AME S COVID19: Procedures & Results”.

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CLASIFICACION DE SEGURIDADF-DEA-PDO-09 1.0“AME s COVID19: Procedures & Results”.Dr. Francisco Rios TejadaAESA Chief Medical AssessorAMABEL Meeting 2nd October 2020

DisclaimerDisclaimer Information AMABEL Meeting. I have no financial relationships to disclose. I will not discuss off-label use and/or investigational use in thispresentation. This presentation are intended for information purposes only, and shouldnot necessarily reflect the opinion of AESA nor EASA.2/XX

Background Data: 1st WaveCOVID 19: Daily progress of new cases, deaths and recovered.3/XX

Background Data: 2nd Wave4/XX

Background Data: 2nd Wave20th Sept 20205/XX

Instant Basic Reproductive Number (Rt)27th Sept 20206/XX

Background Data: 2nd WaveDeath Rate/100.000 population15/09/20207/XX

ConsequencesAME- Still valid procedures and protocols designed in the 1st Wave.- Protection measures in place during the exam.- Attention to applicants that will show up by the time of the correspondingrenewal or revalidation and got COVID19 during the 1st wave.AUTHORITY- Follow up available data of COVID19:Incidence & consequences (Risk Assessment).- Up to date procedures- Re-arrange oversight: On site very complicate.- Education: turn into e-learning/webinar/distant learning.- EASA guidelines, recomendations and standarization among MS8/XX

Authority Objectives To assist the AME by furnishing guidelines and management instructionsable to identify aircrew and ATCO applicants, that in any way have beenassociated with the COVID19.Help AME To indicate suitable directions and framework to follow, in order to identifythe compatibility of the exposed candidate and what it is established in theEASA Regulation, concerning Infectious diseases and hence COVID19, toassure flight safety.Suitable for flying duties9/XX

IntroductionPRACTICAL GUIDELINESFOR THE EVALUATION OFCOVID19 CASES FOR AMEs& AMCs10/XX

IntroductionAir transport has been demonstrated a powerful vector of transmission,therefore we must assure the actual fitness, which means free COVIDdisease in aircrew members and ATCOs, if we wants to secure the aviationactivity.The aeromedical evaluation either by AME or AeMCs, seems to be critical inthose individuals who might be exposed to the disease in any of the aspectsor domains showed by COVID19.11/XX

Aircrew: Implementing Rule1178/2011MED.B.040 Infectious diseasesa) Applicants will be considered unfit if any clinical diagnosis or medical history ofany infectious disease that might interfere with the safe exercise of the privilegesof the licence.AMC1 MED.B.040 Infectious disease(a) Infectious disease GeneralIn cases of infectious disease, consideration should be given to a history of, or clinicalsigns indicating, underlying impairment of the immune system.12/XX

ATCOs: Implementing RuleATCO.MED.B.040 Infectious Diseasesb) applicants with symptoms or diagnosis of infectious disease such (*):1) Syphilis;2) active tuberculosis;3) infectious hepatitis;4) tropical diseases,Should be deferred to the authority in order to be evaluated. A fitassessment can be evaluated after a complete recovery and report ofspecialist will demonstrate that treatment does not interfere with theprivileges of the licence.(*) can be extrapolated to COVID-19AMC1 ATCO.MED.B.040 Infectious disease(a) Infectious disease — GeneralIn cases of infectious disease, consideration should be given to a history of,or clinical signs indicating, underlying impairment of the immune system.13/XX

EASA RecomendationsGuidance on aircraft cleaning and disinfectionin relation to the COVID-19 pandemicSafety Information Bulletin Aerodromes – OperationsSIB No.: 2020-02R5Issued: 30 June 2020Subject: Coronavirus COVID-19 Pandemic — Operational recommendationsGuidance on the management of crew membersin relation to the COVID-19 pandemicCOVID-19 Aviation Health Safety Protocol. Operational guidelines for themanagement of air passengers and aviation personnel in relation to theCOVID-19 pandemic14/XX

COVID19: Considerations of interestThe applicant must be specifically asked by the AME about items:- 105 (other respiratory diseases),- 128 (other diseases),- 129 (hospitalization),- 130 (medical visit) displayed in the application form and associated to COVID19.The AME:- Will collect whatever medical reports provided by the applicant and,- Will ask about his/her Labour and Social Security Medical Status.15/XX

COVID19: Considerations of interestIt will be necessary to identify:- Diagnosis, course of treatment and hospital admission.- In case of mild disease, what kind of preventive measures has been followed,including quarantine and possible confirmed contacts.A comprehensive review:- Medical reports: clinical data, complementary testing, Lab testing, imagediagnosis, and treatment provided, including oxygen therapy or assistedventilation.16/XX

COVID19: Considerations of interestAttention will be paid to presence of comorbidity and complications.Once the data has been collected:1. Find out if information provided is good enough for an appropriateaeromedical assessment or if any additional testing we think it might benecessary for a final adequate assessment.2. In situ or referrals: temperature, TC/TCAR, thoracic ecography,pulmonary function test, SpO2 follow-up, disnea scale (MRC) & qualityof life, 6 min walk test, ECG (QT/QTc), echocardiography, comorbidity,target organs involvement and specialist report.17/XX

COVID19: Considerations of interestAttention!!Keep in mind that infection by COVID 19, is a dynamic process, that respond to avariable clinical course, but with a quite uniform syndromic expression.Disease course may vary from a mild evolution, treated at home and phonefollow-up to medical ambulatory /visit medical follow-up, to hospital admissionor ICU care.18/XX

COVID19: Considerations of interestThe ever-changing nature of this illness means that we need to change our focuson the effect of the infection.AME should considered the changes and scientific evidence and the situation ofthe disease at the time of the applicant examination.19/XX

COVID19: Considerations of interestEvidence showed that classification scheme of Siddiqi, might be modified byadding a fourth or a fifth phase, where systemic non pulmonary complications(cutaneous, eye, neurologic, renal, cardiac, coagulation disorders), ageinvolvement (kids) or respiratory complications such pulmonary fibrosis andsome others not yet clearly defined.20/XX

COVID19: PhasesCOVID19: Clinical-Therapeutic Staging Proposal. Hasan K. Siddiqi21/XX

COVID19: PhasesStage IV/VNew InfectionRe-infectionClasical SXSide effectsCorticosteroidsRemdesivirVaccineCOVID19: Clinical-Therapeutic Staging Proposal. Hasan K. Siddiqi(Modified)22/XX

COVID19: Considerations of interestEvidence showed that classification scheme of Siddiqi, might be modified byadding a fourth or a fifth phase, where systemic non pulmonary complications(cutaneous, eye, neurologic, cardiac, coagulation disorders), age involvement(kids) or respiratory complications such pulmonary fibrosis and some others notyet clearly defined.It is necessary to rule out complications and take into account the possibility tocheck additional testing if we want to rule out target organs involvement suchheart and lungs (Echocardiography, Respiratory Function test, Image diagnosis).23/XX

Side Effects24/XXSystemSide EffectsUpper AirwaysAnosmia, ageusia, cough, mucousLower AirwaysDispnoea, cough, chest painMuscle & JointsWeakness, erratic painNeurocognitiveLoss of attention, memory loss & slepnessNeurologicalNeurodegenerative disease, stroke, brainhemorrhage, encephalitis, peripheral nervedamage.PsychologicalAnsiety, depression, psychosisDigestive/RenalGut microbiota dysbiosis, Electroliticdisturbance, Acute Kidney Injury, Renalreplacement therapyOthersLoss weight & hair

Gastro-intestinal side Effects25/XX

Pulmonary side effects 6MWD increased from 16% to 43%: 57% to gain. Fatigue, exercise intolerance, and poor concentration can be particularlyproblematic. Unfortunately, optimal management remains unclear. While the effects of COVID-19 for the pulmonary circulation are being defined,several lines of evidence suggest that the molecular features of SARS-CoV-2infection are strikingly similar to what is seen in pulmonary vascular diseasedevelopment, promoting endothelial dysfunction, lung coagulopathy andmicrothrombi, and hemodynamic impairments (Table). A pragmatic approach to primary care management might include first lineinvestigations such chest radiography and oxygen saturation measurements,with referral to secondary care where lung pathology needs investigation.BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3001 (Published 03 August 2020)Citethis as: BMJ 2020;370:m3001Am J Physiol Lung Cell Mol Physiol 319: L277–L288, 2020. First published June17, 2020; doi:10.1152/ajplung.00195.202026/XX

Pulmonary Side Effects27/XX

Pulmonary Side Effects28/XX

Pulmonary Side Effects29/XX

Pulmonary Side EffectsPulmonary Fibrosis?Just a few data so farExtrapolate from:- SARS-CoV: 62% of Pt with Interstitial Pattern at discharge time. After 15 yearsa 4,6 % still affected.- MERS-CoV: Fibrotic changes in 1/3 of Pt at discharge time.COVID19- At discharge time 8,1% normal radiology and 53% normal after 3 weeks.- Very slow and torpid recovery: several months after, Pts still sympthomatic, withnormal radiolog: Clinical- Radiological dissociation.- Presence of fibrotic radiological pattern more associated to severe COVID19findings.- Discussion: many Pulmonary especialist agree on dissociation in betweenclinical findings and Spo2, Espirometry and radiological status.- Need to study other causes: Muscular, Cardiac, Trombotic .30/XX

Pulmonary Side Effects31/XXFindingsRisk Factors for Fibrosis- Parenquimal bands- Reticulation- Traction Brochiectasis- Irregular interphases-AgeHypertensionDispnoeaLinphopeniaPCR and IL6 elevatedNumber of Hospitalization daysICUTX Esteroids and antiretrovirals

Cardiac Side EffectsMyocarditisPericarditisArrythmias32/XX

Pulmonary Side Effects- Long term effects still unkown- Follow up studies neded- Multi-organ involvement- Still questions to answer:-33/XXPathophysiology of the infectionFatal complications: PTE and Difuse Endotelial DisordersRole of comorbiditiesCharacteristics of host and viral load

COVID19: Considerations of interestThe AME should take into account psychological and mental involvement as aconsequence of family or acquaintance mourning, long stay in ICU, and financialconsequences due to loss of employment, layout etc. Labour consequences in theaeronautical environment is critical. Such scenario should be explored in themental health interview.Dr. Simmons34/XX

COVID19: Considerations of interest35/XX

COVID19: General Approach36/XX

COVID19: AME Pathway Approach37/XX

AME: Sources of informationAMEF-DEA-PDO-09 1.0CLASIFICACION DE SEGURIDADClinicalBibliographyOTHER SOURCESNational Law38/XX

COVID19: AME s & AeMCs distributionPhysicals between 1 March- 15 July 202039/XX

COVID19: IncidenceReview: 1 March- 15 July 2020 104 AMEs 13 AeMCs40/XX

IncidenceData ReviewINCIDENCE OF COVID1941/XX1 May-15 July 2020Num PhysicalsNum COVID19%Class 12280341,21Class 291280,87LAPL87050,57CC70730,42Class 347291,90TOTAL5848591,001 May-15 July 2019Num PhysicalsTOTAL9196% Decrease 2019 vs 202036,5

PopulationData Review54 males out of 595 females out of 59:- 4 Class 3- 1 Class CCMean Age Class 147Mean Age42/XXClass 2LAPLClass CCClass 35744,55146SevereModerateMild60,351,542

Severity incidenceData ReviewSevere (ARDS)Moderate/PneumoniaMildClass 13229Class 2107LAPL023CC111Class 3036Total5846%8,4713,5579,96Class 1 Severe Cases:- Rotary wing. ARDS. Issue TML 3 m- Commercial. Bilateral Neumonia. Good recovery. Issue- Commercial. Bilateral Neumonia. Severe sequelae. Attention &focus disorder. Denied43/XX

DiagnosisData Review40: Clinical LabTotal of 5919: Clinical (mild cases)Mental Health issues: 3 cases- Class 1, family problem related to COVID- Class 1, Medevac pilot, close involvement COVID- Class 1, Comercial, ARDS, Attention disorder, loss memory44/XX

Conclusions AME guidelines has been demosnstrated as an useful tool. AME approach under scientific up to date EASA, ICAO, IATA . 2nd Wave in place: AMEs alertness. AME preventive measures: Safety distance, protection, hygiene, etiquete. AME: Search for COVID19 HX, followup and potential side effects. Low incidence of COVID19 in aircrews. COVID19 severityage related. Higher rates in Class 1 and 3. Most cases45/XXmild and moderate outcomes.

AESA Aeromedical DivisionThanks for your Attentionsenasa.frt@externomf.es46/XX

9/XX Authority Objectives To assist the AME by furnishing guidelines and management instructions able to identify aircrew and ATCO applicants, that in any way have been associated with the COVID19. To indicate suitable directions and framework to follow, in order to identify the compatibility of the exposed candidate and what it is established in the

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