March 21, 2012

Understanding the Infusion Pump Crisis

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A process-based analysis to better understand why smart infusion pumps have become so problematic. Hint: Design alone is not to blame.

The use of smart infusion pumps has become ubiquitous in many U.S. and international clinical settings due to the tremendous patient benefits these devices offer. Briefly, infusion pumps are medical instruments that deliver medications to a patient’s body in a “controlled, precise, and automated manner” (FDA, 2010, p. 2). There are several key attributes that distinguish smart infusion pumps from their more traditional counterparts. The key benefits of smart infusion pumps include: (1) the ability to incorporate a large medication library into the device, (2) the ability to alert users of potential use errors, and (3) the ability to collect usage data, which can be used to improve work practices.

These benefits, however, do not eliminate use-related risks. Improper use of and/or malfunctioning smart infusion pumps can cause serious adverse health effects and even death. In fact, since 2005 more than 56,000 reports of adverse-related events have been reported and more than 87 product recalls have been conducted (FDA, 2010, p. 3). This is important to understand because 90 percent of hospital patients take advantage of infusion pumps during their stay in the hospital (Brady, 2010).

Are We Identifying the Right Problems?

The dichotomy is clear, but what is not clear is why smart infusion pumps have become so dangerous. Unfortunately, many stakeholders, including the FDA, have been quick to point out inadequacies in infusion pump designs as key obstacles to patient safety. While design flaws have been identified, the real problem is more complex and involves multiple systems and stakeholders. Design alone cannot solve the entire problem. It is important, therefore, that we use a detailed analysis of the infusion pump process to identify more pervasive issues.

Systemic Challenges to Smart Infusion Pump Design

The opportunity for error occurs across multiple steps of the infusion pump process, with many occurring both before and after actual use of the smart infusion pump. Therefore, the infusion pump process will be analyzed according to six key areas to better understand why certain problems have persisted. Key areas include: (1) policy, (2) prescribing and ordering, (3) medication storage, (4) medication preparation, (5) administering, and (6) monitoring.

Policy One of the biggest challenges to understanding the root cause of problems associated with infusion pump use is the lack of infusion pump standards. There is little agreement on what should be standardized, let alone what the standards should be. Many stakeholders believe consensus on infusion pump standards would lead to immediate, short-term benefits and safer infusion pump use. As a starting point, standards should include drug name, recommended minimum and maximum dosages, upper and lower administration rate limits, standardized concentrations, and dosing units. The standards should also address special cases, including certain patient populations and clinical conditions, medication administration techniques (i.e., IV push), and monitoring requirements (ASHP, 2008).

Despite the relative acceptance of these measures, there are still many challenges to overcome. For example, the culture of fear propagated by liability concerns has made it increasingly less likely that practitioners will share their drug libraries. Nothing short of a cultural shift will help overcome the secretive nature of this information, which would allow drug libraries to be more accurate and more comprehensive.

Prescribing and Ordering Current prescription and ordering practices do not dictate how IV medications are ordered. Practices differ amongst practitioners, geographical regions, and clinical settings. As a result, different medications often end up looking very similar, leading to confusion and increasing the likelihood of administering errors. This situation could be improved by decision support systems that reinforce best practices at the point-of-care, which smart infusion pumps are in a unique position to provide.

Medication Storage States often control professional regulations, including storage practices, which can lead to very different practices from one clinical setting to the next. Drug compounding, for example, often takes place in different locations, making it difficult to store “commercially available ready-to-administer infusions” in consistent locations, such as patient care areas (ASHP, 2008, p. 2370). Unfortunately, storage problems are not something that can be solved by the design of the infusion pump itself. Only standardized storage practices will lead to quicker response times and improved patient outcomes.

Medication Preparation Many IV medications come in forms that need to be manipulated by a person before being administered. Leaving the admixing to any practitioner, however, leaves the door open to human error. In addition, there is no recognized format for labeling admixtures (ASHP, 2008). These are both key causes for concern. Providing medications in ready-to-administer form would greatly reduce IV drug administering errors, and standardized labels with machine-readable bar codes would enable smart infusion pumps to verify the correct medication is being delivered to the right person.

Administering Administering the drug is one of the most difficult steps of the process because the hospital environment challenges the user’s ability to make appropriate decisions. In addition, many users will find workarounds for systems that unintentionally increase time delivering medication (Yang, Ng, Kankanhallia, & Yip, 2011). The perceived need for speed consistently outweighs safe practices in clinical settings (Koppel, Wetterneck, Telles, Karsh, 2008). It is not surprising, then, to discover that users override approximately 90 percent of all infusion pump alarms (Brady, 2010). Smart infusion pumps can and should be designed to promote safe administering practices while limiting the ability of users to practice unsafe workarounds.

Monitoring There is no national standard operating procedure for documenting and/or responding to suspected medication errors, leading to the pervasive inability to identify the root causes of problems. This may be the result of the punitive culture of the healthcare environment itself. As the ASHP pointed out, there is a general “fear of blame and punishment for reporting errors or raising safety concerns” (2008, p. 2373). Unfortunately, this has led to a surprising lack of data that could lead to a better understanding of smart infusion pump usage. One benefit of utilizing smart infusion pumps is the ability to capture and analyze usage data, which would help identify bad practices.

Concluding Discussion

Drug libraries will never be complete and nor should they be. As a result, smart infusion pump systems cannot exist without regular library updates. Effective library updates and maintenance can be achieved through a committed interdisciplinary staff, including stakeholders that may not have been traditionally involved, such as information technology (ISMP, 2009). The updates should be closely monitored by regulated oversight.

Clearly, design alone is not to blame for the problems facing smart infusion pumps. New medicine and patient care options will continue to expand and smart infusion pumps need to keep pace with the advances in medicine. The problems that have been outlined, which are certainly not exhaustive, exist throughout the process and the environment of use. The future of safe smart infusion pump use depends wholly on improved practices throughout the process, including standardization of healthcare practices, an improved culture of trust and safety, and a collaborative effort that leads to consensus on safe practices.

*This article was originally featured in Consultant's Corner, a Qmed publication, on March 12, 2012.

References

American Society of Health-System Pharmacists (ASHP). (2008, July). Proceedings of a summit on preventing patient harm and death from i.v. medication errors. American Journal of Health System Pharmacy, 65, 2367-2379.

Brady, J.L. (2010). First, do no harm: making infusion pumps safer. Biomedical Instrumentation & Technology. 44(5), 372-380.

Koppel, R., Wetterneck, T., Telles, J.L., Karsh, B. (2008). Workarounds to barcode medication administration systems: Their occurrences, causes and threats to patient safety. Journal of the American Medical Informatics Association, 15(4), 408-423. DOI: 10.1197

Institute for Safe Medication Practices (ISMP). (2009). Proceedings from the ISMP summit on the use of smart infusion pumps: guidelines for safe implementation and use. Retrieved from: http://www.ismp.org/tools/guidelines/smartpumps/comments/printerVersion.pdf

U.S. Food and Drug Administration, Center for Devices and Radiological Health. (2010). White Paper: Infusion Pump Improvement Initiative. Retrieved from U.S. Food and Drug Administration website: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm205424.htm

Yang, Z., Ng, B., Kankanhallia, A., & Yip, J.W. (2011). Workarounds in the use of IS in healthcare: A case studyof an electronic medication administration system. International Journal of Human-Computer Studies, 70(2012), 43–65. DOI: 10.1016/j.ijhcs.2011.08.002

Tags: Medical Devices Medical device design Infusion device Infusion pump

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