AAMI/FDA Reprocessing Summit Agenda: Day 2
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DAY 2: WEDNESDAY, OCTOBER 12, 2011 |
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9:00-9:15 am |
First Day Review | ||
| The Summit Moderator will summarize the discussions and address some of the key issues from Day 1. | |||
9:15-9:30 am |
Reprocessing Standards Activities | ||
| Michael Scholla, DuPont | |||
| This session will provide a brief overview of the status of current standards activities in medical device reprocessing. | |||
9:30-11:00 am
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Considerations for Selecting Test Soils and Evaluating Biomarkers | ||
| Trabue Bryans, WuXi App Tec, Inc. Emily Mitzel, Nelson Laboratories, Inc. |
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| Panelists will review available test soils and biomarker endpoints for use in cleaning validation studies as outlined in AAMI TIR 30. They will discuss currently available information and processes (e.g., manufacturer processes, test laboratory processes, regulatory influences) that guide the choice of a clinically relevant test soil for the intended use of a medical device, and entertain the need for criteria in selecting test soils and for test soil classifications. The critical relationship between test soil and measured endpoints to evaluate effectiveness of cleaning will be explored. Audience members will then be invited to give their input on the adequacy of available test soils for simulated worst case validation studies (e.g., should test soils simulate worst case diseased or healthy human excretions / secretions) or if better test soils or use of actual human secretions are needed. The most relevant number and type of endpoints (e.g., qualitative vs. quantitative) and measurement / acceptance criteria for validation of cleaning processes will also be discussed. The audience will be tasked with prioritizing the challenges and identifying corresponding goals. |
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| Session goals: | |||
| a. Reach consensus on the necessary criteria for clinical relevance and worst case test soil (including use of worst case healthy vs. worst case diseased human secretions in guiding the choice of test soil for a validation study) b. Identify the greatest challenges test soils and validation endpoints present to manufacturers and test laboratories in their execution of worst-case simulated validation studies c. Prioritize the top 3-5 challenges to be addressed regarding test soils and cleaning validation endpoints for manufacturers and test laboratories and identify corresponding goals and action items to address the top 3 challenges from item b above |
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11:15 -12:45 pm |
Standardized Reprocessing Requirements and Terminology | ||
| Rose Seavey, Seavey Healthcare Consulting, Inc. Rod Parker, Stryker |
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| Inconsistent reprocessing requirements and use of terminology by manufacturers and points of contact within a single manufacturer can contribute to confusion, inappropriate or inadequate cleaning procedures, and ultimately patient infections. Following a panel discussion about the benefits of standardized requirements such as temperature, duration, etc. and related terminology from different manufacturers for similar devices, the panel and audience will discuss challenges such as extended cycles and mismatched messages from manufacturing sales, corporate, and regulatory staff. The panel will review available resources to facilitate standardized processing and reprocessing requirements (e.g., AAMI ST79; AAMI TIR 12; CDC 2008; new AAMI workgroups, etc.). The moderator will ask the audience to make their own recommendations for requirements and ways to implement and communicate them to manufacturers and end-users. | |||
| Session goals are to: | |||
| a. Identify the requirements and terminology that can and should be standardized across all devices that are intended to be reprocessed
b. Gain consensus on those requirements c. Discuss the importance of consistent terminology and use of that terminology across all points of contact within a manufacturer (sales staff, corporate staff, regulatory staff, and others) |
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1:45 - 3:45 pm |
Establishing Action Plans and Deliverables from the Summit | ||
| The Summit Moderator will briefly review the findings of the Summit discussions and compile a complete list of priorities resulting from audience input. Audience feedback will be required to refine the priorities and provide direction on action plans. | |||
| Session goals: | |||
| a. Review the “Master List” of problems and issues from Day 1 and Day 2 discussions b. Identify the top 5 priorities on the Master List according to its importance and impact on patient safety c. Identify the potential timeframe of “addressing” or “fixing” each issue d. Identify stakeholders that should be involved in addressing the priorities and develop an organizational structure necessary to get the work done |
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3:45 - 4:15 pm |
Summit Wrap-Up and Closing Remarks | ||
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