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: Restrictions lifted at British bird flu farm

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

Restrictions lifted at British bird flu farm

6 hours ago

Britain on Sunday lifted all restrictions at a duck farm in northern England after last month's outbreak of H5N8 bird flu, the same strain seen in recent cases across Europe.

Recorded Ebola deaths top 7,000

Dec 20, 2014

The worst Ebola outbreak on record has now killed more than 7,000 people, with many of the latest deaths reported in Sierra Leone, the World Health Organization said as United Nations Secretary-General Ban ...

Liberia holds Senate vote amid Ebola fears (Update)

Dec 20, 2014

Health workers manned polling stations across Liberia on Saturday as voters cast their ballots in a twice-delayed Senate election that has been criticized for its potential to spread the deadly Ebola disease.

Evidence-based recs issued for systemic care in psoriasis

Dec 19, 2014

(HealthDay)—For appropriately selected patients with psoriasis, combining biologics with other systemic treatments, including phototherapy, oral medications, or other biologic, may result in greater efficacy ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.