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
- Analyze the operational and ethical challenges posed by ambiguous, impractical, or inaccessible Instructions for Use (IFUs) in medical device reprocessing.
- Discuss how unclear IFUs increase the burden on healthcare facilities, leading to non-compliance, errors, and potential harm to patients.
- Recommend strategies for manufacturers to improve IFU clarity, accountability, and collaboration with healthcare providers to enhance patient safety and operational efficiency.
- 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.
Course Includes
- 1 Lesson
- 1 Test
- Course Certificate
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
HSPA (Healthcare Sterile Processing Association) has pre-approved this in-service for 1.0 Continuing Education Credits for a period of three years.
For more information, direct any questions to Healthcare Purchasing News (941) 259-0832.
