Reducing Medication Error: Systems Approach, Human Factors & Usability Testing

It is currently estimated that over 250,000 deaths from medical errors occur yearly in the United States (Makary & Daniel, 2016; James 2013).

That estimate makes medical errors the third leading cause of death in the United States, a subset of which is related to medications. In fact, the U.S. Food and Drug Administration (FDA) estimates receiving over 100,000 reports of suspected medication errors each year (Federal Food and Drug Administration, 2019).

What exactly falls under “medication error”? The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer” (© 2020 National Coordinating Council for Medication Error Reporting and Prevention. All Rights Reserved.). Simply put, they are medication use mistakes made by the end user that could have been avoided.

When we enter a hospital or clinical care environment, we expect to have our health needs addressed in a way that improves, not worsens, our overall health and safety. Even when we are outside of a clinical care environment, interacting with a home-use medical device or taking a medication, we do so with the intent on improving our health. With the high rate of error incidence, patients are finding themselves at increased risk in moments intended to increase health.

VIEW THE INDUSTRY THROUGH A SYSTEMS LENS

One approach to improving healthcare safety is to view the industry through a systems lens. This shifts healthcare away from a blaming culture and towards a just culture. Taking a systems approach provides insight for understanding when and how errors occur instead of automatically jumping to blaming the clinician for the error. When we view a hospital as a system, we see that a hospital is made up of several subsystems such as the staff, devices, medications, units (i.e., emergency room, ICU, etc.), and patients. When we view a medical device, such as an autoinjector, as its own system, we see that the system is made up of individual components that allow for the injections to be completed (e.g., needle shield, button, viewing widow, etc.). The success of hospital system is determined by the success of the interactions between the human users (staff and patients) and technology (devices) within the clinical environment (units). Successfully completing an injection is based on the user’s ability to comprehend the application and effectively and safely use the device to deliver the medication within the hospital system.

INTEGRATE HUMAN FACTORS

Part of improving the performance of the overall healthcare system is working towards improving healthcare subsystems such as medical devices. How do we do that? One way that drug and device companies can improve their products in the healthcare setting is through the use of human factors. Human factors is a scientific approach to increasing the usability, efficiency, and safety of human users and the systems in which they operate. Furthermore, human factors integration in clinical settings via embedded or non-embedded researchers and in device development via human factors practitioners allow for the mitigation of safety issues. In clinical settings, human factors researchers and practitioners investigate human interactions with device and software technology within healthcare. Research is conducted to investigate how cognitive and affective states, such as workload and stress, as well as the vigilance performance of the users are influenced through the use of technology. These investigations seek out ways of improving the overall performance of the human-machine system within clinical-based environments (e.g., monitored floors, operating rooms, emergency rooms, etc.). During device development, human factors practitioners (i.e., human factors engineers, researchers, consultants, etc.) apply their knowledge and expertise throughout the design lifecycle to improve the safety and effectiveness of medical devices that deliver medications or other therapeutic interventions in clinical and non-clinical environments. 

COMPLETE USABILITY TESTING DURING DEVICE DEVELOPMENT

We mentioned two reasons for the integration of human factors within your organization in our previous blog (See HF101: What is Human Factors?). Those reasons stem from the requirements of regulatory agencies and the benefits related to producing well-designed products. The safety and effectiveness of medical device designs is influenced by the completion of usability testing. The FDA requires that medical devices undergo human factors usability testing prior to receiving their approval and provide their own guidance for the application of human factors (See FDA HF Guidance). International standards such as ISO 62366 provide requirements for the application of human factors/usability engineering to medical devices while other documents such as ANSI/AAMI HE75 provide guidance for the design of medical devices.

The purpose of completing usability evaluations is to proactively attempt to discover and mitigate design flaws prior to a product being released. However, no matter how well the usability study is designed, it is possible for new use errors to be discovered once the product enters everyday service. The FDA collects safety information and adverse events for FDA-regulated biologics, medical devices, and medications as reported by those who are required (e.g., manufacturers) make a report and those who voluntarily report the information (e.g., consumers) via MedWatch. In addition to providing a system for reporting events, the public can search through the FDA’s database, called the Manufacturer and User Facility Device Experience (MAUDE). This information is available to the public and can provide insight into use errors after the product has been put into service. Manufacturers can use this information to assist and inform their own designs to help avoid similar pitfalls of the similar predecessor devices.

Medical devices come in many shapes and sizes, provide intervention for many different diagnoses, while being used in a wide range of environments. When completing a usability test, it is important to consider the users, uses, and use environments of the medical device you are testing.

User – Who will use the device?

A user is considered anyone that may interact with the device. Each user presents their own unique perspective for using a device. This may come from using a predicate device or a similar type of interface. Users are also driven by the type of training (regardless of formal or informal training) that they have received. The importance of the user characteristics speaks to how the user will interpret the information that is presented to them by the device. Therefore, it is important to identify the typical users for the device you are evaluating (e.g., evaluate a ventilator with respiratory therapists). Some categories of users include:

• Healthcare Practitioners (e.g., nurses, doctors, respiratory therapists, pharmacists, etc.)
• Caregivers (i.e., have some level of training)
• Laypersons (e.g., average untrained users such as yourself, parents, grandparents, etc.)

Uses – How the device will be used?

When developing the tasks for the study it is important understand the purpose for the device. The device’s intended use will inform the typical actions users will be required to make when using the device in actual care environments, like in a patient’s room or in an operating room. For example, a defibrillator requires specific steps (i.e., having no one touching the patient while defibrillating) to occur to ensure the safety of all parties. Examples of the reasons for using medical devices include:

• Delivering medication (e.g., autoinjectors, pre-filled syringes, nebulizers, etc.)
• Regulating heart beats (e.g., implantable pacemakers)
• Sustaining life (e.g., ventilators)
• Completing diagnostics (e.g., MRIs, X-rays, heart monitors, etc.)

Use Environment – Where the device will be used?

When determining the use environment for the usability study it is important to remember what the actual use environment will be for the device. This will help determine if an actual use environment test or simulated-use test is more appropriate. When completing simulated use testing it is important to make every effort to replicate the actual use environments of the device. Each use environment presents its own unique obstacles that make it more or less conducive for effective device use. Environmental factors such as lighting and noise can influence how well a device is used. The lighting influences how well a user can read, identify, or interpret the presented information. Noise level is one of the factors that influences the amount of distractions that the user potentially experiences, but also an environment with too much background noise can allow important sounds (i.e., start-of- or end-of-dose clicks). Some examples of use environments include:

• Clinical (e.g., doctors’ offices, hospitals, urgent care facilities, etc.)
• Nonclinical settings (e.g., apartments, homes, parks, airports, etc.)

Understanding the users, uses, and use environments of the device will provide insight into design considerations that may or may not have been originally considered during early phases of device development. For example, attempting to use a device with gloves vs. without gloves can result in varied outcomes. Knowing information such as the target users, why the device is being used, and real use environments, combined with the risk analysis of the device, will enable the usability specialist to more effectively generate the tasks for the usability evaluation. Generating the tasks based on the risk analysis will create the list of critical steps that must be attempted and validated during the usability study. A conclusion of the device’s safety and usability can only be drawn if the critical steps have been evaluated.

CONCLUSION

Using a systems lens, integrating human factors, and using both throughout the development process are methods for reducing medication or medical errors to improve patient outcomes.  A healthcare provider’s number one concern, at all times, should be providing the highest standard of care to every patient without having to worry whether or not their equipment will hinder their ability to care for their patients. Therefore, a medical device manufacturer’s number one concern should be to design the most user-friendly and safe devices possible prior to proceeding to commercialization and prompt corrective actions to remedy post-market issues.

Remember, human factors is a regulatory requirement, but it can also lead to broader adoption of your product. If you feel your team needs guidance or support to make human factors a reality for your products, Suttons Creek will assist your team at any phase of the design process. At Suttons Creek, we are proud to support our clients on the journey of providing the highest-quality medical devices available to their consumers. Our human factors team has the expertise to aid you with all your human factors needs. Our team has experience with over 100 formative studies, over 40 summative studies, and all our summative work has been approved by the FDA. Together we can make healthcare safer for both clinicians and patients.

By: Matthew Nare, Consultant – Matthew Nare is a junior consultant on the human factors team for Suttons Creek, Inc. His previous work as a physical therapy aide provided an opportunity to gain clinical experience in inpatient and outpatient rehabilitative care settings. He came to Suttons Creek, Inc. following an internship completing clinical observational research with MedStar Health’s National Center for Human Factors in Healthcare. Additionally, he spent over a year completing accessibility evaluations at Cal State Long Beach’s Center for Usability in Design and Accessibility. This combination of work experience and his educational background provides him with a unique perspective on how the medical devices and their users function.

LinkedIn: Matthew Nare

Sources:

Food and Drug Administration (August 23, 2019). Working to reduce medication errors. Retrieved June 19, 2020.

James, J. T.  (2013). A new, evidence-based estimate of patient harms associated with hospital care. Journal of Patient Safety, 9(3), 122-128. doi: 10.1097/PTS.0b013e3182948a69 

Makary, M. A. & Daniel, M. (2016). Medical error – The third leading cause of death in the US. British Medical Journal, 353, 1-5. doi: 10.1136/bmj.i2139