What happens when AI writes your IFU?

With all the recent news of DeepSeek emerging as a viable contender to ChatGPT, we took part in a fun thought experiment to see how these two models would handle the task of writing the IFU for a kerrison ronguer. Pasted below is the exact output that resulted, with some formatting edits. What are your thoughts?

Prompt

Please create an IFU document (instructions for use) for a kerrison rongeur which contains information about how to reprocess, clean, sterilize, maintain and store this reusable surgical instrument. This would be a document used by sterile processing departments in hospitals to safely and effectively reprocess the item for surgical use.

ChatGPT's Response

Here’s a professional draft for an Instructions for Use (IFU) document for the Kerrison Rongeur surgical instrument. This document is designed to meet the needs of sterile processing departments in hospitals:

Instructions for Use (IFU)

Micro Kerrison Detachable Rongeur (Small Handles, Thin Footplate, 9.0mm Opening)?

1.?Device Description

a.?The Micro Kerrison Detachable Rongeur is a reusable surgical instrument designed for precise bone removal in orthopedic and neurosurgical procedures. It features:

i. Detachable parts for thorough cleaning.

ii.?Small handles with a thin footplate.

iii.?A 9.0mm opening for precise cutting.

2.?Intended Use

a.?This instrument is intended for surgical procedures requiring bone cutting. It must be cleaned, disinfected, and sterilized before initial use and after each subsequent use.?

3.?Warnings and Precautions

a.?Inspect the instrument for damage or wear before each use.

b.?Do not use if components are bent, cracked, or otherwise compromised.

c.?Follow all cleaning and sterilization procedures as outlined.

d.?Avoid use of abrasive cleaning agents or tools that could damage the surface.

4.?Cleaning and Reprocessing Instructions?

a.?Point-of-Use Cleaning

i.?Immediately After Use: Remove gross contaminants with a damp, lint-free cloth or disposable wipe.

ii.?Avoid letting organic matter dry on the instrument.

iii.?Disassemble the instrument carefully according to the manufacturer’s instructions to expose all surfaces.?

b.?Preparation for Cleaning

i.?Fully disassemble the instrument.

ii.?Rinse each part under running lukewarm water (20°C to 45°C) to remove visible soil.

c.?Manual Cleaning

i.?Submerge all parts in a neutral pH enzymatic cleaning solution.

ii.?Use a soft-bristle brush to scrub all surfaces, paying close attention to crevices, joints, and openings.

iii.?Flush internal channels and moving parts using a syringe or water jet.

iv.?Rinse thoroughly under running distilled or deionized water for at least 2 minutes.?

d.?Automated Cleaning (Optional)

i.?Place disassembled parts in a washer-disinfector.

ii.?Use a validated cycle with an alkaline cleaning detergent.

iii.?Follow with a neutralizing rinse and a final rinse with deionized water.

5.?Inspection and Maintenance

a.?After cleaning, inspect the instrument under magnification for residual soil or damage.

b.?Check for smooth operation of moving parts and proper alignment of the cutting edges.

c.?Lubricate moving parts with a medical-grade instrument lubricant (e.g., water-soluble lubricant) before sterilization.?

6.?Sterilization

a.?Recommended Method

? i.?Sterilize the instrument using steam sterilization:

1.?Method: Pre-vacuum (dynamic air removal) autoclave.

2.?Temperature: 132°C to 135°C (270°F to 275°F).

3.?Exposure Time: 4 minutes.

4.?Drying Time: 20 minutes.

b.?Sterilization Preparation

i.?Ensure the instrument is completely dry before sterilization.

ii.?Place the disassembled parts into sterilization trays.

iii.?Wrap the tray in sterilization-compatible material or use sterilization pouches.?

7.?Storage

a.?Store the instrument in a clean, dry, and temperature-controlled environment.

b.?Avoid stacking heavy objects on top of the instrument to prevent deformation.

c.?Reassemble the instrument only when ready for surgical use.

8.?Troubleshooting?

a.?Issue Cause Solution

i.?Difficult to disassemble

1.?Improper cleaning or wear

2.?Clean thoroughly; replace worn components.

ii.?Sticking moving parts

1.?Lack of lubrication or debris

2.?Lubricate; re-clean and inspect.

iii.?Cutting inefficiency

1.?Blunt or damaged cutting edges

2.?Inspect; replace as necessary.?

9.?Disposal

a.?Dispose of the instrument in accordance with local regulations if it becomes irreparably damaged or worn.

DeepSeek's Response

Instructions for Use (IFU) Micro Kerrison Detachable Rongeur Small Handles, Thin Footplate, 9.0 mm Opening

This document provides detailed instructions for the safe and effective reprocessing, cleaning, sterilization, maintenance, and storage of the Micro Kerrison Detachable Rongeur. These instructions are intended for use by sterile processing departments (SPD) in healthcare facilities to ensure the device is properly prepared for reuse in surgical procedures.

1.?General Information

a.?Device Description: The Micro Kerrison Detachable Rongeur is a reusable surgical instrument designed for precise bone and tissue removal during neurosurgical, orthopedic, and spinal procedures. It features small handles, a thin footplate, and a 9.0 mm opening.

b.?Intended Use: For cutting and removing bone or tissue during surgical procedures.

c.?Material: High-quality stainless steel, designed for repeated reprocessing and sterilization.

d.?Reprocessing: The device is reusable and must be thoroughly cleaned, disinfected, and sterilized after each use.

2.?Safety Information

a.?Always wear appropriate personal protective equipment (PPE) during reprocessing, including gloves, gowns, masks, and eye protection.

b.?Inspect the instrument before and after each use for damage, wear, or malfunction. Do not use if defects are found.

c.?Follow local, national, and international guidelines for reprocessing reusable surgical instruments.

3.?Reprocessing Instructions

a.?Point-of-Use Pre-Cleaning

i.?Immediately after use, remove gross soil and debris from the instrument using a sterile water-moistened sponge or cloth.

ii.?Keep the instrument moist to prevent drying of biological material. Use a enzymatic or neutral pH detergent solution if available.

iii.?Transport the instrument to the decontamination area in a closed, leak-proof container to prevent exposure to staff and the environment.

b.?Manual Cleaning

i.?Disassembly: Detach the rongeur handles and footplate according to the manufacturer’s instructions. Ensure all components are separated for thorough cleaning.

ii.?Pre-Rinse: Rinse all parts under lukewarm water (≤ 45°C/113°F) to remove residual debris.

iii.?Cleaning:

1.?Immerse the instrument in a validated enzymatic or neutral pH detergent solution.

2.?Use a soft-bristle brush to clean all surfaces, including serrations, hinges, and hard-to-reach areas.

3.?Pay special attention to the jaws and cutting edges to ensure all biological material is removed.

iv.?Rinse: Thoroughly rinse all parts with purified water to remove detergent residues.

v.?Inspection: Visually inspect the instrument under magnification to ensure all soil and debris have been removed. Repeat cleaning if necessary.

c.?Automated Cleaning (if applicable)

i.?Use a validated medical-grade washer-disinfector.

ii.?Load the instrument according to the manufacturer’s instructions, ensuring all parts are exposed to the cleaning solution.

iii.?Select a cycle that includes a thermal disinfection phase (≥ 93°C/199°F for 10 minutes).

iv.?After the cycle, inspect the instrument for cleanliness and functionality.

4.?Sterilization

a.?Preparation:

i.?Ensure the instrument is completely dry before sterilization.

ii.?Reassemble the rongeur according to the manufacturer’s instructions.

iii.?Place the instrument in a sterilization tray or container designed for surgical instruments.

b.?Sterilization Method:

i.?Steam Sterilization (Preferred Method):

1.?Cycle: Pre-vacuum or gravity displacement.

2.?Temperature: 132°C–135°C (270°F–275°F).

3.?Exposure Time: 4 minutes (pre-vacuum) or 15 minutes (gravity displacement).

4.?Dry Time: Ensure adequate drying to prevent moisture-related issues.

ii.?Alternative Methods: If steam sterilization is not available, follow validated instructions for low-temperature sterilization methods (e.g., ethylene oxide, hydrogen peroxide plasma).

c.?Sterility Maintenance: Store the sterilized instrument in a closed, sterile container until use.

5.?Maintenance

a.?Lubrication:

i.?Apply a water-soluble, medical-grade lubricant to the hinges and moving parts after cleaning and before sterilization.

ii.?Avoid excessive lubrication, as it can interfere with sterilization.

b.?Inspection:

i.?Regularly inspect the instrument for signs of wear, corrosion, or damage, such as loose parts, dull cutting edges, or misalignment.

ii.?Remove damaged instruments from service and contact the manufacturer for repair or replacement.

6.?Storage

a.?Store the instrument in a clean, dry, and temperature-controlled environment.

b.?Use a designated storage area to protect the instrument from physical damage and contamination.

c.?Ensure the instrument is stored in a manner that prevents stress on the hinges and cutting edges.

7.?Troubleshooting

a.?Stiff or Stuck Mechanism: Clean and lubricate the hinges. If the issue persists, discontinue use and contact the manufacturer.

b.?Dull Cutting Edges: Do not attempt to sharpen the instrument. Contact the manufacturer for evaluation and repair.

c.?Corrosion or Discoloration: Ensure proper cleaning and drying procedures are followed. If corrosion is present, discontinue use.

Note: This IFU is intended as a general guide. Always follow the specific reprocessing protocols and guidelines established by your healthcare facility and regulatory authorities.