Domain dossier
Shared background for a clinical problem, keyed by domain rather
than by candidate, so the second idea in an area starts from the first one's research.
A dossier carries no confidence tags. A line here has to be copied into a
candidate's claims as unverified before anything can check or score it.
Used by: idea-023
Research reports behind it: none yet — see research_fleet.py status
Wound cleansing is the step at almost every dressing change where fluid is used to lift debris, exudate and loose devitalised tissue off a wound bed. It sits underneath a large and growing wound population, is done by nurses far more often than by physicians, and is almost never separately paid for in the US. What it is done with (tap water, saline, a surfactant or an antiseptic cleanser such as hypochlorous acid, PHMB or chlorhexidine) and how (soak, swab, squeeze bottle, syringe, gravity bag, powered pulsatile lavage) is where the products in this domain compete. Two plausibly different candidates read this file: a solution (a new cleanser) and a delivery device (a pressure-controlled applicator, splash shield or closed kit).
Read the thinness first. This is a first-pass dossier built in one session on 2026-10-04, with no research-fleet report behind it (no fleet plan exists for this domain). Four things are thin and the file says so where they bite: (1) no US figure was found for how often a wound is professionally cleansed or irrigated — the closest proxies are a UK nurse-visit count and a US Medicare count of debridement services, neither of which counts irrigations; (2) no contract or GPO price for any HOCl cleanser was retrieved — only that contracts exist, plus retail list prices; (3) the clinical evidence that any cleansing solution beats saline or tap water is low or very low certainty, and for HOCl in chronic wounds no RCT (randomised controlled trial) met one systematic review's eligibility criteria; (4) EU/Danish rows rest on documents no connector reaches (TED API fields, an SEC filing, company press releases).
This file carries no confidence tags. Every line below is context with a source attached. To affect a score, a line must be copied into a candidate's ## Claims as unverified via engine/scripts/append_research_claims.py and pass the Verifier or the Corroborator. See README.md in this directory.
Citation convention: bracketed numbers [n] refer to the numbered ## Sources list at the end, which carries each entry's resolvable identifier. "Abstract only" means the PubMed structured abstract was read via connectors literature-detail; no methods section, risk of bias or funding disclosure was appraised unless stated.
as_of: 2026-10-04 · sources searched: connectors literature (wound prevalence Medicare/US; pressure injury prevalence; UK wound burden; dressing-change and visit frequency) + literature-detail on the PMIDs below; connectors procedures on wound debridement codes · not searched: incidence by wound type; MEPS/NHAMCS ambulatory visit counts; VA wound data; Medicare Advantage (Medicare Advantage); commercial claims; burn incidence beyond one abstract's figure
| Fact | Quantity (n, population, date) | Source |
|---|---|---|
| Medicare beneficiaries with any wound | 8.2 million (2014) rising to 10.5 million (2019); prevalence 14.5% to 16.4%. All wound types in the study's definition (diabetic foot, arterial, venous, pressure, surgical, traumatic, skin disorders, other); 2019 data fee-for-service only | [1] |
| Medicare wound spending | "Nearly 15% of Medicare beneficiaries (8.2 million) had at least one type of wound or infection"; total Medicare spending estimates for all wound types $28.1-96.8 billion; 2014 Medicare 5% Limited Data Set | [2] |
| Pressure injury prevalence, US acute care | 8.97% of patients had at least one pressure injury (26,562 of 296,014), 2.58% hospital-acquired; critical care 14.32%; IPUP survey 2018-2019, 914/887 facilities | [3] |
| Pressure injury prevalence by setting, US | Overall 13.5% (2006) to 9.3% (2015); long-term acute care 32.9% (2006) to 28.8% (2015); IPUP survey n=918,621, 2006-2015 | [4] |
| Burn hospitalization (context only) | "Over 40,000 patients in the United States (US) require hospitalization for burns annually" — stated in the background of a cost model, not the paper's own measurement | [39] |
| Trend | Medicare wound prevalence rose 13% 2014-2019 [1]; UK NHS (National Health Service) wound prevalence rose 71% 2012/13 to 2017/18 [5]. US pressure-injury prevalence fell 2006-2015 then plateaued 2015-2019 [3][4] | [1][3][4][5] |
| Encounter frequency (UK, revealed behaviour) | NHS 2017/18: an estimated 3.8 million patients with a wound; wound management used 54.4 million district/community nurse visits, 53.6 million healthcare-assistant visits and 28.1 million practice-nurse visits in the year (THIN database, random cohort n=3,000) | [5] |
| Professional wound procedures (US, revealed behaviour) | Medicare Part B (Medicare Part B) physician/practitioner services, data year 2024, national: 97597 684,939; 97598 135,222; 11042 2,042,234; 11043 506,331; 11045 650,800. Fee-for-service only; excludes hospital outpatient facility claims, Medicare Advantage, commercial, Medicaid, VA. These count debridement services, not irrigations | [7] |
| Visit frequency and healing (US wound clinics) | US Wound Registry, n=39,750 DFUs: DFUs seen at intervals of 2 weeks or less had HR 0.098 (95% CI 0.09-0.11) for healing versus those seen 7.5 or more times per 4 weeks. The abstract gives no distribution of visit frequency | [8] |
Verbatim, for anything load-bearing:
"the number of Medicare beneficiaries with a wound increased from 8.2 million to 10.5 million. Wound prevalence increased by 13% from 14.5% to 16.4%" — [1]
"Annual levels of resource use attributable to wound management included 54.4 million district/community nurse visits, 53.6 million healthcare assistant visits and 28.1 million practice nurse visits." — [5]
Gaps: No US source was found that counts professional wound cleansings or irrigations, or dressing changes per wound per week across settings (searched: PubMed "dressing change frequency", "dressings changes per week", home-health wound utilization; found only product-specific dressing-change differences, e.g. [10a] −1.66 changes/week for one foam dressing class, which is not a population baseline). The UK nurse-visit count [5] is the best revealed-behaviour proxy found and it is a different health system. The Medicare Part B counts [7] are a floor on physician/practitioner-billed wound procedures only.
as_of: 2026-10-04 · sources searched: literature on home health wound care, wound-clinic visit frequency, cleansing practice surveys; CFR text for setting payment; IWII 2022 consensus · not searched: OASIS/home-health claims data; SNF MDS data; hospital wound-team staffing surveys; who performs irrigation by setting in any US dataset
| Step in the pathway | Setting / site of service | Who performs it | What equipment is already there | Source |
|---|---|---|---|---|
| Wound cleansing at each dressing change; "therapeutic" vigorous cleansing for wounds with slough, debris or suspected biofilm | All settings | Predominantly nurses (UK cohort: "wound management is predominantly a nurse-led discipline") | Saline/water, gauze, syringe; antiseptic cleansers where stocked | [6][12] |
| Mechanical irrigation at 4-15 psi recommended over passive soaking or swabbing | All settings | Clinician | Syringe-and-needle/angiocatheter combinations tabulated by psi (e.g. 35 mL + 19G = 8 psi) | [12] |
| Sharp/selective debridement with cleansing | Physician office, hospital outpatient, wound clinic | Physicians, podiatrists, advanced practice providers (billable 97597/11042 family) | Procedure room, sharp instruments, irrigation supplies | [7][12] |
| Home health wound visits | Patient's home | Skilled nursing visits (RN/LPN); one enterprise shifted 1.9% of roles toward LPNs | Supplies carried in or held by patient; supply shortfalls after discharge are reported | [9][10][10b] |
| Powered pulsatile lavage | OR, bedside in SCI inpatient unit, wound care area | Surgeons, PT (physical therapist)/wound nurses | Battery or console-driven disposable handpiece, suction | [28][31][32] |
| Danish municipal and regional care (EU/DK row) | Region Nordjylland hospitals and 10 municipalities buy wound products on one joint tender | Not established from the tender data | Tender lots include NaCl rinse, wound irrigation fluid with and without HOCl, and an irrigation capsule | [65] |
Verbatim:
"Passive soaking or swabbing of the wound bed with wet gauze may not adequately cleanse the wound. Mechanical irrigation applied at a force of 4–15 pounds per square inch (PSI) is recommended." — [12], p.26
"Many home health agencies operate below capacity due to clinician shortages, meeting only 61% to 70% of demand and frequently declining wound care referrals." — [9] (background statement in the abstract, not the study's own measurement)
Gaps: No source establishes, for any US setting, the share of cleansings done by pressurized irrigation versus soak, swab, spray bottle or squeeze bottle. The Canadian survey [11] reports one technique (30% routinely use gauze soaking) but not irrigation. Not searched: whether US SNFs and home health agencies stock HOCl cleansers on formulary at any measured rate.
as_of: 2026-10-04 · sources: CFR payment text, payer policy article, GPO/FSS announcements, surveys of current practice. No stakeholder intent is recorded here (class 3)
| Role | Who they are | What they gain | What they lose / what it costs them | Whose budget | Source |
|---|---|---|---|---|---|
| Prescriber / decider | Wound physicians, podiatrists, WOC nurses, surgeons; facility formulary/value-analysis committees | Product choice is theirs; no separate payment follows it | Nothing billed for the cleanser itself | n/a | [57][58] |
| Operator / daily user | Bedside, clinic, SNF and home-health nurses; OR staff | — | Splash exposure: OSHA requires masks with eye protection or face shields wherever splashes, spray, spatter or droplets may be generated | Employer | [57] 29 CFR 1910.1030(d)(3)(x) |
| Purchaser | Hospital, SNF, home health agency, wound clinic supply chain; GPO contracts (Premier lists Vashe from 2020-04-01); VA/DoD via FSS V797D-50441 and DAPA | — | Every unit is a supply cost inside a bundled payment (row below) | Facility/agency supply budget | [60][61][57] |
| Payer | Medicare: OPPS packages "medical and surgical supplies"; SNF per-diem is "payment in full for all costs (routine, ancillary, and capital-related)"; home health 30-day payment "represents payment in full for all costs associated with furnishing home health services"; Part B surgical-dressing benefit lists A6260 (a HCPCS code for a supply) wound cleansers and irrigating solutions as non-covered | — | — | CMS (Centers for Medicare & Medicaid Services) (inside bundles) | [57][58] |
| Patient | Wound patient; OTC cleansers are sold at retail | — | Pays out of pocket for OTC/retail purchase (one MAUDE (Manufacturer and User Facility Device Experience) reporter bought Vashe OTC on a physician's advice) | Patient | [54][62] |
Gaps: No published measure was found of how much clinician time a cleansing step takes, or of PPE use per irrigation, in any US setting. Purchaser behaviour beyond the existence of GPO and FSS contracts (award shares, prices) is not established.
as_of: 2026-10-04 · sources searched: connectors literature + literature-detail; IWII 2022 PDF read directly; connectors trials sweep for hypochlorous interventions · not searched: NPIAP/EPUAP 2019 guideline text; WOCN and WHS guidelines; IWGDF 2023 guideline text; full texts beyond PMC8944418; AHCPR guideline text (not retrieved, see Gaps)
| Item | What it establishes | Evidence quality (design, n, endpoint) | Source |
|---|---|---|---|
| Guideline/consensus: irrigation pressure | IWII 2022: mechanical irrigation at 4–15 psi "is recommended"; table of syringe/gauge combinations (35 mL+25G 4 psi; 35 mL+19G 8 psi; 12 mL+19G 20 psi) | International consensus document, references cited inline; not a graded guideline | [12] |
| Guideline/consensus: older antiseptics | IWII 2022: hydrogen peroxide, traditional sodium hypochlorite (EUSOL, Dakin's) and chlorhexidine "are no longer recommended for use in open wounds" due to tissue-damage risk; super-oxidised solutions with HOCl as antimicrobial preservative listed among contemporary cleansers | Consensus | [12] |
| Origin of the 4-15 psi range | AHCPR CPG No. 15 (1994) is the document cited for it, e.g. in FDA (US Food and Drug Administration) 510(k) (premarket notification) summary K210987 (an FDA 510(k) clearance number): "published safe and effective wound impact pressures of 4 to 15 psi (Clinical Practice Guideline Number 15 AHCPR...)". Guideline text itself not retrieved | Submitter quoting guideline | [25][24] |
| Animal basis for "high pressure" | Saline at 15 psi removed 84.8% of soil infection-potentiating factors (experimental, Rodeheaver 1975); low-pressure asepto-syringe irrigation "did not significantly cleanse" experimental wounds (Stevenson 1976); high-pressure syringe and pulsatile irrigation disseminated fluid laterally into tissue and caused tissue injury that impairs defenses (Wheeler 1976, pigs) | Animal/experimental, abstracts only; no abstract states the 4 psi lower bound | [20][21][22] |
| Contrary animal finding | Lower-pressure higher-volume irrigation (mean 1.6 psi) washed out S. aureus as effectively as syringe-catheter irrigation (mean 8.8 psi) in inoculated rat wounds | Animal, abstract only | [23] |
| Largest RCT on irrigation pressure (open fractures, not chronic wounds) | FLOW, 41 centres, n=2,447: reoperation 13.2% high (>20 psi), 12.7% low (5-10 psi), 13.7% very low (1-2 psi) pressure; no significant difference. Castile soap worse than saline (14.8% vs 11.6%, HR 1.32) | RCT, 2x3 factorial, NEJM 2015 | [19] |
| Water vs saline | Cochrane 2022: 13 trials, 2,504 participants; tap water vs saline effects on infection and healing uncertain, low/very-low certainty [14]. A 2025 meta-analysis of 12 trials (3,330 patients): infection RR 0.78 (95% CI 0.59-1.03) tap water vs saline | SR/MA | [14][70] |
| Cleansing solutions, venous leg ulcers | Cochrane 2021: 4 RCTs, 254 participants; insufficient evidence for PHMB vs saline, aqueous oxygen peroxide vs water, propyl betaine/polihexanide vs saline, octenidine vs Ringer's; very low certainty; no trial of cleansing vs no cleansing or of technique | Cochrane SR | [15] |
| Cleansing, pressure ulcers | "little trial evidence to support the use of any particular wound cleansing solution or technique" | SR 2008 | [16] |
| Cleansing solutions, DFU (diabetic foot ulcer) | Dakin's/chloramines and hypertonic saline "may improve" healing vs saline, but only three low-quality, high risk-of-bias studies; "certainty of the evidence is low" | SR 2024 | [17] |
| HOCl in chronic wounds (systematic review) | Antiseptics SR: 6 RCTs, 725 patients, 1989-2020; "No studies assessing chlorous agents met our eligibility criteria"; "We could not assess the effect of hypochlorous agents on chronic wound healing" | SR, full text read (PMC8944418) | [18] |
| HOCl RCT, chronic leg ulcers | Stabilized HOCl + acetic acid (SoftOx SBE) first-in-human: randomized double-blind single-dose phase n=16 SBE vs 4 saline placebo, then open-label n=8; safety/tolerability primary; bioburden median reduction 98% vs 49% | Phase 1, small, safety endpoint | [37] |
| HOCl vs mafenide, burns | Retrospective, one ABA-verified burn centre 2012-2024, n=274: infection requiring antibiotics 41.9% HOCl vs 37.0% mafenide (P=.58); no difference in mortality or morbidity | Retrospective cohort | [38] |
| PHMB/betaine (Prontosan) vs saline | Single-blind RCT n=289, PUs and vascular leg ulcers, 28 days: BWAT total score difference p=0.0248 favouring PHMB/betaine; no pain difference; manufacturer supplied material and paid ethics fees | RCT, surrogate endpoint | [35] |
| Low-pressure pulsatile lavage, SCI pressure ulcers | RCT n=28 (14 vs 14 sham), 11 psi daily, 3 weeks: greater rates of dimension reduction in treatment group | Small RCT | [31] |
| Antiseptic irrigants, host tissue (animal) | Bacitracin, Clorpactin, Irrisept, Prontosan, Bactisure all had "negative effects on host tissue in the acute phase" vs saline but no compromised healing at 10 days (murine, single short exposure) | Animal | [36] |
| Expert-panel/consensus economic claims for HOCl | A 10-person panel "supports pHA as a dominant strategy"; "This work did not include the development of a consensus statement" [40]. A 15-member NPWTi panel reports agreement "appear[s] to reflect individual preferences" [41] | Expert opinion; not evidence of effect | [40][41] |
Known negative / equivocal findings, at the same weight: FLOW found no benefit of higher pressure [19]; a rat model found 1.6 psi as effective as 8.8 psi [23]; 20 psi pulsatile lavage caused myonecrosis and dystrophic calcification in all rats so treated versus none with bulb syringe (p=0.001) [29]; higher impact pressure gave deeper soft-tissue penetration in vitro [30]; HOCl showed no infection advantage over mafenide in burns [38]; one SR found no eligible HOCl RCT in chronic wounds [18].
Trial registry: connectors trials --intervention hypochlorous since 2010 returned 40 of 115 records (truncated); most are dental, peritoneal or skin-prep studies. No posted-results RCT of HOCl irrigation versus saline in chronic wounds was among the 40 read. This is not a search of all 115.
Gaps: AHCPR CPG 15 text was not retrieved (NCBI Bookshelf NBK63905 returned a reCAPTCHA page). The 8 psi figure for a 35 mL syringe with a 19G angiocatheter is found in IWII 2022's table [12], which cites its own references; the primary measurement behind it was not read. NPIAP, WOCN, WHS and IWGDF guideline text on cleansing solutions was not searched.
as_of: 2026-10-04 · sources searched: connectors clearance-summary, clearances, recalls (FRO, FQH, KYZ since 2012), maude by device name since 2010, literature; WebFetch on company announcements and one retailer · not searched: GUDID (Global Unique Device Identification Database) records beyond one search hit; FDA safety communications (fda.gov gated); distributor contract price files; any discontinuation-rate study for any cleanser (none surfaced)
No discontinuation-rate, adherence or withdrawal-reason table was found for any cleanser or irrigation device in this domain. Cleansing is a step inside a dressing change, not a therapy a patient stays on, so the abandonment record here is assembled from guideline downgrades, recalls, MAUDE narratives, outbreak investigations, utilization shares and practice surveys. That is a weaker kind of signal than a pivotal trial's dropout table, and it is labelled as such.
| Signal | Quantity (n, population, date) | Source |
|---|---|---|
| Recurring failure mode — sterility | Medline sterile saline wound wash recalled because the manufacturer "may not have manufactured products to meet the minimum required sterility assurance level" (Z-1431-2026, 2026-01-05); Nurse Assist sterile water/saline recall propagated into irrigation trays and kits (Z-0513-2024, 2023-11-06; Cardinal irrigation tray Z-1049-2024) | [53] |
| Recurring failure mode — container | Medline 100 mL sterile water and saline bottles leaking at the peel-foil interface (Z-1705/1706-2025) | [53] |
| OR mixing errors (surgical context, not chronic wounds) | US survey of 401 OR staff: 90% of OR-mixed irrigation solutions made with nonsterile ingredients; concentration different from intended in 50.2% of mixtures | [13] |
| Practice gap | Canadian nurses (n≈198, 2024): 68% support gauze soaking, 30% use it routinely | [11] |
| Signal | Quantity | Source |
|---|---|---|
| MAUDE | 1 report since 2010 (MW5160932, 2024-10-09): a parent reports a wound that "was closing and healing appropriately" before Vashe was introduced; reporter's account, no denominator | [54] |
| Recalls | none found by firm or product name in the FRO recall sweep | [53] |
| Withdrawn from distribution | not found | — |
none by name since 2010; no recall found in FRO sweep; nothing found. Not searched: Innovacyn GPO contracts.
| Signal | Quantity | Source |
|---|---|---|
| Recall — material incompatibility | Z-2275-2026 (2026-04-27), PhaseOne Antimicrobial Solution (Oculus Technologies of Mexico; related 510(k) K172851): "corrosion of the internal metallic spring within the sprayer component ... caused by material incompatibility between the product solution and the stainless steel spring", trace iron, chromium and nickel in solution; root cause "Component design/selection" | [51] |
| Recall — preservative stability | Z-0890-2013, Atrapro hydrogel (Oculus Innovative Sciences): free available chlorine 4 ppm at 13 months against a >10 ppm specification | [52] |
| Recall — stability | Z-0763-2017, Ceramax skin barrier cream samples "not meeting stability standards" | [53] |
none by name; no recall found. Class-level context: IWII 2022 says traditional sodium hypochlorite (EUSOL, Dakin's) is no longer recommended in open wounds and that some hypochlorite products have been redeveloped at lower concentrations [12]. Whether Anasept falls in either group is not established here.
none; no US recall found. Too new in the US for a record.
| Signal | Quantity | Source |
|---|---|---|
| MAUDE volume | 81 reports matching "Prontosan" since 2010 (20 read; truncated); no denominator | [54] |
| Recurring failure mode — look-alike packaging | 3007120504-2026-00002 (2026-08-11): Austrian authority relayed that "Prontosan instead of NaCl was accidentally administered externally ... the packaging is extremely similar ... already several similar cases; Change in the packaging of Prontosan urgently needed" | [54] |
| Recurring complaint — allergy | reports quoting the IFU's listed allergic reactions (e.g. 3007120504-2024-00003, "ALLERGIC REACTION") | [54] |
| Signal | Quantity | Source |
|---|---|---|
| Guideline downgrade (class) | IWII 2022 lists chlorhexidine among older antiseptics "no longer recommended for use in open wounds due to the risk of tissue damage" — this is about CHG in open wounds as a class, not a statement about the 0.05% Irrisept product | [12] |
| MAUDE — reported discontinuation | 34 reports since 2010; MW5190883-90 (2026-07-21) aggregate voluntary report from a single surgeon's penile-prosthesis series: adoption of Irrisept "was temporally associated with an increase in the 90-day device-infection/reoperation rate relative to the periods immediately before and after its use" — the reporter's account of stopping, not an FDA finding | [54] |
| Recalls | Z-0191-2020 (2019-08-16) potential sterile pouch seal defect; Z-0490-2019 (2017-09-05) Irrisept OR leaking containers | [53] |
| Animal host-tissue effect | acute negative effects on host tissue similar to other antiseptics, healing not compromised at 10 days (murine) | [36] |
| Signal | Quantity | Source |
|---|---|---|
| Outbreak | Multidrug-resistant A. baumannii, 1000-bed tertiary hospital, Baltimore, 2003: 6 of 7 cases vs 4 of 28 controls had pulsatile lavage (OR 36, 95% CI 2.8-1721); strain recovered from all 6 typed lavage patients and "multiple surfaces in the wound care area"; authors: "Infection control precautions are not routinely used during the procedure and are not included in pulsatile lavage equipment package labeling" | [28] |
| Tissue harm (animal) | 20 psi lavage: radiopaque lesions in all lavage-treated rats, none with bulb syringe (p=0.001); wound complications 5/12 vs 0 | [29] |
| Splash | "current devices can cause significant splashing and increase the risk of contaminated fluid exposure to healthcare professionals" (technique note proposing an improvised larger guard) | [34] |
| Device malfunction (MAUDE, no denominator) | InterPulse: 460 reports since 2010 (20 read); e.g. 50465556 (2026-08-27) "Irrigator did not have any power ... A second pulse irrigator ... functioned but very weak and slow". Pulsavac: 283 reports (20 read); battery shorting, failure to prime, brush-tip breakage | [54] |
| Recalls | Z-1246-2018 InterPulse handpieces, bioburden above limits; Z-2062-2015 Stryker woundcare replacement kit, sterility breach | [53] |
| No benefit of higher pressure (open fractures) | FLOW: no difference across >20, 5-10 and 1-2 psi | [19] |
| Bedside safety (one centre) | 28 SCI patients, mean 46 days of daily bedside lavage: one 6-day interruption for minor bleeding, no backsplash injuries documented | [32] |
Verbatim, for anything load-bearing:
"Many older antiseptics, including hydrogen peroxide, traditional sodium hypochlorite (e.g. EUSOL and Dakin's solution), and chlorhexidine are no longer recommended for use in open wounds due to the risk of tissue damage associated with their use." — [12], p.31
"The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring" — [51]
"Transmission was apparently caused by dissemination of multidrug-resistant A baumannii during the pulsatile lavage procedure, resulting in environmental contamination." — [28]
Utilization shares that are revealed behaviour (not preference): in one ABA-verified US burn centre 2012-2024, 88.7% of grafted burn patients received mafenide and 11.3% HOCl as the initial antiseptic (n=274) [38]. No equivalent share was found for chronic-wound settings.
Gaps: No discontinuation or switching study for any cleanser. No contract price. No measure of how often clinicians abandon a powered lavage for a manual method, or why, beyond the outbreak and malfunction record. Dakin's solution (compounded or commercial) was not worked as a separate product. GUDID listings, FDA safety communications on CHG hypersensitivity, and the FDA Medical Device Shortage list were not searched (fda.gov gated).
as_of: 2026-10-04 · sources: connectors hcpcs, payment, rvu, procedures, apc; connectors regulation + direct eCFR full-section reads (title 42, issue 2026-10-01); policy article A54563 as recorded on idea-023 claim 29 · not searched: MS-DRG case-level supply costs; commercial payer policies; state Medicaid fee schedules for A6260
| Item | Detail | Source |
|---|---|---|
| Codes in use | HCPCS (Healthcare Common Procedure Coding System) A6260 "Wound cleansers, any type, any size"; A4217 sterile water/saline 500 mL; A4322 irrigation syringe, bulb or piston, each; debridement CPT (Current Procedural Terminology) numbers 97597/97598, 11042-11047 (descriptors not reproduced) | [58][7] |
| Coding route | HCPCS Level II supply codes; no code isolates the irrigation step | [58] |
| Payment rate | A6260: no row in the cached CMS payment or DMEPOS files; A4217 $3.80-$4.47 and A4322 $3.78-$4.35 (DMEPOS July 2026 allowed amounts) | [58] |
| RVU (relative value unit) split | 97597 (2026, CF 33.5675): work 0.75 + PE(non-facility) 2.24 + MP 0.05 → non-facility $102.05 (PE portion $75.19), facility $31.22. The non-facility PE is where office-based supplies are priced | [59] |
| Site-of-service | Facility payment of 97597 to the practitioner is $31.22; the facility's own OPPS payment status for 97597 not checked (no OPPS Addendum B cache) | [59] |
| OPPS bundling | 42 CFR 419.2(b)(4): packaged costs include "Anesthesia, certain drugs, biologicals, and other pharmaceuticals; medical and surgical supplies and equipment; surgical dressings" | [57] |
| SNF | 42 CFR 413.335(b)(1): SNF PPS rates "represent payment in full ... for all costs (routine, ancillary, and capital-related) associated with furnishing inpatient SNF services"; 42 CFR 411.15(p) consolidated-billing exclusion for services furnished to SNF residents by other entities | [57] |
| Home health | 42 CFR 484.205(d): the 30-day payment "represents payment in full for all costs associated with furnishing home health services"; 409.45(f) medical supplies "may be covered as a home health benefit"; 409.100(a)(2) payment for home health services including medical supplies "is made to the HHA"; 484.205 separately pays disposable NPWT (negative-pressure wound therapy), showing the bundle's one carve-out for a wound device | [57] |
| Inpatient | 42 CFR 412.2(a) per-discharge payment (recorded on idea-023 claim 30; text does not mention supplies) | idea-023 claim 30 note |
| Coverage policy | Policy article A54563 (related LCD (local coverage determination) L33831 (a Medicare local coverage determination number)): "Wound cleansers (A6260) or irrigating solutions" listed as non-covered under the surgical dressing benefit | [58] |
| Ex-US (prose only) | Denmark: regional and municipal wound products bought on joint tenders (Region Nordjylland + 10 municipalities, 48-month lots) | [65] |
| Whose budget | Facility, SNF or agency supply budget inside a bundled payment; patient out of pocket for OTC | [57] |
Gaps: OPPS Addendum B is not cached, so apc cannot say whether 97597 is packaged or separately paid under OPPS (a CMS download through engine/scripts/fetch_data_file.py; Addendum B ships as a zip/xlsx and would need conversion to the expected CSV). State Medicaid treatment of A6260 not searched.
as_of: 2026-10-04 · sources: connectors clearances --product-code FRO --since 2020-01-01 (98 records, not truncated); clearance-summary; literature; patent-scan · not searched: FQH and KYZ clearance counts by year; electrochemical on-site HOCl generators
| Change | When | What it enabled | Source |
|---|---|---|---|
| HOCl cleansers move from small bottles to irrigation bags | Puracyn Plus K232080 (2024-05-31), 1-3 L bags; K251757 (2026-01-05) | Bag-format HOCl irrigation already cleared | [56] |
| A self-contained antiseptic irrigation kit moves from FQH to FRO | Irrisept K080779 (FQH, 2009) → K240552 (FRO, 2024) | Precedent for a solution-plus-applicator cleared as one FRO device | [56] |
| Continued entry of HOCl/antimicrobial cleansers under FRO | 2020-2026 FRO clearances with cleanser/irrigation titles include K243875 Spectricept (2025-04-21), K243415 Granudacyn (2025-07-22), K252759 revyve (2026-01-08), K252023 MiraChlor (2026-03-25), K261023 Microdacyn Wound Irrigation (2026-06-24), K253665 Vashe Plus (2026-08-11) | A crowded and still-filling FRO category | [55] |
| Proposed reclassification of liquid wound washes | FR Doc 2023-26209 (proposed 2023-11-30); not codified in eCFR as of 2026-09-30 (idea-023 claims 11-12) | Possible future Class II special controls or Class III (FDA device class III) tier | idea-023 claims 11-12 |
| HOCl in NPWT with instillation | Consensus 2024 (15-member panel) | Second route of HOCl use beyond manual cleansing | [41] |
| Warmed lavage | US 12,178,977 B2 "Lavage systems and devices having warming component" (CareFusion 2200), filed 2021-10-14, in force | Warming integrated into lavage hardware is patented by a large incumbent | [66] |
HOCl chemistry constraints that bear on any warmed or sprayed format: a 200 ppm, pH 6 HOCl solution was "unstable against ultraviolet (UV) light, sunshine, contact with air, and elevated temperature (≧25℃)", with storage <10 °C recommended [43]; neutral electrolysed water lost available chlorine to <0.01 mg/L after 52 days at 25 °C in high surface-to-volume bottles but was more stable at 4 °C [44]; HOCl and NaOCl degradation "was accelerated by temperature and lighting" [47]. Contrary evidence from a different chemistry: 1-5.25% NaOCl (endodontic, alkaline, ~50-500 times more concentrated) stayed stable for 60 min at 45 and 60 °C [45] and over 30 days after heating to 50 °C [46]. No study was found measuring a wound-care HOCl solution held at about 37 °C for an irrigation session.
Aerosol and chlorine exposure: NaOCl surface spraying vs wiping in a mock clinical room: Cl2 "remained below detection limits"; spraying gave lower cumulative inhaled ultrafine-particle dose because it was faster [48]. NaOCl disinfection at 38 °C and strong light gave the highest ultrafine-particle exposure under poor ventilation [49]. Aerosolized HOCl dry fog from a 500 ppm solution was cytotoxic and genotoxic to cultured fibroblasts; 300 ppm for 3 minutes was not [50]. No study measured clinician exposure during HOCl wound irrigation.
Gaps: a counted series of FQH/KYZ clearances per year was not built. Counted series cannot carry a tag in this repo (docs/backlog.md 1.10).
as_of: 2026-10-04 · sources: openFDA 510(k), recall and MAUDE connectors; SEC EDGAR 10-K; company press releases fetched directly; TED API (EU) · not searched: Irrimax, Innovacyn and B. Braun corporate filings; market-share reports (licensed); Zimmer Biomet/Stryker lavage product-line status
| Player | Position | Entered / exited | Recent activity (funding, launch, recall) | Source |
|---|---|---|---|---|
| Urgo Medical North America | Vashe HOCl line | Formed 2018-09-26 (Urgo majority stake in SteadMed) | FSS 2019; Premier GPO 2020; Vashe Plus K253665 cleared 2026-08-11 | [64b][60][61][55] |
| Innovacyn | Puracyn / Puracyn Plus | — | K232080 (2024) bags; K251757 (2026) | [56] |
| Sonoma Pharmaceuticals | Microcyn/Microdacyn HOCl | — | US revenue $2.611M FY2025; Medline US distribution from Aug 2024; Microdacyn60 Wound Care certified Class IIb under EU MDR (medical device report); PhaseOne spring-corrosion recall 2026 | [63][51] |
| Mölnlycke | Granudacyn | Acquired P.G.F. Industry Solutions, completed 2025-05-27 | K243415 (2025) | [64][56] |
| B. Braun | Prontosan PHMB | US clearances 2008-2017 | MAUDE look-alike packaging report 2026 | [55][54] |
| Irrimax | Irrisept CHG kit | K080779 (2009); K240552 (2024) | Three 2025 patent applications on delivering "synergistic active agents" | [56][66] |
| Zimmer Biomet / Stryker | Powered pulsatile lavage | — | Ongoing MAUDE malfunction reports; InterPulse bioburden recall 2017 | [54][53] |
| Medline | Saline wound wash (private label); Sonoma distributor | — | Sterility-assurance recall 2026 | [53][63] |
| Danish wound-product suppliers (EU/DK row) | Tenderers/winners on Region Nordjylland joint wound tender CAN 705177-2025 include OneMed, Mediplast, Mediq Danmark, KCI Medical, Apodan, Smith & Nephew, Abena, Lohmann & Rauscher, Coloplast, Mölnlycke, Furine, B. Braun, ConvaTec, Essity | Award notice 2025-10-24 | Per-lot winners not mapped (see Gaps) | [65] |
EU/DK rows (prose; no connector):
Gaps: No US market-share, unit-volume or contract-price data for any cleanser. Irrimax, Innovacyn and Anacapa ownership/funding not searched. EUDAMED not searched. Danish tender award values not published in the fields retrieved (tender-value fields read "0").
| Question | Class (1 registry / 2 published / 3 stakeholder-future) | What would settle it | Reachable by? |
|---|---|---|---|
| How many professional wound cleansings/irrigations happen per wound per year in the US? | 2 | A US claims- or EHR (electronic health record)-based study of dressing-change or nurse-visit frequency by setting (none found); the UK THIN cohort [5] is the analog | Literature; or a human-attached licensed dataset |
| What share of cleansings use pressurized irrigation rather than soak/swab/spray? | 2 | A practice-observation or survey study reporting technique shares (Canadian survey [11] reports gauze soaking only) | Literature |
| What do hospitals, SNFs and agencies pay per litre of HOCl cleanser vs saline? | 2 (published contract price) | VA FSS V797D-50441 price list (GSA eLibrary/VA NAC catalog, returned 503 on 2026-10-04); Premier contract price (confidential) | Retry GSA/VA catalog; human ask to a GPO member |
| Would facilities pay a premium for a closed HOCl kit? | 3 | Not answerable. Twin researched: GPO (Premier 2020) and FSS (2019) contracts for Vashe exist [60][61]; Danish tender carries a dedicated HOCl irrigation lot [65]; one US incumbent's US revenue is $2.6M/yr [63] | — |
| Do clinicians believe HOCl beats saline? | 3 | Not answerable. Twin researched: guideline position [12]; utilization share in one burn centre 11.3% HOCl [38]; survey: 34% of Canadian nurses consider HOCl and NaOCl equally safe [11] | — |
| Does HOCl hold its labelled free chlorine when warmed to ~37 °C for a session? | 2 (bench) | Contract-lab FAC titration at 20/37 °C over 0-60 min in the bag material | Bench test (human-commissioned) |
| What do bag, tubing and nozzle materials do in contact with HOCl? | 1 (recall record) / 2 (bench) | Recall Z-2275-2026 shows stainless spring corrosion in an HOCl sprayer [51]; materials compatibility test | Bench test |
| Clinician inhaled Cl2/aerosol during HOCl irrigation at 4-15 psi? | 2 | An exposure-measurement study (none found); NaOCl surface-spray studies [48][49] are the nearest analog | Bench/field study |
| What tier would HOCl get if FR 2023-26209 is finalized? | 1 | Read the HOCl row of the proposed rule's antimicrobial table (connectors policy 2023-26209 --expect "hypochlorous") | Connector |
| Is there an FDA-approved drug application for HOCl or sodium hypochlorite? | 1 | openFDA drugsfda returned no application with an active ingredient matching HYPOCHLOR* on 2026-10-04 [67]; an absence result, not proof | Re-query; Drugs@FDA UI |
| FTO (freedom to operate): do claims of US 12,178,977 (warmed lavage), US 10,391,207 (irrigation fluid containment) or the Schultz family read on a three-nozzle shielded head with a warming bag? | 1 (status) + counsel | patent / patent-status done for status [66]; claim reading is counsel work | Counsel |
| Danish HOCl-lot award criteria and winner | 2 (published notice) | The full TED XML of 549630-2024 / 705177-2025 (WAF-blocked to automated fetch), or the EU-Supply tender documents | Human download |
| Do Danish home-care nurses irrigate chronic wounds at home? | 3 as phrased; twin is 2 | Twin: a Danish study or municipal statistic on wound-care visits in hjemmesygepleje (searched PubMed; none found) | Literature (Danish-language sources not searched) |
| Section | as_of | How it was gathered | Never checked |
|---|---|---|---|
| 1 Epidemiology | 2026-10-04 | connectors literature/literature-detail; procedures (CMS MUP data year 2024) | MEPS/NHAMCS; VA; commercial claims |
| 2 Care pathway | 2026-10-04 | literature; IWII PDF; eCFR | OASIS/MDS; staffing surveys |
| 3 User groups | 2026-10-04 | eCFR; policy article A54563 (via idea-023 claim 29); company PRs | Time-and-motion; PPE use data |
| 4 Clinical evidence | 2026-10-04 | literature-detail; PMC full text 8944418; IWII PDF; trials sweep (40 of 115) | NPIAP/WOCN/WHS/IWGDF texts; AHCPR text (blocked) |
| 5 Reference products | 2026-10-04 | clearance-summary; clearances; recalls; maude; literature; retailer and company pages | Contract prices; GUDID; FDA safety communications; Dakin's |
| 6 Reimbursement | 2026-10-04 | hcpcs; payment; rvu; procedures; eCFR full-text reads | OPPS Addendum B (not cached); state Medicaid; MS-DRG supply costs |
| 7 Technology | 2026-10-04 | clearances FRO since 2020; literature; patent | FQH/KYZ annual counts; on-site HOCl generators |
| 8 Market players | 2026-10-04 | SEC EDGAR 10-K; press releases; TED search API | Irrimax/Innovacyn/B. Braun filings; EUDAMED; licensed market reports |
What this dossier has never looked at: any primary US measurement of irrigation frequency or technique share; any contract price; Dakin's solution as a product; NPIAP/EPUAP, WOCN, WHS and IWGDF guideline text; FDA guidance documents and safety communications (fda.gov gated); EUDAMED; Danish-language municipal statistics and tender documents beyond TED API fields; veterinary use; pediatric wounds; CPT descriptors (licensed, never reproduced). Absence of scanning is not absence of change.
python3 -m connectors procedures <code> for 97597, 97598, 11042, 11043, 11045.
connectors recalls --product-code FRO.
connectors recalls: Z-1431-2026, Z-1435-2026, Z-1705-2025, Z-1706-2025, Z-0513-2024, Z-1049-2024, Z-0763-2017, Z-0191-2020, Z-0490-2019, Z-1246-2018, Z-2062-2015.
connectors maude --device-name: MW5160932 (Vashe); 3007120504-2026-00002, 3007120504-2024-00003 (Prontosan); MW5190883-MW5190890 (Irrisept); 50465556 (InterPulse); 25201143, 23989137, 0001526350-2026-00437 (Pulsavac); 3888144 (Zerowet). Counts since 2010-01-01: Prontosan 81, Irrisept 34, InterPulse 460, Pulsavac 283, Vashe 1, Zerowet 1, Puracyn/Microcyn/Anasept/Granudacyn none.
connectors clearances --product-code FRO --since 2020-01-01 (98 records) and --device-name Prontosan; IFUs via clearance-summary for K253665, K252023, K243875, K261023.
connectors clearance-summary: K123072, K131848, K093697, K232080, K251757, K090206, K172851, K233399, K142592, K243415, K073547, K072876, K110744, K161623, K080779, K240552, K210987, K974288, K201138, K951666 (claim-level detail on idea-023 claims 4-18, 60).
connectors hcpcs/payment; Medicare Coverage Database policy article A54563 (as read by the Verifier on idea-023 claim 29).
connectors rvu.
connectors patent / patent-status / patent-scan: US12178977B2 (and US2022118167A1, US20250082838A1); US10391207B2 (family of US2016095964A1); US2020069862A1 (abandoned 2024-09-09); WO2008040020A2 (US members abandoned); US9168318B2, US9642876B2, US10016455B2 (lapsed); US8834445B2, US9072726B2, US9782434B2 (in force); US10342825B2 (in force, record last exchanged 2023-01-07); US20250213505A1, US20250213542A1, US20250213777A1 (Irrimax).
products.active_ingredients.name:HYPOCHLOR*, 2026-10-04: NOT_FOUND (query syntax validated: CHLORHEXIDINE GLUCONATE returned 37).
_shared/plain-language.md