Medical harm

According to the Cedars-Sinai Elimination of Retained Foreign Object Task Force, 30% of objects accidentally left in the body as a result of surgery are surgical instruments.^[1]

Medical harm refers to any systemic failure in the health care system that results in a negative psychological or physical consequence. Medical harm is not limited to iatrogenic illness.

The Institute for Healthcare Improvement (IHI) defines medical harm as the “[u]nintended physical injury resulting from or contributed to by medical care (including the absence of indicated medical treatment), that requires additional monitoring, treatment or hospitalization, or that results in death. Such injury is considered harm whether or not it is considered preventable, whether or not it resulted from a medical error, and whether or not it occurred within a hospital.”^[2] With this definition, IHI estimates that “15 million instances of medical harm occur each year”^[2] in the United States. The term medical harm does not imply intent or negligence nor indicate the severity of the damage.

While some progress has been made in recent decades in determining the best ways to reduce incidents of medical harm, some advocates, including Dr. Barbara Starfield^[3] and Dr. Lucian Leape^[4], believe that additional measures are necessary to reduce preventable harm. Proposed measures include more widespread systems change in hospitals and other healthcare facilities; financial incentives or disincentives; and creating a national regulatory body with mandated incident reporting.

History

The term "medical harm" was first used after a Harvard Medical study in 1991 concluded that patients incurred a substantial amount of injury from medical management, and the injuries were a result of substandard care.^[5] A 1999 report by the Institute of Medicine, “To Err is Human,” further defined the scope of the problem and outlined comprehensive recommendations for reducing harm.^[6]

One of the most infamous examples of deliberate medical harm is the Tuskegee syphilis experiment, a study initiated by the Public Health Service in 1932 to examine the effects of untreated syphilis that used a group of poor rural black men as participants. The study continued until 1972, long after treatment for syphilis became widely available, and as a result several participants died of syphilis and its complications, infected their wives, and fathered offspring born with congenital syphilis.^[7] As a result of public outcry, the study was ended and new regulations for the ethical conduct of medical research were established. However, these regulations are exclusive to research and do not apply to or protect patients undergoing routine medical treatment.

Prevalence

In the United States

• 10% of acute hospital admissions resulted in the incidence of an adverse event.^[8]
• In 1999, it was estimated that 44,000 - 98,000 people die in hospitals each year as a result of medical errors, making it the tenth leading cause of death.^[6]
• In 2000, it was estimated 225,000 deaths from iatrogenic causes, making it the third leading cause of death.^[9]
• Twenty to 30 percent of patients in the United States receive care that is contraindicated.^[10]
• Adults 65 years and older are three times more like than younger adults and 60% more likely than middle-aged adults to experience post-operative respiratory failure following elective surgery even after adjusting for co-morbidities.^[11]
• Few studies have been done to determine medical harm in the clinical or outpatient setting.

In Canada

• 7.5 % of hospital admissions resulted in the incidence of an adverse event.^[12]
• In 2003, 197 deaths resulted from adverse care events, 22 from adverse drug events.^[13]
• In 2003, 5.2 million or 24% of Canadians reported they or a family member had experienced a preventable adverse event due to medical care, 52% of these reports stated the event had a serious consequence.^[12]

In the United Kingdom

• 10.3 % of acute hospital admissions resulted in the incidence of an adverse event.^[13]
• In 2002, 413 deaths resulted from adverse care events, 36 from adverse drug events.^[13]

In New Zealand

• 12.3 % of acute hospital admissions result in the incidence of an adverse event.^[13]
• Adverse events in in-hospital healthcare ranks number 11 in the 20 top risk factors that account for 75% of the deaths annually; ahead of air pollution, alcohol and drugs, violence and traffic road injuries; equal to a third of the size of tobacco-related deaths.^[13]

Types of medical harm

In a hospital setting

• nosocomial infection – an infection unrelated to the initial diagnosis that is acquired by a patient while in a health care facility (namely hospitals), could be pneumonia or blood infection
• restraint-related injury - patient in surgical or medical restraints end up with musculoskeletal injuries from poor positioning or skin breakdown
• falls – a patient who may be medicated, physically unstable, or elderly falls and sustains an injury
• burns – can occur from radiation treatment , heating pad or a medical device
• design-related injury - occurs when the long-standing design of a device or instrument inherently produces collateral damage, such as tissue damage
• pressure ulcer – occurs when a patient is unable to move or feel pain and is left in one position for a long time, compromising blood flow to an area and causing skin to breakdown
• mistaken patient identity – a patient is given another patient’s medication or taken for a diagnostic exam or to surgery under another patients name
• wrong-site surgery – the wrong side of the body is treated surgically –left leg rather than right leg amputation
• suicides while in the hospital
• adverse drug effect
• improper transfusions – patients receive the wrong blood type, or incorrect product

In a clinical setting or hospital

• misdiagnosis – a provider incorrectly identifies a patients condition or disease (ex. a patient is diagnosed with heart burn, a gastro-intestinal condition when he actually has a heart condition)
• under-diagnosis – a provider does not fully identify the cause (ex. a patient with Lyme disease, which is caused by a tick and starts out with vague symptoms like fatigue and joint pain is told he has fibromyalgia)
• overdiagnosis – something benign is identified as happening often with cancer where non-specific cancer marker is identified with the potential that the cancer carries no risk to the patient's health.
• unnecessary surgery – a provider performs a surgery without utilizing or ruling out less invasive options (ex. a hysterectomy for uterine bleeding before considering a uterine fibroid artery embolization)
• under treatment – lack of appropriate follow-up or treatment, often related to lack of health insurance, or inability of provider to diagnose
• over treatment – a provider provides more interventions than are required (ex. provider prescribes a multiple medications to ensure his patient with epilepsy is seizure free with out considering the side effects)

Reducing and preventing medical harm

In 1999, the Institute of Medicine released the report "To Err is Human," bringing attention to the issue from both the medical community and the public at large. Emphasizing that "bad systems and not bad people" are the root cause of most harm, the report recommended that safety be a priority for administrators and for hospitals and clinics redesign their systems and create "non-punitive" environments for providers.^[6] As a result of this information and public response, Congress designated $50 million in grants to address the issue. Resulting projects included patient safety culture surveys, effective teamwork training, a patient safety checklist to reduce central line-associated bloodstream infections, reducing hospital readmissions through efficient discharge processes, and addressing resident fatigue. In 2005 President Bush signed The Patient Safety and Quality Improvement Act which created whistleblower protection for reporting errors and implemented a voluntary reporting system.^[3] Institutions that have created "blameless" reporting systems or the ability to report "close calls" as well as actual incidents of harm have had some success in increasing reporting, but these systems have not been universally adopted. Currently, there is no mandatory national reporting system. Payment incentives, or penalties for hospitals that do not conform to safety standards, have also been suggested as possible mechanisms for reducing medical harm. However, some believe that the issue of reducing medical harm has not been adequately addressed and that a national regulatory body is necessary to mandate and coordinate preventive measures.^[4]

References

1. ^ "Cedars-Sinai O.R. - Elimination of Retained Foreign Object Task Force". http://www.csmc.edu/11749.html. Retrieved 2009-10-25. 
2. ^ ^{a b} "Institute for Healthcare Improvement: Campaign". http://www.ihi.org/IHI/Programs/Campaign/Campaign.html?TabId=1. Retrieved 2009-10-25. 
3. ^ ^{a b} Starfield, B (2009). "Physicians and Quality: Answering the Wrong Question". Health Affairs (Project Hope) 28.2: 596–597. 
4. ^ ^{a b} Leape, L. L.; Berwick, D. M. (2005). "Five Years After to Err is Human: What Have We Learned?". Journal of the American Medical Association 293.19: 2384–90. 
5. ^ Brennan, T; Leape, L; Laird, N; Hebert, L; Localio, AR; Lawthers, AG; Newhouse, JP; Weiler, PC et al. (1991). "Incidence of Adverse Events and Negligence in Hospitalized Patients: Results from the Harvard Medical Practice Study". New England Journal of Medicine 324 (6): 370–376. doi:10.1056/NEJM199102073240604. PMID 1987460. 
6. ^ ^{a b c} Kohn, L; Corrigan, J; Donaldson, M (1999), To Err Is Human: Building a Safer Health System, Washington, D.C.: National Academies Press 
7. ^ Byrd, Michael W; Clayton, Linda A (2000), An American Health Dilemma: A Medical History of African-Americans and the Problem of Race, New York: Routledge 
8. ^ Leape, Lucian L. (2009). "Errors in Medicine". Clinica Chimica Acta 404: 2–5. doi:10.1016/j.cca.2009.03.020. 
9. ^ Starfield, B (2000). "Is US Health Really the Best in the World?". Journal of the American Medical Association 284 (4): 483–485. doi:10.1001/jama.284.4.483. PMID 10904513. 
10. ^ Schuster, M; McGlynn, E; Brook, R (1998). "How good is the quality of health care in the United States?". Milbank Quarterly 76 (4): 517–563. doi:10.1111/1468-0009.00105. PMID 9879302. 
11. ^ Thornlow, D; Anderson, R; Oddone, E (2009). "Cascade iatrogenesis: Factors leading to the development of adverse events in hospitalized older adults". International Journal of Nursing Studies 46 (11): 1528–1535. doi:10.1016/j.ijnurstu.2009.06.015. PMID 19643409. 
12. ^ ^{a b} MacDermaid, Laura J (2005), First, Do No Harm: Medical Error in Canada 
13. ^ ^{a b c d e} Conklin, Annalijin; Vilamovska, Anna-Marie; De Vries, Han; Hatziandreu, Evi (2008), Improving Patient Safety in the EU: Assessing the expected effects of three policy areas for future action, RAND Europe & The European Commission 

External links

• To Report a Medication Error
• To Report a case (or close call) of medical harm
• Institute of Medicine Report, “To Err Is Human:”
• Joint Commission
• National Patient Safety Foundation
• Agency for Healthcare Research and Quality - Getting Safer Care