Max hang-time for dried flexible endoscopes reduced from 72 hours to 60 hours without reprocessing trigger. Your current storage protocol references 72 hours and is now non-compliant. ScopeGuard has automatically updated the storage step timer. You must update your written protocol to match.
What changed in your workflow: Step 7 (Storage assignment) now triggers an alert at 60 hours rather than 72 hours. No action needed in the platform — already updated.
📋
FDA · February 14, 2026
Safety Communication — Olympus CF series IFU update
Affects: CF-001, CF-002, CF-003, CF-004, CF-005
Review IFU
FDA issued updated instructions for use (IFU) for Olympus CF-HQ series endoscopes manufactured after January 2023. Section 4.2 (channel brushing sequence) has been revised. Your CF-001 and CF-002 are post-2022 manufacture — confirm IFU version on file matches current FDA guidance.
Scope serial numbers affected: OLY-CF001-2022-4471, OLY-CF002-2022-1882. Verify IFU revision date is Jan 2026 or later.
✓
CMS · January 3, 2026
CoPs Q1 2026 — No reprocessing documentation changes
Acknowledged by J. Martinez · Jan 5, 2026 at 9:14am
Acknowledged ✓
Workflow update history
ScopeGuard automatically updates your workflow when standards change. These changes are logged here.
Step 7 storage timer — updated Mar 29, 2026
Alert threshold changed from 72 hrs to 60 hrs following AAMI ST91 Section 6.4 amendment. Your workflow now compliant with March 2026 standard.
Step 2 brushing note — updated Feb 15, 2026
Channel brushing sequence note updated following FDA Olympus CF IFU revision. Step 2 now references IFU §4.2 Rev. Jan 2026.
AAAHC export template — updated Jan 8, 2026
AAAHC revised Section 9 documentation format for ASC surveys effective Q1 2026. Export template updated to match new surveyor review structure.
State requirements
NJ update
Federal standards (AAMI, CMS) are the floor. Your state may have additional requirements on top. ScopeGuard tracks both.
New Jersey
Updated Jun 2025
Healthcare Finance Enhancement Act (AB 5809) significantly expanded ASC assessment obligations. Key changes affecting your facility:
Annual assessment now applies to your facility — previously exempt as a single-specialty GI center.
Assessment rate restructured — review your tier classification with your healthcare attorney.
Documentation requirements for assessment filing overlap with ScopeGuard's existing reprocessing records — your current exports satisfy the new documentation standard.
Pennsylvania
Current
No CON laws. Department of Health ASC licensure requires annual infection control documentation. ScopeGuard's standard 90-day export satisfies PA DOH requirements.
PA DOH Annual Survey: reprocessing logs for 12 months required on request.
ScopeGuard full-year export available under Audit → Date range → Full year 2026.
Maryland
Current
Highest ASC density per Medicare beneficiary nationally. OHCQ inspection framework requires endoscope reprocessing log availability within 24 hours of request.
ScopeGuard's one-click export satisfies the OHCQ 24-hour production requirement.
FDA adverse event monitor
1 flagged
ScopeGuard monitors the FDA MAUDE adverse event database for reports involving scope models in your inventory. You are alerted when a report is relevant to your equipment.
Olympus CF-HQ190L
Matches: CF-001, CF-002, CF-003, CF-004, CF-005
Review IFU
MDR #2026-0022847 filed Feb 2026. Event type: inadequate reprocessing associated with channel brushing step. Report indicates IFU §4.2 was not followed for post-2023 manufacture date units.
→ Confirm IFU §4.2 Rev. Jan 2026 is on file for all CF-HQ series scopes
Pentax EC-3490Li
Matches: CF-004
No issues
No adverse event reports in MAUDE database for this model in the past 12 months relevant to reprocessing.
Olympus GIF-H290
Matches: EGD-001, EGD-002
No issues
No adverse event reports in MAUDE database for this model in the past 12 months relevant to reprocessing.
Peer benchmarks
NJ · AAAHC · 5–10 scopes
Anonymous aggregated data from ScopeGuard facilities matching your profile: NJ, AAAHC-accredited, 5–10 active scopes, GI endoscopy.
99.5%
Your 9-step completion rate
↑ Top 15% of peers
94.2%
Peer avg completion rate
NJ · AAAHC · similar size
0.35%
Your incident rate
↑ Below peer avg (0.61%)
87
Your compliance score
Peer avg: 82 · Top 10%: 95+
Garden State Endoscopy ranks in the top 20% of similar NJ facilities for reprocessing compliance. 2 gaps remain — resolving CF-003 maintenance and protocol currency would place you in the top 10%.