Thursday, October 01, 2015

Update on Sleep Apnea

Obstructive sleep apnea (“OSA”) is caused by the obstruction of the upper airway due to a collapse of the soft tissue at the back of the throat during sleep. It is characterized by repetitive pauses in breathing during sleep, despite the effort to breathe, and is usually associated with a reduction in blood oxygen saturation. These pauses during breathing, called "apneas" (literally, "without breath"), typically last 20 to 40 seconds. The most serious consequence of untreated OSA is to the heart. Sleep apnea sufferers have a 30% higher risk of heart attack or death than those unaffected. They have a four times greater risk of stroke. It is a disorder that can cause excessive daytime sleepiness. Falling asleep during the operation of rail locomotives, vessels, aircraft and trucks poses a serious risk to individuals and to the public. The Canadian and American legislators are looking at this emerging issue with a view to increasing the regulatory framework to address the problem.

For a comprehensive review of sleep apnea in the transportation industry from a legal perspective see the Fernandes Hearn LLP newsletters of November 2013, December 2013 and January 2014.

In October 2013 U.S. legislators passed a bill that requires the Federal Motor Carrier Safety Administration (“FMCSA”) to use its formal rule-making process to deal with any regulation concerning sleep apnea for the trucking industry. The 2013 legislation requiring that any new OSA requirements be subject to formal rule-making was strongly supported by the trucking industry. It came in response to FMCSA’s stated intention at the time to publish new formal guidance to medical examiners on how to handle suspected OSA cases. The main point of contention: FMCSA’s anticipated recommendation that commercial drivers be screened for OSA if they have a Body Mass Index (BMI) greater than 35. This was estimated to be as much as a third of the commercial driver population with costs for screening and treatment reaching as much as $1 billion a year by one estimate. Industry groups said a change of this magnitude required a formal rule-making proceeding with full opportunity of public review and comment and cost analysis.

The FMCSA has indicated that it is in the process of drafting a formal rule. At this time, it has not issued a formal rule.

However, in January 2015 the FMCSA issued a guidance bulletin to certified medical examiners and medical trainers on the issue of OSA.  FMCSA’s guidance on sleep apnea dates back to 2000. The agency states that the recent bulletin serves as a “reminder” to medical examiners. The bulletin urges medical examiners to use their best judgment in deciding whether a trucker should be tested for OSA as a matter of highway safety. In the U.S., The National Registry of Certified Medical Examiners went live in May 2014. Its implementation came from a final rule that requires all commercial drivers to obtain their physicals and driver medical cards from an FMCSA-certified examiner.

The January 2015 guidance bulletin came amidst ongoing concerns by many in the industry that some medical examiners were overzealous in referring drivers for OSA testing and treatment. There have also been complaints that certified examiner instruction courses used since May 2014 for certifying examiners go beyond FMCSA’s regulations and guidance in advising examiners on how to respond when OSA is suspected.
The bulletin does not carry the legal weight of a regulation or even a formal advisory or interpretation. Nonetheless, missives of this sort must be treated seriously by medical practitioners, if for no other reason than they may be used as evidence of a de facto standard in negligence suits.

Trucking companies and drivers are advised to be aware that, although the FMCSA offers several sweeping recommendations regarding the diagnosis and treatment of OSA, the ultimate bottom line of the most recent bulletin is this: “Medical examiners may exercise their medical judgment and expertise in determining whether a driver exhibits risk factors for having OSA and in determining whether additional information is needed before making a decision whether to issue the driver a medical certificate and the duration of that medical certification.”
While the FMCSA regulations state that a person is physically qualified to drive a commercial motor vehicle if that person "has no established medical history or clinical diagnosis of respiratory dysfunction likely to interfere with his/her ability to control and drive a commercial motor vehicle safely,” trucking organizations in the U.S.A. have recently begun to see an increase in medical examiners refusing to issue certification if a driver exhibits only a few of the indicators of OSA. One of the more commonly used medical exams requires OSA screening if the driver gives an affirmative answer to just three of eight questions. The final three questions being: (1) Is the patient 50 years or older? (2) Is the patient’s neck circumference more than 15.7 inches? and (3) Is the patient a male?  
Trucking companies in the U.S.A. are also finding that some examiners are issuing provisional certifications and requiring drivers to undergo costly sleep studies if they have certain “risk factors” for OSA, which has further increased costs for trucking companies.
What is obvious is that the issues involved are not simple. Is there a significant causal connection between sleep apnea and trucking accidents? While there is medical evidence about the health effects of sleep apnea, increased risk of heart attacks and stroke, there are few studies about its affect on trucking accidents. What type of accidents? Are only long haul drivers affected? Are the statistics for sleep apnea in the U.S.A. the same in Canada? More studies are needed.
The Toronto Rehab Foundation (the “Foundation”) is preparing to do a study on sleep apnea in the trucking industry in the coming two years. The Foundation is presently in the process of raising funds for conducting the study. A number of organizations and insurers have already stepped up to the plate with generous donations. Included among the contributors are Northbridge Insurance, Intact Insurance, Old Republic Insurance, and the Canadian Trucking Alliance. The study will be conducted on an estimated 1000 drivers. Participants will be advised of the results of the study, but the information gathered will not be supplied to their employers, insurers or the government authorities. Participants will be advised if they have sleep apnea for which they should seek medical help. The study will track the participant’s driving history (for accidents) before the testing, after the testing and treatment. The study will attempt to demonstrate the extent of the problem in Canada and the correlation to accidents. A formal rule is a likely to result from the FMCSA in the U.S. and such a rule will impact Canadian drivers going into the U.S. Canadian legislation will surely follow. Trucking companies should take steps today to meet this challenge. The results of the study will assist everyone in the dialogue to come and will be influential in assisting regulators in how much regulation is actually needed. For more information on the study or to make a donation, please contact Rui Fernandes, who is assisting the Foundation with the study.


Post a Comment

<< Home