Health care professionals use IV flush syringes to clear out patients’ catheters and intravenous lines to ensure the tubes are air-free and unobstructed. Nurse Assist, a Texas-based medical device manufacturer, recalled all of its Normal Saline IV Flush Syringes in 2016 after the devices spread a bacterial infection. Patients became sick and some died. How the syringes became contaminated with the bacteria Burkholderia cepacia remains unknown.
If you've suffered from a blood stream infection, bacteremia or sepsis as a result of a Nurse Assist Normal Saline IV flush syringe, you may be eligible for compensation.
Nurse Assist flush syringes were implicated in an outbreak of the Burkholderia cepacia bacterial infection found in the blood of 164 patients in 59 medical facilities, such as nursing homes, in five states. According to the Centers for Disease Control and Prevention, seven people died — five in New York and two in Pennsylvania — although it’s undetermined if the causes of those deaths were the infection, underlying conditions or something else.
New Jersey reported the most cases, with 59, followed by New York with 58 and Pennsylvania with 30. The remaining cases were reported in Delaware (4) and Maryland (12).
CDC researcher Dr. Richard B. Brooks told Drugwatch that the CDC has not yet reported the root cause of the contamination, which led to the recall of more than 386,000 IV Flush syringes nationwide on Oct. 4, 2016. The recall was initiated less than two weeks after the Maryland Department of Health and Mental Hygiene first alerted the CDC to a cluster of infections among patients at long-term rehabilitation facilities who were receiving intravenous fluids and/or antibiotics through central venous catheters.
After reviewing patient records and culturing suspect products, investigators quickly discovered that the affected patients were all in skilled nursing facilities supplied by the same pharmacy, which distributed saline flushes from the same manufacturer. On Oct. 3, they found B. cepacia bacteria in sealed saline flushes made at one of the manufacturer’s facilities. The next day, the recall was initiated.
“Quick action and open inter-state collaboration prevented additional cases and identified the outbreak source,” Brooks, a CDC epidemic intelligence service officer assigned to the Maryland Department of Health, said in an email to Drugwatch.
“This investigation demonstrates the need for us to be able to better track compounded medications and medical devices, including saline flush syringes, throughout the manufacturing and distribution process, up to the point at which they are given to individual patients,” Brooks told Infectious Disease News.
Asked by Drugwatch to elaborate on this, Brooks said, “Currently, there is not a good mechanism in place for tracking individual saline flushes to an individual patient. That made determining which patients in this outbreak were at risk for having been exposed to the contaminated flushes challenging. An improved mechanism for tracking flushes and other similar devices might help in more quickly identifying patients who have received a specific product.”
In May 2017, the FDA issued a warning letter to Nurse Assist over its record keeping. In particular, inspectors found company records showed more cases of syringes manufactured than sterilized prior to the outbreak. The FDA was critical of Nurse Assist for failing to catch the discrepancy and address it.
The letter also said records showed Nurse Assist employees had taken product samples to test for endotoxins. But FDA inspectors found the company failed to document whether or not any batches of syringes were contaminated.
Warning letters are one of the more serious actions the FDA can take toward manufacturers. The agency issues them when it finds a manufacturer “has significantly violated FDA regulations.” The letters set deadlines for manufacturers to correct the problems the FDA has identified.
IV Flush Syringes are found everywhere in medical settings, such as hospitals and clinics.
Nurse Assist prefills each IV Flush Syringe with 0.9 percent sodium chloride — a mixture of salt and water — which is compatible with body fluids and tissues. Doctors use sodium chloride for a number of medical uses, and the intravenous formula is the most common preparation.
Nurse Assist sells these plastic syringes in three different doses: a 3 ml fill, 5 ml fill and 10 ml fill for a 12 ml syringe.
However, these devices come with disadvantages as well, including reports of infectious outbreaks allegedly due to poor manufacturer compliance with FDA regulations.
A study conducted by Vanderbilt University Medical Center in Nashville concluded that “prefilled saline syringes cause the patient to experience a taste and/or smell after their IV catheter is flushed with saline.” Participants in the study reported that they were 7.3 times more likely to experience a taste and 10.4 times more likely to experience a smell with the prefilled syringe when compared with the multi-dose bag.
Health care providers and patients use these syringes to clear out devices that deliver medicine directly into the veins of a patient through a needle or catheters. Hospitals and clinics use them before and after starting IV medication drips or fluids in patients. This ensures the lines stay clean and prevents blockages.
To flush the IV, nurses and other health care professionals clean the IV port and connect the IV Flush Syringe to it. Then, they slowly pull back on the syringe plunger until a small amount of blood is visible. Next, they inject the flush solution into the IV or catheter. At this time, the nurse may start a medication drip. Before beginning another medication in the line, they will flush it again.
But it’s a mystery how syringes that were supposed to be sterilized became contaminated with a bacteria, Burkholderia cepacia, which can be deadly in some immune compromised patients, particularly those with cystic fibrosis and the elderly. Otherwise healthy people who are infected may show no symptoms at all.
“Since the FDA has not reported the root cause of contamination at the manufacturing or sterilizing facilities, it is impossible to say how the syringes became contaminated,” Brooks said. “It is unlikely that the bacteria would have survived properly conducted sterilization with gamma radiation. Therefore, the most likely explanations for contamination include: 1) the syringes somehow failed to undergo sterilization; 2) there was a problem with the sterilization process in such a way that sterilization was not effective; or 3) bacteria were somehow introduced into the saline in the syringes after sterilization.”
Burkholderia cepacia is a bacterium found naturally in river sediments and moist soil around plant roots. It causes rot in certain plants, including garlic and onions. It is adaptable and able to survive in hostile environments, including disinfectants. It can survive for years in water. It is naturally resistant to many common antibiotics. It even uses penicillin as a nutrient. Healthy people are rarely infected by it.
There have been other instances of Burkholderia cepacia being transmitted through contaminated health care products, including mouthwash, nasal spray, liquid stool softener and sublingual probes.
Since Burkholderia cepacia is commonly found in soil and water, Brooks was asked, should consumers be wary of any water-based medical products, even those that are sterilized, in light of what happened here?
No, the researcher said. People need not worry, but they can take precautions.
“Fortunately, outbreaks such as the one we investigated are very rare, and regulations that are in place to ensure the safety of medications provide excellent protection for consumers,” he said. “Consumers can check the FDA’s searchable MedWatch website to learn about reported adverse events associated with regulated products. They can also further protect themselves by asking their providers if they are following evidence-based infection control practices, including hand hygiene protocols and safe injection practices.”
The recall involved Normal Saline Flush 12ml IV Flush Syringe with fill volumes of 3ml, 5 ml and 10 ml. It covered lots of product codes 1203, 1205, 1210 and 1210-BP with the manufacturing dates between September 24, 2015 to August 1, 2016. The distribution dates were February 16, 2016 to September 30, 2016.
The CDC advises medical-device distributors, health care facilities and providers to stop using any of the remaining Nurse Assist prefilled saline flush syringes and immediately recover unused syringes from pharmacies, medication carts, preparation and patient-care areas. Also, notify local or state health authorities of any cases of B. cepacia bloodstream infections in patients who received intravenous care at a facility that was using these products and whose symptoms began since Aug. 1, 2016.
In May 2017, nearly eight months after the Nurse Assist syringes were recalled, the FDA issued an advisory notifying manufacturers of non-sterile, water-based drug products of recent recalls linked to Burkholderia cepacia contamination. B. cepacia, the warning said, can be found in pharmaceutical water systems and can survive and multiply in non-sterile, water-based products because it’s resistant to certain preservatives and antimicrobial agents.
Brooks said that advisory wouldn’t have applied to the IV Flush Syringes because they’re sterile.
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