FDA 510(k) Cleared 99% of Flexible Scopes Terminal Sterilization On-site Solution

SteroScope® Answers the FDA Call to Solve Endoscope Safety Issues

The FDA has repeatedly issued safety communications warning that high-level disinfection cannot ensure the elimination of all microorganisms in flexible endoscopes.

Despite process improvements, patient outbreaks and exposures continue, even though regulatory standards such as AAMI ST91 now emphasizes sterilization whenever feasible.

Ideate Medical answers that call with a validated, low-temperature solution that transforms reprocessing into a consistent standard of care, with terminal sterilization for immediate patient-ready scopes.

“The margin of safety associated with reprocessing endoscopes is minimal. Endoscopes are heavily contaminated with microbes. The internal channel of gastrointestinal endoscopes may contain 10⁸–10¹⁰ enteric microorganisms.”

- JAMA “A Need to Shift from Disinfection to Sterilization”

William A. Rutala, PhD, MPH

Professor, UNC School of Medicine

Science of Contamination

Even after cleaning and high-level disinfection, complex endoscope channels often retain active microscopic bioburden that persists.

Studies confirm that residual organic matter and biofilm protect harmful microorganisms from disinfectants. SteroScope changes this equation with true terminal sterilization that penetrates and deactivates bioburden, protecting patients.

Comparative solutions today reveal a persistent challenge in achieving endoscope sterility. In addition, Low-Temp Vaporized Hydrogen Peroxide sterilization is simply not viable for 87% of flexible endoscopes due to its limitations

Hospitals continue to rely on traditional ETO sterilization, High-Level Disinfection (HLD), and single-use scopes with significant drawbacks. For example, ETO adds cost with delays and exposure to staff, while HLD leaves residual microbial risk. At the same time, single-use options are expensive, less functional, and wasteful.

Patient Safety & Clinical Excellence

Patient Safety & Clinical Excellence

SteroScope replaces disinfection with validated terminal sterilization, proven 1 million times more effective at eliminating microorganisms.

By removing human error and variability, it delivers consistent sterility assurance for patient-ready scopes, protecting patients with reduced infection risk to create a new standard of clinical excellence.

Operational Efficiency & Simplification

Operational Efficiency & Simplification

We simplify endoscope reprocessing by eliminating drying times, requiring zero plumbing, and delivering a 6-month sterile shelf life for the flexible scopes.

The SteroScope system eliminates drying cabinets, rinse steps, water filter maintenance, disinfection of AERs, HLD minimum effective concentration testing, and weekly reprocessing. This results in freeing staff time, reducing errors, and maximizing the safety of ready-to-use scopes.

Financial & Resource Optimization

Financial & Resource Optimization

SteroScope empowers health systems to achieve measurable savings while improving care delivery.

We eliminate significant facility and ancillary capital equipment costs and lower per-cycle processing costs. This allows hospitals to reduce capital waste, cut labor expenses, and strengthen financial performance without compromising patient safety.

FDA Compliance & Environmental (31)

FDA Compliance & Environmental (31)

We ensure FDA compliance and demonstrate true leadership in infection prevention excellence.

Our FDA-cleared and fully validated SteroScope aligns with CDC guidance on sterilizing rather than disinfecting. Its low-temperature, closed process produces no hazardous waste or water use, reinforcing environmental stewardship.