AAMI/FDA Reprocessing Summit Agenda: Day 1
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DAY 1: TUESDAY, OCTOBER 11, 2011 |
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9:00-9:30 am |
Keynote Presentation |
| Dr. Evelyn McKnight, HONOReform Foundation | |
9:30-11:00 am
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Defining "Clean" |
| Ralph Basile, MBA, Healthmark Chuck Hughes, SPSmedical Supply Corp. Daniel Schwartz, MD, MBA, CMS/CMCS and Karen Hoffman, RN, MS, CIC, FSHEA, CMS/CMCS |
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| A “cleaned” device may have as many meanings and interpretations as there are devices that are “cleaned.” The first order of business is for the audience to determine what we mean by “clean” and why this is important. Panelists will highlight various definitions of “clean” that reprocessors use (in hospital and non-hospital settings), review the available types of technology for user verification of cleaning endpoints, and point out the safety problems that can occur from multiple definitions. The moderator will facilitate a discussion with the audience to gain consensus on aspects of “clean.” The results will assist in developing a standard for the term, in the context of reprocessing. |
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| Session goals: | |
| a. Identify essential factors to be considered when defining “clean” for handling and further reprocessing b. Identify the greatest challenges to end user verification of the manufacturer-recommended device cleaning processes c. Identify and prioritize the additional scientific evidence needed to assist in creating a uniform definition of “clean” for further reprocessing d. Prioritize the top 3-5 challenges to be addressed in pursuing a definition of “clean” and identify corresponding goals to overcome these challenges |
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11:15-12:45 am |
Design Issues with Reusable Medical Devices |
Mark Duro, New England Baptist Hospital |
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| The session will begin with an overview of the most common cleaning challenges associated with design features of reusable medical devices. Panelists will discuss these challenges in the context of disassembly, re-assembly, extended cleaning steps, and the impact that repair can have on the effectiveness of reprocessing procedures. Audience members will discuss these and other challenges related to device design considering manual and automated reprocessing technologies. The audience will also be tasked with prioritizing the challenges and identifying corresponding reprocessing improvement goals. | |
| Session goals: | |
| a. Identify design features that present challenges to reprocessing
b. Identify needed improvements to the manufacturing design requirements to facilitate better reprocessing c. Identify factors that currently impede industry progress in designing and producing devices that can be reprocessed more thoroughly d. Identify potential solutions to the issue of reprocessing challenges and effectiveness following device repairs e. Prioritize the top 3-5 challenges to be addressed based on the severity of patient risks for infection Identify corresponding goals to address the top 3-5 challenges |
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1:45 - 3:15 pm |
Human Factors Considerations in Reprocessing Procedures and Instructions |
R. Darin Ellis, PhD, Wayne State University |
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| Building on the previous session, panelists will present human factors issues in device reprocessing and repair (e.g., feasible cleaning processes, content and format of instructions, and terminology). Panelists will further review available tools for standardizing content and format of instructions (e.g. FDA 1996 guidance on labeling reusable medical devices). Audience members will then engage in a discussion about the human factors challenges they have experienced when cleaning reusable devices. The audience will be tasked with prioritizing the challenges and identifying corresponding goals. | |
| Session goals: | |
| a. Identify human factors issues that manufacturers, design engineers, and end users must consider when establishing reprocessing procedures b. Identify the critical elements of feasible reprocessing processes (e.g., number of steps, number of processes, etc.) c. Identify the critical elements of clear instructional documents for end users d. Prioritize the top 3-5 human factors challenges to be addressed |
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3:30 - 4:45 pm |
Competency Requirements for Reprocessing Staff |
| Ramona Conner, Association of Perioperative Registered Nurses (AORN) all speakers Sue Klacik, CCSMC, FCA, ACE, IACHSMM Eileen Young, RN, CNOR, Olympus America, Inc. |
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| Panelists will briefly discuss the baseline competency requirements currently applied in leading hospitals and healthcare facilities and point out the disparity between them. The moderator will solicit input from the audience to help identify essential competencies that anyone should possess when reprocessing medical devices. | |
| Session goals: | |
| a. Identify any current challenges and barriers to implementing core competency requirements in the variety of settings where medical devices are reprocessed (e.g., hospitals, private practice outpatient offices, ambulatory surgery / endoscopy centers, etc.) b. Gain consensus on essential criteria such as experience, education, and physical abilities to ensure proper reprocessing c. Prioritize the top 3-5 criteria to assist in developing a standardized core competency requirement and continuing education program for anyone that is reprocessing devices |
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4:45 - 5:15 pm |
First Day Wrap-up |
| The Summit moderator will review discussions from Day 1, and review the schedule for Day 2. Audience members will have the opportunity to bring up their observations from the day or ask additional questions about the discussions. | |
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