The Challenges and Opportunities Related to Medical Device Reprocessing
This symposium will address key issues such as the dangers associated with improperly processed devices; the real-world situations that impede proper sterile reprocessing; the clarion themes that emerged from the 2011 AAMI/FDA workshop and the recent/pending new guidance on medical device reprocessing from the FDA; as well as the opportunities that clinicians and industry have to collaborate to identify solutions/the agenda for the future.
The symposium features two webinar presentations:
Challenges to Reprocessing Medical Devices
Donna Swenson, BS, CRCST, CHL, CSPDM, president and CEO of Sterile Processing Quality Services, Inc., will:
- Identify the many stakeholders who are responsible for ensuring that medical devices are effectively cleaned, disinfected and/or sterilized between patient uses.
- Suggest the reasons why, after patient use, it can be difficult to adequately clean, disinfect and/or sterilize medical devices.
- Discuss potential solutions for improving the process of cleaning, disinfection and sterilization of medical devices.
Medical Device Reprocessing: Clarion Themes and Industry Guidance
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, president of Chobin & Associates Consulting and Sterile Processing University, LLC, will:
- Describe the need for accurate and current manufacturer’s instructions for use (IFUs)
- Discuss how to interpret IFUs
- Identify training and competency assessments for staff to ensure compliance with IFUs
Donna Swenson has more than 30 years of experience in the sterilization of medical devices, working with both healthcare providers and the medical device industry. For several years, Ms. Swenson has been the lead U.S. delegate to the ISO committee on moist heat sterilization of medical devices. In this position, she actively participated in the development of ANSI/AAMI/ISO 17665-1, -2 and -3; Sterilization of health care products—Moist heat—Part 1 Requirements, Part 2 Guidance, and Part 3 Product Families.
She is currently co-chair of the Industrial Moist Heat Sterilization of Medical Devices and Protective Barriers Committee. Ms. Swenson also serves on the AAMI Industrial Sterilization Scientist Certification Council and the AAMI Industrial Sterilization Editorial Board. She is also a member of the Benchmarking Committee, co-sponsored by AAMI and IAHCSMM, and is a member of the Certification Council for IAHCSMM.
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER is President of Chobin & Associates Consulting and Sterile Processing University, LLC, an online SPD education and continuing education website, as well as founder of the Certification Board for Sterile Processing & Distribution, Inc., retiring from the position of executive director in December 2013. She is certified as a Sterile Processing & Distribution Technician (CSPDT); Certified Surgical Instrument Specialist (CIS), Certified Flexible Endoscope Reprocessor CFER) and Certified in Sterile Processing Management (CSPDM), and is a member of AORN, AAMI, SGNA and IAHCSMM.
*This nursing continuing education activity is offered by Infection Control Today/Informa Exhibitions, an approved provider (California BRN provider #16526) by the California Board of Registered Nursing.