Decoding Medical Device Symbols: A Guide for Sterile Processing Professionals

 

By Martin Li, MA, CRCST, CER, CIS, CHL

Figure 1The symbols above are standardized according to ISO 15223-1, a critical guideline for labeling medical devices.

Introduction

In the fast-paced and critical environment of Sterile Processing Services (SPS), understanding the symbols and labels on medical devices is crucial. These symbols, standardized by ISO 15223-1, provide essential information about medical device handling, usage, and restrictions. As Sterile Processing Technicians (SPTs), it's imperative to be familiar with these symbols to ensure the proper processing and safe use of medical devices.

Key Symbols and Their Meanings

Let's break down some of the key symbols found on medical devices, as illustrated in the above-provided symbols glossary.

1. Consult the Electronic Instructions for Use (eIFU)
• Symbol:
  
  
  
• Description: This symbol directs you to consult the electronic instructions for use at the provided website. Understanding and following these instructions are crucial for ensuring that the device is used correctly and safely.
• ISO 15223-1 Reference: 5.4.3
2. Caution
• Symbol:
  
  
  
• Description: This symbol indicates that special care should be taken when handling the device. It often accompanies important warnings or precautions that must be observed to avoid potential hazards.
• ISO 15223-1 Reference: 5.4.4
3. Non-Sterile
• Symbol:
  
  
  
• Description: This symbol indicates that the device is not sterile. It should be sterilized according to the manufacturer’s instructions before use to ensure patient safety.
• ISO 15223-1 Reference: 5.2.7
4. Use-By Date
• Symbol:
  
  
  
• Description: This symbol shows the expiration date of the device. A device past this date may compromise its integrity or effectiveness, so adhering to this timeline is essential.
• ISO 15223-1 Reference: 5.1.4
5. Catalog Number
• Symbol:
  
  
  
• Description: This symbol indicates the product’s catalog number, which is useful for inventory management and ordering purposes.
• ISO 15223-1 Reference: 5.1.6
6. Batch Code
• Symbol:
  
  
  
• Description: The batch code symbol helps track the specific batch of a product, which is essential for traceability in case of recalls or quality issues.
• ISO 15223-1 Reference: 5.1.5
7. Authorized Representative in the European Community/European Union
• Symbol:
  
  
  
• Description: This symbol identifies the authorized representative for the device within the EU, ensuring compliance with European regulations.
• ISO 15223-1 Reference: 5.1.2
8. Medical Device
• Symbol:
  
  
  
• Description: This symbol designates that the item is a medical device, helping distinguish it from other types of equipment or supplies.
• ISO 15223-1 Reference: 5.7.7
9. Manufacturer
• Symbol:
  
  
  
• Description: Indicates the device's manufacturer, which is important information for traceability and contacting the manufacturer if needed.
• ISO 15223-1 Reference: 5.1.1
10. Date of Manufacture
• Symbol:
  
  
  
• Description: This symbol provides the date when the device was manufactured, which is critical for assessing the product's shelf life.
• ISO 15223-1 Reference: 5.1.3
11. Do Not Re-use
• Symbol:
  
  
  
• Description: This symbol clearly states that the device is intended for single use only. Reusing it could lead to contamination or device failure.
• ISO 15223-1 Reference: 5.4.2
12. Package Integrity
• Symbol:
  
  
  
• Description: This symbol warns against using the device if the packaging is damaged, as this could compromise its sterility.
• ISO 15223-1 Reference: 5.2.8
13. Rx Only
• Symbol:
  
  
  
• Description: This indicates that the device is restricted to use by or on the order of a licensed practitioner, in compliance with U.S. federal law.
• Regulation Reference: U.S. 21 CFR 801.109
14. Registered Trademark
• Symbol:
  
  
  
• Description: Indicates that the reticle is a registered trademark of Acumed and may appear alone or with the Acumed name.
15. CE Mark
• Symbol:
  
  
  
• Description: This mark shows that the device complies with the essential requirements of the EU Medical Device Directive, ensuring it meets safety and performance standards.
• Reference: Article 17 of EU Directive 93/42/EEC

Why These Symbols Matter

For SPTs, recognizing and understanding these symbols is vital. These symbols provide immediate, at-a-glance information that ensures devices are handled correctly, processed appropriately, and stored safely. Failure to adhere to these guidelines can lead to serious consequences, including the risk of infection, non-compliance with regulatory standards, and potential harm to patients.

Final Thoughts

As the backbone of infection control in healthcare, SPTs must be well-versed in these symbols to ensure that every device processed in the department meets the highest standards of safety and effectiveness. By familiarizing themselves with these symbols and their meanings, SPTs can contribute significantly to the overall quality of care provided in their facilities.

Understanding and adhering to the information conveyed through these symbols is not just best practice—it’s a critical component of patient safety and regulatory compliance in the field of sterile processing.