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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - Reprocessing of Reusable Medical Devices, June 8-9, 2011

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:

  1. What are the nature, scope, and impact of reusable medical device reprocessing problems that have been observed? What are the causes of these problems?
  2. 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?
  3. 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used in various healthcare environments (e.g., hospital, ambulatory surgical center, physician’s office), based on the draft guidance document, Processing / Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling?
  4. What factors or criteria should be considered by a healthcare facility when developing reusable device reprocessing procedures and quality assurance processes?
  5. How should problems with reusable medical device reprocessing be identified, reported, and acted upon by industry and users?


Date, Time and Location

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.

Background

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

Agenda

Webinar Part//StartTimeTopic/SessionSpeaker(s)
Day One
1//0:05:038:30 AMWelcomePamela Scott, FDA
1//0:15:108:40 AMKeynote AddressDr. Michelle McMurry-Heath, FDA
Topic: Defining the Problem  
1//0:25:128:55 AMHealthcare-associated Infection Outbreaks and Notifications Associated with ReprocessingMelissa Schaefer, Centers for Disease Control and Prevention, Division of Healthcare Quality Promotion
1//0:45:189:15 AMChallenges and Current Practices with Reprocessing Devices - Healthcare Facility PerspectiveLinda Condon, Johns Hopkins University Hospital
1//1:18:049:35 AMDefining the Problem – Industry PerspectiveNigel Wilkinson, Smith & Nephew Endoscopy
1//1:42:459:55 AMReducing Risk from Reusable Devices - Patient PerspectiveMr. Steve Langan and Dr. Frank Nemec, HONOReform Foundation
 10:15 AMBreak 
Topic: Quality Systems  
2//0:03:4310:30 AMApplying Quality Systems to Mitigate RiskPatrick Weixel, FDA
2//0:42:0911:15 AMReducing Risk through quality system improvements in device design or IFU - Industry PerspectiveDr. Eamonn Hoxey, AAMI, Johnson & Johnson
2//0:59:0511:35 AMQ & A/Discussion Session #1Pamela Scott, FDA - moderator
 12:00 PMBox Lunch 
Topic: Healthcare Facility Perspectives  
3//0:01:311:15 PMReprocessing challenges and current practices IJahan Azizi, University of Michigan Hospitals
3//0:22:291:35 PMDecontamination of Complex InstrumentationGloria Hinkle, Carilion Clinic
3//0:50:541:55 PMSterile Processing Department Transformation within the Veterans Health Administration:  Lessons LearnedDr. Andrea Buck, Veterans Health Administration
3//01:14:052:15 PMReporting Medical Devices Reprocessing IssuesStephanie Joseph, FDA
 2:30 PMBreak 
Topic: Healthcare Facility Quality Assurance  
4//0:01:432:45 PMCMS Survey Updates for Reprocessing Reusable Medical DevicesDr. Daniel Schwartz/Karen Hoffman - Centers for Medicare & Medicaid Services
4//0:21:033:05 PMJoint Commission Accreditation Process: Reprocessing of InstrumentsDr. Michael Parmer, the Joint Commission
4//0:41:353:25 PMThe "A,B,C's" of Monitoring Manual Cleaning Efficacy for Flexible EndoscopesDr. Michelle Alfa, Boniface General
4//1:14:403:55 PMQ & A/Discussion Session #2PM Speakers - Marilyn Flack, FDA moderator
4//1:53:404:20 PMPre-registered public commentMarilyn Flack, moderator
4//2:25:345:20 PMFirst day closing commentsPamela Scott, FDA
Webinar Part//Start Time Topic/Session Speaker(s)
Day Two
 StartTopicSpeaker
1//0:00:178:30 AMSummary of Day OnePamela Scott, FDA
Topic: Industry Guidance & Standards  
1//0:07:088:45 AMDraft Guidance on Reprocessing - FDA OverviewSteve Turtil and Dr. Sheila Murphey, FDA
1//1:05:389:45 AMAAMI Tools and ResourcesMary Logan, AAMI
1//1:35:2810:15 AMQ&A/Discussion Session #3Geetha Jayan, FDA - moderator
 10:45 AMBreak 
Topic: Designing for Clean  
2//0:19:1511:00 AMDesign for Cleanability - Lessons from the Food IndustryTimothy Rugh, 3-A Sanitary Standards, Inc.
2//0:48:0011:20 AMMedical Device Cleaning: Design, Clean, Verify?Dr. Stephen Spiegelberg, Cambridge Polymer Group
2//3:54:3011:40 AMQ & A/Discussion Session #4Pamela Scott, FDA - moderator
 11:55 AMBox Lunch 
2//1:21:4112:10 PMDesign Simulation Tools (optional session during lunch break)FDA/Industry Panel - Donna Lochner, FDA - moderator.
Topic: Science of Reprocessing  
2//2:26:421:25 PMHow Clean is "Clean Enough" when Reprocessing Surgical Instruments?Dr. Michelle Alfa, St. Boniface General Hospital
2//2:44:021:45 PMTwo-Phase Flow Cleaning of Endoscope Channels - Fundamentals of CleaningDr. Mohamed Labib, Novaflux
2//3:10:542:05 PMA Method to Quantitatively Assess Residual Solid Soils in Reusable DevicesDr. Shani Haugen, FDA
2//3:32:202:25 PMThe Use of the Radionuclide Method to Validate Cleaning ProcessesKlaus Roth, SMP GmbH Pruefen
2//3:54:302:45 PMQ&A/Discussion Session #5Janine Morris, FDA - moderator
 3:00 PMBreak 
2//4:12:513:15 PMPanel DiscussionJanine Morris, FDA - moderator
2//5:19:494:15 PMSummary and Closing RemarksPamela Scott, FDA

Webcast Archive

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.

Transcripts

Online transcripts are available in PDF format.

Contact Us

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
    Phone: 301-796-3241
    Email: Carol.Krueger@fda.hhs.gov