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National Summit on Medical Errors and Patient Safety Research
Panel 3: Particular Systems IssuesTestimony of Testimony of Mark E. Bruley, ECRI (Continued) Research Agenda Question 3Does the frequency and severity of device-related error justify developing broader reporting and prevention interventions? The development of effective recommendations for error prevention requires effective investigation which is, in turn, dependent in part on accurate and thorough reporting. The reporting of accidents and errors is also needed to provide a baseline for determination of the effectiveness of remedial measures. It has been generally perceived that with numerous sources of patient data it is possible to easily fathom the cause of a medical error. This does not hold related to medical device-related medical errors. Thirty years of investigating medical errors involving medical devices at ECRI has shown that this perspective is not correct. We routinely establish the causes of accidents and mishaps through detailed device investigation and incident analysis. Yet this approach has its limitations. It is inherently retrospective and limited to selective high risk device types and category of device related of accidents. With the universe of medical devices comprised of some 5,000 different device types, research into "medical error and medical devices" it is simply too general an approach. Given this vast universe of medical device types, and given the disparate range of clinical users, it is difficult to derive valid denominator data from studies relying on data from broad-based incident reporting systems. Similarly, the number of categories of different types of injury from medical errors involving medical devices is, in our experience, extensive. A taxonomy of these injury types is included in Appendix A. Beyond these patient injury categories, medical errors involving medical devices have many potential categories of cause of a device related medical mishap. For example, there are 2,180 coded categories in the FDA Form 3500A Device Coding Manual used by medical device manufacturers and healthcare facilities to comply with the Medical Device Reporting regulation at 21 CFR Part 804. Within this FDA manual, the codes are subordinated into categories of 807 patient related codes, 683 device related codes, 21 codes for the method of device evaluation, and 669 codes for the results of device evaluations. These numerous categories in the FDA classification scheme are applicable to the regulatory environment, but may be unwieldy for studies of medical error with healthcare technology which, by necessity, require development of denominator data. Broad-based medical device incident reporting systems would typically provide too few incidents within a specific category to provide sufficient data for effective analysis and support development of systems-bases approaches to prevention. Due to historical problems in deriving denominator data for medical errors that involved the use of a medical device, it is not readily possible to ascribe commonality. Consequently, without a determination of commonality, development of systems based approaches for prevention cannot proceed effectively. It is also important to understand that the limitations on reporting are fundamentally linked to human nature. ECRI has decades of history designing and implementing voluntary adverse event reporting systems for medical devices, such as our Health Devices Problem Reporting System. In addition, we developed a continuously updated 800,000+ record database (Health Devices Alerts) that indexes and abstracts the literature on medical device hazards and adverse events. We also have an in-depth knowledge of the difficulties government agencies have experienced with both voluntary and mandatory reporting worldwide and developing a taxonomy for classifying medical device errors so that information entered into databases can be standardized. (Such a taxonomy could be a useful adjunct for all medical errors, not just device-related ones.) ECRI has historically employed five broad categories which, based on our experience, are at the heart of all medical errors involving a medical device (10, 25). These broad ECRI categories, shown below, are (1) device factors, (2) user errors, (3) external factors, (4) tampering and sabotage, and (5) support system failures. We further break these five categories into additional subcategories, presented in Appendix A, each of which is potentially worthy of it own research agenda. Equipment failure can trigger an accident or it may complicate the recognition and treatment of other problems (33). The equipment failure itself may occur due to a variety of causes, such as equipment defect, improper set-up or maintenance, or environmental factors and, as noted above, that failure is rarely the sole cause of the adverse device event. Other factors combine with equipment failures to result in the accident. Research into healthcare technology related medical error will shed light on these combinations of factors by examining the association of equipment failure with other factors such as human error, external or environmental factors, and management support system factors. Needed is a system for collection of accurate information so that an effective initial analysis can be performed, hopefully leading to early resolution, or lead to undertaking of an effective investigation. An understanding of the severity of the injury is an important risk management concept and is useful in evaluating Question 3. It helps to prioritize risk management interventions and facilitate appropriate use of resources. In the cost-conscious environment of healthcare delivery, healthcare managers with limited budgets and resources must protect the safety of patients and personnel. The answer to severity-related questions will help to focus their efforts and allocate resources in the most cost- effective manner, implementing changes that will have the greatest impact and/or that will minimize the risk of the most serious errors and injuries. Manufacturers may use similar information to improve product design, labeling, recalls, customer service, and training. Regulators would likewise benefit by being able to prioritize enforcement efforts and allocate scarce resources. SUMMARYResearch into medical errors with healthcare technology, devices, instruments, and information systems will have a variety of applications to different constituencies throughout the healthcare community, including healthcare providers, healthcare institutions, accreditation groups, regulators, and manufacturers and vendors. Healthcare institutions may use the study results to examine their management and training practices and processes, identify areas of risk in areas of medical specialty, and modify policies and procedures to mitigate those risks. Regulators and accreditors may use the study results to identify areas for improvement in human factors, clinical procedures and processes, or organizational systems. Practitioners, researchers, and others investing resources in risk mitigation and accident prevention will use the results from such research to guide their priorities and focus their efforts. Medical and nursing schools may use the study results for healthcare technology curriculum development and enrichment in patient safety. The current (and ever increasing) level of dependence on healthcare technology dictates that errors associated with its use be a focus of future patient safety research. Medical device development is proceeding apace and healthcare technology, in the broad sense, will become ever more sophisticated. Greater sophistication and new developments are both good and bad. They are good in the sense that technology will likely be more efficacious and reliable, but bad in that more errors are likely to occur with more complicated equipment. This will be especially true in technology intensive medical specialties. Research into medical errors involving healthcare technology and medical devices should be targeted by medical specialty or by technology type. In this regard, we pose the following specific research agenda questions:
Success in developing effective strategies for technology related error prevention has been achieved in a few specialties, such as anesthesia and cardiopulmonary bypass perfusion, but research in many other clinical areas of high technology use are needed. These areas of medical specialty include intensive care medicine, emergency medicine, obstetrics and gynecology, general surgery, cardiac catheterization, clinical laboratory, and respiratory therapy. Ensuring a research agenda on medical errors that involve the use of a healthcare technology holds the potential for developing a large base of empirical data that may highlight common areas of risk in other healthcare settings. This, in turn, would point to promising broad-based methods for preventing healthcare technology related medical errors. Such research could be conducted using a large-scale healthcare accident databases that could facilitate the study of risk factors associated with medical technology and could help identify opportunities for accident prevention. The inclusion of healthcare technology in the future research agenda on medical error will, in keeping with the goals of the AHRQ and QuIC Task Force, "foster improvement in patient safety throughout the nation's healthcare system." References1. Abramson NS, Wald KS, Grenvik AN, Robinson D, Snyder JV. Adverse occurrences in intensive care units. JAMA 1980 Oct 3;244(14):1582-4. 2. Andrews LB, Stocking C, Krizek T, Gottlieb L, Krizek C, Vargish T, Siegler M. An alternative strategy for studying adverse events in medical care [see comments]. Lancet 1997 Feb 1;349(9048):309-13. 3. ASHP guidelines in the safe use of automated compounding devices for the preparation of parenteral nutrition admixtures. Am J Health- Syst Pharm 2000:57(Jul 15):1343-1348. 4. 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Wilson RM, Runciman WB, Gibberd RW, Harrison BT, Newby L, Hamilton JD. The Quality in Australian Health Care Study. Med J Aust 1995 Nov 6;163(9):458-71. Appendix AECRI Taxonomy of Healthcare Technology Related Injuries and Causes of Related Accidents In its 30 years of investigating patient injuries from errors and accidents involving healthcare technology, instruments, devices, and systems, in both the hospital and laboratory settings, ECRI has developed the following list of mechanisms by which patients are injured in. Healthcare Technology Related Injuries
Beyond these mechanisms of injury, ECRI has historically employed five broad categories which, based on our experience, are at the heart of all medical errors involving a healthcare technology. These broad categories and their additional subcategories are listed below. Causes of Healthcare Technology Accidents Device Factors
User Error
External Factors
Tampering/Sabotage Support System Failure
These categories and terms have proven useful in application during clinical and laboratory investigations of medical device accidents (10, 25). They are complimentary to, but more succinct than the terminology used in the 2,180 coded categories in the FDA Form 3500A Device Coding Manual used by medical device manufacturers and healthcare facilities to comply with the Medical Device Reporting regulation at 21 CFR Part 804. Current as of September 2000 Internet Citation: Testimony of Mark Bruley, Panel 3: Particular Systems Issues. Written Statement. National Summit on Medical Errors and Patient Safety Research. September 2000. http://www.quic.gov/summit/wbruley1.htm Return to Testimony Directory |