FMCSA Bulletin on Sleep Apnea is not Rule

Finally some guidance to medical examiners from FMCSA in this bulletin on obstructive sleep apnea. Although not a “rule” and therefore no specific details of exactly how to screen, evaluate, certify/disqualify, or manage these cases, the guidance here is consistent with previous recommendations and medical expert panel reports.

It is also consistent with our well established program of screening all DOT/Commercial driver examinees for OSA.

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FMCSA Bulletin Highlights

Let’s take a look at some of the highlights of the FMCSA bulletin on obstructive sleep apnea:

  • The applicable “rule” or law in the current FMCSA standard is that individuals are prohibited from receiving a medical examiner’s certificate to operate commercial motor vehicles in interstate commerce if they have an  “established medical history or clinical diagnosis of a respiratory dysfunction likely to interfere with his or her ability to control and drive a commercial motor vehicle safely.” (49 CFR 391.41(b)(5)).   OSA is considered a respiratory dysfunction when there is a determination that it is likely to interfere with the driver’s ability to operate safely because of the severity of the case.
  • OSA may culminate in unpredictable and sudden incapacitation (e.g., falling asleep at the wheel), thus contributing to the potential for crashes, injuries, and fatalities.
  • In driving simulations, OSA patients were more likely to unintentionally swerve and strike objects – a serious and dangerous outcome for the transportation industry.
  • The bulletin reiterates the Oct, 2000 FMCSA advisory criterion regarding the respiratory standard (standards are law) making it clear that OSA is considered a “respiratory dysfunction that interferes with oxygen exchange” and therefore these drivers should be referred for further evaluation and therapy:

    When the examiner recognizes risk factors for OSA

    When it is known that the driver has an established diagnosis of OSA

  • FMCSA’s physical qualifications standards and advisory criteria do not provide OSA screening, diagnosis or treatment guidelines for medical examiners to use in determining whether an individual should be issued a medical certificate.
  • This is still left to the discretion of the medical examiner (authors note:  medical examiners should obtain additional training to enable consistent screening, diagnosis and treatment guidelines to utilize in their practice and management of these drivers.)
  • Certification may be withheld until additional information is available to the medical examiner
  • Certification may be for less than 2 years due to the need to monitor any serious medical condition more closely

OSA algoritm graphic

The Agency encourages medical examiners to consider the following in making the medical certification decision:

  • The primary safety goal regarding OSA is to identify drivers with moderate-to- severe OSA to ensure these drivers are managing their condition to reduce to the greatest extent practical the risk of drowsy driving. Moderate-to-severe OSA is defined by an apnea-hypopnea index (AHI)1 of greater than or equal to 15.

authors note: we identify drivers using evidence based screening criteria and refer them for additional evaluation

  • The Agency does not require that these drivers be considered unfit to continue their driving careers; only that the medical examiner make a determination whether they need to be evaluated and, if warranted, demonstrate they are managing their OSA to reduce the risk of drowsy driving.

authors note:  In most cases, the driver suspected of having OSA can be temporarily certified while obtaining further evaluation of the condition.  Diagnosis can be made using convenient, affordable home sleep testing

  • Screening: With regard to identifying drivers with undiagnosed OSA, FMCSA’s regulations and advisory criteria do not include screening guidelines. Medical examiners should consider common OSA symptoms such as loud snoring, witnessed apneas, or sleepiness during the major wake periods, as well as risk factors, and consider multiple risk factors such as body mass index (BMI), neck size, involvement in a single-vehicle crash, etc.

authors note:  These are the risk factor criteria we use to identify drivers at risk of OSA to determine if further evaluation is needed, which may lead to temporary certification, the need for shorter time periods to certification/recertification

Sleep Apnea Management program

  • Diagnosis: Methods of diagnosis include in-laboratory polysomnography, at-home polysomnography, or other limited channel ambulatory testing devices which ensure chain of custody.

authors note:  we use home sleep testing on a confirmatory basis, e.g. if our screening process indicates a high likelihood of OSA, a negative home screening test will prompt an in-lab sleep study.  This obviates any question of the unattended home study not being applied properly or tampering (yes, it happens)

  • Treatment: OSA is a treatable condition, and drivers with moderate-to-severe OSA can manage the condition effectively to reduce the risk of drowsy driving. Treatment options range from weight loss to dental appliances to Continuous Positive Airway Pressure (CPAP) therapy, and combinations of these treatments. The Agency’s regulations and advisory criteria do not include recommendations for treatments for OSA and FMCSA believes the issue of treatment is best left to the treating healthcare professional and the driver.

authors note:  previous recommendation in medical expert panel reports have recommended only PAP therapy for OSA patients with an Apnea-Hypopnea Index (AHI) of greater than 20, as this is the only treatment that can produce compliance reports.  The use of dental appliances is effective for many patients, and there may soon be compliance procedures available for these devices.  Until then, we would reserve the use of dental appliances to drivers with an AHI < 20, and require full compliance reports on those with AHI > 20.

The bulletin concludes that the FMCSA relies on medical examiners to make driver qualification decisions based on their expertise, yet acknowledges that they make no specific guidelines regarding screening, evaluation or treatment.  Medical examiners are left to rely on their medical training and expertise in this area.

Access Medical Examiner Training for Sleep Apnea here