Lost in Translation: Ethical Dilemmas in Medical Manufacturing Instructions

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.