UTMB ASM Residency Grand Rounds The Practice of Aerospace Medicine in the Age of Commercial Space Tourism James M. Vanderploeg, MD, MPH University of Texas Medical Branch Chief Medical Officer, Virgin Galactic September 25, 2007 Objectives z z z Identify the challenges presented by the broad range of individuals wishing to fly to space on commercial vehicles Describe the pre-flight testing and training used to identify and quantify the medical risks for commercial space flight participants Describe the regulatory and legal climate affecting preparations for flying commercial space flight participants Commercial Space Tourism z Who’s doing what? z Space Adventures – $25M for 10 days on ISS z z z Launch & Return on Soyuz Extensive medical evaluations and training Commercial space vehicle operators z z z z z z Virgin Galactic – SpaceShip Two ($200,000) Bigelow – Hotel / Lab in orbit Rocket Plane Space X Planet Space Blue Origin Potential Evolution of Civilian Space Flight Markets Market Expansion / Contraction (not to scale) Milestones Virgin Galactic Inaugural Flight From Mohave Space Port VG Inaugural Launch From NM Space Port Suborbital Tourism RocketPlane Inaugural Flight From Burns Flat, OK Space Port Space Adventures Inaugural Launch From UAE Space Port 1st SpaceX Failed Launch of Falcon I Rocket Plane Orbital Capability 1st Agreements Executed P2P Suborbital SpaceX $100M DoD Contract Complete RocketPlane 1st Crewed Orbital Flight Inaugural Crewed Flight to Orbit Using low-cost technology Orbital Tourism NASA COTS RocketPlane Launches Japanese1 Satellite to Study Drug Development Orbital R&D NASA CEV Phase II Award 2006 2007 1st China Spacewalk 2008 Space Shuttle Retired 2009 2010 Int’l Space Station Retired Beyond 2011 Medical Challenges z z No medical standards – only guidelines Population of space flight participants z z z z z z Age: mid 20’s to mid 70’s (outliers to near 90) Average Age: ~ 55 Gender: 80% male and 20% female Medical status: healthy to debilitated Psychological status: ??? Very little data on which to base “standards” or passenger acceptance criteria Medical Considerations z Acceleration z Launch: +3.5 Gx and Gz (or more?) z Re-entry: +6 Gx (or more?) z Cabin pressurization z Sea level vs. 5,000 to 8,000 feet z Pressure suits – yes or no On board medical capability – not likely z Cardiovascular, Pulmonary, Neurological, Psychological, Musculoskeletal concerns z Pre-flight Testing & Training z Purposes z Identify and quantify medical risks z Ameliorate risk through training and “hardening” z Provide “informed consent” for risks identified z Advise operators on “passenger acceptance” criteria Pre-flight Testing & Training z Acceleration – increased G exposure z Centrifuge z NASTAR (ETC) z Brooks City Base (Wyle) z QinetiQ z Others z Microgravity – decreased G exposure z Zero-G z Flights Altitude Physiology – decreased O2 levels z Hypobaric chambers Virgin Galactic Activities z z z z z SpaceShip Two and White Knight Two under construction by Scaled Composites (Burt Rutan) in Mohave, CA Founders Group (first 100 passengers who pay $200,000 in advance) Medical workshops – panel of Aerospace Medicine experts convened Medical screening ongoing – history and physical by personal physicians Centrifuge testing/training started Virgin Galactic Flight Profile SpaceShip Two Regulatory & Legal Climate Uncertain to Unknown Philosophy Behind Medical Standards/Guidelines z Government Programs z z z z z Exclusion – many disqualifying conditions No medical mission impact Limit risk of medical events Maintain safety Longer term clearance z Commercial Programs z z z z z Inclusion – maximize the number of passengers Accept limited mission impact Accept some risk of medical events Maintain safety One-time flyers ISS and Soyuz Criteria z z z z Will not need emergency care during flight and a medical condition will not negatively affect the completion of the flight program while on board the Soyuz or the ISS Can safely perform emergency egress No physical handicaps that prevent standard use of flight equipment Can participate in all pre-flight training and inflight operations that may be required in contingency situations Three-phased Medical Certification Medical Screening – medical history and records review, screening exam z Medical Evaluation – in-depth examination and evaluation by the JSC Flight Medicine Clinic or IBMP/GCTC z Medical Certification z z Initial z Recertification Waiver of Standards Definition and cause of condition z Stability of condition z Sequelae of condition z Risk of recurrence – especially during flight z Risk to mission success z Impact on condition from space flight z z environmental, duration of mission, acceleration exposure, medical care on board, impact of emergency evacuation Medical Standards Documents z System-by-system description of examination and evaluation tests z Ancillary tests: centrifuge, hypobaric chamber, vestibular tests, zero-G flight z Extensive system-by-system list of disqualifying conditions Are Waivers Possible? z Yes – for example, Greg Olsen z Extensive medical evaluation to “prove” that the waiver criteria can be met z Review and approval by MSMB and Russian SFCB of IBP and the GCTC Commercial Space Flight Participants Aerospace Medical Association Space Passenger Task Force published two reports in ASEM z October 2001 z z Considered both sub-orbital and orbital SFPs z Long list of disqualifying conditions z November 2002 z Considered only sub-orbital flights z Broad guidelines based on 5 assumptions AsMA Space Passenger Task Force Report - II z Assumptions: 1. 2. 3. The space vehicle interior will be small and confining with a capacity for 4 – 6 passengers The flight will be suborbital of 1 to 3 hours duration including about 30 minutes in microgravity The cabin will be pressurized to sea level with an 80% nitrogen, 20% oxygen atmosphere and no life support equipment will be necessary for nominal flight Task Force Report II (continued) z Assumptions (continued) 4. 5. z Acceleration will range between 2 – 4.5 +Gz or Gx (depending on the space vehicle) There will be different emergency egress procedures (depending on the space vehicle) Other considerations: z Space motion sickness, pregnancy, sudden incapacitation, and age Task Force Report II Summary “In summary, the 2nd Task Force on Space Travel offers only broad guidelines, rather than specifics, for short-duration flights. The application of these guidelines should be left to the discretion of the companies, physicians, and passengers. In cases of passengers with significant illness, sound medical judgment will be essential.” FAA Documents z z z March 2003 – Guidance for Medical Screening of Commercial Aerospace Passengers February 2005 – Draft Guidelines for Commercial Suborbital Reusable Launch Vehicle Operations with Space Flight Participants February 2005 – Draft Guidelines for Commercial Suborbital Reusable Launch Vehicle Operations with Flight Crew FAA Documents (cont.) December 2005 – NPRM: Human Space Flight Requirements for Crew and Space Flight Participants; Proposed Rule z January 2006 – Guidance for Medical Screening of Commercial Aerospace Passengers (DOT/FAA/AM-06/1) z December 2006 – Human Space Flight Requirements for Crew and Space Flight Participants; Final Rule z So we’re OK now, right? Not so fast z FAA Final Rule – medical requirements z z Crew Members: those with a safety-critical role must posses and carry an FAA secondclass airman medical certificate z Space Flight Participants: nothing FAA Final Rule z Space Flight Participants must z Sign informed consent after education about the risks z Sign waiver of claims against the U.S. Government z Have training for emergency situations – smoke, fire, depressurization, emergency exit z Meet security requirement – the SFP may not carry on board any explosives, firearms, knives, or other weapons Commercial SFP Medical Standards There aren’t any! FAA Medical Guidance – Jan. 2006 Categorizes passengers into suborbital and orbital, but the G force definitions associated with each will put some operators’ passengers into the orbital category for suborbital flights z Assumptions: z z Cabin pressure <= 8,000 feet z G level limits: +4 Gz, -2 Gz, +/- 4 Gx, +/- 1 Gy z Recommendations for medical history and pre-flight physical exam Basis for SFP Medical Standards z Commercial SFP Profile z Age: mid 20’s to mid 70’s (ave. age = 55) z Gender: 80% male and 20% female z Medical status: Healthy to ??? z Psychological status: ??? z Very little data z Virtually no centrifuge data for this population z John Glenn’s space flight z Space Adventures SFPs Where to Set the Bar z Too High z Limits pool of customers z Makes entry too onerous z Too Low z Risk of injury or death z Bad outcome could severely hamper development of the industry What Are Operators Doing? z z z z z Concerned about the lack of standards and the liability they are incurring Working with Aerospace Medicine consultants Convening medical panels to help them define their medical screening and training programs Planning training/testing activities using centrifuge rides, microgravity flights, etc. Using FAA required “informed consent” to limit liability z Considering “tailoring” flights for specific individuals with limiting medical conditions z z z z z z Lower altitude flights to limit G levels Use (or not) of pressure suits Medical monitoring equipment Medical attendant / Flight attendant Allowing for (or providing) medical “tune up” to meet passenger acceptance criteria Accepting possibility of aborting flight for medical event Examples of AM “Patients” z Mid 70’s z World explorers z Treks to both North and South Poles z Climbed mountain peaks above 14,000 ft. z Visited the Titanic z Mid 50’s to mid 60’s z High health risks z Coronary bypass surgery z Hypertensive on multiple meds z Diabetes z COPD Stephen Hawking Zero-G Flight April 26, 2007 from Kennedy Space Center z Practice flight the previous day with body double (14 y/o 8th grader) – simulated various medical scenarios z Four physicians on board z z Pulmonary specialist z Critical care specialist / anesthesiologist z Zero-G Chief Medical Officer z Aerospace medicine specialist z Two caregivers – RNs Medications and Monitoring z z Preflight medications: glycopyrrolate 200 mg, dexamethasone 8 mg and ondansetron 4 mg intravenously 1 hour before flight Monitoring: non-invasive blood pressure measurement every 2 minutes with continuous 3-lead electrocardiography, and respiratory rate; transcutaneous SaO2 and PcapCO2. Supplemental oxygen was available at 2 or 4 l/min delivered via a standard tracheostomy mask. IV access in place with heparin lock The picture says it all Questions ???