Labeling Requirements for Surgical Staplers and Staples for Internal Use

What You Need to Know? 👇

What are the key labeling requirements for surgical staplers under FDA’s 2021 guidance?

The FDA guidance requires specific contraindications, warnings, directions for use, and technical characteristics. Key elements include tissue thickness limits, compatibility information, safety mechanisms, and package labeling with critical device selection information like cartridge colors and staple heights.

How do adverse events with surgical staplers impact patient safety?

Between 2011-2018, FDA received over 41,000 adverse event reports including 360+ deaths. Common issues include staple line opening, misfiring, and misapplied staples, leading to complications like bleeding, sepsis, prolonged surgeries, and additional interventions.

What tissues should be avoided when using surgical staplers according to FDA recommendations?

Staplers should not be used on necrotic, friable, or tissues with altered integrity (ischemic or edematous). The aorta should also be avoided. Proper tissue assessment and staying within labeled thickness limits are critical for safe use.

What technical information must appear on surgical stapler package labels?

Package labels must include cartridge colors with corresponding staple heights, cartridge size, shaft length, articulation angles, staple patterns, maximum reloads, pre-fire compression time, safety mechanisms, and compatible trocar sizes for proper device selection.

How does the FDA guidance address stapler-staple compatibility issues?

The guidance requires clear identification of compatible staple models and staplers in labeling. Manufacturers must demonstrate compatibility and provide lists of compatible devices to prevent mismatched combinations that could cause malfunctions or patient harm.

What are the implementation timelines for the new surgical stapler labeling requirements?

For devices under 21 CFR 878.4740, manufacturers should refer to the Final Order implementation dates. For other surgical staplers and staples, FDA recommends implementing labeling changes within 180 days of the guidance publication date.

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What You Need to Do 👇

Recommended Actions

1. Review current device labeling against guidance requirements
2. Update labeling to include all required warnings, contraindications, and technical specifications
3. Ensure package labels clearly display critical information for device selection
4. Implement changes within 180 days of guidance publication for non-878.4740 devices
5. Evaluate if labeling changes require new 510(k) submission
6. Update reprocessing instructions if applicable
7. Add clear visual indicators and diagrams where appropriate
8. Include specific tissue compatibility information
9. Document compatibility with other devices/materials
10. Implement clear safety mechanism identification

Key Considerations

Labelling

• Must include specific contraindications regarding use on necrotic, friable, or altered integrity tissues
• Must include warnings about tissue thickness limits, avoiding obstructions, tissue damage, aorta use, blood vessel control
• Must provide clear instructions for proper device use and cartridge handling
• Must list compatible staples and key performance parameters
• Package labels must include critical technical characteristics for proper device selection
• Must include validated reprocessing instructions for reusable components
• Must specify expiration date/shelf life

Safety

• Must include safety mechanisms identification
• Must provide warnings about crossing staple lines
• Must include information about blood vessel control methods in case of failure

Other considerations

• Must specify technical characteristics like:
  • Maximum/minimum tissue thickness
  • Angles of articulation
  • Cartridge specifications
  • Maximum number of firings
  • Compatible reinforcing products

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Relevant Guidances 🔗

• Device Labeling Requirements and Content for Premarket Approval Applications
• Labeling Requirements and Recommendations for Medical Devices
• Device Labeling Requirements and Content for Premarket Approval Applications
• Reprocessing Instructions for Reusable Medical Devices and Non-Sterile Single-Use Devices - Development and Validation

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Original guidance

• Labeling Requirements for Surgical Staplers and Staples for Internal Use
• HTML / PDF
• Issue date: 2021-10-08
• Last changed date: 2021-10-07
• Status: FINAL
• Official FDA topics: Medical Devices, Device & Drug Safety, Labeling, General & Plastic Surgery
• ReguVirta ID: ed647d1593af1ece6e4b7e876df588ff