Daily Rules, Proposed Rules, and Notices of the Federal Government
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You may submit comments and related material regarding whether this proposed policy change should be incorporated into a final policy on issuing medical waivers to mariners with ICDs. All comments received will be posted, without change, to
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Coast Guard regulations in 46 CFR 10.215 contain the medical standards that merchant mariners must meet prior to being issued a merchant mariner credential (MMC). In cases where the mariner does not meet the medical standards in 46 CFR 10.215, the Coast Guard may issue a waiver when extenuating circumstances exist that warrant special consideration.
In NVIC 04-08, the Coast Guard states that anti-tachycardia devices and ICDs are generally not waiverable. Since the issuance of NVIC 04-08 on September 15, 2008, a number of mariners have sought and received waivers for anti-tachycardia devices or ICDs in accordance with 46 CFR 10.215(g). However, because NVIC 04-08 does not identify waiver criteria associated with anti-tachycardia devices or ICDs, it has been difficult for Coast Guard personnel to consistently evaluate merchant mariners with anti-tachycardia devices or ICDs and assess whether an applicant's medical condition warrants granting a medical waiver under 46 CFR 10.215(g). Accordingly, the Coast Guard is considering whether to change its policy regarding waivers for anti-tachycardia devices or ICDs, and under what criteria a mariner may be eligible for waiver consideration.
The Coast Guard intends to consider public input as well as the recommendations of the Merchant Mariner Medical Advisory Committee, established under the authority of 46
The Coast Guard specifically requests public comment on the likelihood of an ICD inappropriately firing and whether that shock could potentially incapacitate a merchant mariner. Additionally, the Coast Guard seeks public comment on whether the criteria listed below are appropriate and sufficient to evaluate whether a mariner should be eligible for consideration for a medical waiver under 46 CFR 10.215(g).
Below is a series of 12 questions we are considering as the criteria for granting a medical waiver. A review of the mariner's record should lead the Coast Guard to answer “no” for each question in order for the mariner to be eligible for waiver consideration. We request public comment regarding whether the 12 questions below represent an appropriate and sufficient list of the criteria a mariner should be required to meet in order to be eligible for waiver consideration, or whether we should eliminate or modify any of the questions, or add other questions to the list.
(1) Does the mariner have a diagnosis of a cardiac channelopathy affecting the electrical conduction of the heart (including Brugada syndrome, Long QT syndrome, etc.)?
(2) Does the mariner have a prior history of ventricular fibrillation or episodes of sustained ventricular tachycardia and, if so, did the arrhythmia episode occur greater than three years ago?
(3) Was the ICD or anti-tachycardia device implanted more than three years ago?
(4) Has the ICD fired or has the mariner required anti-tachycardia pacing within the last three years?
(5) Does the mariner's condition present any confounding risk factors for inappropriate shock such as uncontrolled atrial fibrillation?
(6) Is the mariner's ejection fraction greater than 40% with a steady or improving trend?
(7) Does the mariner have a history of any symptomatic or clinically significant heart failure in the past two years?
(8) Does the mariner's record contain any evidence of significant reversible ischemia on myocardial perfusion imaging exercise stress testing?
(9) Has the mariner's exercise capacity been assessed to be greater than or equal to 10 metabolic equivalents (METs)?
(10) Did the mariner provide a written opinion of the treating cardiologist or electrophysiologist that supports a determination that the mariner is at low risk for future arrhythmia, adverse cardiac event or sudden incapacitation based upon objective testing and standard evaluation tools?
(11) Does the mariner have any other medical conditions which may alone, or in combination with an ICD or anti-tachycardia device, affect the mariner's fitness?
(12) Is the mariner applying for an original credential, raise-in-grade, or renewal of an existing credential?
We issue this request for public comments under the authority of 5 U.S.C. 552(a).