News Release

FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities“The FDA has identified evidence that duodenoscopes have contributed to the transmission of infections, including antibiotic resistant infections, to patients. Duodenoscopes undergo a multi-step cleaning and high-level disinfection procedure called reprocessing so the medical devices can be reused between patients. The complex design of the devices makes it difficult to remove contaminants compared to other types of endoscopes. The FDA’s analysis to date also indicates that manufacturer’s reprocessing instructions are not always being followed correctly, as these instructions are labor intensive and prone to human error.” 

Safety Results Using RVA

Healthcare

OR

ICUED

Endo

95%+

99%+

90%+ 100%

90%-100%

Surgical Safety Checklist Compliance – 3+ years with no wrong site surgeries

Overnight Terminal Cleaning & In-Between Case Cleaning Compliance – 10% reduction in surgical site infectionsScope Reprocessing ComplianceHand Hygiene ComplianceLevel II PPE Preparedness Compliance

Red Meat

RTE Foods

Bio-Security

FoodManufacturing

99%+ 99%+

100%

Sanitation Practices Compliance – 60% reduction in E. Coli

X-Ray Tech Services Compliance to Prevent Foreign Objects

Product Transportation Compliance – 10+ years with no security breaches

Ensuring Proper Manual Reprocessing Compliance for Duodenoscopes and Other Upper & Lower Scopes3rd Party Remote Video Auditing (RVA)Arrowsight, the leading developer of Remote Video Auditing (RVA) technology and services, provides a platform of patient safety and efficiency services to hospital and ASC surgical suites across the U.S. In response to FDA and CMS directives to scope manufacturers and health care providers to improve scope reprocessing compliance, Arrowsight has leveraged RVA solutions that are widely used in both food manufacturing and healthcare to significantly improve food safety and patient safety.

RVA Results

RVA Scope Solution Using high resolution pan-tilt-zoom cameras, near real-time RVA is performed throughout the day to identify and audit the explicit multi-step duodenoscope reprocessing protocols. If process steps are missed or performed inadequately, near real-time alerts are sent to wifi-enabled mobile devices informing the reprocessing team to take corrective action prior to the scope being used on another patient. In addition to auditing all duodenoscopes, RVA can be performed on a sampled basis for all other types of scopes being reprocessed (see page 2 for the full RVA workflow details).

RVA Review of Multi-Step Reprocessing(Examples of major steps)

Daily summary reports & text alerts

REPORT

Swab TestElevator Left in CenterShort BrushLong Brush

3rd Party RVA Services for Duodenoscope and Other Upper & Lower Scope Reprocessing R

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tion For more information

Dr. Brian SchurginChief Medical OfficerPhone: (847) 226-5618brian.schurgin@arrowsight.com

• High resolution pan-tilt-zoom cameras installed above the reprocessing sink• RVA performed once every 15 minutes to identify when any scopes are being reprocessed• Hospital reprocessing staff provide visual aid when duodenoscopes are being reprocessed• RVA performed on all steps of duodenoscope reprocessing, including the detailed cleaning of both sides of the elevator by

the long & short brushes, ensuring the elevator is left in the center position and that the swab test is performed and confirmed

• Near real-time email alerts sent to reprocessing staff and endo manager if duodenoscope reprocessing steps are missed or performed inadequately

• Daily performance reports sent to managers• Other upper and lower scopes are audited in near real-time on a sampled basis