthcare facilities with affected product to discontinue use and return the product to the supplier.”
According to the CDC, Burkholderia cepacia (B. cepacia) is the name for a complex of bacteria that can be found in soil and water. B. cepacia bacteria are often resistant to common antibiotics but poses little medical risk to healthy people. However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. B cepacia is a known cause of infections in hospitalized patients. The effects of B. cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis. Transmission of B. cepacia from contaminated medicines and devices has been reported.
In 2005, the CDC was notified by several states of clusters of pneumonia and other infections caused by B. cepacia and associated with contaminated mouthwash. In 2004, the CDC was notified of a voluntary recall of over-the-counter nasal spray due to contamination with B. cepacia complex. Also in 2004, B. cepacia was linked to nosocomial infections among intensive care unit patients and associated with exposure to sublingual probes.
In July 2016, the FDA alerted health care professionals that PharmaTech LLC of Davie, Florida was voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories of Livonia, Michigan, after the FDA confirmed the product had been contaminated with Burkholderia cepacia linked to an outbreak in five states. In August 2016, PharmaTech’s voluntary recall was expanded to include all liquid products due to possible Burkholderia cepacia contamination.
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