The Food and Drug Administration (FDA) held a public workshop to discuss factors affecting the quality of reprocessing of reusable medical devices, and FDA’s plans to address the identified issues. This workshop is part of an ongoing FDA effort to address patient exposure to inadequately reprocessed reusable medical devices with the overall goal to reduce the risk of infection. Additional background about the Reprocessing of Reusable Medical Devices effort can be found at www.fda.gov/reprocessingreusabledevices.
The purpose of the workshop was to discuss factors affecting reprocessing quality, device design as it relates to reprocessing reusable medical devices, reprocessing methodologies, validation methodologies, healthcare facility best practices, and FDA’s plans to address the identified issues. Discussion topics include:
- What are the nature, scope, and impact of reusable medical device reprocessing problems that have been observed? What are the causes of these problems?
- What factors or criteria to facilitate reprocessing should be considered when designing reusable medical devices? How can the design process be improved to better incorporate cleanability as a design endpoint?
- What factors or criteria should be considered when developing reprocessing instructions and validation protocols for devices to be used in various healthcare environments (e.g., hospital, ambulatory surgical center, physician’s office), based on the draft guidance document, Processing / Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling?
- What factors or criteria should be considered by a healthcare facility when developing reusable device reprocessing procedures and quality assurance processes?
- How should problems with reusable medical device reprocessing be identified, reported, and acted upon by industry and users?
- Date, Time and Location
- Federal Register Notice
- Agenda and Presentations
- Webcast Archive
- Contact Us
This workshop was held June 8, 2011 from 8:30 a.m. to 5:30 p.m. EDT and June 9, 2011 from 8:30 a.m. to 5:00 p.m. EDT at the following location:
FDA White Oak Campus
The Great Room (Room 1503), White Oak Conference Center, Bldg 31
10903 New Hampshire Ave
Silver Spring, MD, 20903
Federal Register Notice
The Federal Register Notice for this workshop is also available at www.fda.gov/reprocessingreusabledevices.
Various types of medical devices used in healthcare settings, from surgical suction tips to complex endoscopes, are designed and labeled for use on multiple patients. This effort focuses on medical devices that are intended for reuse after reprocessing. It does not include third-party reprocessing of single-use-only medical devices.
Thousands of reusable medical devices requiring reprocessing are used every day in diagnosing and treating patients. FDA has received a number of reports of patient exposure to inadequately reprocessed medical devices and subsequent healthcare-associated infections (HAIs). Several reports contained evidence suggesting that inadequate reprocessing may have been a contributing factor in microbial transmission and subsequent infection. A definitive causal relationship between reusable device reprocessing and any patient infection is difficult to establish, because inadequate reprocessing is not often investigated as a cause when an HAI is diagnosed. Ensuring adequate reprocessing of reusable medical devices could reduce the incidence of HAIs associated with the use of a reprocessed medical device. This will decrease the public health burden of HAIs in terms of morbidity, mortality and cost.
The adequate reprocessing of reusable medical devices is a critically important factor in protecting patient safety. Inadequate reprocessing between patients can result in the retention of blood, tissue and other biological debris (soil) in reusable medical devices. This soil can allow microbes to survive the high level disinfection or sterilization process, potentially resulting in Healthcare-Associated Infections (HAIs) or other adverse patient outcomes. The Food and Drug Administration (FDA) receives reports of problems in all steps of medical device reprocessing*, including cleaning, disinfecting and sterilizing. Manufacturers, healthcare facilities, healthcare professionals, and the FDA all have a role in reducing the risk of inadequately reprocessed medical devices.
Considering the problems associated with reprocessing medical devices, the FDA has launched a coordinated effort which focuses on improvements in device design, reprocessing procedures and validation methodologies, and healthcare facility quality assurance practices. To help address these issues, the FDA has engaged partners at the Centers for Disease Control and Prevention (CDC), the Centers for Medicaid and Medicare Services (CMS), the Veterans Health Administration (VHA), and The Joint Commission (JC), who bring valuable expertise in disease control and healthcare practices to this effort.
* A more comprehensive description of reprocessing steps is available in FDA’s draft guidance Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling at www.fda.gov/reprocessingreusabledevices
|1//0:05:03||8:30 AM||Welcome||Pamela Scott, FDA|
|1//0:15:10||8:40 AM||Keynote Address||Dr. Michelle McMurry-Heath, FDA|
|Topic: Defining the Problem|
|1//0:25:12||8:55 AM||Healthcare-associated Infection Outbreaks and Notifications Associated with Reprocessing||Melissa Schaefer, Centers for Disease Control and Prevention, Division of Healthcare Quality Promotion|
|1//0:45:18||9:15 AM||Challenges and Current Practices with Reprocessing Devices - Healthcare Facility Perspective||Linda Condon, Johns Hopkins University Hospital|
|1//1:18:04||9:35 AM||Defining the Problem – Industry Perspective||Nigel Wilkinson, Smith & Nephew Endoscopy|
|1//1:42:45||9:55 AM||Reducing Risk from Reusable Devices - Patient Perspective||Mr. Steve Langan and Dr. Frank Nemec, HONOReform Foundation|
|Topic: Quality Systems|
|2//0:03:43||10:30 AM||Applying Quality Systems to Mitigate Risk||Patrick Weixel, FDA|
|2//0:42:09||11:15 AM||Reducing Risk through quality system improvements in device design or IFU - Industry Perspective||Dr. Eamonn Hoxey, AAMI, Johnson & Johnson|
|2//0:59:05||11:35 AM||Q & A/Discussion Session #1||Pamela Scott, FDA - moderator|
|12:00 PM||Box Lunch|
|Topic: Healthcare Facility Perspectives|
|3//0:01:31||1:15 PM||Reprocessing challenges and current practices I||Jahan Azizi, University of Michigan Hospitals|
|3//0:22:29||1:35 PM||Decontamination of Complex Instrumentation||Gloria Hinkle, Carilion Clinic|
|3//0:50:54||1:55 PM||Sterile Processing Department Transformation within the Veterans Health Administration: Lessons Learned||Dr. Andrea Buck, Veterans Health Administration|
|3//01:14:05||2:15 PM||Reporting Medical Devices Reprocessing Issues||Stephanie Joseph, FDA|
|Topic: Healthcare Facility Quality Assurance|
|4//0:01:43||2:45 PM||CMS Survey Updates for Reprocessing Reusable Medical Devices||Dr. Daniel Schwartz/Karen Hoffman - Centers for Medicare & Medicaid Services|
|4//0:21:03||3:05 PM||Joint Commission Accreditation Process: Reprocessing of Instruments||Dr. Michael Parmer, the Joint Commission|
|4//0:41:35||3:25 PM||The "A,B,C's" of Monitoring Manual Cleaning Efficacy for Flexible Endoscopes||Dr. Michelle Alfa, Boniface General|
|4//1:14:40||3:55 PM||Q & A/Discussion Session #2||PM Speakers - Marilyn Flack, FDA moderator|
|4//1:53:40||4:20 PM||Pre-registered public comment||Marilyn Flack, moderator|
|4//2:25:34||5:20 PM||First day closing comments||Pamela Scott, FDA|
|1//0:00:17||8:30 AM||Summary of Day One||Pamela Scott, FDA|
|Topic: Industry Guidance & Standards|
|1//0:07:08||8:45 AM||Draft Guidance on Reprocessing - FDA Overview||Steve Turtil and Dr. Sheila Murphey, FDA|
|1//1:05:38||9:45 AM||AAMI Tools and Resources||Mary Logan, AAMI|
|1//1:35:28||10:15 AM||Q&A/Discussion Session #3||Geetha Jayan, FDA - moderator|
|Topic: Designing for Clean|
|2//0:19:15||11:00 AM||Design for Cleanability - Lessons from the Food Industry||Timothy Rugh, 3-A Sanitary Standards, Inc.|
|2//0:48:00||11:20 AM||Medical Device Cleaning: Design, Clean, Verify?||Dr. Stephen Spiegelberg, Cambridge Polymer Group|
|2//3:54:30||11:40 AM||Q & A/Discussion Session #4||Pamela Scott, FDA - moderator|
|11:55 AM||Box Lunch|
|2//1:21:41||12:10 PM||Design Simulation Tools (optional session during lunch break)||FDA/Industry Panel - Donna Lochner, FDA - moderator.|
|Topic: Science of Reprocessing|
|2//2:26:42||1:25 PM||How Clean is "Clean Enough" when Reprocessing Surgical Instruments?||Dr. Michelle Alfa, St. Boniface General Hospital|
|2//2:44:02||1:45 PM||Two-Phase Flow Cleaning of Endoscope Channels - Fundamentals of Cleaning||Dr. Mohamed Labib, Novaflux|
|2//3:10:54||2:05 PM||A Method to Quantitatively Assess Residual Solid Soils in Reusable Devices||Dr. Shani Haugen, FDA|
|2//3:32:20||2:25 PM||The Use of the Radionuclide Method to Validate Cleaning Processes||Klaus Roth, SMP GmbH Pruefen|
|2//3:54:30||2:45 PM||Q&A/Discussion Session #5||Janine Morris, FDA - moderator|
|2//4:12:51||3:15 PM||Panel Discussion||Janine Morris, FDA - moderator|
|2//5:19:49||4:15 PM||Summary and Closing Remarks||Pamela Scott, FDA|
The webcast can be viewed using Adobe Acrobat Connect Pro. To assist in viewing individual presentations, the start point for each presentation is noted in the Part/Start values column in the agenda column above. For example, the archived Design Simulation Tools panel on June 9 begins 1 hour, 21 minutes, and 41 seconds into Part 2 for that day. You can access that presentation by opening the June 9 Part 2 file, and moving the scroll bar to 1:21:41.
Online transcripts are available in PDF format.
For information regarding the program, contact:
- Carol Krueger
Office of the Center Director
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue,
Bldg. 66, Room 5437
Silver Spring, MD 20993