healthcare value analysis
By Oren Guttman , MD , MBA ; Josh Clark , RN , MBA ; and Barbara Strain , MA , SM ( ASCP ), CVAHP
Driving Down Preventable Harm with Human Factors Engineering : Telling Their Story
Barbara Strain consulted with Josh Clark and Oren Guttman to discuss human factors engineering ( HFE ) at Jefferson Health in Philadelphia . To say they are enthusiastic about spreading the use and understanding of HFE to drive down preventable harm in healthcare is an understatement . Outside of university and research engineering communities , these principles are not very well known in the healthcare industry , specifically when it comes to day-to-day application – neither internally within health systems , nor outside in the medical device technology industry .
FDA and AHRQ : Breaking Down Human Factors Engineering Definitions and Intentions
The Food and Drug Administration ( FDA ) issued the final guidance “ Applying Human Factors and Usability Engineering to Medical Devices ” 1 in 2016 to “ assist industry in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users , uses and use environments . The recommendations in this guidance document are intended to support manufacturers in improving the design of devices to minimize potential use-errors and resulting harm .” The FDA believes that these recommendations will enable manufacturers to assess and reduce risks associated with medical device use .
NOTE : Guidance documents describe the FDA ’ s current thinking on a topic and the use thereof is suggested or recommended , but not required .
Emphasis is on considerations of human behavior , abilities , limitations , and other characteristics of medical device users into the design of medical devices including mechanical and software driven user interfaces . Overall systems , tasks , user documentation , and user training are top of mind to enhance and demonstrate safe and effective use . Testing is intended to be conducted at the end of the device development process to assess user interactions to identify errors that would or could result in serious harm to the patient or user . 2-3
In 2019 , the Agency for Healthcare Research and Quality ( AHRQ ) issued a report from a Patient Safety Network Project 4 where it refers to HFE as the “ discipline that takes into account human strengths and limitations in the design of interactive systems that involve people , tools and technology , and work environments to ensure safety , effectiveness , and ease of use .” In a comparable manner as the FDA , the AHRQ defines processes that include reviewing expectations of humans at the control : physical and skill demands , mental workload , team dynamics , aspects of the work environment ( e . g ., adequate lighting , limited noise , or other distractions ), and device design required to complete tasks optimally . The resultant systems are then designed to optimize safety and reduce the risk of error
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. healthcarehygienemagazine . com • november 2022 in complex environments . Historically , HFE has been used in industries such as aviation and driving-accident prevention but has only recently been applied in healthcare -- which began in anesthesiology but it ’ s an opportune time to bring these processes to light .
Building it From a Systems Perspective
In their own words , the Jefferson Health Safety and Quality professionals emphasized that HFE considers how humans interact with tools , technology , the work environment , and workflow and the importance of integrating these principles into the complexity of day-to-day frontline care . The emphasis is to design primarily for outcomes that have left foundational systems trailing behind the trajectory of complex care . It was this foundational realization that the Jefferson Health program built on and embarked on the convergence of HFE and systems engineering within their organizational clinical operating system .
Guttman highlighted several of examples of how they used this approach to prevent harm by applying HFE and systems engineering approaches : 1 ) observation of the complex workflow involved with insertion and maintenance of central lines to reduce central line-associated bloodstream infection ( CLABSI ); 2 ) medication safety , looking at the ergonomics of orders in the electronic medical record ( EMR ) and accuracy of translation into infusion pump use for medication management ; and 3 ) septic shock early identification and treatment again using the EMR and an AI-like process .
When asked what were the key aspects that made this approach successful , it was no surprise that it was elevating safety to their board level , which approved a comprehensive design and deployment of a modern safety management system . The path to this success was achieved through multiple high-level leadership positions with connections to the chief quality officer , CEO , and president of the board . The true key to making it all work was changing the language and culture of safety and imbuing a philosophy by merely working in the background on updating the outdated systems , removing waste , and simplifying the complex so it was palpably felt at the caregiver level -- they could perform their work in a less stressful , more impactful manner .
Jefferson Health established new safety programs such as the Great Catch through socio-technical systems , a root cause analysis ( RCA ) program using HFE and systems engineering and a Re-work Prioritization program with ergonomic studies and adjudication of machine-learning failures .
Telling Their Story
During the past 24 months Jefferson Health has been telling its story of how it is making large-scale improvements in safety and risk mitigation through HFE and a systems-engineering
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