RMP-RESP-003 Severe allergic reaction (possible anaphylaxis): urgent alert, bring the sealed emergency kit and oxygen kit on command, record vital signs (no drug advice)

1 · Identity and scope

If a crewmember or the CMO says a crewmember may be having an allergic reaction, the robot sends an URGENT alert at once, brings the sealed emergency (anaphylaxis) kit and the closed oxygen kit to the CMO on command, shows the allergy list from the medical record, records the vital signs and oxygen saturation the CMO measures and the medicines and times the CMO states on a clock-time timeline, and after the event reconciles the kits through RMP-PHARM-001 as an inventory record only. Afterwards it offers prompt-only check-ins for the watch period the flight surgeon sets. The CMO assesses, decides and gives every treatment.

Why this protocol was chosen. Anaphylaxis is a sudden, rapidly progressing reaction with airway, breathing or circulation problems, usually with skin or mucosal changes; skin changes can be absent in up to 20% of reactions, and in up to 30% there is no obvious trigger (Resuscitation Council UK, 2021). NASA records list 11 mild-to-moderate allergic reactions among US astronauts through 2006. The guideline stresses calling for help early, and notes biphasic reactions in about 5% of patients, also after milder reactions, with a median time of around 12 hours. Intramuscular adrenaline (epinephrine) is the first-line treatment for anaphylaxis (RCUK 2021; WAO 2020), given by the CMO under the onboard checklist; epinephrine is in the ISS flight formulary (HRP report, 2017). The robot never names, suggests or times a medicine; this is stated only so the kit contents and the checklist can be checked. Severe gastrointestinal symptoms (severe crampy belly pain, repeated vomiting) together with skin or mucosal changes also make anaphylaxis highly likely (WAO 2020). A helper that raises the alarm at once, brings the sealed kit and keeps an exact clock-time record lets the CMO keep both hands on the patient.

Autonomy: Max rung raised from 1 to 2 for supervised fetching and recording, as in batch 1. The robot never opens the kit, chooses, prepares or gives a medicine, or starts oxygen.

Related: RMP-PHARM-001 · RMP-PHARM-003 · RMP-RESP-001 · RMP-RESP-002 · RMP-CARD-001 · RMP-SKIN-004 · RMP-NEURO-004 · RMP-GI-002

2 · Roles

Medical authority

Flight surgeon (ground). Holds medical authority for every run.

Onboard lead

Crew medical officer (CMO), acting under delegated care; uses the pre-approved onboard checklist when there is no link.

Others

• Crewmember with the reaction: answers if able; never asked to wait for the robot
• Second trained CMO: receives alerts if the CMO is the patient, and helps the CMO
• Pharmacy lead and flight surgeon: set the contents of the sealed emergency kit before flight

Commercial flights

On commercial flights, 'flight surgeon' and 'CMO' mean the operator's designated medical authority and trained onboard responder. If no trained responder is aboard, this protocol is not used. (NASA-STD-3001 requires two CMOs per vehicle for NASA programs [V1 3006]; FAA rules set no medical standards for spaceflight participants.) [12]

3 · Preconditions and consent

• PRE-1 A crewmember or the CMO started the protocol by command. Nothing starts it automatically.human_start == trueV2 10174
• PRE-2 Robot self-test passed; it knows the stowage location of the sealed emergency kit and the oxygen kit, and the kit seals were checked at the last inventory.V2 10161V2 7059
• PRE-3 Robot and supplies restrained when not moving.V2 7046
• PRE-4 Link status and current delay known. The CMO never waits for the robot or the link before treating.link_state in [live, delayed, down]

Consent

Recording and questions by voice, with the crewmember's agreement when they can give it; any question can be declined, and an explicit "no" is logged as declined for that question only.

Emergency consent

If the crewmember cannot answer, the URGENT alert stands, the robot asks nothing more, and the CMO leads; recording of the CMO's entries continues as part of the medical record.

Withdrawal

The crewmember can stop video at any time; the URGENT alert and the record of what was given are kept.

4 · Required sensor inputs

5–6 · Steps and decision points

Each step names who acts. Decision points sit after the step they follow and say who decides: Robot Crew Ground. Any stop rule in section 7 can interrupt any step.

1. S1RobotRung 2

   On a crewmember's or the CMO's word, send an URGENT "possible severe allergic reaction" alert to the flight surgeon and the CMO at once. Every URGENT alert goes to the CMO and the flight surgeon at the same time (queued for the flight surgeon if the link is down). If the CMO is the patient, is busy treating, or does not answer, the alert goes to the second trained CMO, or the crewmember named before flight [V1 3006]. An URGENT alert that is not acknowledged within <set by validation> seconds is repeated and sent to the next named crewmember.

   Done when: Alert acknowledged, or escalated to the next named crewmember.

   V2 10174V1 6003V1 3006

2. S2RobotRung 2

   On the CMO's command, bring the sealed emergency kit and the closed oxygen kit to the CMO at once and restrain them within reach. The robot never opens them. This is an emergency fetch on a human command (CMO): no barcode check runs before hand-over and nothing waits for one. The robot reads the kit's own label and seal status only if that adds no delay, says "EMERGENCY FETCH – NOT VERIFIED (CMO command)", and "seal not intact" if so, and hands the kit over anyway. The fetch is logged as an override: time, who asked, the reason as stated, kit ID and seal status. It never says "verified". The CMO never waits for the robot: if the CMO or a crewmember already has the kit, the robot skips this step.

   Done when: Kits within reach, or step skipped; override logged.

   Limit: <set by validation>

   V2 7046

3. S3Crew

   The CMO removes or stops the possible trigger if possible (for example an infusion), assesses airway, breathing and circulation, and decides and gives every treatment under the onboard checklist, with the flight surgeon when the link allows. The second trained CMO helps or takes over if the CMO is the patient.

   Done when: Treatment decisions made by humans; the robot logs what is stated.

   V1 3004

4. S4RobotRung 2

   Show the allergy list from the medical record to the CMO, then ask the red-flag questions by voice if the crewmember can answer (swallowing, throat, breathing, faintness). D1 is checked after every answer.

   Done when: Answers logged, or "no response" logged.

   D1DecisionRobot decides

   Checked after every answer and at any point in the run (even mid-question or mid-step): does any answer, reading or observation meet a red flag?

   • Yes → Stop the current question or step at once and apply the action listed for each matching red flag (URGENT alert, flag, or stop), with the answer or reading itself, never a cause. Every URGENT alert goes to the CMO and the flight surgeon at the same time (queued for the flight surgeon if the link is down). If the CMO is the patient, is busy treating, or does not answer, the alert goes to the second trained CMO, or the crewmember named before flight [V1 3006]. An URGENT alert that is not acknowledged within <set by validation> seconds is repeated and sent to the next named crewmember.
   • No → Continue. The alert from S1 stands; skin changes alone never cancel it.
   D2DecisionRobot decides

   Did the crewmember answer the question?

   • Yes → Continue.
   • Declined explicitly (the crewmember says no to a question) → Log "declined" for that question only; the alert already sent stands.
   • No response, or the answer does not make sense → URGENT: log "no response" (never "declined"); the CMO, or the second trained CMO if the CMO is the patient, checks the crewmember in person at once.
5. S5RobotRung 2

   Record the vital signs, oxygen saturation and observations the CMO enters, and each medicine and time the CMO states. Show them as a timeline of clock times: reaction start, each stated medicine and dose time, and each CMO entry. Give elapsed time only when the CMO asks ("time since the last dose?"), answering in the same words each time. No running counter, tone, colour change or spoken cue is tied to any interval after a dose.

   Done when: Entries time-stamped on the timeline.

   V1 3004

6. S6RobotRung 2

   After any URGENT alert: After an URGENT alert the robot does not leave on its own: it stays at its rest position in the module, with its screen and voice link available, until a human has taken over or tells it to go. It never follows, blocks or touches anyone. It keeps time-stamping what humans say they did, and repeats the alert if it is not acknowledged.

   Done when: Robot at rest in the module until a human releases it; alert acknowledged or escalated.

   V2 10173V1 3006

7. S7Ground

   The flight surgeon (or the CMO under the onboard checklist when there is no link) decides further treatment, the watch period, work limits and any evacuation [V1 3007]. If the trigger may be a medicine, the flight surgeon records it in the medical record. The robot logs the decisions.

   Done when: Decision logged.

   V1 3007

   D3DecisionGround decides

   What is the plan (treatment, watch period, work limits)?

   • Link live → Flight surgeon decides; robot logs.
   • Link down or delay too long → The CMO decides under the pre-approved onboard checklist; the flight surgeon reviews the log at the next contact.
8. S8RobotRung 2

   During the watch period of <set by flight surgeon> hours after the reaction, offer a check-in every <set by flight surgeon> hours. At each scheduled time the robot prompts the crewmember on their own screen; it approaches only when the crewmember (or the CMO) accepts, and a prompt never starts the robot. Any return of symptoms is URGENT (RF5).

   Done when: Each prompt accepted, postponed or answered; log closed by a human.

   V2 10174

9. S9RobotRung 2

   When the CMO says the event is over, run RMP-PHARM-001 reconciliation on each kit fetched: record the items the CMO or crew state were used, the remaining contents against the kit list, seal status and expiry, labelled "inventory reconciliation after emergency use – not a check before use". Flag the override to the flight surgeon and the pharmacy lead, and show each kit as "opened – not restocked" until a human restocks and reseals it. Nothing in this step is recorded as a check before the kit was used.

   Done when: Reconciliation recorded and labelled; override flagged; kit shown as opened – not restocked until resealed.

   V2 7059

10. S10RobotRung 2

    Send the flight surgeon one package: symptom times, possible trigger, CMO entries, medicines and times as stated, alerts and acknowledgements.

    Done when: Package delivered or queued.

    V1 6003V1 7001V1 7003

7 · Stop and escalate rules, red flags

Red flags

The robot reports the sign or value only, never what it means. Numeric thresholds are placeholders for the clinical lead.

8 · Safety limits

9 · Logs and audit

• LOG-1 Every input, robot action, decision (with who made it) and hand-off, time-stamped to the second.V2 10163V2 10164
• LOG-2 Mode changes and safety-limit events are announced to the operator as they happen and logged.V2 10162V2 10172
• LOG-3 Records are stored and sent as private medical data, encrypted, with access limited to the medical team.V1 6003V1 7003
• LOG-4 Results are kept in a permanent, retrievable format so the flight surgeon can see trends.V1 7001
• LOG-5 Symptom onset, each CMO entry and each stated medicine and time on a clock-time timeline, so the flight surgeon can follow the course of the reaction.
• LOG-6 Each URGENT alert, who received it, the time it was acknowledged (or the escalation to the next named crewmember), and the time a human released the robot.V2 10163
• LOG-7 Each emergency fetch as an override (time, who asked, reason as stated, kit ID, seal status) and the later inventory reconciliation, labelled "not a check before use".V2 7059

10 · Links to NASA-STD-3001

IDs as published in Volume 1 Revision C [8] and Volume 2 Revision F [9]. NASA-STD-3001 binds NASA programs; it is not a regulation for commercial flights. Its robot rules are general automation requirements, not medical-device rules.

11 · Validation

1. Simulation. Scripted reactions of every red-flag type, reactions without skin changes or without a known trigger, symptoms that return, a CMO who is the patient, no response and lost link. Pass: Every red flag acts at once; zero medicine, dose or timing suggestions; zero dose-interval cues; zero kit openings; every emergency fetch logged as an override and never as verified; unacknowledged alerts escalate.
2. Training model. CMO training sessions on a manikin with the robot fetching the sealed kits and recording. Pass: Kits delivered within <set by validation> seconds of the command; the CMO is never delayed or obstructed.
3. Parabolic or station demonstration. Fetching and restraining the sealed emergency kit and closed oxygen kit in weightlessness, without a patient. Pass: Kits delivered closed and restrained; seals intact.
4. Flight use under flight surgeon supervision. First use as a recording aid in drills, then in real events alongside the onboard checklist. Pass: No safety events; the record is complete and accurate.

No stage has been run. Pass and fail criteria must be fixed in advance by the clinical lead and safety board.

12 · Human sign-off

Before any use

• Clinical lead for the specialty (sets every clinical threshold marked <set by clinical lead>)
• Flight surgeon, as medical authority
• Robotics and medical-device safety board
• Program approval for the mission

Each run

Started by a crewmember or the CMO. Every alert goes to the CMO and flight surgeon at once; the CMO treats under the onboard checklist; the flight surgeon decides when the link allows.

Restart after a stop

Human only. After any emergency or protective stop, a crewmember must restart the robot; the robot never restarts itself.

None of these sign-offs has happened. This is a Draft v0.4.

13 · Change control for learning

• Every change gets a new version number and a written reason; earlier versions are kept.
• Any change to steps, thresholds, limits or software that touches the patient repeats validation from the simulation stage before use.
• Software and learned-skill updates follow a pre-agreed change plan (what may change, how it is tested, how to roll back), modeled on the FDA predetermined change control plan approach.
• If a new version misbehaves, the robot rolls back to the last validated version and the event is reviewed by the flight surgeon and safety board.
• The robot never changes its own protocol, thresholds or limits.

Change-plan model: FDA guidance [11].

Loss of signal and Mars delay

Live link

Low Earth orbit: the flight surgeon receives the alert at once and can join by voice and video.

Loss of signal

• The robot pauses any movement and tells the CMO; on the CMO's confirmation it keeps recording offline.
• The CMO's emergency-kit treatment, crew oxygen and CPR continue under the onboard checklist and never wait for the link or the robot.
• The CMO (or the second trained CMO) treats under the pre-approved onboard checklist; nothing waits for the link.
• At the next contact the robot sends one package: times, entries, stated medicines and alerts.

Mars-class delay

• Replies may take up to about 21-23 minutes each way, with blackouts of about 2-3 weeks; treatment cannot wait for the ground, so the onboard checklist and two trained CMOs lead.
• The watch period and check-in schedule after a reaction are set before flight.

[10]

Sources

1. Resuscitation Council UK. Emergency treatment of anaphylaxis: guidelines for healthcare providers (May 2021; printed review date May 2026, which has passed. The RCUK guideline page, as fetched on Oct 20, 2026, still lists May 2021 as the most recent version; a newer version was not found). www.resus.org.uk/sites/default/files/2021-05/Emergency%20Tre… Supports: Anaphylaxis is characterised by sudden onset and rapid progression of symptoms, Airway and/or Breathing and/or Circulation problems, and usually skin or mucosal changes; airway problems include throat or tongue swelling, hoarse voice and stridor; breathing problems include wheeze, persistent cough, increased work of breathing, tiredness and hypoxaemia (SpO2 below 94%); circulation problems include pale clammy skin, fast heart rate, low blood pressure, dizziness, decreased conscious level and collapse; skin or mucosal changes alone are not a sign of anaphylaxis and may be absent in up to 20% of reactions; in up to 30% of cases there may be no obvious trigger; gastrointestinal symptoms without airway, breathing or circulation problems do not usually indicate anaphylaxis; call for help early; biphasic reactions occur in around 5% of patients, also after milder reactions, with a median time of around 12 hours, and observation for 6-12 hours may miss over half of them; adrenaline is the first-line treatment, given intramuscularly, and is repeated after 5 minutes if airway, breathing or circulation problems persist; medication accounts for 39% of anaphylaxis-related deaths (Table 1), and allergens given by a parenteral route (for example an IV drug or intramuscular injection) cause a more rapid onset; patients must not walk or stand during acute reactions.
2. Cardona V, Ansotegui IJ, Ebisawa M, et al. World Allergy Organization anaphylaxis guidance 2020. World Allergy Organ J. 2020;13(10):100472. PMID 33204386. doi:10.1016/j.waojou.2020.100472 Supports: Anaphylaxis is highly likely with acute skin or mucosal involvement plus respiratory or cardiovascular involvement, or severe gastrointestinal symptoms (severe crampy abdominal pain, repetitive vomiting), especially after exposure to non-food allergens; intramuscular epinephrine (adrenaline) continues to be the first-line treatment; remove exposure to the trigger if possible (for example, discontinue administration of drugs or therapeutic agents).
3. Golden DBK, Wang J, Waserman S, et al. Anaphylaxis: a 2023 practice parameter update. Ann Allergy Asthma Immunol. 2024;132(2):124-176. PMID 38108678. doi:10.1016/j.anai.2023.09.015 Supports: AAAAI/ACAAI practice parameter on anaphylaxis, including epinephrine use. Only the citation and abstract were checked; the "first-line" statement in this protocol rests on RCUK 2021 and WAO 2020.
4. NASA Human Research Program. Evidence Report: Risk of Adverse Health Outcomes and Decrements in Performance due to In-Flight Medical Conditions (2017). humanresearchroadmap.nasa.gov/evidence/reports/Medical.pdf Supports: Table 2: 11 mild-to-moderate allergic reactions among US astronauts (Shuttle, Mir and ISS through 2006). Epinephrine is among the compounds in the ISS operational flight formulary (2017 report; current kit contents and form not verified).
5. Institute for Safe Medication Practices. Guidelines for the safe use of automated dispensing cabinets (2019). www.ismp.org/system/files/resources/2019-11/ISMP170-ADC%20Gu… Supports: Override is limited to medicines needed in emergent circumstances where waiting could harm the patient (3.3b); limit what is available on override (3.4b); require documentation of the override rationale (3.4d); routinely analyze override reports (3.6). Used for the emergency-fetch pattern by analogy (a robot fetching a sealed kit is not a dispensing cabinet).
6. Institute for Safe Medication Practices. Lack of proper escalation process for BCMA scanning failures. ISMP Medication Safety Alert! Acute Care, March 21, 2024. www.ismp.org/sites/default/files/newsletter-issues/20240321.… Supports: Unsafe practices include scanning after medication administration; procedures must include an escalation process for barcode scanning failures. Used so that the reconciliation after an emergency fetch is never recorded as a check before use.
7. NASA OCHMO. Medical Operations. Technical Brief OCHMO-TB-044 (2025). www.nasa.gov/wp-content/uploads/2025/08/ochmo-tb-044-medical… Supports: The crew surgeon keeps medical authority when care is delegated; crew medical officers train on the JSC 48522 medical checklist.
8. NASA. NASA-STD-3001, Space Flight Human-System Standard, Volume 1: Crew Health, Revision C (2023). www.nasa.gov/wp-content/uploads/2023/11/nasa-std-3001-vol-1-… Supports: Requirement IDs beginning V1.
9. NASA. NASA-STD-3001, Volume 2: Human Factors, Habitability, and Environmental Health (Rev F, 2026), including Section 10.6 Automated and Robotic Systems. standards.nasa.gov/standard/NASA/NASA-STD-3001_VOL_2 Supports: Requirement IDs beginning V2.
10. NASA. Mars communications disruption and delay (fact sheet, 2023 Moon to Mars Architecture Concept Review). www.nasa.gov/wp-content/uploads/2024/01/mars-communications-… Supports: One-way Earth-Mars delay up to about 21-23 minutes, plus blackouts of about 2-3 weeks near solar conjunction.
11. U.S. Food and Drug Administration. Marketing submission recommendations for a predetermined change control plan for artificial intelligence-enabled device software functions (guidance). www.fda.gov/regulatory-information/search-fda-guidance-docum… Supports: A model for planning, validating and rolling back software updates.
12. U.S. Code of Federal Regulations, Title 14, Part 460: Human space flight requirements. www.ecfr.gov/current/title-14/chapter-III/subchapter-C/part-… Supports: Federal rules for crew and spaceflight participants on licensed commercial flights; they set no medical standards for spaceflight participants.

Checked on 2026-10-20: links opened (HTTP 200 or publisher redirect), DOIs and PubMed IDs matched, NASA documents read in full text. The framework comes from Part 1.