Nursing and Human Factors Collaboration Optimized Power Injection Indicator

1. Nursing and Human Factors Collaboration Optimized Power Injection Indicator • Tracy VonBriesen RN, BSN • Sr. Manager Medical Affairs , Baxter Healthcare Corp • Angela Muriset • Principal Human Factors Engineer, Baxter Healthcare Corp Table 1 Objectives To help prevent the mechanical failures of vascular access devices, medical device manufacturers began to develop catheters and catheter extension sets that could withstand the increased pressures seen during injection of contrast media. Currently, there is no standardized method to identify devices that can be safely used during power injection. Color coding is one method that manufacturers have used to identify their devices as capable of withstanding power injection. However, this can lead to confusion and risk for misconnections. So what can manufacturers do instead? In order to develop an effective indicator for it’s newly developed power-injectable catheter extension set, Baxter used a collaborative approach, involving both nursing and human factors engineering. Human factors engineering (HFE) is “the application of knowledge about human capabilities (physical, sensory, emotional, and intellectual) and limitations to the design and development of tools, devices, systems, environments, and organizations…HFE involves the use of behavioral science and engineering methodologies in support of design and evaluation.”3 According to ANSI/AAMI HE75: 2009, development of safe and effective medical devices relies upon the application of human factors processes and principles.3 Baxter’s approach to developing the power injection indicator on the new catheter extension set was a collaborative approach. It consisted of evaluations of prototypes with intended users and developing an understanding for the risks associated with the product and the use environment. The ability to apply human factors techniques, while leveraging strong understanding of the clinical users and environment, ultimately led to the successful indicator design. Abstract During the development of new catheter extension sets, it was necessary to provide a visual indicator on sets that can be used during power injection. Human Factors and nursing collaborated to evaluate four prototype indicators. Together with a review of the literature regarding use of color coding and the risks of misconnections, the results of the user evaluation informed the manufacturer’s decision of which prototype indicator to implement in the final design. • The objectives of human factors engineering and nursing were to develop an indicator that would allow the clinician to determine that a catheter extension set can be used during CT and MRI scans without the risk of ruptured tubing. The indicator needed to: • Provide a message that is easily understood with little or no training • Remain with the device throughout the life cycle of the device • Be able to be used hospital wide without increasing risk for misconnection Background Methods In 2009 nursing and HFE met with CT technicians and nurses from across the United States during a series of customer visits. The clinicians were interviewed to evaluate their understanding of the meaning of the indicators on four different power injectable catheter extension set prototypes. Following the customer visits, a literature search was completed to evaluate if there were risks associated with any of the indicators that were not mentioned by the clinicians that could increase the potential for misconnections (i.e., connecting something other than an IV system component to the devices). • The use of contrast media injections during CT-scans has significantly increased in the United States, from approximately 18 million CT- scans performed in 1993 to greater than 70 million in 2007.1 Although CT–scans have proven to be a valuable tool to help diagnose and manage diseases, they have inadvertently increased risk to patients with vascular access devices. • The FDA issued a reminder about the potential for serious injury related to the use of vascular access devices not designed to withstand the high pressures exhibited during CT-scans and MRI procedures2. • Reported adverse events included device ruptures of central venous catheters, implanted ports, catheter extension sets, and small peripheral catheters. Many of these ruptures resulted in: • Required surgical intervention • Loss of venous access • Clinician exposure to blood and contrast media Results Prototype Evaluation Seventeen clinicians (N=17) were interviewed individually or in small group settings. Table 1 shows the clinicians’ responses associated with each prototype. Overall, the clinicians preferred prototype D: purple stripe along the tubing with 325psi/2241kPa embossed on the clamp.

2. Nursing and Human Factors Collaboration Optimized Power Injection Indicator Tracy VonBriesen RN, BSN Sr. Manager Medical Affairs , Baxter Healthcare Corp Angela Muriset Principal Human Factors Engineer, Baxter Healthcare Corp Table 1: Results of Prototype Evaluation PrototypeB: Prototype D: PrototypeC: • PrototypeA: • Printing of 325 psi/2241 kPa along the tubing- purple clamp • Favorable Response: • Clinicians understood the significance of the “325psi/2241kPa” • Unfavorable Response: • Written text on the tubing was difficult to see • Printing of 325psi/2241kPa along the tubing - 325psi/2241kPa embossed on purple clamp • Favorable Response: • Clinicians understood the significance of the “325psi/2241kPa” writing on the clamp and liked the printing located on the clamp • Unfavorable Response: • One clinician felt the text on the tubing and slide clamp would require additional education because patients would want to know what it means • One clinician thought the text on the clamp was not necessary • Purple stripe along the tubing- purple clamp • Favorable Response: • The majority of the clinicians associated purple with power injection and the purple was easily seen across the room • Unfavorable Response: • Clinicians may think there is blood or medications left in the line • Would need education to what purple means • One clinician warns against using the color purple alone as this may be confused with other manufacturers who use different colors • One clinician felt the pressure rating should be somewhere on the device • Purple stripe along the tubing 325psi/2241kPa embossed on purple clamp • Favorable Response: • The majority of the clinicians associated purple with power injection and the purple was easily seen across the room • Like the text written on the clamp • Unfavorable Response: • Clinicians may think there is blood or medications left in the line • Once the clinician understands the text on the clamp, they will rely on the color purple to determine if the device is power injectable

3. Nursing and Human Factors Collaboration Optimized Power Injection Indicator Tracy VonBriesen RN, BSN Sr. Manager Medical Affairs , Baxter Healthcare Corp Angela Muriset Principal Human Factors Engineer, Baxter Healthcare Corp Literature Review Infusion Nurses Society The Joint Commission ISMP • In 2009, the Institute for Safe Medical Practices published a medical safety alert stating that purple is not an official standard for either enteral feeding equipment or PICC lines. The alert highlighted a medication error when a nurse infused oral KEPPRA (levetiracetam) into the patient’s vascular system via a power injectable PICC. The color purple may have played a role in the nurse incorrectly identifying the route of administration :4 • ISMP warns against the use of color coding in medical devices due to:5 • Poor memory recall for color • Potential confusion with other medical devices with similar color • Potential to misperceive color due to dark hospital rooms or colored medications may change the appearance of the medical device • Potential to instill a false sense of security without tracing lines. 2011 Standards of Practice Standard 17: Verification of Products and Medications, INS warns against the use of color coding as well: “Practice Criteria A: The nurse should not use color coding, color differentiation, or color matching for product or medication identification. Color coding can lead users to rely on the color coding rather than ensuring a clear understanding of which tubing and catheters are connected.” 6 In 2006, The Joint Commission published a Sentinel Event Alert related to misconnections of medical devices in the clinical setting.7The medical devices included central venous catheters, feeding tubes, peritoneal dialysis catheters, blood pressure insufflator tubes and tracheostomy cuffs. Risk factors associated with the misconnections include patients moving from one clinical area to another and healthcare worker fatigue.7 Although the use of color coding is intended to aid the clinician to identify different tubes and catheters, The Joint Commission warns against using color coding: “This can lead users to rely on the color coding rather than assuring a clear understanding of which tubes and catheters are connected correctly to which body inlets. In addition, the training and educating of all staff (including temporary agency and travel staff) about the institution’s color-coding system requires continuing attention. Finally, color-coding schemes often vary across institutions in the same community, creating increased risk when agency and travel staff are used”.7 Figure 1

4. Nursing and Human Factors Collaboration Optimized Power Injection Indicator • Tracy VonBriesen RN, BSN • Sr. Manager Medical Affairs , Baxter Healthcare Corp • Angela Muriset • Principal Human Factors Engineer, Baxter Healthcare Corp Conclusions References Input from the clinicians during the prototype evaluation demonstrated that most clinicians associated the color purple with power injector compatibility. Clinicians all understood that the terminology “325psi / 2241 kPa” identified the extension sets as power injectable compatible. While clinicians had preferences among the four prototypes and offered suggested improvements, all four prototypes were acceptable in terms of meeting the intended users’ needs surrounding identification as power injectablecompatible. Knowing that all four prototypes would be acceptable to the intended user, nursing and HFE turned to the literature review to guide the selection of the final concept. The development team determined that even though the clinicians associated the color purple with power injectable compatibility, it should be eliminated from the device so that the indicator used for CT/MRI procedures would not inadvertently lead to misconnections in other areas of the hospital. The team selected prototype B with “325psi / 2241 kPa” written along the tubing, and chose to enhance the font for improved legibility while maintaining visualization of the fluid path. The clamp is embossed with “325 psi/2241 kPa” and the color of the clamp was changed from purple to white, thus removing the risk for misconnections associated with color. A collaborative human factors approach entails more than just developing the product that a user states he, or she prefers. In this instance, data was collected from 17 intended users in a way that allowed the development team to understand their needs and the constraints of their workflow and environment. Once this understanding was cultivated, the solution could be developed in a way that would meet user needs and also minimize risks that had been identified analytically through the literature review. The balance of methods and collaborative participation of nursing, human factors engineering and end users led to the successful development of the final product. • Sarma, Asha, et al. "Radiation and Chest CT Scan Examinations Radiation and Chest CT Scan Examinations What Do We Know?." CHEST Journal 142.3 (2012): 750-760. • "Reminders from FDA Regarding Ruptured Vascular Access Devices from Power Injection." Www.FDA.gov. U.S. Food and Drug Administration, 21 Mar. 2013. Web. 17 Mar. 2014. • ANSI/AAMI HE75: 2009. "Human factors engineering-Design of medical devices.” • Alert, ISMP Medication Safety. “Acute Care" Purple is not an official standard for either enteral feeding equipment or PICC lines 14.11 (2009): 2. • Alert, ISMP Medication Safety. “Acute Care" Will color-tinted IV tubing help? July 30, 2009. • Infusion Nurses Society (INS): Infusion nursing standards of practice, J InfusNurs34 (suppl 1S):S1-S110, 2011 • “Sentinel Event Alert: Tubing Misconnections—a Persistent and Potentially Deadly Occurrence." Www.jointcomission.org. The Joint Commission, 3 Apr. 2006. Web. 17 Mar. 2014. • Baxter is a registered trademark of Baxter International Inc. Any other trademarks, product brands or images referenced herein are the property of their respective owners.