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Revisiting To Err Is Human a Decade Later

2009; Association for the Advancement of Medical Instrumentation; Volume: 43; Issue: 6 Linguagem: Inglês

10.2345/0899-8205-43.6.476

1943-5967

Marilyn Sue Bogner,

Quality and Safety in Healthcare

Ten years ago, the Institute of Medicine's report, To Err Is Human, stated that up to 98,000 patient deaths occurred annually from care-related errors.1 Although books on medical errors had been published prior to the report,2, 3 the IOM's status and perhaps the Zeitgeist provided tinder that ignited public outrage. Patient safety became a societal issue.The IOM report advocated learning from errors by establishing reporting programs that “can hold providers accountable for performance or alternatively they can provide information that leads to improved safety.” For the former function, the report recommended mandatory reporting programs that focus on errors that result in death or serious injury. Research was funded to develop and implement such reporting with a goal of reducing the incidence of error by 50% in five years. At the end of the five years the goal was not approached in any sense, except for some successes due to dedicated individuals in specific facilities.The second function of reporting programs—focusing on safety improvement by identifying and addressing vulnerabilities in care before harm is done—was considered primarily as addressing near misses. The report stated that the development of reporting programs for that information was voluntary since no harm is done, hence there are no accountability issues.Although provider error reporting programs have not reduced error, the attitude persists that the provider is the sole cause of, hence accountable for, errors. In the decade since the IOM report, attempts have been made to reduce errors including the introduction of a safety culture, not blaming the care provider, and developing a just culture—all addressing the care providers and all having limited success. The medical device industry has heeded the success of human factors considerations in various industries and employed human factors personnel to address errors. However, progress in reducing error from that resource has not been noteworthy.In the spirit of investigative journalism, reporters Crowley & Nalder cited instances of patient deaths as the direct result of the activity or inactivity of care providers.4 They also quoted reactions of patient safety leaders to the non-declining, if not rising, incidence of health care error. This is disquieting because nothing seems to reduce medical errors, so seeking healthcare is painted as a risky endeavor. To reduce the potential risk, renewed emphasis on accountability has been proposed with punishment in the form of education plus short-term denial of privileges for physicians who do not respond to initial warnings and counseling.5Currently, there are two options to address errors. One is to continue the effort to reduce medical errors by devising ways to address the provider as the sole cause of error. The second option is to acknowledge that the provider-as-the-sole-source-of-error approach has not been successful and adopt another approach. The alternative approach is the second function of reporting programs—that of addressing system vulnerabilities. It is not what is there other than the care provider that causes errors, it is what there is together with the care provider that causes errors. This has profound implications for the medical device industry.The chink in considering the care provider as the sole source of error is the belief that individuals can act totally on their own, motivated only by their mental processes. That is not the case for any entity. Behavior of any organism reflects the interaction of the organism with environmental factors. Care providers are such an organism and an error is behavior. What might be considered as acting totally without external stimulation is reacting to a memory triggered by a factor or cues in the environment. Thus error can be addressed as reflecting the interaction of the care provider with contextual factors—factors that include a means of providing care such as a medical device. To effectively reduce error, it is necessary to identify and change the vulnerable components of the system which can be a medical device.The attitude that the care provider is the sole source of the error which resulted in death or serious injury is understandable from the perspective of society's need for accountability or the patient's or the patient's family urge for retribution. This attitude also is apparent in considering a death or serious injury involving a medical device as the result of the provider not using the device as intended.Despite the activities directed toward care providers to remedy situations, there has been no notable reduction in error in the decade since the IOM report. Indeed, an estimated annual death rate of over 190,000 was attributed to medical errors in 2004.6 The momentum of the belief that the provider is the sole cause of error must be broken so medical error can be addressed as involving system vulnerabilities.When addressing an error, both components of the error—the device as well as the provider—must be considered. To effect change, this consideration must be more than classifying the error. Classification describes the error, which can be useful, but it does not indicate what can be done to change the error behavior. The provider must identify actionable items that can be rectified to reduce the likelihood of recurrence of the error.The process of identifying actionable items can be accomplished by employing the “5 Whys” technique in which the person involved in the error asks why it occurred. Given the response, the person asks why that occurred, drilling down by asking why of each response until there seems to be no response to why and a target for change is identified. If that target is some aspect of a medical device, the temptation is to focus on the provider and advocate training, particularly given the potential loss of market share in modifying the device design. That approach won't reduce errors across providers. Too many factors can undermine the effects of training—providers can be absent when the training is given, they can forget critical aspects of it, and they can be fatigued, hence cognitively compromised when using the device.The effective approach to reducing errors is in the design of the device. The application of the 5 Whys can point to a design target to modify to reduce use errors. The provider can be accountable for identifying error- inducing factors—targets for change in the context of care including medical devices. Training or punishment affects one or a few people; design change affects all who use the device.Although medical devices are not considered as consumer products, they are. Lessons in reducing use errors can be learned from the design and development of consumer products.Consumer products are designed from the users' perspective. No matter how expert a person may be in human-machine interactions or how well social scientists understand human needs, unless they are clinicians currently providing healthcare, they do not understand providers' needs. The value of designing from the perspective of actual care providers is apparent in the success of the operating room checklist, which was conceived by a clinician who identified error-inducing factors in the context of care and developed means to address them. It is understandable that industry responds to what care providers say they want as a medical device, but what they say they need may not be articulated well or it may be altered in communication.If the charge of the IOM report to reduce error is to be realized, those who currently are actually using or will be using a device, must be included in all aspects of its development or modification. They also should be involved as in consumer products in pre-market testing in real world situations, simulated if necessary, to ensure the device design is usable, useful, and safe for the care provider as well as safe for the patient.It is time to treat medical devices as consumer products with the same consideration as the design of an electric can opener, and to change the focus from the care provider as the sole source of error to the care provider and medical device as an interdependent system for providing care. This change of focus requires the active involvement of device designers with the actual in-the-trenches care provider consumers.Technology is a temptress whose seduction must be harnessed to develop medical devices that not only are safe and effective but also are non-error inducing in meeting the needs of the actual user in the spirit of an electric can opener. No matter how technologically sophisticated or how simple a device is, if it is not readily usable by the clinician, it is not viable and will not contribute to reducing errors as advocated by the IOM report a decade ago.The medical device industry has a pivotal role in achieving this goal. The time is ripe to exercise that role.