Safety TIM 2025 - Health and Medical Domain Areas.pdf

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CLDP Safety TIM

Health & Medical Domain Areas

Todd Cureton Human Health & Performance Safety

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Overview HH&P is responsible for numerous disciplines that are relevant to Hazard Analysis and Crew Survival, but they typically don’t fit classical System Safety as cleanly as Engineering subjects (for example, Hazard Severity is often more subjective). This presentation highlights some of the key areas, as well as unique Safety considerations.

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Major Areas of Interest

• Environmental

• Flight Medicine

• Human Factors

• Mechanical Hazards

• Crew Provisioning

• Emergency Ops

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Environmental

• Ionizing Radiation

• Non-Ionizing Radiation

• Toxicology

• Microbiology

• Acoustics

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Ionizing Radiation

• From space

– habitability concern for vehicles or modules

• related to Engineering Hazard of hardware susceptibility

• only Control is shielding, but that’s rarely 100% effective

– disagreement about whether or not to even write HRs for this

– the Severity has been deemed Critical, but this is still frequently a subject of debate

• From radioactive material

– uncommon, but sources can be present in some sensors or Payloads

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Non-Ionizing Radiation

• Radio Frequency (RF)

– Hazard present any time there’s an intentional transmitter (antennas)

• hardware is usually more sensitive than tissue, so this is often enveloped by risks to critical avionics

• Lasers

– usually obvious when this hazard is present, but...

• may exist in COTS electronics

• may not be a visible laser

• may involve Hazards to ground observers

• may need to assess for aided optics viewing

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Non-Ionizing Radiation

• Incoherent Electromagnetic Radiation (“light”)

– Hazard may come from high-intensity light sources

• includes visible, infrared, and UV

– windows are also a source for this hazard

• exposure to solar radiation – particularly UV

– some very unexpected sources are occasionally encountered, such as hydrogen detonation

• Other

– other radiation sources (such as X-rays) along the

EM spectrum are rare, but would need to be assessed if present

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Toxicology

• Liquids, particulates*, or gases

– historically assessed by JSC Toxicology via HMST

• data submittal and assessment process will be defined by CLDP Safety and via the DRD

– must also account for any chemical changes that occur during operation, such as in some Payloads

• constituents generated after a failure are typically not assessed (e.g., combustion products)

• Spacecraft Maximum Allowable Concentrations

– JSC Tox also sets the SMAC limits that establish the trace contaminant control requirements

• includes offgassing and metabolic sources

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*Particulates

• Even if they’re non-reactive (i.e., not a Tox issue), particulates can still present physical Hazards

– release of a large mass of fine particulates / dust in a small closed volume can result in asphyxiation

– glass fragments or other frangible materials can be inhaled or get in the eyes in a weightless environment and damage soft tissue

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Microbiology

• Bio-Safety

– applies when flying biological samples

• bacteria, cell cultures, plant seeds, research animals, etc.

• data submittal and assessment process will be defined by CLDP Safety and via the DRD

• Micro

– concerned with the potential to grow strains already present in the vehicle / habitat

• potable water / water processing systems

• human waste

• surface and atmosphere cleanliness

• any other potential growth media

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Acoustics

• Too loud

– noise sources can present Hazards that need to be assessed by the JSC Acoustics Office

• this can include intentional sound-generating devices such as alarms or in-ear speakers

• this is a good example of an HH&P Hazard where the Severity exists across a Likelihood spectrum

• Not loud enough

– JSC Acoustics is also involved with verifying audibility and intelligibility requirements applicable to communication systems and alarms

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Flight Medicine

• Occupant Protection

• Habitable Environment

– shared responsibility with ECLSS Engineering

• Exercise Countermeasures

• Suits

• Patient Medical Equipment

• Ground Systems

• Flight Surgeons

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Occupant Protection

• Dynamic injury

– usually comes from either vibration or sustained translational and rotational accelerations

• debate about whether this applies post-landing (e.g., during capsule up-righting)

• Flail

– potential for head, arms, or legs to impact fixed objects during dynamic phases of flight

• related to seat and restraint design

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Habitable Environment

• Pressure

– dealing with both absolute pressure limits and rate of pressure change

• ppO2

– dealing with minimum oxygen limits to sustain crew health

– always balanced against flammability concerns

• ppCO2

– dealing with maximum carbon dioxide limits for short- and long-term exposure

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Habitable Environment

• Trace Contaminant Control

– covered earlier under Toxicology

• Thermal

– concerned with maintaining core body temperature

• Air Mixing

– adequate airflow is a fundamental assumption for most of the previous ECLSS-related Hazards

– even if the cabin bulk average is compliant, dead zones can have locally unsafe air pockets

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Exercise Countermeasures

• Injury from exercise

– experts from Exercise Lab should review the proposed use of any new exercise equipment

• different kinematics in micro-gravity

• Deconditioning from lack of exercise

– while some exercise hardware is flown to demonstrate the technology, some is critical to maintaining crew health

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Suits

• Launch & Entry

– nominal functions often include cooling and orthostatic intolerance protection

– contingency functions provide survival capability in the event of loss of cabin pressure or a contaminated environment

• may also provide some sea survival functions

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Patient Medical Equipment

• Efficacy (“Must Work”)

– take credit for FDA or CE if COTS

– functional requirements are often specified by

Flight Surgeons

• Safety (“Must Not Work”)

– FDA / CE if COTS

– bring in Flight Surgeons if custom (or used “off-label”)

– unique electrical shock requirements if the patient is intentionally part of the circuit (EKGs, etc.)

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Ground Systems

• Pad Egress

– nominal or emergency

– may bring in Tox, Human Factors, lighting, suits, and other discipline areas

• Post-landing Recovery

– land or water

– self-egress or assisted egress

• account for effects of deconditioning on crew

– prop systems can result in Tox concerns

– includes MEDEVAC capability

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Flight Surgeons

• Flight Medicine specialist

– needed when there are specific questions about the clinical effects on crew health

• such as when any of the previous Flight Medicine disciplines’ requirements are exceeded

– may be required to provide a formal Flight Medicine position when other disciplines disagree

• Crewmember doctor

– needed when there are medical questions related to an individual crew member

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Human Factors

• Anthropometry (and Human Capability)

• Human Error

• Displays & Controls

• Waste & Hygiene

• Restraints & Mobility Aids

• Lighting

• Translation Paths

• Manual Piloting

• Ergonomics

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Strength & Anthropometry

• Dimensions

– must accommodate astronaut cohort, including physical changes such as spinal elongation

– requirements are always applicable, but generally only correlates to a Hazard for “Must Work” systems

• Physical capability

– must design for physical limitations (strength, etc.)

of astronaut cohort, including deconditioning

– again, only a Hazard if crew can’t perform Must

Work functions

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Human Error

• Inadvertent action

– applicable any time doing the “right” thing at the wrong time could cause a Hazard

• Erroneous action

– applicable any time doing the wrong thing at the

“right” time could cause a Hazard

• HR FT approach does not lend itself well to this sort of analysis due to difficulty counting cognitive errors

• Failure to act

– applicable for time-critical tasks

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Displays & Controls

• Inadvertent commanding

– protect for sending a command at the wrong time

• switch covers, button spacing, multi-step commanding, software lock-outs, etc.

• Erroneous commanding

– protect for sending a wrong command

• good layout design, error rate demonstrations, etc.

• Inability to command

– protect for ability to send critical commands

• demonstration of reach, access, and visibility across mission phases, notification of stale data, etc.

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Waste & Hygiene

• Design of “facilities”

– unique Hazards related to collection, treatment, storage, and / or processing of human waste

• overlaps quite a bit with Tox / Micro, but with a focus on usability in microgravity

• Other livable areas

– sleep stations, crew quarters, gallies, etc.

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Restraints & Mobility Aids

• Seats and harnesses

– provide protection during dynamic phases

• coupled with Occupant Protection

– must not impede egress

• Mobility aids

– unlikely to contribute to a Hazard, with the exception of facilitating egress

• EVA is different...

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Lighting

• Excessive lighting

– already covered

• Insufficient lighting

– not usually a Hazard by itself, but can be a contributor to other Hazard Causes

• crew error, inability to egress, etc.

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Translation Paths

• Permanent aisle-way obstructions

– only a Hazard if the emergency egress corridor is obstructed

• smaller than the nominal translation path “tunnel”

• requires modeling of the module or vehicle with all hardware installed

• Temporary aisle-way obstructions

– need to show crew has capability to clear the path quickly in the event of an emergency egress scenario

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Manual Piloting

• Nominal

– unique Hazards related to meeting Handling Qualities and maintaining pilot proficiency

– most applicable to docking and re-entry phases

• Contingency

– if a response to other failures, may allow for loosening of HQ requirements

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Ergonomics

• Mostly covered by other areas previously discussed

– more closely associated with habitability, but poor ergonomic design can contribute to operator error and inability to perform Must Work functions

• Maybe potential for repetitive motion injuries through poor hardware design?

– I’ve never seen a HR for this, but maybe credible for certain EVA tasks or extended glovebox activities

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Mechanical Hazards

• Touch Temperature

– high or low

• Entrapment

– holes, entanglement, etc.

• Pinching / Crushing

– levers, sliding mechanisms, large masses, etc.

• Cutting

– sharp edges / corners or manufacturing defects

• Impacts

– stored mechanical energy, rotating machinery, etc.

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Crew Provisioning

• Manifesting enough

– need to ensure there’s sufficient food and water, with margin, for worst-case mission duration (including contingencies)

• Maintaining quality

– need to ensure the food and water is delivered free of contamination and protected from contamination during the mission

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Emergency Ops

• Regardless of whether Contingency scenarios are covered in Hazard space versus Crew Survival space, HH&P is a stakeholder

– same interests as previously identified, with a strong reliance on Flight Medicine for emergency responses and recovery ops

– examples:

• crew performance in reduced pressures (depress)

• chemical release / toxic contamination

• post-fire decontamination procedures

• medical events – stabilization and treatment

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“Safety Adjacent” Subjects

• Radioactive sources

• Human research (IRB)

• Medical privacy

• Habitability

• Psychological health

• Pharmaceuticals

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Radiation Regulations

• NASA will conduct a hazard analysis through the

Form 44 process for non-exempt radioactive sources

• For launch, return, and radiation source integration logistics, the commercial provider should have individuals skilled in radiation safety with a comprehensive understanding of the NRC and each State’s regulations

– 39 states have unique regulations, and 16 states are specifically NRC regulated

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Radiation Cont’d

– 39 states have unique regulations, and 16 states are specifically NRC regulated

• Texas, California, and Florida are all different

• Federal facilities are regulated by the NRC, but the Air

Force has its own set of rules and processes

• Comm between stakeholders (NASA, CLD Provider, Launch Provider, AF, and vendors) is key

– recommend having in place agreements detailing information exchange and roles and responsibilities prior to launching radioactive sources

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Human Research

• If research is being conducted on USG crew members, uses NASA facilities, or hardware, the study protocol is subject to approval by the JSC IRB

– compliance required by the CFR and NASA NPRs and NPDs

– this requirement is in addition to the Hazard

Report process as it deals with other considerations such as research ethics and integrated risks

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Human Research Cont’d

– IRB requirements must be met before subject testing or training can take place

– note: human research is different from a human-in-the-loop test, but the distinction is not always clear-cut; NASA has processes available to guide investigators or test conductors

• https://www.nasa.gov/institutional-review-board/ https://www.nasa.gov/institutional-review

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Medical Data Privacy

• Not a Hazard per NASA Severity definitions, but a critical consideration whenever dealing with human systems

– consequences can be financial, legal, contractual, and / or reputational

• Per HIPAA, medical data (both clinical and research-derived) must be protected

– including data collection, storage, and transmission

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Habitability

• HH&P’s habitability requirements exist to facilitate living and working in space

• These are not Safety requirements per se, but it can be hard to determine where the line is

– example: being able to set cabin temperature between 60F and 80F is for crew comfort, but core body temp is what matters for Safety

– example: a poorly designed (e.g., noisy, bright, confined) sleep station can disrupt crew rest, resulting in degraded performance

• doesn’t directly Cause a Hazard, but can contribute

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Psychological Health

• Deterioration in crew mental well-being and behavioral health can lead to Safety impacts

• Mitigations:

– crew screening, selection, and annual certification

– habitat design

• e.g., windows, private CQ, food system accommodations for crew to dine together, habitability

– crew training

• e.g., cross-cultural competencies, conflict management, expeditionary skills

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Psychological Health Cont’d

– in-mission monitoring and intervention

• e.g., PPCs, WINSCAT

– in-flight behavioral countermeasures

• e.g., communication with friends and family, shared meals, privacy, rest / down-time, entertainment, exercise, care packages

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Pharmacy Considerations

• Concerned with preparation, packaging, storage, dispensing, transport, and disposing of medications

• CLD Providers must follow all relevant federal regulations

• Inappropriate processing and handling of medications can lead to impact to safety or efficacy of medications

• Mitigations

– ensure pharmaceutical team training, skills, licensing, and certification

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Pharmacy Cont’d

– appropriate facilities for medication storage, preparation and packaging

• including DEA controlled substance tracking / destruction and Drug Supple Chain Security Act

– documented processes for medication management

• record keeping and retention schedule, pharmaceutical dispensing for spaceflight (environmental controls for meds, packaging / repackaging, labeling), drug recalls, medication shortages, ground processing, in-flight procedures for med usage and inventory, disposition of unused / expired medications