Cardiovascular Advisory Panel Guidelines for the Medical Examination of Commercial Motor Vehicle Drivers - Federal Motor Carrier Safety Administration

Cardiovascular disease (CVD) is the leading cause of medical illness and sudden death in commercial motor vehicle drivers (CMV). CVD will have an increasingly powerful impact on the health and safety of CMV drivers because of its prevalence in the population, its progressive nature, the aging work force, and recent advances in diagnosis and therapy.

The Federal Motor Carrier Safety Administration (FMCSA) administers the Federal Motor Carrier Safety Regulations (FMCSRs) concerning the medical qualifications of commercial drivers in interstate commerce. While only a small percentage of crashes are caused by cardiovascular disease, they are responsible for significant mortality and morbidity.

The Department of Transportation (DOT) examination is an essential part of assuring a healthy CMV driver workforce. The guidelines assist medical examiners in the evaluation and certification of each person on whom they perform a DOT examination. The last DOT review of its cardiac guidelines for CMV drivers was published in December 1987.

In fall, 2001, the FMCSA convened a Cardiovascular Medical Advisory Panel to develop new guidelines to reflect the medical advances that have occurred over the last 15 years. Panel members submitted medical review papers on their topics. The papers reviewed the currently accepted scientific opinion on the risks, diagnoses and treatments of numerous cardiovascular diseases. For easier use, the recommendations are summarized and placed in table format at the end of each paper.

Each Panel member's topic is intended to assist medical examiners in determining if the commercial vehicle driver's cardiovascular condition increases his/her risk of sudden death or incapacitation that the driver endangers their health and safety and the health and safety of the public sharing the road with them. The level of risk must be considered within the context of the setting and activity in question and what society considers acceptable. Determining acceptable risk becomes a matter of public policy and the decision to certify or disqualify a commercial driver is both a medical and a societal decision.

SUMMARY OF TOPICS

Ischemic Heart Disease Dr. Roger Blumenthal and Dr. Joel Braunstein

Findings

Almost 12% of those over age 40 have coronary heart disease (CHD). In the general population, the initial presentation of CHD is catastrophic in over two-thirds of cases.

Risk factor identification and treatment is the key strategy in decreasing the mortality and

morbidity of CHD. Commercial drivers have an increased prevalence of cardiovascular risk factors relative to other occupations; specific work-related factors further elevate the risk of CVD.

Recommendations

There is some evidentiary utility for using the exercise tolerance test (ETT) to assess CMV drivers who have risk factors but no symptoms or signs of CHD. Because of its lack of specificity and sensitivity and its unknown cost effectiveness when used as a screening tool in this population, the Panel is not able to recommend for or against this strategy.

Medical examiners have been provided recommendation tables to assist in deciding whether to certify commercial drivers with coronary artery risk factors, with known CHD, following a cardiac event, or following a cardiac procedure.

Hypertension Dr. Roger Blumenthal and Dr. Joel Braunstein

Findings

An estimated 50 million Americans have hypertension. Commercial drivers have an increased propensity for the development of hypertension that exceeds the risk seen in other professions. Long-term data show increased rates of cerebral, cardiac, and renal complications in patients with elevated blood pressure. Hypertension is progressive in nature if uncontrolled and requires regular follow-up. The effect of hypertension on target organs also increases the risk of sudden incapacitation.

Recommendations

The Panel adopted the sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 6). Certification, disqualification, and follow-up are based on the blood pressure. A blood pressure exceeding 140/90 mmHg is considered elevated for most individuals who have no other cardiovascular risk factors.

Valvular Disease and Myocardial Disease Dr. Bernard J. Gersh

Findings

Consistent with other CVD, improved diagnostic testing and treatment can increase the number of CMV drivers with valvular or myocardial disease who seek certification. Valvular and myocardial diseases are often progressive and require long-term follow-up. This section reviews the risks of these diseases and the effect of prosthetic valves on certification.

Recommendations

Due to the complexity of this area, a cardiologist's assessment is often recommended. Because of the progressive nature of these diseases, there is a need for follow-up evaluations of these drivers.

This comprehensive review includes the current recommendations from the American College of Cardiology and the American Heart Association. The use of these guidelines makes assessment of the driver more uniform and provides accepted medical standards for medical examiners.

Arrhythmias Dr. Andrew Epstein

Findings

Arrhythmia is the most likely cause of sudden death or driver incapacity, with CHD as its underlying etiology. Arrhythmia, depending on the type, location and classification fall along the spectrum from harmless to instantaneously fatal. Certain arrhythmias are more likely to produce conditions that most threaten the safety of the public and the driver: syncope (fainting), collapse, sudden death or other sudden incapacitation. Moreover, the more serious arrhythmias often occur in those with no prior knowledge or diagnosis of heart disease. The review includes arrhythmias that can produce hemodynamic compromise, pacemakers, and implantable cardioverter-defibrillators.

Recommendations

In addition to risk-identification and management of arrhythmia, treatment of the

underlying heart disease (if present) is of paramount importance.

Congenital Heart Disease Dr. Heidi Connolly

Findings

Heart failure and sudden death are the major causes of death among patients with congenital heart disease. Because of advances in surgical and medical management, over 85% of infants born with congenital heart diseases are expected to survive to adult life. The number of individuals with congenital heart disease requesting commercial driver certification is expected to rise proportional to the increasing patient population. Applicants for certification are likely to be those with milder forms of congenital heart disease or those who have had surgical repair.

Recommendations

To maintain certification, it is recommended that these drivers have regular, ongoing follow-up by a cardiologist knowledgeable in adult congenital heart disease.

Diseases of the Arteries and Veins Dr. Ellison Wittels

Findings

Arterial disease is most often secondary to atherosclerosis. The diagnosis of arterial disease should trigger an evaluation for the presence of other cardiovascular diseases. Rupture is the most feared complication of an abdominal aortic aneurysm (AAA), and is related to the size of the aneurysm. Intermittent claudication is the primary symptom of peripheral vascular disease (PVD) of the lower extremities, usually a slowly progressive disease. Deep venous thrombosis (DVT) can be the source of acute pulmonary emboli or lead to long-term venous problems.

Recommendations

AAA requires ongoing follow-up because of its high mortality rate (78-94%) upon rupture. PVD can require surgical revascularization, angioplasty or amputation. Acute DVT disqualifies the commercial driver until adequately treated. Varicose veins do not medically disqualify the CMV driver.

Recommendations of the Advisory Panel

In the United States, CVD is the fastest growing and most prevalent chronic, progressive condition. Paradoxically, advances in diagnosis and management insure that a larger number of commercial drivers will be able to continue to work even though they have been diagnosed with CVD. The inherent progressive nature of CVD however, will necessitate the ongoing updating of medical guidelines and increasingly active participation and consultation from cardiac specialists.

The Panel provided specific recommendations designed to:

Improve database research;
Increase support of Medical Examiners;
Systematically review guidelines and examinations;
Conduct specific research; and
Establish a standing medical advisory panel.

Ellison H. Wittels, MD, FACP; Chairman, Cardiovascular Advisory Panel

INTRODUCTION

Background Top

The growing size of the commercial driver population coupled with the prevalence of cardiovascular disease (CVD) in the United States makes certain that heart-related illness will have an increasingly powerful impact on the health and safety of commercial motor vehicle (CMV) drivers in specific, and the traveling public in general.

In the United States, heart disease ranks first and stroke third as the leading causes of death (1, 2). According to current estimates, one in five persons has some form of CVD, including approximately 50 million with hypertension, more than 3 million who have survived a stroke, and 12.4 million with coronary heart disease (CHD) (3, 4).

There are nearly 9 million U.S. drivers who hold a commercial drivers license (CDL), and another 2 million drivers with non-CDL commercial licenses. Nearly all of these CMV license holders are required to meet federal medical standards as a condition of employment.

The Federal Motor Carrier Safety Administration (FMCSA) is responsible for the establishment and enforcement of the Federal Motor Carrier Safety Regulations (FMCSRs), including the medical qualifications of commercial motor vehicle drivers. The current medical standard covering commercial drivers with CVD has been in effect since 1970, and permits qualification of individuals to operate CMVs if they have no current clinical diagnosis of myocardial infarction, angina pectoris, coronary insufficiency, thrombosis, or any other cardiovascular disease of a variety known to be accompanied by syncope, dyspnea, collapse, or congestive cardiac failure. The decision whether the nature and severity of a drivers condition will cause sudden incapacitation is on an individual basis and rests with the medical examiner.

FMCSR Guidelines Top

To assist medical examiners, FMCSA periodically convenes expert medical panels to review its guidelines and recommend qualification criteria, test procedures and decision matrices that reflect current medical knowledge and technology. Medical guidelines help standardize the certification process and decrease the risk of medically unfit commercial drivers receiving certification. FMCSAs goal is not to prevent drivers from working, but to help ensure that the roads and highways are safer for the commercial driver and those who share the road with the driver.

In 1995, the agency convened an expert panel to update its qualification criteria for anticoagulation treatment of commercial drivers. The final report was submitted on April 1, 1996.

The last major review of the cardiovascular guidance materials, a two-day conference, was held in October 1986. The final report, "Conference on Cardiac Disorders and Commercial Drivers," was published in December 1987, and is the basis for FMCSAs current guidelines on CVD and commercial drivers (5).

2001 Cardiovascular Medical Advisory Panel and Topics Top

In October 2001, the FMCSA convened a medical advisory panel to update the

cardiovascular guidelines.

Panel Members	Cardiovascular Disease Topic
Dr. Roger Blumenthal and Dr. Joel Braunstein, Johns Hopkins University Medical Center	Ischemic Heart Disease, Hypertension
Dr. Heidi Connolly, Mayo Clinic	Congenital Heart Disease
Dr. Andrew Epstein, University of Alabama at Birmingham	Arrhythmias, Sudden Death, Pacemakers
Dr. Bernard J. Gersh, Mayo Clinic	Valvular Disease, Myocardial Disease
Dr. Ellison H. Wittels, Chairman Concentra Medical Centers	Peripheral Vascular Disease, Transplantation

Ms. Sandra Zywokarte, MPH, Office of Bus and Truck Standards and Operations, Federal Motor Carrier Safety Administration, has served as the Program Technical Representative. Mr. John Sheridan of Cherry Engineering Support Services (CESSI), provided administrative support.

FMCSA Directives to the Cardiovascular Advisory Panel Top

The panel was asked to conduct a systematic review of the cardiovascular guidelines to ensure that they reflect current medical knowledge and technology and to recommend qualification criteria, test procedures and decisions matrices to assist medical examiners.

The Panel was requested to provide findings and recommendations that:

Identify potential risk factors (complications or medical factors) that might be associated with driving impairment;
Discuss how identified risk factors may affect driving ability;
Identify treatment technology that can be used to control each risk factor or medical condition; and
Update the specific recommendations from the 1987 Conference on Cardiac Conditions and Commercial Drivers.

Resources Used in the Development of the New Guidelines Top

The Panel members used a number of resources. The Medical Review is based on:

Current literature on the natural history, symptoms, signs, testing and treatment of cardiovascular disease;
A review of the literature on driving and cardiovascular disease;
Federal Motor Carrier Safety Regulations, Section 391.41(b)(4) and (6);
Federal Aviation Administration Guide for Aviation Medical Examiners;
Guidelines from other countries; References (6), (9), (26) and (34);
The 1987 Office of Motor Carriers Conference Report on Cardiac Disorders and Commercial Drivers; and
Input and synthesis of the Cardiovascular Advisory Panel members.

Process Used by the Panel Top

The Panel members combined their academic backgrounds with their clinical experience in diagnosing and treating CVD. Each Panel member not only submitted a medical review paper with recommendations for certification, disqualification, testing and re-certification, but also reviewed other Panel members papers. When necessary, additional questions were posed to Panel members. Conclusions, along with dissents, are noted. The final report was presented to the FMCSA. As part of their commitment, Panel members will be available over the next several years to answer questions that may arise about the guidelines.

Format of Papers Top

Each of the CVD topics has a medical review and specific recommendations based on the medical review. Cardiovascular pharmacological agents and their effects are reviewed under the appropriate section.

Medical Review

Each medical review is designed to provide the medical examiner information on the anatomy and physiology of cardiovascular diseases. Because most cardiovascular diseases are progressive over time, their natural history has been well documented. In addition, much attention has been paid to the testing required to assess the cardiovascular condition of the driver. It is not likely that medical examiners will conduct the testing outlined in this section. However, review of the testing requirements provides the examiner the information to assess whether the driver has been adequately evaluated and to classify the severity of the disease as it relates to the driver's general health and ability to be medically certified.

Recommendation Tables

The Recommendation Tables are based on the medical review and are found at the end of each paper. The tables have been written to make the recommendations clear, concise and easier to access. Guidelines that are too complex or too long will not be read (6).

Guidelines Versus Standards Top

The medical examiner should distinguish between the medical standard (49 CFR 391.41), and the medical guidelines. The standard must be followed. Guidelines are recommendations that the medical examiner should follow. While not law, the guidelines are intended as standards of practice for medical examiners. Although the medical examiner is responsible for determining if the commercial driver is medically qualified under the FMCSRs, these guidelines have been issued by FMCSA and are based on the medical literature. If the medical examiner chooses not to follow the guidelines, the reason(s) for the variation should be documented.

Guideline Limitations Top

The medical examiner is not expected to act as the commercial drivers primary physician. The guidelines are not intended to decide medical or surgical treatment. However, the Panel did minimize variation from appropriate clinical practice. For example, the Panel did not wish to require extensive testing that would not otherwise be required to assess the drivers medical condition (7).

There are times when the medical assessment and the guidelines may yield different conclusions about the severity of the condition. A driver could have a benign underlying medical problem with an excellent prognosis, but still not be medically qualified as a commercial driver. For example, if a benign supraventricular arrhythmia

causes syncope, the person cannot be medically certified until the problem has been corrected (8).

Because atherosclerosis can affect different vascular beds, the presence of clinical disease in one vascular bed may be a clue that there is significant atherosclerosis in other parts of the body. While the CVD topics have been presented separately, several cardiovascular diseases may be present at the same time. While these guidelines are comprehensive, it is not possible to review all combinations of medical diseases (9).

If a driver has more than one cardiac problem (e.g., valvular heart disease plus chronic atrial fibrillation), the criteria for each should be satisfied and the driver then assessed to determine how the conditions occurring together affect certification to drive.

Overview of Medical Illness and Motor Vehicle Crashes Top

Acute medical illness is responsible for a small percentage of motor vehicle crashes, with estimates ranging from less than 0.1% to 3% (10-12). In the United States, commercial driver illness and blackouts were recorded in 0.3% of crashes (13). While the incidence of crashes is low, they are responsible for significant morbidity and mortality. Most studies have shown that CVD is the major cause of acute medical illness that results in motor vehicle crashes (11,14-17).

Establishing Risk for Commercial Drivers Top

Risk is an expression of the probability of an event occurring over a certain period of time (18). The level of risk must be considered within the context of the setting and activity in question and what society considers acceptable. Determining "acceptable risk" becomes a matter of public policy. Therefore, the decision to certify or disqualify a commercial driver is both a medical and a societal decision (19).

Common sense and a well-researched literature make it clear that there is no zero risk in certifying commercial drivers, including those in whom a diagnosis of CVD has not yet been made. Focusing more on societies concerns and risk avoidance makes licensing more restrictive. Focusing more on the driver's right to earn a living in their occupation of choice makes licensing less restrictive. The right of the individual to pursue his/her desired occupation and to earn a living should not be unreasonably denied; however, there are times when the commercial driver with cardiovascular (or other) disease may not be medically safe to drive. Given the complex demands of operating a large truck or bus, coupled with the high fatality risk for occupants of the other vehicle in crashes involving CMVs, a conservative approach is required.

The fundamental question when deciding if a driver should be certified is whether the CMV driver has a cardiovascular disease that so increases his/her risk of sudden death or incapacitation that the driver endangers his/her health and safety and the health and safety of the public sharing the road with them.

Qualifications and Duties of Medical Examiners Top

For many years in the United States, only Doctors of Medicine and Doctors of Osteopathy were designated to perform medical certification examinations for CMV drivers. In 1992, the FMCSRs were amended to allow physician assistants, advanced practice nurses and Doctors of Chiropractic to perform certification examinations, if their state license allows them to do so. This has expanded the pool of medical examiners and provided easier access to the medical certification process.

Medical examiners are not required to have any specific training and do not need to demonstrate any special competence to medically certify commercial drivers. The FMCSA does not certify or regulate medical examiners. However, examiners are expected to exercise good medical judgment during the evaluation and may be open to litigation in the case of an undesirable outcome. The medical examiner cannot shed his/her responsibility to evaluate carefully each person on whom they perform a physical examination (20).

The medical examiner must:

Have some familiarity with the physical demands and the mental and emotional responsibilities of a CMV driver;
Be familiar with the requirements in 49 CFR 391.41 and the medical guidelines; and

3. Record accurately the information required on the examination and

certification forms (49 CFR 391.43).

Consideration of Job Demands Top

The demands on the driver vary greatly with the type of vehicle and the type of driving required. Commercial drivers usually cannot choose their work hours or routes. Overall, CMV drivers have a multitude of job demands. For example, a commercial trucker's duties may include loading and unloading, making multiple stops, driving cross-country or in heavy city traffic, working with load securement devices, or changing tires. A commercial bus driver has responsibilities that are different from the commercial trucker (21).

To improve health and safety, the FMCSA requires not only that CMV drivers meet higher medical standards for driving, but also requires that drivers are medically suitable to perform the (potential) physical demands of commercial driving. The medical examiner must either certify or not certify a driver; the examiner cannot place additional restrictions or accommodations other than those listed on the certification form. In granting medical certification, the medical examiner is certifying that the person is able to perform any job duty required of a commercial driver, not just his/her current CMV job duties.

Medical Evaluation Top

The physical examination is an essential part of assuring a healthy commercial driver work force (7,22-24). The medical assessment is based on information provided by the driver (History), objective data (Physical), and additional testing requested by the medical examiner. In the vast majority of instances, evidence of CVD is found when the history is honestly given and carefully reviewed and when the physical examination is done thoroughly (25 ) . However, the Canadian Cardiovascular Society warned, symptoms may change when some privilege or economic benefit is involved (26). The demands of driving commercial vehicles reflect physical, psychological and environmental factors. The medical examiner needs to consider each of these three factors (27-30).

Consideration of Non-Cardiovascular Factors Top

CVD and its effects on driving cannot be considered in isolation; the effect of heart disease on driving has to be viewed in relation to the general health of the individual. There are also times when other medical conditions may exacerbate a cardiovascular condition. Medical certification to drive depends on a comprehensive medical assessment of overall health and informed medical judgment about the impact of single or multiple conditions on the whole person.

The New DOT Medical Examination Form Top

The medical form has been revised for the first time since 1970. FMCSA published its final rule (65 FR 59363) for the new examination form on October 5, 2000 (31). Use of the new form has been required since November 2001 (32). The medical examination form is found on FMCSAs web site at www.fmcsa.dot.gov - keyword Medical Examination Report Form.

Medical History and Physical Examination Top

Because the form does not provide a complete CVD history, the examiner may supplement the questions on the form when CVD is identified or suspected. The medical form asks specific questions about prior diagnosed CVD. The examiner may wish to supplement the questions on the form by asking about CVD symptoms, including questions about the presence of chest pain, pressure, or acheat rest or with exertion, dyspneaat rest or with exertion, and recurrent and/or severe palpitations. Similarly, questions can be asked about the symptoms of claudication, such as buttock, leg, or calf pain with ambulation that resolves with rest. The examiner should distinguish between pre-syncope (dizziness, light-headedness) and true syncope (loss of consciousness).

The examiner may elect to expand the physical examination when cardiovascular disease is present or suspected. Findings of the examination can be recorded for future reference. Findings that require additional testing should be documented.

Required Testing Top

The only test required is a urinalysis for specific gravity, protein, blood, and sugar.

Additional Tests Available to the Medical Examiner Top

The examiner may require additional testing if there are concerns about the presence or extent of CVD. The examiner may order and interpret additional tests or may refer the applicant to a specialist or the drivers primary healthcare provider.

An electrocardiogram is not required and should be obtained only if clinically indicated. It is often insufficient in detecting cardiac disease (33).

Interpretation of Test Results Top

Using only test measurements to define acceptable standards for the driver may be misleading. Estimates of parameters such as aortic valve gradient, left ventricular ejection fraction, or the degree of coronary artery stenosis on angiography are subject to observer error. As a result, a driver could be certified or removed from driving based on a minimal variation in the measurement. Therefore, in addition to individual technical measurements, the medical determination should reflect the clinical judgment of a knowledgeable medical examiner (6).

Consultation Top

The guidelines recommend caution in driver certification when a cardiovascular diseases clinical course is uncertain or unknown. If the examiner is uncertain about a driver's condition or prognosis, the decision for certification needs to be postponed until the additional necessary information is obtained. When helpful, the Panel recommends that the medical examiner review the decision to certify/disqualify a commercial driver with the treating doctor. A specialist who is treating the driver's CVD should be consulted.

Review of Results with Applicant Top

Findings that are disqualifying need to be explained to the applicant. Cardiovascular conditions that may not be immediately disqualifying should also be discussed with the applicant. This is particularly important when, if neglected, the condition could eventually interfere with the persons health and ability to drive safely. The driver should be referred to his or her doctor.

Completing the Form Top

The form should be completely and accurately filled out. It is useful to elaborate on a Yes answer by adding information to the drivers responses. Applicable restrictions need to be identified. The final decision should reflect a combination of clinical judgment and test results (6).

Waiting Period Top

The driver can be temporarily disqualified. The waiting period is the time interval during which commercial driving is not allowed. If more than one waiting period applies, the longer one should be used, except where stated otherwise. For example, for a commercial driver treated with coronary angioplasty (waiting period one week) following an acute myocardial infarction (waiting period two months), the waiting period should be two months. Recurrence of the disqualifying condition resets the waiting period.

Frequency of Re-certification Examinations Top

Under the FMCSRs, the Medical Examiners Certificate is not valid for more than two years. The driver can be certified for three months, six months, one year, or another length of time decided on by the examiner, not to exceed two years.

A commercial driver with a clinical diagnosis of CVD should be re-certified at least annually. A commercial driver who has multiple risk factors for CHD and is 45 years of age or older should be re-certified annually.

References Top

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Ischemic Heart Disease

Joel B. Braunstein, MD

Fellow, Division of Cardiology and

Robert Wood Johnson National Clinical Scholar,

Johns Hopkins Medical Institutions

Roger S. Blumenthal, MD

Director, Preventive Cardiology,

Division of Cardiology,

Johns Hopkins Medical Institutions

ISCHEMIC HEART DISEASE

Background