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  • × Critical Connections: Improving SP and OR SynergyCritical Connections: Improving SP and OR Synergy 1 × $10.00
  • × Sterilization Quality Control: Your Path to Protecting Your PatientsSterilization Quality Control: Your Path to Protecting Your Patients 1 × $10.00
  • × Ensuring Success: Become a Preceptor for Robotic Assisted Surgery Instruments in the Sterile Processing DepartmentEnsuring Success: Become a Preceptor for Robotic Assisted Surgery Instruments in the Sterile Processing Department 1 × $10.00
  • × Lost in Translation: Ethical Dilemmas in Medical Manufacturing InstructionsLost in Translation: Ethical Dilemmas in Medical Manufacturing Instructions 1 × $10.00
  • × What Sterile Processing Should Know About Multidrug-Resistant Organisms (MDRO)What Sterile Processing Should Know About Multidrug-Resistant Organisms (MDRO) 1 × $10.00
  • × Education Nation: Curriculum-Based In-ServicesEducation Nation: Curriculum-Based In-Services 1 × $10.00
  • × Making the Right Choice for Sterile Processing Consumable Stock OutagesMaking the Right Choice for Sterile Processing Consumable Stock Outages 1 × $10.00
  • × UV-C Disinfection Technologies: How it works and what are the current applications for health care settingsUV-C Disinfection Technologies: How it works and what are the current applications for health care settings 1 × $10.00
  • × The Differences Between Peracetic Acid High-level Disinfectants and SterilantsThe Differences Between Peracetic Acid High-level Disinfectants and Sterilants 1 × $10.00
  • × The Mystery of Bowie & Dick: Alterations in the Vacuum on Your Sterilizer Throughout the YearThe Mystery of Bowie & Dick: Alterations in the Vacuum on Your Sterilizer Throughout the Year 1 × $10.00
  • × Meeting the Challenges of Endoscope Reprocessing and DocumentationMeeting the Challenges of Endoscope Reprocessing and Documentation 1 × $10.00
  • × Education Nation: Sterile Processing Quality Management SystemsEducation Nation: Sterile Processing Quality Management Systems 1 × $10.00
  • × Tips for a New Sterile Processing TechnicianTips for a New Sterile Processing Technician 1 × $10.00
  • × Product testing: The overlooked 4th pillar of a robust sterilization process monitoring programProduct testing: The overlooked 4th pillar of a robust sterilization process monitoring program 1 × $10.00
  • × Importance of Water Quality for Medical Device ReprocessingImportance of Water Quality for Medical Device Reprocessing 1 × $10.00
  • × Mechanical Cleaning Safety: A Tale of Two SidesMechanical Cleaning Safety: A Tale of Two Sides 1 × $10.00
  • × Sterilization Choices for the SPDSterilization Choices for the SPD 1 × $10.00
  • × When Is Disposable the Right Choice for SPD?When Is Disposable the Right Choice for SPD? 1 × $10.00
  • × Education Nation: Sterile Processing Leadership Planning SessionsEducation Nation: Sterile Processing Leadership Planning Sessions 1 × $10.00
  • × How Safe Is Your Sink?How Safe Is Your Sink? 1 × $10.00
  • × Sterile Processing Education – The balancing act between documentation and applicationSterile Processing Education – The balancing act between documentation and application 1 × $10.00
  • × Moisture Absorption Devices….No This Is Not a Wet Pack ArticleMoisture Absorption Devices….No This Is Not a Wet Pack Article 1 × $10.00
  • × Positive Biological IndicatorsPositive Biological Indicators 1 × $10.00
  • × Washer disinfector release for use after maintenanceWasher disinfector release for use after maintenance 1 × $10.00
  • × Beyond the visual: The importance of quality cleaning verification programsBeyond the visual: The importance of quality cleaning verification programs 1 × $10.00
  • × Education nation: Creating Sterile Processing Department SOPsEducation nation: Creating Sterile Processing Department SOPs 1 × $10.00
  • × Cross out cross contamination in endoscope processingCross out cross contamination in endoscope processing 1 × $10.00
  • × What’s new in AAMI ST79:2017? A reviewWhat’s new in AAMI ST79:2017? A review 1 × $10.00
  • × PlaceholderHealthcare soils 101: Identifying and removing them 1 × $10.00
  • × Expiration dating in the SPDExpiration dating in the SPD 1 × $10.00
  • × The Science of SpeedThe Science of Speed 1 × $10.00
  • × The fantastic four: Sterile processing, operating room, quality and educationThe fantastic four: Sterile processing, operating room, quality and education 1 × $10.00
  • × Ugh! Another wet pack. What’s a technician to do?Ugh! Another wet pack. What’s a technician to do? 1 × $10.00
  • × Sterilization quality control: Validation, routine monitoring go hand in handSterilization quality control: Validation, routine monitoring go hand in hand 1 × $10.00
  • × Manual cleaning – The critical human elementManual cleaning – The critical human element 1 × $10.00
  • × Water for cleaning medical devicesWater for cleaning medical devices 1 × $10.00
  • × Can you afford to ignore obsolescence?Can you afford to ignore obsolescence? 1 × $10.00
  • × Automatic Equipment and Productivity in a Sterile Processing DepartmentAutomatic Equipment and Productivity in a Sterile Processing Department 1 × $10.00
  • × The Sound of CleanThe Sound of Clean 1 × $10.00
  • × PlaceholderEducation Nation: Understanding the Factors That Shape Sterile Processing 1 × $10.00
  • × External Transport of Medical DevicesExternal Transport of Medical Devices 1 × $10.00
  • × Troubleshooting Washer-Disinfector PerformanceTroubleshooting Washer-Disinfector Performance 1 × $10.00
  • × PlaceholderOwn Your Growth: Grit and Self-Leadership Skills Every Sterile Processing Technician Should Develop 1 × $10.00

Subtotal: $430.00

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43

Shopping Cart

View Cart
  • × Critical Connections: Improving SP and OR SynergyCritical Connections: Improving SP and OR Synergy 1 × $10.00
  • × Sterilization Quality Control: Your Path to Protecting Your PatientsSterilization Quality Control: Your Path to Protecting Your Patients 1 × $10.00
  • × Ensuring Success: Become a Preceptor for Robotic Assisted Surgery Instruments in the Sterile Processing DepartmentEnsuring Success: Become a Preceptor for Robotic Assisted Surgery Instruments in the Sterile Processing Department 1 × $10.00
  • × Lost in Translation: Ethical Dilemmas in Medical Manufacturing InstructionsLost in Translation: Ethical Dilemmas in Medical Manufacturing Instructions 1 × $10.00
  • × What Sterile Processing Should Know About Multidrug-Resistant Organisms (MDRO)What Sterile Processing Should Know About Multidrug-Resistant Organisms (MDRO) 1 × $10.00
  • × Education Nation: Curriculum-Based In-ServicesEducation Nation: Curriculum-Based In-Services 1 × $10.00
  • × Making the Right Choice for Sterile Processing Consumable Stock OutagesMaking the Right Choice for Sterile Processing Consumable Stock Outages 1 × $10.00
  • × UV-C Disinfection Technologies: How it works and what are the current applications for health care settingsUV-C Disinfection Technologies: How it works and what are the current applications for health care settings 1 × $10.00
  • × The Differences Between Peracetic Acid High-level Disinfectants and SterilantsThe Differences Between Peracetic Acid High-level Disinfectants and Sterilants 1 × $10.00
  • × The Mystery of Bowie & Dick: Alterations in the Vacuum on Your Sterilizer Throughout the YearThe Mystery of Bowie & Dick: Alterations in the Vacuum on Your Sterilizer Throughout the Year 1 × $10.00
  • × Meeting the Challenges of Endoscope Reprocessing and DocumentationMeeting the Challenges of Endoscope Reprocessing and Documentation 1 × $10.00
  • × Education Nation: Sterile Processing Quality Management SystemsEducation Nation: Sterile Processing Quality Management Systems 1 × $10.00
  • × Tips for a New Sterile Processing TechnicianTips for a New Sterile Processing Technician 1 × $10.00
  • × Product testing: The overlooked 4th pillar of a robust sterilization process monitoring programProduct testing: The overlooked 4th pillar of a robust sterilization process monitoring program 1 × $10.00
  • × Importance of Water Quality for Medical Device ReprocessingImportance of Water Quality for Medical Device Reprocessing 1 × $10.00
  • × Mechanical Cleaning Safety: A Tale of Two SidesMechanical Cleaning Safety: A Tale of Two Sides 1 × $10.00
  • × Sterilization Choices for the SPDSterilization Choices for the SPD 1 × $10.00
  • × When Is Disposable the Right Choice for SPD?When Is Disposable the Right Choice for SPD? 1 × $10.00
  • × Education Nation: Sterile Processing Leadership Planning SessionsEducation Nation: Sterile Processing Leadership Planning Sessions 1 × $10.00
  • × How Safe Is Your Sink?How Safe Is Your Sink? 1 × $10.00
  • × Sterile Processing Education – The balancing act between documentation and applicationSterile Processing Education – The balancing act between documentation and application 1 × $10.00
  • × Moisture Absorption Devices….No This Is Not a Wet Pack ArticleMoisture Absorption Devices….No This Is Not a Wet Pack Article 1 × $10.00
  • × Positive Biological IndicatorsPositive Biological Indicators 1 × $10.00
  • × Washer disinfector release for use after maintenanceWasher disinfector release for use after maintenance 1 × $10.00
  • × Beyond the visual: The importance of quality cleaning verification programsBeyond the visual: The importance of quality cleaning verification programs 1 × $10.00
  • × Education nation: Creating Sterile Processing Department SOPsEducation nation: Creating Sterile Processing Department SOPs 1 × $10.00
  • × Cross out cross contamination in endoscope processingCross out cross contamination in endoscope processing 1 × $10.00
  • × What’s new in AAMI ST79:2017? A reviewWhat’s new in AAMI ST79:2017? A review 1 × $10.00
  • × PlaceholderHealthcare soils 101: Identifying and removing them 1 × $10.00
  • × Expiration dating in the SPDExpiration dating in the SPD 1 × $10.00
  • × The Science of SpeedThe Science of Speed 1 × $10.00
  • × The fantastic four: Sterile processing, operating room, quality and educationThe fantastic four: Sterile processing, operating room, quality and education 1 × $10.00
  • × Ugh! Another wet pack. What’s a technician to do?Ugh! Another wet pack. What’s a technician to do? 1 × $10.00
  • × Sterilization quality control: Validation, routine monitoring go hand in handSterilization quality control: Validation, routine monitoring go hand in hand 1 × $10.00
  • × Manual cleaning – The critical human elementManual cleaning – The critical human element 1 × $10.00
  • × Water for cleaning medical devicesWater for cleaning medical devices 1 × $10.00
  • × Can you afford to ignore obsolescence?Can you afford to ignore obsolescence? 1 × $10.00
  • × Automatic Equipment and Productivity in a Sterile Processing DepartmentAutomatic Equipment and Productivity in a Sterile Processing Department 1 × $10.00
  • × The Sound of CleanThe Sound of Clean 1 × $10.00
  • × PlaceholderEducation Nation: Understanding the Factors That Shape Sterile Processing 1 × $10.00
  • × External Transport of Medical DevicesExternal Transport of Medical Devices 1 × $10.00
  • × Troubleshooting Washer-Disinfector PerformanceTroubleshooting Washer-Disinfector Performance 1 × $10.00
  • × PlaceholderOwn Your Growth: Grit and Self-Leadership Skills Every Sterile Processing Technician Should Develop 1 × $10.00

Subtotal: $430.00

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Sterilization ,

Lost in Translation: Ethical Dilemmas in Medical Manufacturing Instructions

Instructions for Use (IFUs) are essential for guiding healthcare providers in reprocessing medical devices.

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By Anna Castillo-Gutierrez, CRCST, CSPDT, CHL, CIS, CFER

Instructions for Use (IFUs) are essential for guiding healthcare providers in reprocessing medical devices. However, many IFUs remain vague, impractical, or inaccessible, presenting challenges that facilities must navigate without adequate support. Many specify chemistries or products that are not manufacturer-neutral, forcing facilities to adapt to instructions that may not align with their resources. Some IFUs also fail to account for real-world conditions, leaving sterile processing departments (SPDs) and healthcare teams to navigate unclear guidance that was never tested in collaboration with end-users.

Learning Objectives

  1. Analyze the operational and ethical challenges posed by ambiguous, impractical, or inaccessible Instructions for Use (IFUs) in medical device reprocessing.
  2. Discuss how unclear IFUs increase the burden on healthcare facilities, leading to non-compliance, errors, and potential harm to patients.
  3. Recommend strategies for manufacturers to improve IFU clarity, accountability, and collaboration with healthcare providers to enhance patient safety and operational efficiency.
  4. Promote partnerships between manufacturers, healthcare facilities, and regulatory bodies to ensure that IFUs are practical, accessible, and tested for real-world conditions.

About the Author

Anna Castillo-Gutierrez, CRCST, CSPDT, CHL, CIS, CFER is an experienced Sterile Processing Technician certified with IAHCSMM and CBSPD. Proficient in multitask projects, Cross-functional teams and Lean/Six Sigma. Educator with a mindset on Patient Safety and Student Achievement. Goal oriented, friendly good nature and extensive knowledge in Sterile Processing Policy and Procedure according to AAMI, ANSI, SGNA, AORN, OSHA and CDC. Meditech, SMART Procurement and Tracking Systems knowledgeable. Experienced in purchasing, contract acquisition and project planning and management. Supervisor/Manager who empowers and challenges staff to educate themselves and grow into leaders.

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Course Content

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Course Includes

  • 1 Lesson
  • 1 Test
  • Course Certificate

  • CBSPD

    The CBSPD (Certification Board for Sterile Processing and Distribution) has pre-approved this in-service for one (1) contact hour for a period of five (5) years from the date of original publication. Successful completion of the lesson and post test must be documented by facility management and those records maintained by the individual until re-certification is required.

    DO NOT SEND LESSON OR TEST TO CBSPD.

    For additional information regarding certification contact CBSPD – 148 Main Street, Suite C-1, Lebanon, NJ 08833

    www.sterileprocessing.org.

    HSPA

    HSPA (Healthcare Sterile Processing Association) has pre-approved this in-service for 1.0 Continuing Education Credits for a period of three years.

    myhspa.org

    For more information, direct any questions to Healthcare Purchasing News (941) 259-0832.