Endoscope Reprocessing Instructions Why Unclear IFUs Are Risky and How to Make Them Workable

Every reusable endoscope comes with manufacturer instructions for use (IFU) that spell out how to clean, disinfect or sterilize, dry and store it. When those instructions are long, hard to follow, or hard to find at the sink, steps can be missed or done out of order. That puts patients at risk and wears on staff and equipment. The U.S. Food and Drug Administration and CDC both stress following the manufacturer's reprocessing instructions (FDA (opens in a new tab); CDC (opens in a new tab)). The fix is rarely "try harder." It's turning each IFU into clear, step-by-step work that's guided and recorded.

What reprocessing instructions are, and why they're hard

FDA expects manufacturers of reusable devices to provide validated reprocessing instructions in the labeling (FDA guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (opens in a new tab)). For a flexible endoscope, that usually means pre-cleaning, leak testing, manual cleaning of each channel, rinsing, high-level disinfection or sterilization, drying and storage, each with specific products, times and accessories.

Real-world reasons IFUs are hard to follow:

• Every model is different. A department with several scope types, brands and generations may be working from many IFUs at once.
• They're long and technical. Key steps can be buried in dense documents.
• They change. Manufacturers update instructions, and the copy at the sink may be out of date.
• They don't match the room. Instructions may name a brush, detergent or equipment the department doesn't use.
• The pace is fast. Busy days push staff to work from memory.

What can go wrong

Risk to patients

Endoscopes have long, narrow channels and complex parts. If cleaning or disinfection is incomplete, contamination can remain and be passed to the next patient. FDA has publicly described infections associated with reprocessed duodenoscopes and the role of following reprocessing instructions (FDA, Infections Associated with Reprocessed Duodenoscopes (opens in a new tab)).

Damage to scopes

Using the wrong chemical, the wrong brush, or skipping a leak test can damage delicate parts, leading to repairs, loaners and scopes out of service.

Workflow disruption

Unclear steps lead to repeat processing, staff stopping to look things up, scopes not ready for the next case, and schedule delays.

Gaps in the record

If a step isn't documented, it's hard to show it was done, whether for an audit, a manufacturer notice, or a patient lookback.

What public guidance recommends

Public guidance points to a program, not just a document:

• Follow the manufacturer's IFU for each device model.
• Train staff and check competency on each device type, at hire and on a regular schedule (CDC/HICPAC Essential Elements).
• Keep the IFU current and easy to reach where the work happens.
• Document each step and who performed it.
• Use national standards such as AAMI ST91 (flexible and semi-rigid endoscope processing) and SGNA's standards for GI reprocessing to build your program.

Your infection prevention team sets how these apply in your facility.

Turning IFUs into steps staff can actually follow

1. Inventory your fleet. List every scope model and the current IFU version for each.
2. Break each IFU into steps. Turn dense text into a numbered checklist per model, approved by infection prevention.
3. Put the right steps in front of staff. Show the steps for this scope at the sink, not a binder for every scope.
4. Record as you go. Capture each step, the person and the time when it's done.
5. Check competency by device. Make sure each person is trained and current on the models they process.
6. Watch for updates. When an IFU changes, update the checklist and retrain.
7. Review the records. Look for skipped steps, repeat processing and repair trends, and fix the cause.

Signs your IFU process needs attention

You don't need an audit finding to know something's off. Watch for these everyday signals:

• Staff ask each other how to do a step instead of checking the instructions.
• The IFU at the sink is a printout nobody can date, or a binder covering every model at once.
• The same scope keeps going out for repair, especially for damage that cleaning could cause.
• Scopes get reprocessed twice because someone wasn't sure a step was done.
• New scope models arrive before checklists and training are updated.
• Records are filled in at the end of the shift, from memory.
• Competency records live somewhere else, and no one is sure who's current on which model.

Each of these points to the same gap: the instructions exist, but they aren't turned into clear, current steps that are followed and recorded at the moment of work. That's fixable, and it's usually a process and tooling problem, not a people problem. Start with the model your team processes most, rebuild its checklist with infection prevention, and expand from there.

How ScopeCycle^® helps

ScopeCycle^® is NewCura's cloud software for endoscope tracking and reprocessing documentation. It's built for exactly this job:

• Guided reprocessing workflows, configured to your facility's policies and procedures and to manufacturer instructions
• A record of every step, with the user and time
• Scope history in minutes for audits and lookbacks
• Staff competency records kept alongside the work
• Task management for preventive maintenance and recurring chores
• Reports on reprocessing history, repairs, loaners and utilization

ScopeCycle^® assists with compliance with SGNA, CDC and multi-society guidelines by guiding each step and keeping the record. It works on its own and connects to EndoManager^® EMS for automatic exam and scope data.

About NewCura

NewCura has built endoscopy software since 1999 and supports more than 500 facilities, with a global presence. Call 866.578.5713. Real people answer 24/7/365.

Frequently asked questions

What is an endoscope IFU?

The manufacturer's instructions for use. For reprocessing, it spells out how to clean, disinfect or sterilize, dry and store that specific model.

Who is responsible for reprocessing instructions?

Manufacturers provide validated instructions in the device labeling, as FDA expects. Facilities are responsible for following them and building a program around them.

Why are endoscopes hard to reprocess?

They have long, narrow channels and complex parts, and each model has its own steps.

How often should reprocessing staff be checked for competency?

CDC's reprocessing guidance recommends competency checks at hire and on a regular schedule for each device type. Your facility sets the interval.

What standards apply to endoscope reprocessing in the U.S.?

Commonly referenced sources include the manufacturer's IFU, AAMI ST91, CDC/HICPAC's Essential Elements, SGNA standards and the multi-society reprocessing guideline.

Can software replace the IFU?

No. Software like ScopeCycle^® puts IFU-based steps in front of staff and records them. The IFU and your facility's policy stay the source.

Related: ScopeCycle^® · Endoscope tracking guide · Pricing and demo

EndoManager^® and ScopeCycle^® are registered trademarks of Summit Imaging, Inc. d/b/a NewCura. AAMI is a trademark of the Association for the Advancement of Medical Instrumentation. Other names are the property of their owners.