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Diagnosing is the frontline of medical interventions. Errors, misconceptions or misuse of diagnostics result in propagating the errors down the medical intervention. Significant part of medical errors is caused by inaccurate or/and imprecise diagnosing. Three potential sources of errors are caused by 1) over diagnosing due to false positives responses or misconceptions, 2) under diagnosing due to false negatives and/or sample preparation issues, and 3) no diagnosing due to high costs and invasiveness.
Johns Hopkins University Professor Martin Makary and research fellow Michael Daniel conducted a study, in which they assessed the contribution of medical errors to mortality. They found that medical errors are reluctantly reported or frequently reported under other categories. In the U.S. death certificate there is no respective code and lines to report a death caused by erroneous medical intervention. Nevertheless, even well-documented medical errors represent the third leading cause of death in U.S.. Makary and Daniel quote a typical case history, which demonstrates how the deformation of a medical error may transform into the category of cardiovascular cause of death.
Medical error is not included on death certificates or in rankings of cause of death. Significant part of errors remains unreported . Analysis of case histories reveal the tendency of administering unnecessary therapeutic and diagnostic procedures that result in additional damage to the patients. How big is the problem of medical errors? A 1999 Institute of Medicine (IOM) report, which is limited and outdated, . The report describes an incidence of 44,000-98,000 deaths annually .
This conclusion was not based on primary research conducted by the institute but on the 1984 Harvard Medical Practice Study and the 1992 Utah and Colorado Study [4, 5]. But as early as 1993, Leape, a chief investigator in the 1984 Harvard study, published an article arguing that the study’s estimate was too low, contending that 78% rather than 51% of the 180,000 iatrogenic deaths were preventable (some argue that all iatrogenic deaths are preventable).This higher incidence (about 140,400 deaths due to error) has been supported by subsequent studies which suggest that the 1999 IOM report underestimates the magnitude of the problem. A 2004 report of inpatient deaths associated with the Agency for Healthcare Quality and Research Patient Safety Indicators in the Medicare population estimated that 575,000 deaths were caused by medical error between 2000 and 2002, which is about 195,000 deaths a year.
Similarly, the U.S. Department of Health and Human Services Office of the Inspector General examining the health records of hospital inpatients in 2008, reported 180,000 deaths due to medical error a year among Medicare beneficiaries alone. Using similar methods, Classen et al described a rate of 1.13%. If this rate is applied to all registered US hospital admissions in 2013-15 it translates to over 400,000 deaths a year, more than four times the IOM estimate. Similarly, Landrigan et al reported that 0.6% of hospital admissions in a group of North Carolina hospitals over six years (2002-07) resulted in lethal adverse events and conservatively estimated that 63% were due to medical errors. Extrapolated nationally, this would translate into 134,581 inpatient deaths a year from poor inpatient care. Of note, none of the studies captured deaths outside inpatient care—those resulting from errors in care at home or in nursing homes and in outpatient care such as ambulatory surgery centers.
i-Diagnostics addresses all three potential sources of errors due to its superior accuracy and precision. i-Diagnostics will be a safety net and will create a social network that will help to prevent and combat naturally occurring epidemics, such as Corona virus COVID-19, influenza, Ebola, HIV/AIDS, Zika, STDs, and other infectious diseases. It will have thousands of other applications, including early diagnosing and prognosing of cancer, cardio-vascular, Alzheimer’s disease and other neurological disorders, longevity studies, food and water safety, biodefense, forensic, environmental, and agricultural analyses. i-Diagnostics platform offers an accurate, rapid, personalized, yet affordable molecular diagnostics for individual home use. It will make preventive, precision, individualized medicine available for all. In several years, DNA manipulation, synthetic biology, biological printers, and artificial intelligence will become available to millions [3, 4]. To prevent naturally occurring epidemics and minimize the risks of man-made pandemics , an accurate, rapid, and yet affordable diagnostic device, such as i-Diagnostics, should be available for all. i-Diagnostics is a handheld device for such individual home use, but is as powerful as a centralized laboratory.
1. Makary MA, Daniel M, “Medical error - the third leading cause of death in the US.” BMJ 2016; 353: i2139.
2. Leape LL, Lawthers AG, Brennan TA, Johnson WG. “Preventing medical injury.” Qual Rev Bull 1993;19:144-9.
3. Kohn LT, Corrigan JM, Donaldson MS. To err is human: building a safer health system.National Academies Press, 1999.
4. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370-6. doi:10.1056/NEJM199102073240604 pmid:1987460.
5 Thomas EJ, Studdert DM, Newhouse JP, et al. Costs of medical injuries in Utah and Colorado. Inquiry 1999;36:255-64.pmid:10570659.