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Repairing Healthcare: Reducing Medical Error by Design

REPAIRING HEALTHCARE:

Reducing Medical Error           by Design

Rebekkah Carney, MIM

 On May 6, 2016, The Guardian published an article claiming that medical error was the third leading cause of death in the United States, responsible for 9.5% of annual deaths, and claiming at least 250,000 US lives in 2015. While shocking, this actually represents a reduction of almost half from estimates cited by The Journal of Patient Safety in 2013, before hospital quality and accountability measures came into effect. The horrible extent of the current impact of medical error in healthcare is evident when we calculate not only the huge loss of lives, but the additional harm to the two to four million patients a year subject to grave medical error who survive.

The costs associated with medical error and the desperate measures to reverse those errors is huge. Between malpractice, treatment, and impact on livelihood, it has been conservatively estimated at $1 trillion USD per year. A portion of these cases can be attributed to medication or prescription error, professional incompetence, or overworked staff and understaffed facilities, to be sure. However, there is a substantial opportunity for us as medical device engineers, designers and manufacturers to have a positive role in reducing medical error by building devices that make it easier to do the right thing than the wrong one.

User-based design that incorporates human factors as a core part of the R&D program rather than just as a validation test or as a regulatory afterthought is critical to this process. Not only does the FDA look favorably on proof that user experience and the principles outlined in ANSI/AAMI HE:75 are incorporated in the design of a device, but a device incorporating these factors in its design has a competitive advantage in both ease of use, and cost savings associated with reduced incidence of medical error.

It’s no longer enough to build a corrective iteration of a previous product with recall issues (infusion pumps of every type), unclear labeling (drug packaging), indistinguishable alarms (patient monitoring), or that failed to navigate the tradeoff between small incision size and low visibility of the patient anatomy (laparoscopic instruments), to name a few examples. And it’s not enough to rely on bench testing in a lab environment, followed by a testing protocol finalized shortly before a 510k submission. As designers, engineers and manufacturers, we have to understand our users before embarking on the design process, and understand that users are not necessarily masters of the tools we build and that the margin for acceptable error is very small indeed.

Users themselves might be everyone from patients and caregivers to surgeons, nurses, and even payors managing patient risk for the patients. Understanding the following from the perspective of the user is critical to creating a device that minimizes medical error risk:

·        Intended use, preparation, maintenance, and disposal of the product

·        Associated risk if the product is not used, maintained, or disposed of as intended

·        Cognitive, perceptual  and biomechanical limitations of the user

·        Psychosocial perceptions associated with various designs

·        Ease of interface with software and hardware components

·        Ease of communication (hours are wasted in hospitals throughout the country because the staff can’t determine which piece of equipment is--or is not--working)

·        The stress, resources, and workload associated with the use environment

The key to effective design that minimizes the impact of medical error on patients, healthcare practitioners and institutions, and healthcare costs is understanding the user’s needs, capabilities and environment before generating the design. The HE:75 is not a mere checklist, it’s a practice guide. The recommendations help us address and test the needs of users with regard to maximizing safe and effective use, but it’s up to us to do the legwork to understand the user’s needs before we go to the drawing board. The good news is that our efforts yield savings for healthcare and competitive advantage for our products, which is a rare win-win in the industry.

Rebekkah Carney, MIM has been conducting market research on behalf of the medical device industry for over 20 years. She is the proprietor and principal for Kinemedica Market Solutions, LLC. www.kinemedica.com

 http://www.mdtmag.com/blog/2016/05/repairing-healthcare-reducing-medical-error-design