President’s Corner, 1Q14, “Obstructive Sleep Apnea – A Wake-Up Call”
by Quay Snyder, MD, MSPH
Late last year, the aviation community received a wake-up call from the FAA regarding the hazards associated with obstructive sleep apnea (OSA). Because of the known hazards in other forms of transportation and recent research regarding the many serious health complications of OSA, the FAA’s Office of Aerospace Medicine felt compelled to identify pilots at high risk for this condition as an important safety measure. The aviation community pushed back. The outcome will most likely be good for all.
Introduction
The Federal Air Surgeon’s Medical Bulletin in November 2013 announced an intended policy of more comprehensive screening of pilots at risk for obstructive sleep apnea (OSA). The announcement created a furor in the aviation community media and pilot organizations. As a result of the public response, the Federal Air Surgeon convened a webinar in December and hosted a meeting of key stakeholders in January to address their concerns. I participated in all of the FAA events with aviation organizations, safety representatives and medical experts. Numerous communications since then have helped reach a consensus that protects nearly everyone’s interests.
As a result of these communications, the Federal Air Surgeon’s office has clarified its OSA policy adopting many inputs from the stakeholders. This new policy will be an improvement over the previous policy, not only in terms of aviation safety, but also in health, career preservation and financial protection for professional pilots.
Historical FAA Policy on OSA
OSA has been a disqualifying condition for all classes of FAA medical certification since 1996. Previously, once a pilot was diagnosed with OSA, s/he was immediately grounded pending presenting the FAA with evidence of adequate treatment and no significant medical complications of OSA. This process required one or more evaluations by a physician board certified in sleep medicine including polysomnograms (overnight sleep study in a laboratory) with and without treatment.
Previous requirements also included an all day Maintenance of Wakefulness test (MST) and stimulant drug testing, which were dropped in 2009. Multiple Sleep Latency Testing was dropped earlier. The tests were expensive, difficult to schedule quickly and hard to locate. The medical community did not have the resources to support large numbers of evaluations. The MWT did not provide useful information for pilot certification and this component of the evaluation was discontinued.
Even more costly to pilots was the very long wait time from diagnosis, obtaining treatment, obtaining documentation of effectiveness of treatment and review by the FAA. Approval to return to flight duties required review by Regional Flight Surgeon offices or the FAA Aeromedical Certification Division. Aviation Medical Examiners (AME’s) did not have the authority to clear a pilot without a Special issuance Authorization for OSA from the FAA. The uncertainty of if and when a pilot would return to flying was a strong disincentive to seeking evaluations or reporting sleep studies to AME’s.
Frequently, pilots remained grounded for three to six months pursuing these requirements for FAA certification. The financial losses from lost wages, use of sick leave, poor insurance coverage and difficulties in adjusting to treatments were substantial. Rather than seek evaluations for health reasons, pilots chose to forego the testing for economical reasons.
NTSB Highlights Safety Risks
Growing numbers of transportation accidents and incidents led the NTSB to recommend changes in the FAA’s OSA policy. As a result of the 2008 Go! Airlines overflight of their Hawaiian destination and other incidents, the NTSB published six recommendations to address the safety risk of OSA and fatigue (A-09-61 to A-09-66).
These included modifying the airman medical application form to elicit information about OSA risk factors, implementing a program to screen pilots for OSA and document effective treatment prior to medical certification, provide information to pilots/employers/physicians about the risks of OSA and that effective treatment resulted in routine medical certification. Three NTSB recommendations were related to fatigue.
FAA Preliminary Response
The FAA addressed these recommendations is several ways. First, the FAA developed a primer on OSA for pilots as part of the Pilot Safety Brochures. Aviation Medical Examiners (AME’s) were encouraged to distribute them to pilots at risk for OSA. Second, every FAA AME initial and recurrent training seminar included a session on OSA addressing both the medical issues and the certification polices.
Because of the expense of changing the medical application form, AME’s were instructed to solicit information regarding OSA from pilots. The FAA also added a Body Mass Index (BMI) calculator to the Guide for AME’s. The BMI was derived from the height and weight already recorded on the medical application form. In most cases, however, AME’s took no action regarding risk factors for OSA unless the pilot already had obtained an evaluation.
2013 Announcement
The November 2013 issue of the Federal Air Surgeon’s Medical Bulletin contained an editorial by Dr. Fred Tilton. The editorial announced an intent to require OSA screening evaluations for all pilots with a BMI of 40 or greater, those at highest risk for OSA. It further stated the intention was to move the screening threshold to lower BMI’s over time when the FAA had the resources. Dr. Tilton’s article pointed out that male pilots with a neck circumference of 17 inches or greater were also at risk and that 30% of those with OSA would have normal BMI’s. Contrary to some media reports, there was no intention to use neck circumference as a universal screening tool.
The subsequent actions by the Office of Aerospace Medicine in response to widespread negative reaction led to several opportunities for feedback from interested parties, including ALPA and other aviation organizations, sleep medicine experts, organizations of AME’s, the NTSB and FAA physicians.
Primary concerns for pilots and aviation organizations addressed by the FAA included aeromedically appropriate screening, minimizing grounding periods during the evaluation and certification process, minimizing costs for evaluations, the availability of physicians qualified to conduct the evaluations and the ability to economically maintain certification if diagnosed and treated for OSA.
AME’s tasked with conducting the OSA screening raised concerns about the ability to the OSA screening fairly, the workload increase and time / administrative burden incurred, the FAA’s ability to review the results of evaluations on a timely basis and their relations with pilots.
Airlines were concerned about the loss of a large number of pilots during the screening and certification process that would limit availability of the pilots, disrupt manning schedules, increase sick leave and medical / disability costs. Nearly all involved expressed concerns over how the process of instituting screening was instituted, as many felt that this was a major policy change that required public comment.
FAA’s Current OSA Policy
The Office of Aerospace Medicine has addressed many of these concerns with its new draft policy announcement considering the inputs from various interested parties. The final policy will be forthcoming soon and most likely will include the following elements.
Screening will still occur during medical examinations by AMEs. However, grounding periods for those diagnosed and effectively treated for OSA will be virtually eliminated. The ability to obtain an evaluation is substantially improved, with lower cost options and a wider variety of physicians able to complete the screening.
Pilots who are otherwise medically qualified will not be denied medical certification, regardless of BMI or risk factors. Those whose BMI is 40 or greater will be directed to obtain an evaluation for OSA by a letter from the FAA. AME’s should inform pilots who have a BMI greater than 40 to obtain the evaluation and note this counseling on the medical application with the pilot’s calculated BMI. The results of the evaluation must be provided to the AME or FAA within 90 days the date of a letter received from the FAA. This letter may not arrive for several weeks or more after the pilot’s medical exam.
This evaluation may be conducted by the primary care physician or any physician willing to do the evaluation, not only sleep specialists. Originally, the FAA proposed only allowing an evaluation by a sleep specialist, which presented cost and scheduling challenges. For the pilot, AME’s will also provide information on the risks of OSA to other pilots who may have risk factors. The FAA will provide guidance and materials for AME’s to distribute to pilots regarding OSA.
Evaluation
Evaluations for OSA may be completed by any physician. If the physician’s determination is that there is no evidence for OSA, pilots may present that information to the AME or the FAA and no further evaluation is required. Physicians may also recommend home screening tests and if the results are negative, provide that information as evidence of a negative evaluation.
If the results of either home studies or a formal sleep study show sleep apnea, the pilot may present evidence of adequate treatment to the AME and be cleared to continue flying. Pilots who are diagnosed with OSA without symptoms and are seeking treatment, but do not have documentation of effective treatment, may continue to fly on the medical certificate issued by the AME.
Effectiveness of CPAP is demonstrated by a download of data from a compliance chip in the CPAP machine showing use of the CPAP for an average of 6 hours per day at least 75% of the days accompanied by a statement from the treating physician that any symptoms of OSA (excessive daytime sleepiness, fatigue, headaches, cognitive changes, etc.) have been eliminated. The clearance will require the AME to contact the AMCD or the Regional Flight Surgeon’s office and submitting the supporting documentation. The pilot may continue to fly and will receive a SIA letter from the FAA documenting follow-up reporting requirements.
Alternative treatments
Several treatments in addition to CPAP are acceptable to the FAA. These include an oral appliance tomove the jaw forward and/or surgery to correct the obstructing airway. Following these treatments, a follow-up polysomnogram or Level 2 home sleep study (7 channels) is required to document effective treatment.
Maintaining Special Issuance
Pilots treated for OSA must present evidence that they continue to have effective treatment on an annual basis (1st and 2nd class). Generally, this will be a download of the compliance chip data from the polysomnogram and a status report from a physician that there are no complications from OSA. Pilots should document use of the CPAP device at least 75% of total days available and average 6 hours or more of daily use. Pilots using two devices (one for home and a portable travelling unit) may combine the data from both devices. If surgical treatment is successful, a Special Issuance will not be required after one year of follow-up and a repeat polysomnogram.
Conclusion
The new FAA policy screens a wider population for OSA because of its significant adverse impact on safety. Treatment of OSA reduces the risk of heart attacks, hypertension, strokes, diabetes, depression and heart rhythm disturbances, which are potentially disqualifying conditions. Thus, the secondary benefit is improved pilot health and career longevity. Fortunately, the changes in the certification process reduce costs and improve physician screening options to reduce the costs of evaluations. The most significant benefits come from the elimination of grounding periods for those diagnosed and effectively treated for OSA, saving months of flying compared to the previous procedures. Overall, aviation safety and pilot health will be enhanced while reducing the financial burdens and disincentives for obtaining OSA evaluation and treatment. Improved AME and pilot awareness of the dangers of OSA and the benefits of treatment will grow.
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