Medical Evaluation of Spaceflight Participants for NASA’s Commercial Crew Era paceflight Participant Richard T. Jennings, MD, MS CharlesMedical H. Mathers, ScreeningMD, MPH James M. Vanderploeg, MD, MPH Smith Johnston, MD, MS

Working Together to Work Wonders. Working Together to Work Wonders. Commercial Crew Era NASA

Boeing CST-100 Starliner SpaceX Dragon 2 ISS Destination and ISS Medical Systems NASA Primary Medical Operations Control Commercial Company Medical Teams NASA and International Partner Medical Certification (MSMB) Bigelow Module, Blue Origin, Free Flyers?

Working Together to Work Wonders. Design Reference Mission

Low-earth Orbit NASA or IP Professional Astronaut Crews Maximum Duration 30 days ISS Destination Normal Cabin Atmosphere Space Suit for Hazardous Operations Acceleration Launch and Landing Water Landing

Working Together to Work Wonders. Boeing

Working Together to Work Wonders. Working Together to Work Wonders. Working Together to Work Wonders. Working Together to Work Wonders. Working Together to Work Wonders. SpaceX

Working Together to Work Wonders. Working Together to Work Wonders. Working Together to Work Wonders. Working Together to Work Wonders. Working Together to Work Wonders. Working Together to Work Wonders. Working Together to Work Wonders. Medical Certification Commercial Crew Space Adventures Spaceflight Participants UTMB and Partners NASA Medical Operations and Space Medicine Board International Partners MSMB

• NASA • CSA • JAXA • ESA • RSA (IBMP, GCTC)

Working Together to Work Wonders. Orbital Medical Standards Spaceflight Participants

MED Volume C, Published Dec, 07 Appendix F Medical Examination Requirements Most Will Be Outside the Standards in Certain Areas Risk Assessment Process, Risk Reduction, and Waiver Process Critical Waiver Process and Flight Safety • Risk of Event Occurrence • Severity of Event • Impact to Mission

Working Together to Work Wonders. Rare Unlikely Possible Likely Almost Certain LIKELIHOOD Remote possibility (once Could happen but rare Could happen Could happen often (on Could happen frequently every 3 years or more) (typically once a year) occasionally (on average average once a month or (once a week or more) 1 2 quarterly) more) 5 IMPACT 3 4

Insignificant 1 Low Low Low Low Medium 1 2 3 4 5

Minor 2 Low Low Medium Medium Significant 2 4 6 8 10

Moderate 3 Low Medium Significant S Major 3 6 9 Significant 15 12

Significant 4 Low Medium Significant Major Major 4 8 12 16 20

Major 5 Medium Significant Major Major Major 5 10 15 20 25

Working Together to Work Wonders. Working Together to Work Wonders. Working Together to Work Wonders. Overview Orbital Medical Findings To Date

• 15 Prime and Backup Crew Examined UTMB • Mean Age At Initial Evaluation: 48 • Age Range: 29-67 • 12 Born Outside U.S. • 5 Female • No Psychiatric, Genital or Reproductive Data Included

Working Together to Work Wonders. Prescreen Results from 15 Spaceflight Participants

Ventricular Ectopy (Multiple) Cavernous Hemangioma Brain

• Up to 11,000 PVCs/24h Cholelithiasis and Polyps • Bigeminy, couplets, triplets Allergies Requiring Desensitization Bullous Emphysema (FEV1 53%) Injections

Pneumothorax (2) PRK

Giant Hepatic Hemangioma (11.5 CM) Radial K

Single Cross-Fused Ectopic Kidney Intraocular Lens Replacement

Insulin Treated DM Defective Visual Acuity (Common)

Coronary Artery Disease • High Myopia (10 diopters) Lacunar Cysts Brain

Working Together to Work Wonders. Prescreen Results From 15 Orbital Participants UBOs Brain (Multiple with White Matter Hemorrhoids (Multiple) Densities) Chronic Gastritis Familial Essential Tremor Chronic Sinusitis Pectus Excavatum/SP Surgical Repair Gastric Polyps Mild Pulmonary Restriction Scoliosis GERD with Barrett’s Esophagus Chronic Sinusitis (Multiple and Post Lung and Mediastinal Masses Surgical) (talcomas, round atelectasis) H. pylori (Multiple) Inguinal Hernias Basal Cell Carcinoma Dental Disease with Incomplete Dysplastic Nevi restorations, Sinus Tracts with Apical Bone Resorption Nephrolithiasis (Bilateral) Hearing Loss (multiple)

Working Together to Work Wonders. Prescreen Results From 15 Orbital Participants

Colon Polyps Failed Tilt Test (Multiple) • Adenomas (12) History Shoulder Dislocation • Tubulovillous adenoma Hiatus Hernia (Multiple) Atrial Enlargement Spine Degenerative Changes Childhood Asthma History (Multiple) Hyperlipidemia/medication Osteopenia Calcified Aorta Prostate hypertrophy requiring Prior Surgeries medication VAT, T&As, Sinus, Knees, Chest (2), Diverticulosis (multiple) Appendectomies, Rhinoplasty, Hypothyroidism requiring Rx Laparotomies, Hernias

Working Together to Work Wonders. Invasive Interventions for Spaceflight

Hepatic Trisegmental Liver Resection Cholecystectomy Thoracoscopic Abrasive Pleurodesis Percutaneous Pulmonary and Mediastinal Biopsies (47) Surgical Excision of Skin Hemangioma Lithotripsy Electrophysiological (EP) Cardiac Studies

Working Together to Work Wonders. Orbital Flights by the Number

Total: 7 made 8 Flights Mean Flight Age: 51 No Missions Were Adversely Affected by Medical Events

Working Together to Work Wonders. “In a few minutes, you’re going to meet two nice gentlemen dressed in white coats.”

Working Together to Work Wonders. Appendix F For Short Duration Missions ISS Medical Disposition Category 2 (MDC2)

History and Physical Equiv to FAA Class I CACS (male 40, female 50) 24-hour Holter Monitor Within 12/6 Months Preflight by Commercial Crew Surgeon and IP Assigned Crew Surgeon Echocardiogram Dental/orthopantomogram or Full Mouth Pulmonary Function Testing X-rays CXR, Abdominal and Pelvic Audiometry/Tympanogram Ultrasound Optometry per Med Vol C Mammography Acuity, Refractive Error, Tonometry, Fundoscopy, Visual MRI/MRA Brain (within 5 yrs flight) Fields, Color Vision As Clinically Indicated (ACI) Psych exam/Screen by IP psychiatrist Colonoscopy, carotid US, EKG, EST/VO2 Max Thyroid US, DXA

Working Together to Work Wonders. Appendix F For Short Duration Missions ISS Medical Disposition Category 2 (MDC2)

Laboratory L-90/30 MRSA, GABHS, H Pylori CBC, PT, PTT L-14/10 Medical Evaluation by Crew Chem Profile per Med Vol C Surgeon ID Profile (HIV, Hep B&C, L-2/1 Prelaunch Medical Evaluation PPD) Immune Status UA, Drug Screen Physiologic Training High Performance/Vehicle Specific G training (What??) MSMB and IP Agency

Working Together to Work Wonders. Cost?

Working Together to Work Wonders. When in the Timeline Should SFP Medical be to Presented to NASA?

32 Annual Evaluation Pending Flight Assignment

Interval History Exercise Stress Test/VO2 Max Physical Examination including DRE (ACI) Abdominal/Pelvic Ultrasound Dental Exam Mammography per protocol Audiometry MRI/MRA Brain Each 5 years Laboratory Colonoscopy within 5 years of CBC, UA, Chemistry, Lipids, flight Liver Enzymes, HbA1c, etc Optometry per Med Vol C Update vaccination status EKG, Resting

Working Together to Work Wonders. Operational Medical Support and Risk Mitigation for Flight

Aggressively manage medical conditions while awaiting flight to assure stability and prevent advancement of disease or secondary decrements Prepare individualized medical kits based on general needs and disease specific requirements Assure integration of any equipment with spacecraft systems, power requirements, radiation effects, EMI, etc. Assure checklists and adequate training of crewmembers to assist in medical care when needed

Working Together to Work Wonders. Working Together to Work Wonders. Working Together to Work Wonders. Additional Considerations

Older Individuals who can afford multi-million dollar flights have established care through their own medical providers Assuming their medical information available, UTMB tries to avoid repeat testing, particularly if involves risk, discomfort, and/or radiation Medical partnerships may be beneficial

Working Together to Work Wonders. Medical Challenges Moving Forward in Orbital Commercial Spaceflight Timing for examination when there are known medical problems and decision regarding investment in a flight Mission-specific medical certification testing Eventual shift to private medical certification from governmental agencies—legal issues Disease-specific risk models and mitigation strategies appropriate for the mission Integrate personalized medicine and genomics Improve real-time on-orbit monitoring and medical management capabilities Data collection, archival, and integration of lessons learned from a small cohort

Working Together to Work Wonders. Questions

Working Together to Work Wonders.