Stringent Patient Monitoring at Johns Hopkins Uncovers Serious Safety Problem with New Medical Device

Sudden and unexplained increases in bloodstream infections at the Johns Hopkins Hospital led to the discovery of a completely unintended and unforeseen health and safety hazard with a new catheter device that was actually supposed to make patient care easier and safer.

According to Dr. Trish Perl, senior hospital epidemiologist and an associate professor of medicine and pathology at The Johns Hopkins University School of Medicine: "No one could have anticipated this outcome. But, our experience underscores how advances in technology designed to improve health care may also have hidden risks to patients that can only be identified by paying close attention to what happens after the technology is put into practice."

As reported in the current online edition of the journal of Infection Control Hospital Epidemiology, the new device known as the Alaris SmartSite Plus intravenous catheter valve, caused a steep increase in potentially deadly bloodstream infections contracted by patients in Johns Hopkins’ pediatric intensive care unit (PICU) and other ICUs.

Although no one at the hospital died from the infections, the anomaly caused a great deal of concern and could have turned out much worse, indeed.

As a result of the discovery of the problem, an internal investigation was launched by the hospital and headed up by Dr. Lisa Maragakis, the hospital’s epidemiologist, who stated: "While new technology in health care is frequently beneficial or easier to use, it takes time and use to determine whether these devices are in fact safe. It may be harder to clean and disinfect some new technologies, which can lead to potential complications. New medical devices should be monitored after their introduction as closely as drug therapies because, as more hospitals are finding out, the ‘bug’ may be in the equipment itself."

The Alaris device and others like it are considered safer and easier to use than previous models because a positive pressure feature prevents blood from flowing back into the catheter. The valve also contains an enclosed needle plunger with a screw-top for easy attachment to syringes for administering medications and taking blood samples.

Unfortunately, as the Hopkins investigation revealed, the Alaris device and others like it also have ridges in the screw-top mechanism that could potentially catch blood or other fluids, thereby providing a breeding ground for possible infections. An opaque plastic cover made it impossible for hospital staff to see through it to make sure that such fluids were cleaned out between procedures.

According to Dr. Maragakis, who is also an assistant professor at Hopkins: "Guarding against bloodstream infections is a daily battle in the hospital environment because patients are unusually susceptible to catching something hazardous, many are weak from their own illness with limited immune defenses, and they are also at increased exposure to other sick peoples’ germs."

Patients in intensive care are already at greater risk for picking up infections because have intravenous tubing such as a central catheter put inside them. Such openings in the body make ICU patients vulnerable to dangerous bacteria.

A spike in bloodstream infections in the PICU triggered an investigation that then analyzed statistics compiled quarterly by the hospital that revealed bloodstream infections in the catheterized patients in the ICU had increased dramatically over the latter half of 2004.
At first, the staff was stumped by the increase and approached the problem by tightening up and monitoring safety practices and following infection control procedures “to the letter.” When all human error was eliminated, the investigative team concluded the likely source of the problem was mechanical.

Fortunately, one of the infection control staff, Karen Bradley, R.N., B.S.N., had recently attended a national meeting of medical professionals where participants discussed reports of new catheter valve devices being linked to an outbreak of bloodstream infections. The design of the device appeared to be the problem in that it did not allow for a complete  cleanout of fluids thereby permitting blood and other fluids to collect and serve as a source of infection.

Upon recognizing the similarity to the previously reported case, Bradley also found that a new catheter device had been introduced at Hopkins. When the old-style catheters were re-introduced in the PICU, the bloodstream infections there quickly dropped back to previous baseline levels.

These results prompted the hospital to discontinue the use of the new device throughout the hospital. Hopkins also reported its findings to the Food and Drug Administration (FDA), the agency that approves the use of medical devices, and the Centers for Disease Control and Prevention (CDC), which monitors infections in hospital.

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