Sterility ≠ Cleanliness: The Hidden Risk of Black Flecks in Surgical Trays

Over the past six months, Moab Healthcare has been engaged by leading health systems to help rectify the presence of black flecks in sterile surgical trays. The initial response for each of these hospitals was to call their SPD equipment provider.  So why was Moab engaged?  As SPD experts, Moab brought a comprehensive, holistic approach to assessing root cause analysis.  We reviewed all SPD operations and all SPD / OR interactions.  Black flecks are not always present because of faulty equipment.

Simply put, black flecks are becoming a growing concern for hospitals across the country. While trays may pass sterilization, visible debris is unacceptable for surgical use. These contaminants can lead to case delays, tray rejections, and patient safety risks—issues that ripple across the entire health system.

Key Questions for Leaders:

  • How many trays are being rejected in your facility due to black flecks?
  • What mitigation strategies are in place?
  • What is the financial impact of these rejections?
  • What root cause analysis have you deployed to correct the problem?

Common Causes of Black Flecks

  • Water Quality Issues
    Poor steam or wash water quality can leave mineral deposits or particulates.
    Solution: Install RO/RODI systems and follow ANSI/AAMI ST108 standards for water treatment and monitoring.
  • Sterilizer Component Breakdown
    Aging sterilizers can shed carbon or gasket material into trays as seals degrade.
  • Instrument Material Degradation
    Older instruments (e.g., black-handled scissors) may flake if coatings or steel are compromised.
  • Detergent or Chemical Residue
    Incomplete rinsing or incompatible chemicals can cause discoloration during sterilization cycles.
  • Steam System Contamination
    Boiler compounds or corrosion in steam lines can deposit particles on trays.
    Tip: Inspect steam quality and follow AORN technical bulletins.

Industry Guidelines to Know

  • ANSI/AAMI ST79: Comprehensive guide for steam sterilization and sterility assurance.
  • ANSI/AAMI ST108 (2023): New water quality standard requiring:
  • Risk analysis and water management programs.
  • Monitoring and validation of water systems.
  • Defined categories for Utility Water, Critical Water, and Steam.

Troubleshooting Tips

  • Inspect particles under magnification to identify composition.
  • Test water quality (hardness, conductivity, endotoxin levels).
  • Check sterilizer gaskets and chamber integrity.
  • Validate detergent compatibility and rinsing protocols.
  • Implement preventive maintenance per ST108.

Why It Matters:

Sterile Processing is the backbone of surgical safety. Addressing black flecks isn’t just about compliance—it’s about protecting patients, reducing delays, and safeguarding operational efficiency.