Investigation of contaminated heparin syringes highlights medication safety issues

Oct 12, 2009

An outbreak of bloodstream infections appears to have been caused by the contamination of pre-filled heparin and saline syringes made by a single company, according to a report in the October 12 issue of Archives of Internal Medicine. The subsequent investigation revealed that the company was not in compliance with safety regulations and identified challenges and areas for improvement in medication monitoring systems.

Between October 2007 and February 2008, the Centers for Disease Control and Prevention (CDC) received reports of clusters of bloodstream infections caused by the bacteria Serratia marcescens at health care facilities in several states, according to background information in the article. Based on initial information from facilities in Texas and Illinois, the investigation into the cause of the outbreak focused on syringes pre-filled with the blood thinner and saline from one company (company X).

David Blossom, M.D., of the , Atlanta, and colleagues report that the company was able to provide records for other facilities that had received the same syringes. The CDC contacted these recipients and posted requests on e-mail distribution lists to solicit additional infection case reports. Culture specimens were taken from unopened pre-filled heparin and saline syringes at facilities reporting infections as well as at company X.

A total of 162 S. marcescens bloodstream infections in nine states were reported among patients at facilities using syringes from the same company. Cultures of unopened pre-filled heparin and saline syringes manufactured by this company grew S. marcescens. Of 83 blood samples that contained S. marcescens submitted to the CDC from seven states, 70 (84 percent) contained bacteria genetically related to that grown from the pre-filled syringes.

"To ensure the of manufactured medical products, companies must adhere to the U.S. Food and Drug Administration's Good Manufacturing Practices [GMPs], a comprehensive body of regulations that govern all aspects of production," the authors write. "An onsite inspection of the manufacturer by the FDA revealed poor compliance with the FDA's GMPs and quality system regulations. Within days of this inspection, company X discontinued production of all medical products." The company also issued a voluntary national recall of the pre-filled syringes.

"Close collaboration among federal agencies, public health authorities and clinicians was critical to the identification of the cause of this outbreak," the authors conclude. "In the course of the investigation, we also identified several challenges to medical product tracking that should be addressed promptly so that disease outbreaks caused by exposure to contaminated medications can be dealt with more efficiently in the future." For example, a large number of distributors acted as intermediaries between the manufacturer and the health care facilities that used the products, and none of the syringes bore company X's name on the label, but rather had the names of subsidiaries or different companies.

In addition, some batches of the syringes were contaminated whereas others were not; this intermittent nature made identifying the source of the outbreak more difficult. This suggests that investigations of potential contamination must include both epidemiologic and laboratory components, since initial laboratory tests may prove inconclusive.

More information: Arch Intern Med. 2009;169[18]:1705-1711.

Source: JAMA and Archives Journals (news : web)

Explore further: Researchers discover target for treating dengue fever

add to favorites email to friend print save as pdf

Related Stories

3 states investigating hep C-infected scrub tech

Jul 17, 2009

(AP) -- Hundreds more patients have been advised to get tested for hepatitis C as health officials in two more states launched investigations into an infected Colorado surgery tech who allegedly swapped clean ...

FDA to test all heparin at U.S. border

Mar 16, 2008

The U.S. Food and Drug Administration has issued an import alert and plans to test all shipments of the drug heparin before they enter the country.

Scrub tech causes major hepatitis scare in Colo.

Jul 12, 2009

(AP) -- Kimberly Spencer's 9-year-old son went to Audubon Ambulatory Surgery Center last month for what was supposed to be a routine surgery. The rambunctious child stuck a BB in his ear and doctors had to ...

Heparin recall spreads in Europe

Mar 27, 2008

France, Italy and Denmark are recalling heparin after an Italian firm purchased contaminated ingredients from China, EU drug regulators said.

Nevada confirms 7th hepatitis case

Mar 20, 2008

An investigation into a hepatitis C outbreak in Nevada has found a seventh case, this one linked to another endoscopy center owned by Dr. Dipak Desai.

Recommended for you

Researchers discover target for treating dengue fever

4 hours ago

Two recent papers by a University of Colorado School of Medicine researcher and colleagues may help scientists develop treatments or vaccines for Dengue fever, West Nile virus, Yellow fever, Japanese encephalitis and other ...

Tracking flu levels with Wikipedia

4 hours ago

Can monitoring Wikipedia hits show how many people have the flu? Researchers at Boston Children's Hospital, USA, have developed a method of estimating levels of influenza-like illness in the American population by analysing ...

User comments : 0

More news stories

Turning off depression in the brain

Scientists have traced vulnerability to depression-like behaviors in mice to out-of-balance electrical activity inside neurons of the brain's reward circuit and experimentally reversed it – but there's ...

Researchers discover target for treating dengue fever

Two recent papers by a University of Colorado School of Medicine researcher and colleagues may help scientists develop treatments or vaccines for Dengue fever, West Nile virus, Yellow fever, Japanese encephalitis and other ...

Our brains are hardwired for language

A groundbreaking study published in PLOS ONE by Prof. Iris Berent of Northeastern University and researchers at Harvard Medical School shows the brains of individual speakers are sensitive to language univer ...

Study recalculates costs of combination vaccines

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Better thermal-imaging lens from waste sulfur

Sulfur left over from refining fossil fuels can be transformed into cheap, lightweight, plastic lenses for infrared devices, including night-vision goggles, a University of Arizona-led international team ...

Hackathon team's GoogolPlex gives Siri extra powers

(Phys.org) —Four freshmen at the University of Pennsylvania have taken Apple's personal assistant Siri to behave as a graduate-level executive assistant which, when asked, is capable of adjusting the temperature ...