A preliminary study of apparent causes and outcomes of reported failures with patient management software

Abstract

Patient management software (PMS) plays an increasingly critical role in the operation of modern health care systems. While more PMS systems are coming online, many practitioners have raised concerns regarding the quality of such systems, in particular with respect to safety. Recently, the software engineering research community has stepped up efforts investigating the specific challenges in health care in order to translate best engineering practices to this domain. While incidental reports about failures of PMS have been published, little information is available about their outcome and severity. Such evidence would be useful for focusing research efforts. In this paper, we report on a study that seeks to contribute to building up such evidence. We analyzed FDA records of safety incidents with PMS that were submitted over a period of two years. This paper reports on our findings and shows that patient misidentification, end-user customization, and HCI issues are among the most frequent causes for failure.

The safety of Electronic Medical Record (EMR) systems

“…In 2010, The Huffington Post Investigative Fund with help of the FDA, identified and extracted 237 reports that were submitted over a period of roughly two years (Jan. 08 to Feb. 15, 10). In earlier work, we analyzed these reports with respect to the identification of apparent causes for the reported errors and the device type associated with the malfunctions [32]. The description of the majority of reported incidents either indicate a potential for injuries or the actual occurrences of injuries or death.…”

“…While researchers have initially published predominantly about (potential) safety benefits of EMRs, observed in experiments with prototypes in carefully controlled environments, voices have become far more critical when it comes to experiences with commercial EMR products in day to day health care practices [4,19,7]. Caregivers and practitioners have alerted the industry and governments about unforeseen and potentially dangerous 'sideeffects' of EMRs [32]. There is mounting pressure on regulators to put in place mechanisms that assure the safety of health systems using EMRs [30,33,12].…”

Software Certification and Its Implementation in Malaysian Software Industry: A Survey

“…Currently, customers are becoming concerned about the quality of software delivered to them 1,2 . Nevertheless, there still exist complains about customers' dissatisfactions 3,4 . The study by Standish Group indicated that the success rate of software projects has decreased, from 35% in year 2006 to 32% in year 2009.…”