Pennsylvania Patient Safety Advisory CT Contrast Media Power Injectors Can Rupture Conventional IV Sets ABSTRACT The patient IV tubing split during power injection of PA-PSRS has received reports of intravenous (IV) tub- contrast; contrast went all over the patient. ing rupturing during contrast media injections into patients during computed tomography scans. Many The patient was given [brand name omitted] IV con- of these occurrences result in contrast or blood and trast during a CT scan when the IV tubing ruptured. fluids contacting patients or staff. Similar events have Members of the staff were sprayed with blood and also been reported to the U.S. Food and Drug Admin- fluid. istration (FDA). Contact with contrast media or blood A Breakdown of the Problem and fluid could result in harm to patients or staff. In addition, rupture of a set would cause delay or can- To prepare the patient for a contrast study, the clini- cellation of the contrast study. Often, conventional IV cian connects the power injector to the proximal tubing, which can easily rupture, is used to introduce end of the tubing. The distal end of the tubing is the contrast media through a power injector, spraying connected to a vascular access port, typically at a contrast medium or blood and fluid onto patients or peripheral intravenous access site (e.g., the hand) on staff. FDA has developed guidelines to prevent harm the patient. The contrast medium is then delivered to to patients and staff during contrast injections, which the patient. For CT scans, typical power injector peak include checking the labeling of each vascular access pressures can be between 300 to 325 psi, but could device for its maximum pressure and flow rates, know- exceed those pressures because of problems related to ing the pressure limit setting for the power injector the patency of the access or some other obstruction.1 and how to adjust it, and ensuring that the pressure Those pressures can exceed the maximum pressure limit set for the power injector does not exceed the tolerances of conventional IV sets, which can typi- maximum labeled pressure for the tubing or other cally tolerate 10 or 15 psi for IV or epidural delivery, vascular access device. (Pa Patient Saf Advis 2008 respectively.1 Therefore, the higher pressures of power Sep;5[3]:136-7.) injectors can readily cause conventional IV tubing to rupture. Even when the conventional IV tubing has not been visibly damaged by the high pressures of the injector, the seals of the IV tubing connectors may Contrast media are sometimes used during computed become compromised, potentially causing leaks or air tomography (CT) and magnetic resonance imaging entrained into the IV sets.1 scans to enhance the contrast between blood ves- Conventional IV sets are often used for contrast sels and their surroundings, such as in angiograms.1 media injection as a matter of convenience. For Typically, a contrast medium is introduced into a example, some patients may already have an IV set patient’s blood vessel via a power injector. Contrast connected to an access port (e.g., for medication IV power injectors are typically flow-rate controlled therapy) before undergoing a contrast study. Using with user-adjustable pressure-limiting capability. The this existing set is convenient for clinicians because flow rate is dependent on solution viscosity, solution they do not have to create a new access site or volume, pressure, and the cross-sectional area of the disconnect the set from a catheter and connect a high- tubing. Often, the contrast is introduced though pressure set specifically designed for use with power conventional intravenous (IV) sets (i.e., sets used with injectors. However, using the existing set creates infusion pumps to deliver medication therapy), which opportunities for the set to rupture or leak. The con- may rupture if the injector pressures exceed the pres- sequences of such occurrences could result in harm to sure tolerance of the IV set. A ruptured IV set can patients or staff. expose a patient or staff member to the contrast solu- The U.S. Food and Drug Administration (FDA) has tion or blood and fluid, potentially resulting in harm. identified some consequences of ruptured IV sets, For example, contrast solution or blood sprayed into including IV set fragmentation, sometimes with the eyes of a patient or staff member could result in embolization or migration requiring surgical interven- burning of the eyes or cross-contamination, respec- tion; extravasation of contrast media; loss of venous tively. Between July 2004 and March 2008, 29 reports access requiring set replacement; and contamination were submitted to PA-PSRS related to IV tubing rup- of the CT room and personnel with blood and con- turing during contrast media injection into patients. trast media.2 Another consequence is compromised Below are descriptions of a few of the reports submit- patient therapy, brought about by reuse of a conven- ted through PA-PSRS. tional set for IV therapy after contrast injection, in which the set may have sustained a leak due to the The patient underwent a CT scan with IV contrast. high pressure of the injector. Additionally, when IV The IV tubing ruptured and the patient was splashed tubing ruptures during injection, as demonstrated in the eyes with the contrast. in the PA-PSRS reports above, contrast is sprayed or Page 136 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Vol. 5, No. 4—December 2008 Pennsylvania Patient Safety Advisory spilled from the IV set, resulting in delay or cancella- ■ Check the labeling of each vascular access device tion of the contrast study. for its maximum pressure and flow rates. If none are provided, assume that the device is not FDA Reports of Ruptured IV Tubing intended for use with power injectors and do not A search of FDA’s Manufacturer and User Device use it. Experience (MAUDE) database, using the keyword ■ Know the pressure limit setting for your power search terms “power” and “injector” and “ruptured,” injector and how to adjust it. revealed 158 reports between 1996 and 2008 describ- ing similar events of conventional IV tubing rupturing ■ Ensure that the pressure limit set for the power during contrast media power injection, some resulting injector does not exceed the maximum labeled in patient blood loss. Many of the manufacturer nar- pressure for the vascular access device, but is ratives from the reports concluded that conventional not too low so as to compromise the quality of IV sets were used instead of the recommended high- the study. pressure sets appropriate for use with power injectors. Notes FDA Prevention Guidelines 1. ECRI Institute. A high-pressure situation: conven- tional IV sets can burst when used with CT contrast FDA has developed the following guidelines to pre- media injectors [hazard report]. Health Devices 2004 vent or minimize harm to patients or staff and, as a Mar;33(3):100-2. secondary benefit, to prevent damage from ruptured 2. U.S. Food and Drug Administration. Reminders from IV tubing or other venous access devices when used FDA regarding ruptured vascular access devices from with power injectors:1, 2 power injection [online]. 2004 Jul 7 [cited 2008 Aug ■ When possible, avoid the use of conventional IV 29]. Available from Internet: http://www.fda.gov/cdrh/ tubing with contrast media power injectors. medicaldevicesafety/tipsarticles/reminder-rvad.html. Vol. 5, No. 4—December 2008 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Page 137 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 5, No. 4—December 2008. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority as part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). Copyright 2008 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to https://www.papsrs.state.pa.us/ Workflow/MailingListAddition.aspx. To see other articles or issues of the Advisory, visit our Web site at http://www.patientsafetyauthority.org. Click on “Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the PA-PSRS program, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the PA-PSRS program or the Pennsylvania Patient Safety An Independent Agency of the Commonwealth of Pennsylvania Authority, see the Authority’s Web site at http://www.patientsafetyauthority.org. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.