{ "$schema": "https://spacemedicinefoundation.org/robotic-medicine/protocols/schema/protocol.schema.json", "schema_version": "0.3", "id": "RMP-SKIN-001", "slug": "rmp-skin-001", "title": "Wound cleaning and dressing: hold and pass supplies, photo documentation (crew leads)", "version": "0.7", "status": "draft", "conceptual": true, "not_for_clinical_use": true, "category": "skin", "tier": 1, "max_autonomy": 2, "rung_note": "Raised from rung 1 in the outline for fetching, passing supplies and photo positioning. Holding a limb is rung 1 and is its own step (S5), so the build checks it: the CMO places the limb and the robot only holds it still while the CMO keeps a hold command active.", "missions": [ "leo", "commercial", "moon", "mars" ], "updated": "2026-10-21", "review": { "state": "reviewed-ai-assisted", "requested": "2026-10-20", "reviewed": "2026-10-20", "human_clinician_review": false, "text": "AI-assisted clinical and source review by the Medical Research Assistant, Oct 20, 2026; no named human clinician. All corrections from that review are applied in this version (see Corrections). Written with AI assistance; sources self-verified." }, "fixed_rules": { "flight_surgeon_is_medical_authority": true, "cmo_acts_under_delegated_care": true, "human_starts_and_restarts_robot": true, "robot_never_diagnoses": true, "no_drug_or_fluid_advice_by_robot": true, "safe_state_on_fault_or_no_response": true, "lost_link_pause_then_cmo_decides": true }, "robot_lockouts": { "diagnosis": true, "drug_or_fluid_advice": true, "starting_stopping_or_adjusting_oxygen_or_any_medicine": true, "self_start_or_self_restart": true, "changing_own_protocol_thresholds_or_limits": true, "handing_over_a_mismatched_item_as_verified": true }, "result_language": { "use": [ "photo recorded", "measured (for human review)", "flagged for human review" ], "never": [ "normal", "no problem found", "all clear", "negative", "any diagnosis or cause", "healing well", "infected", "not infected" ] }, "scope": { "summary": "For a minor wound (cut, scrape or skin tear), the CMO cleans and dresses it while the robot brings the kit, holds a containment pad or bag, passes items on request, holds the limb steady if asked, and takes standard photos with a scale and color reference before and after dressing and at each dressing change.", "why": "In weightlessness, fluid and debris containment must be planned for: blood tends to dome at the wound, but droplets can break free. Standard, repeatable photos let the flight surgeon follow a wound across days. (Skin rashes, a different problem, were the most reported clinical event in one study of 46 long-duration crew; rashes are covered by RMP-SKIN-004; RMP-SKIN-003 is the wound photo log.)", "covers": [ "Clean, minor cuts, scrapes and skin tears", "Follow-up photos at each dressing change" ], "locked_out": [ "Cleaning, closing or dressing the wound itself", "Handling sharps", "Choosing a dressing, ointment or any medicine", "Judging infection or healing", "Deep, gaping or heavily bleeding wounds, and dirty or major wounds: punctures, crush injuries, bites, embedded foreign material or contaminated wounds (crew trauma care; see RMP-MSK-001)", "Any advice on tetanus vaccination or immune globulin (decided by the CMO and flight surgeon)", "Burns (RMP-SKIN-002) and eye wounds (RMP-EYE-001)", "Suturing (research only, RMP-SKIN-005)" ], "related": [ "RMP-SKIN-002", "RMP-SKIN-003", "RMP-MSK-001", "RMP-INF-002" ] }, "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": [ "Patient: can stop the robot at any time", "Second crewmember if available (wears eye protection)" ], "robot_may": [ "Fetch the wound kit, containment supplies and camera", "Hold an absorbent pad or bag under the wound", "Pass items on request (no sharps)", "Hold a limb still after the crew place it, within force limits", "Take standard photos and log supplies used" ], "robot_may_not": [ "Touch the wound", "Handle sharps", "Choose any dressing or medicine", "Say a wound is infected, not infected or healing", "Advise on tetanus vaccination", "Photograph the face unless the wound is on the face and the patient agrees" ], "commercial": "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.)" }, "preconditions": [ { "id": "PRE-1", "text": "The CMO judged the wound minor and started the run.", "refs": [ "V2 10174" ] }, { "id": "PRE-2", "text": "Patient, CMO and supplies restrained.", "refs": [ "V2 7046" ] }, { "id": "PRE-3", "text": "Robot self-test passed; gripper surfaces cleaned.", "refs": [ "V2 10161" ] }, { "id": "PRE-4", "text": "Bleeding controlled with pressure before the robot comes close." }, { "id": "PRE-5", "text": "Link status and delay known." }, { "id": "PRE-6", "text": "Patient, CMO and helper wear eye protection; absorbent containment in place before any irrigation.", "check": "eye_protection_on == true and containment_ready == true" } ], "consent": { "standard": "Patient agrees by voice or touch, including to photos; logged. Photos frame the wound and reference card only.", "emergency": "If the patient cannot agree, the robot only fetches and passes supplies on the CMO's decision; photos wait for consent unless the flight surgeon decides otherwise.", "withdrawal": "Patient can stop photos or robot help at any time." }, "inputs": [ { "id": "IN-1", "name": "Camera image with scale and color reference card", "source": "Robot camera", "required": true, "if_missing": "CMO takes photos with a handheld camera and the reference card." }, { "id": "IN-2", "name": "Wound location, time and how it happened", "source": "Entered by the CMO", "required": true, "if_missing": "Log \"not entered\"." }, { "id": "IN-3", "name": "Tetanus immunization date", "source": "Medical record (shown to the CMO and flight surgeon; the robot does not advise)", "required": true, "if_missing": "Show \"tetanus status unknown\" to the CMO and flight surgeon." }, { "id": "IN-4", "name": "Pain score (0-10)", "source": "Patient", "required": false, "if_missing": "Log \"not answered\"." }, { "id": "IN-5", "name": "Grip force and position while holding a limb", "source": "Robot force sensors", "required": true, "if_missing": "Do not hold the limb." }, { "id": "IN-6", "name": "Supplies used", "source": "Barcode scan or CMO entry", "required": false, "if_missing": "CMO enters after the procedure." }, { "id": "IN-7", "name": "Link status and delay", "source": "Communications system", "required": true, "if_missing": "Treat as link down." } ], "steps": [ { "id": "S1", "actor": "robot", "rung": 2, "action": "On request, bring the wound kit, eye protection, containment supplies and camera; restrain them by the patient. Show the CMO the tetanus immunization date from the medical record (shown only; the robot gives no advice).", "success": "Kit restrained at the patient; tetanus record shown.", "refs": [ "V2 7046" ] }, { "id": "S2", "actor": "robot", "rung": 2, "action": "Hold an absorbent pad or containment bag under the wound area.", "success": "Pad in place; CMO confirms." }, { "id": "S3", "actor": "robot", "rung": 2, "action": "Take a \"before\" photo with the scale and color card; label it. Frame the wound and reference card only; exclude the face unless the wound is on the face and the patient agrees.", "success": "Photo passes the focus and framing check.", "refs": [ "V1 6003" ] }, { "id": "S4", "actor": "crew", "action": "If a limb needs holding, the CMO places it and starts a hold command.", "success": "Limb placed; hold command active, or no hold needed.", "refs": [ "V2 10164" ] }, { "id": "S5", "actor": "robot", "rung": 1, "action": "Hold the limb still only while the CMO keeps the hold command active, within force limits; release at once on X6 or when the command ends.", "success": "Limb held steady, or released on command.", "limit": "", "refs": [ "V2 10165", "V2 10172" ] }, { "id": "S6", "actor": "robot", "rung": 2, "action": "Pass items on request during cleaning and dressing (never sharps).", "success": "Each requested item handed over." }, { "id": "S7", "actor": "crew", "action": "CMO cleans the wound.", "success": "CMO reports cleaning complete.", "refs": [ "V2 7046" ] }, { "id": "S8", "actor": "crew", "action": "CMO chooses and applies the dressing.", "success": "Dressing applied." }, { "id": "S9", "actor": "robot", "rung": 2, "action": "Take an \"after\" photo with the same framing; log supplies used.", "success": "Photo stored; inventory updated.", "refs": [ "V2 7059" ] }, { "id": "S10", "actor": "robot", "rung": 2, "action": "Bag waste per the biohazard procedure; clean robot surfaces per the cleaning protocol.", "success": "Cleaning logged." }, { "id": "S11", "actor": "robot", "rung": 2, "action": "Send photos and the log to the flight surgeon as private medical data, or queue them; set up follow-up photo sessions at each dressing change as the flight surgeon directs.", "success": "Delivery confirmed or queued; schedule logged.", "refs": [ "V1 6003", "V1 7001", "V1 7003" ] } ], "decisions": [ { "id": "D1", "after": "S1", "decided_by": "crew", "question": "Is the wound beyond minor or dirty: deep, gaping, heavy bleeding, affecting the eye, face, a joint or hand function, or a puncture, crush injury, bite, embedded foreign material or a contaminated wound?", "branches": [ { "if": "Yes", "then": "Stop this protocol; CMO starts trauma care and calls the flight surgeon (RMP-MSK-001). Tetanus status and wound type go to the flight surgeon." }, { "if": "No", "then": "Continue." } ] }, { "id": "D2", "after": "S3", "decided_by": "robot", "question": "Did the photo pass the quality check?", "branches": [ { "if": "Yes", "then": "Continue." }, { "if": "No after tries", "then": "Hand the camera to the CMO." } ] }, { "id": "D3", "after": "S11", "decided_by": "ground", "question": "What is the dressing and follow-up plan?", "branches": [ { "if": "Link live", "then": "Flight surgeon decides; robot logs." }, { "if": "Link down", "then": "CMO follows the onboard checklist; flight surgeon reviews photos later." } ] } ], "stop_rules": [ { "id": "X1", "trigger": "The patient (or the crewmember being examined) says stop, or withdraws consent", "action": "Robot stops all motion at once, backs away to its rest position and tells the CMO. Recording stops unless the patient agrees to keep it running.", "level": "stop", "refs": [ "V2 10165" ] }, { "id": "X2", "trigger": "Any crewmember presses stop or takes over control", "action": "Protective stop; robot holds its stopped position; only a human may restart it.", "level": "safe-state", "refs": [ "V2 10165", "V2 10168", "V2 10174" ] }, { "id": "X3", "trigger": "Robot fault, sensor fault, or a force, speed or reach limit is reached", "action": "Protective stop and hand control to the CMO; log the fault.", "level": "safe-state", "refs": [ "V2 10172", "V2 10168" ] }, { "id": "X4", "trigger": "CMO is asked to take over and does not respond (for example, the CMO is the patient)", "action": "Robot stays stopped; the next named crewmember is called.", "level": "safe-state", "refs": [ "V2 10173", "V2 7045" ] }, { "id": "X5", "trigger": "Loss of link, or delay longer than the limit for live guidance", "action": "Only the robot pauses; crew care never waits for the link or the robot. Robot pauses any movement in its stopped position and tells the CMO. The CMO decides whether to continue offline under the pre-approved onboard checklist; the robot resumes only on the CMO's confirmation. Everything is logged and sent to the flight surgeon at the next contact.", "level": "pause", "refs": [ "V2 10172", "V2 10173" ] }, { "id": "X6", "trigger": "Patient flinches or reports pain while the limb is held", "action": "Robot releases the limb at once and backs away.", "level": "stop", "refs": [ "V2 10172" ] } ], "red_flags": [ { "id": "RF1", "sign": "Bleeding not controlled by pressure", "threshold": "after minutes", "action": "URGENT: CMO trauma care and flight surgeon call" }, { "id": "RF2", "sign": "Crew-reported spreading redness, warmth, swelling, pus or red streaks", "threshold": "any", "action": "URGENT call to flight surgeon with photos" }, { "id": "RF3", "sign": "Fever", "threshold": " °C or higher", "action": "URGENT call; see RMP-INF-001" }, { "id": "RF4", "sign": "Numbness, weakness, or loss of movement beyond the wound", "threshold": "any", "action": "URGENT call" } ], "safety_limits": [ { "id": "L1", "name": "Grip force when holding a limb", "value": "", "enforced": "Force sensing; release on exceed", "refs": [ "V2 10172" ] }, { "id": "L2", "name": "Hold duration", "value": "", "enforced": "Timer; then release and re-confirm" }, { "id": "L3", "name": "Robot speed near an open wound", "value": "", "enforced": "Hard limit" }, { "id": "L4", "name": "Sharps handling", "value": "not allowed", "enforced": "Gripper refuses tagged sharps" }, { "id": "L5", "name": "Limb hold without an active CMO hold command", "value": "not allowed", "enforced": "Hold releases when the command ends", "refs": [ "V2 10165" ] } ], "logs": [ { "id": "LOG-1", "text": "Every input, robot action, decision (with who made it) and hand-off, time-stamped to the second.", "refs": [ "V2 10163", "V2 10164" ] }, { "id": "LOG-2", "text": "Mode changes and safety-limit events are announced to the operator as they happen and logged.", "refs": [ "V2 10162", "V2 10172" ] }, { "id": "LOG-3", "text": "Records are stored and sent as private medical data, encrypted, with access limited to the medical team.", "refs": [ "V1 6003", "V1 7003" ] }, { "id": "LOG-4", "text": "Results are kept in a permanent, retrievable format so the flight surgeon can see trends.", "refs": [ "V1 7001" ] } ], "requirements": [ { "id": "V1 3004", "use": "In-mission care includes performing procedures, recording outcomes and restraints, personal protective equipment (biohazard and sharps containment), and privacy considerations." }, { "id": "V1 3006", "use": "Two crew medical officers per vehicle for NASA programs (see the commercial-flight note)." }, { "id": "V1 6003", "use": "Private medical communications." }, { "id": "V1 7001", "use": "Photos kept for trend review across dressing changes." }, { "id": "V1 7003", "use": "Secure records." }, { "id": "V2 7045", "use": "Usable by non-physician crew." }, { "id": "V2 7046", "use": "Patient, caregiver and supplies restrained." }, { "id": "V2 7059", "use": "Inventory updated with supplies used." }, { "id": "V2 10161", "use": "Status shown." }, { "id": "V2 10162", "use": "Mode changes are announced to the operator." }, { "id": "V2 10163", "use": "Data recorded and shared." }, { "id": "V2 10164", "use": "Shows who acts." }, { "id": "V2 10165", "use": "Human override." }, { "id": "V2 10168", "use": "Human takeover." }, { "id": "V2 10172", "use": "Protective stop and release." }, { "id": "V2 10173", "use": "Robot stays stopped if no one takes over." }, { "id": "V2 10174", "use": "Only a human starts or restarts the robot." } ], "validation": [ { "stage": "simulation", "what": "Robot passing, holding and photo tasks in simulation, including fluid release.", "pass": "Zero force-limit violations; photos framed consistently." }, { "stage": "training model", "what": "Wound-care trainer limbs with simulated fluid.", "pass": "Containment success at or above ; photo sets judged usable by clinicians." }, { "stage": "Earth analog", "what": "Analog crews; photos reviewed remotely.", "pass": "Pass criteria set in advance." }, { "stage": "parabolic or station demonstration", "what": "Containment pad and passing tasks in weightlessness, without a patient.", "pass": "Fluid containment and hand-over work as specified." } ], "signoff": { "protocol": [ "Clinical lead for the specialty (sets every clinical threshold marked )", "Flight surgeon, as medical authority", "Robotics and medical-device safety board", "Program approval for the mission" ], "restart_after_stop": "Human only. After any emergency or protective stop, a crewmember must restart the robot; the robot never restarts itself.", "each_run": "Started by the CMO. Flight surgeon review of photos when the link allows; otherwise at the next contact." }, "change_control": [ "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." ], "comms": { "live": "Low Earth orbit: photos and video go to the flight surgeon live.", "loss_of_signal": [ "Only the robot pauses; crew care never waits for the link or the robot.", "The robot pauses any movement and tells the CMO; on the CMO's confirmation it continues under the onboard checklist; photos and logs are queued.", "Follow-up photo sessions continue on the last agreed schedule." ], "mars_delay": [ "No live review; the flight surgeon follows the wound through photo packages.", "Escalation signs and the photo schedule are agreed before flight." ] }, "sources": [ { "key": "khanna", "text": "Khanna R, Li Y, Cook M, et al. Surgery for interplanetary space missions. Br J Surg. 2026;113(3):znag005.", "url": "https://doi.org/10.1093/bjs/znag005", "doi": "10.1093/bjs/znag005", "pmid": "41823369", "supports": "Means of fluid and debris containment must be planned for in space surgery; the review also notes that fluid management may be less difficult than expected, because blood tends to stay at the wound (surface tension makes it dome), though arterial bleeding can form a stream of droplets." }, { "key": "cdctet", "text": "U.S. Centers for Disease Control and Prevention. Clinical guidance for wound management to prevent tetanus (updated September 8, 2026).", "url": "https://www.cdc.gov/tetanus/hcp/clinical-guidance/index.html", "supports": "Dirty or major wounds include penetrating or puncture wounds, wounds containing dirt, soil, feces or saliva (for example bites), and wounds with devitalized tissue such as crush injuries and burns; the need for tetanus vaccination or immune globulin depends on the wound type and vaccination history." }, { "key": "crucian", "text": "Crucian B, Babiak-Vazquez A, Johnston S, et al. Incidence of clinical symptoms during long-duration orbital spaceflight. Int J Gen Med. 2016;9:383-391.", "url": "https://doi.org/10.2147/IJGM.S114188", "doi": "10.2147/IJGM.S114188", "pmid": "27843335", "supports": "Among 46 long-duration ISS crewmembers, skin rashes were the most reported clinical event in the categories studied (infections, allergies, rashes and hypersensitivities), at 1.12 per flight year. Wounds were not studied." }, { "key": "tb033", "text": "NASA OCHMO. Spaceflight Experience and Medical Care. Technical Brief OCHMO-TB-033 (2023).", "url": "https://www.nasa.gov/wp-content/uploads/2023/12/ochmo-tb-033-spaceflight-experience-medical-care.pdf", "supports": "Headaches are more common in spaceflight, with elevated CO2, fluid shifts and pressure changes among contributing factors; pre-mission exams include ECG, eye exams and photo documentation of skin." }, { "key": "tb044", "text": "NASA OCHMO. Medical Operations. Technical Brief OCHMO-TB-044 (2025).", "url": "https://www.nasa.gov/wp-content/uploads/2025/08/ochmo-tb-044-medical-operations.pdf", "supports": "The crew surgeon keeps medical authority when care is delegated; crew medical officers train on the JSC 48522 medical checklist." }, { "key": "v1", "text": "NASA. NASA-STD-3001, Space Flight Human-System Standard, Volume 1: Crew Health, Revision C (2023).", "url": "https://www.nasa.gov/wp-content/uploads/2023/11/nasa-std-3001-vol-1-rev-c-with-signature.pdf", "supports": "Requirement IDs beginning V1." }, { "key": "v2", "text": "NASA. NASA-STD-3001, Volume 2: Human Factors, Habitability, and Environmental Health (Rev F, 2026), including Section 10.6 Automated and Robotic Systems.", "url": "https://standards.nasa.gov/standard/NASA/NASA-STD-3001_VOL_2", "supports": "Requirement IDs beginning V2." }, { "key": "marsdelay", "text": "NASA. Mars communications disruption and delay (fact sheet, 2023 Moon to Mars Architecture Concept Review).", "url": "https://www.nasa.gov/wp-content/uploads/2024/01/mars-communications-disruption-and-delay.pdf", "supports": "One-way Earth-Mars delay up to about 21-23 minutes, plus blackouts of about 2-3 weeks near solar conjunction." }, { "key": "pccp", "text": "U.S. Food and Drug Administration. Marketing submission recommendations for a predetermined change control plan for artificial intelligence-enabled device software functions (guidance).", "url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence", "supports": "A model for planning, validating and rolling back software updates." }, { "key": "faa460", "text": "U.S. Code of Federal Regulations, Title 14, Part 460: Human space flight requirements.", "url": "https://www.ecfr.gov/current/title-14/chapter-III/subchapter-C/part-460", "supports": "Federal rules for crew and spaceflight participants on licensed commercial flights; they set no medical standards for spaceflight participants." } ], "corrections": [ { "date": "2026-10-20", "version": "0.2", "source": "AI-assisted clinical and source review by the Medical Research Assistant, Oct 20, 2026", "items": [ "Removed the rash statistic as evidence for wound care; it is now noted as a separate problem (Crucian 2016 did not study wounds).", "Khanna 2026 wording: containment must be planned for (not \"unsolved\").", "Dirty or major wounds (puncture, crush, bite, embedded foreign material, contaminated) now escalate to trauma care; the tetanus immunization date is shown to the CMO and flight surgeon (CDC wound guidance); the robot gives no tetanus advice.", "New PRE-6: eye protection for patient, CMO and helper; containment in place before irrigation.", "Photo privacy: wound and reference card only; the face only if the wound is on the face and the patient agrees.", "Limb holding is now its own robot step at rung 1 (S5), active only while the CMO holds a hold command, so the build checks it.", "Loss of link (X5) now means: pause motion, tell the CMO, and continue offline only on the CMO's confirmation (fixes the contradiction with the comms branch).", "Added a commercial-flight note on who the flight surgeon and CMO are, and a fixed list of robot lockouts checked by the build." ] }, { "date": "2026-10-21", "version": "0.2", "source": "Batch 5 editorial (AI-assisted), Oct 21, 2026; batch 4 review item 49", "items": [ "Inherited stop-rule and requirement wording: \"holds a safe position\" → \"holds its stopped position\"; \"stays in its safe state\" → \"stays stopped\"; \"take over safely\" → \"take over\"; \"Robot stays safe if no one takes over\" → \"Robot stays stopped if no one takes over\". Schema level name safe-state and never-word list entry \"safe\" unchanged." ] }, { "date": "2026-10-21", "version": "0.3", "source": "Batch 6 editorial (AI-assisted), Oct 21, 2026", "items": [ "Requirement use for [V2 10173] changed from \"Safe default.\" to \"Robot stays stopped if no one takes over.\" (batch 5 review item 25; editorial, behaviour unchanged)." ] }, { "date": "2026-10-21", "version": "0.4", "source": "Batch 7 editorial (AI-assisted), Oct 21, 2026", "items": [ "Citation labels changed to the site's year-only convention: \"(approved for public release )\" now reads \"(YYYY)\", and NASA-STD-3001 Volume 2 \"Revision F (approved July 14, 2026)\" now reads \"(Rev F, 2026)\" (sources: v2). Editorial; no change to steps, thresholds or limits." ] }, { "date": "2026-10-21", "version": "0.5", "source": "Batch 7 review and batch 8 editorial (AI-assisted), Oct 21, 2026", "items": [ "X5 and the comms loss-of-signal branch now open with \"Only the robot pauses; crew care never waits for the link or the robot.\" (batch 7 review suggestion 29). Editorial; robot behaviour unchanged." ] }, { "date": "2026-10-21", "version": "0.6", "source": "Batch 9 editorial (AI-assisted), Oct 21, 2026", "items": [ "Rashes are routed to RMP-SKIN-004 (planned); RMP-SKIN-003 is now the wound photo log." ] }, { "date": "2026-10-21", "version": "0.7", "source": "Batch 11 editorial (AI-assisted), Oct 21, 2026", "items": [ "Cross-links to the batch 11 drafts no longer say \"(planned)\" now that those protocols exist as v0.1 drafts." ] } ] }