Less binder.
More patient.

We replace paper reprocessing binders with a guided digital workflow designed for how your team actually works. No hardware. No IT department. Built right here in New Jersey.

For Customers · Try the Demo · What's Your Exposure? · For Investors

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IN DEVELOPMENT
scopeguard.health

📋 The reality today

Modernize and automate your compliance workflow.

Every GI center documents a multi-step reprocessing workflow by hand — every scope, every cycle, every day. It works until it doesn't. And when it doesn't, the consequences fall on the administrator.

📋

Missed steps

A leak test gets checked off before it was run. A scope hits its cycle limit and no one notices.

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Documentation gaps

The AER printout ends up in the wrong folder. Patient-scope linkage gets lost between binders.

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Survey surprises

Four hours to pull 90 days of records when a surveyor arrives — and no guarantee they're complete.

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Ongoing updates

Regulations and manufacturer IFUs change constantly — but the process on the floor rarely gets updated to match.

⚠ Recent public incidents — anonymized

This isn't a historical problem. These are recent incidents.

6,400

Patients notified by a federal medical center after a wrong scope connector went undetected for five years. Public report · 2024

2,200

Patients notified by a regional medical center after infection control gaps were identified in endoscopy — some dating back two years. Public report · 2024

Top-10 AMC

Suspended a GI endoscopy physician after inappropriate scope handling — at a major academic medical center, just months ago. Public report · Late 2024

Facility names omitted intentionally. All incidents drawn from publicly reported events within the past 18 months.

📈 What's changed

The pressure is increasing, not decreasing.

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AAMI ST91:2021

Tightened storage and documentation standards. Many centers don't realize their current protocols are non-compliant until a surveyor cites them.

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CMS expansion

Expanded ASC procedure list and launched New Jersey prior authorization requirements in December 2025.

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NJ Healthcare Finance Act

June 2025 law pulled single-room practices into annual assessments starting this year.

Cadence is rising. 2024–2025 is the peak.

FDA safety communications, CDC guidance, AAMI revisions, and accreditor bulletins are arriving faster than independent centers can absorb them.

Reprocessing-related regulatory updates per year

📐 A quick self-check

How exposed is your facility — and what could it cost?

Answer four quick questions for an exposure score, then estimate the dollar impact. Both use industry-published averages. Neither is a quote, an assessment, or a diagnosis — just a starting point.

Step 1 · Exposure quiz

Tell us about your facility.

Question 1 of 4

How many endoscopy suites does your facility operate?

Question 2 of 4

When was your last AAAHC or Joint Commission survey?

Question 3 of 4

Has your facility received a reprocessing or infection control deficiency in the past?

Question 4 of 4

How confident are you that you could produce 90 days of cycle records in under an hour?

Estimated compliance exposure—

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Survey citation probability

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Notification cost band

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Patients per undoc. cycle

Step 2 · Cost estimate

What could noncompliance cost?

Procedures per week

1045 / week120

Documentation method today

$186,000

Estimated breach notification cost if a reprocessing failure occurs

5.4 hrs

Staff hours lost to documentation per week

🛠 Here's what we're building

Built for independent facilities, not just hospital systems.

Enterprise compliance software is built for 400-bed sterile processing departments. ScopeGuard is built for your facility — 3 to 20 scopes, a small team, a binder on the counter.

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Guided reprocessing checklist

Your tech confirms each step on their phone. Timestamps are automatic. The AER machine log imports itself when the cycle finishes — no more printouts in the tray.

✅

One-click survey export

AAAHC, Joint Commission, or CMS formats — generated in seconds. 90 days of reprocessing records, AER data, and patient-scope linkage ready for surveyors instantly.

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Device and regulatory intelligence

Manufacturer IFU updates for your specific scopes, AAMI ST91 revisions, FDA safety communications, and state requirements — surfaced automatically so you're never surprised.

✓
Cycle documentation that maps to AAMI ST91:2021 §10.Every cycle traceable to scope serial, technician, AER, chemistry, MEC test result, leak test result — the fields surveyors actually request.
✓
Manufacturer reference library maintained by ScopeGuard.Olympus 180/190 series, Pentax 90i/i10 series, Fujifilm 700 series, and the AERs and chemistries that pair with them — selected from a library rather than configured from scratch.
✓
IFU update propagation with audit trail.When manufacturer guidance changes, your facility's documentation reflects it — and you have proof of when and how.

🖥 The prototype

Click through the prototype.

A live, access-gated walkthrough of the working product. Enter your access code in the window to explore. Open full screen ↗

app.scopeguard.health

🤝 For the New Jersey ASC community

We're grateful for the chance to introduce ourselves to the independent ASC community in New Jersey.

If you run a GI center or know someone who does, we'd love to hear from you. We're launching in New Jersey first — because this is our home market, our regulatory environment, and the community we want to serve.

Pilot partnership opportunities for the first 5 New Jersey centers
Free 90-day trial with full onboarding and clinical support
Direct input on product development from founding-stage pilots
Clinical advisory board seats available for interested administrators

✉ Get in touch

Let's talk about your facility.

Whether you're an administrator, nurse manager, infection preventionist, or industry contact — we'd like to hear from you. We reply personally, usually within two business days.

📧 hello@scopeguard.health
📍 New Jersey · USA

Name

Facility / organization

I'd like to discuss

Message (optional)

Responses typically within 2 business days

Thank you.

Your email client should now be open with your message ready to send. If it didn't open, please email us directly at hello@scopeguard.health.

AAAHCAccreditation Association for Ambulatory Health Care. The most common ASC accreditor in the US. Standard 5.II covers infection prevention & control.
AAMIAssociation for the Advancement of Medical Instrumentation. Sets the technical standard (ST91) for endoscope reprocessing. Not a regulator, but the standard surveyors cite.
AERAutomated Endoscope Reprocessor. The machine that performs high-level disinfection on flexible endoscopes after manual cleaning.
ASCAmbulatory Surgery Center. An outpatient facility where same-day surgical procedures are performed. ScopeGuard's core focus.
CMSCenters for Medicare & Medicaid Services. The federal agency that sets Conditions for Coverage (42 CFR 416 for ASCs). Non-compliance threatens Medicare participation.
EGDEsophagogastroduodenoscopy. An upper endoscopy procedure examining esophagus, stomach, and duodenum.
FDAU.S. Food and Drug Administration. Regulates medical devices including endoscopes; issues safety communications when reprocessing failures cause harm.
GIGastroenterology / gastrointestinal. The medical specialty performing colonoscopies, upper endoscopies, and related procedures.
HLDHigh-level disinfection. The standard reprocessing method for most flexible endoscopes; not equivalent to sterilization.
IFUInstructions For Use. The manufacturer-published reprocessing protocol for a specific scope, AER, or chemistry. Surveyors verify facilities follow the current IFU.
MECMinimum Effective Concentration. The lowest concentration of high-level disinfectant that still meets the manufacturer's efficacy claims. Verified per cycle with a test strip.
NJAASCNew Jersey Association of Ambulatory Surgery Centers. The state body representing nearly every independent ASC administrator in NJ.
PHIProtected Health Information. Patient data covered under HIPAA. Reprocessing data is largely operational but still requires HIPAA-aligned handling.
SOC 2A widely-recognized security and privacy controls framework. Type I attests to the design of controls; Type II attests to their operating effectiveness over time.
ST91The AAMI standard for flexible endoscope reprocessing. ST91:2021 is the current version; it added storage and documentation requirements that many facilities haven't yet operationalized.
TJCThe Joint Commission. The other major ASC accreditor (more common in hospital-affiliated centers). Equivalent infection control chapter to AAAHC.

~19 million GI endoscopic procedures annually in the US Multiple sources, including Stony Brook visualization framework analysis (~14M colonoscopies/year) and additional ~5M upper endoscopies. Cross-referenced with NIDDK Burden of Digestive Diseases reports. NIDDK
8+ reprocessing-related regulatory updates in 2025; cadence accelerating across 2024–2025 Aggregated count of reprocessing-related FDA safety communications and early alerts, CDC Guideline for Disinfection and Sterilization updates (2024), AAMI standard revisions, and accreditor bulletins (AAAHC, TJC). Headline milestones include the SHEA/ASGE multisociety guidance partnered with seven professional bodies, Infection Control & Hospital Epidemiology, April 28, 2025.
AAMI ST91:2021 adds $52–$68 + 24.3 minutes per cycle; capital-amortized cost reaches ~$400/cycle at low-volume facilities vs. ~$77/cycle at high-volume Hoffman D, Cool C. "Costs involved in compliance with new endoscope reprocessing guidelines." Clinical Endoscopy, 2024;57(4):534-541. e-ce.org · DOI: 10.5946/ce.2023.164
65% of facilities are non-compliant with current reprocessing guidelines Joint Commission Perspectives, "Full-year 2019 top standards noncompliance data," 2020. The Joint Commission found 65.58% of hospitals noncompliant in reducing the risk of infections associated with medical equipment. Cited in Hoffman/Cool 2024.
125% increase in FDA infection-control reports for reusable endoscopes between 2019 and 2021 FDA MAUDE database (Manufacturer and User Facility Device Experience), as cited in Hoffman/Cool 2024.
19M new screening-eligible patients since 2021 United States Preventive Services Task Force (USPSTF) 2021 recommendation lowering colorectal cancer screening initiation age from 50 to 45, expanding eligible population by ~19 million adults.
21% projected ASC volume growth by 2034 CMS National Health Expenditure projections and industry analyst forecasts; Ambulatory Surgery Center Association (ASCA) industry reports.
Recent public incidents — patient notifications and physician suspension Public reports drawn from US Department of Veterans Affairs Office of Inspector General reports, state health department public notices, and academic medical center press releases. Facility names omitted in deference to anonymized public-record context.

Less binder.More patient.

Modernize and automate your compliance workflow.

This isn't a historical problem. These are recent incidents.

The pressure is increasing, not decreasing.

How exposed is your facility — and what could it cost?

Built for independent facilities, not just hospital systems.

Click through the prototype.

We're grateful for the chance to introduce ourselves to the independent ASC community in New Jersey.

Let's talk about your facility.

Thank you.

The standards

How ScopeGuard maps to the standards

About this page

The ROI calculator and risk questions

Privacy notice (contact form)

Trademark & attribution

Regulatory disclaimer

Less binder.
More patient.