MDEN Medical Device Engineering Network

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MDEN - Medical Device Engineering Network

• Jay Crowley, FDA CDRH
• Terrie Reed, CODA
• Michael Dumais, Brigham Womens

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Todays Agenda

• What is No Problem Found?
• Brigham Womens Approach
• Small Groups
• Description of the Medical Device Engineering
  Network (MDEN)

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Small Group Discussion

• Review Case Study/Make a Flow Chart
• Answer the following
• How would you analyze and track the problem?
• What resources would you use?
• What would happen to the results of analysis?
• What would happen to the device?

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MDEN

• What is it?
• Medical Device Engineering Network
• Method for sharing information on new or
  unresolved problems
• Collection of easily accessible lessons learned

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MDEN

• What is it?
• Work in Progress
• Relies on Your participation
• Problem
• Solution
• NOT DESIGNED TO REPLACE MEDSUN REPORTING
• Entries are limited to MedSun Participants
• Resulting Website is publicly available

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MDEN

• What is it?
• FDA will facilitate discussion, but only
  participate if
• No involvement by group
• FDA has addressed the issue through guidance or
  other activities

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MDEN

• How does it work?
• Role of Clinical Engineer
• Submit questions to MDEN related to recurring
  problems, high frequency and high importance
  errors. Device problems that are reported on the
  floor, but cannot be duplicated via testing (No
  Problem Found could also be discussed).

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MDEN

• How does it work?
• Role of Clinical Engineer (contd)
• Review solutions offered by other members of the
  network, perform internal review and analysis as
  appropriate and provide feedback to FDA staff
  regarding follow-up experiences.
• Respond to questions submitted to the list by
  sharing best practices, troubleshooting ideas,
  and common experiences that the original
  requestor could use as part of internal review
  and analysis.

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MDEN

• How does it work?
• Role of FDA
• Review and clarify questions/issues that are
  posted, then post to the group.
• Obtain and report information from manufacturers
  or other reference sites that might be relevant
  to the device problems (updates that address
  design issues, company responses etc.).

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MDEN

• How does it work?
• Role of FDA (contd)
• Notify participants of the FDA device-related
  guidance and news that would potentially impact
  clinical engineers.
• Organize requests for information and practical
  solutions into a searchable lessons learned
  repository available on the MedSun participant
  web site.

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MDEN

• Types of Problems
• Device meets specifications/passes tests after
  adverse event or potential for harm reported
• Workflow issues
• Policies on use
• Staff expectations differ from device design

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Home
Submit a New Issue MedSun Report No. (if
applicable) N/A Manufacturer Samsan Device
Brand Name Cardiac Monitor General Device
Class N/A Description of device function and
problem/malfunction Increase in frequency of
reports from clinical staff that monitors are
blinking. Environment of use Patient Room How
was issue identified? Nurse complaints to
biomedical engineering Test results from product
testing Tests show that monitors are operating
normally Comments/concerns
Submit a New Issue (requires Login)
Submit a New Issue
Respond to an Issue
Search Lessons Learned
Premarket Approval (PMA)
Premarket Notification (510K)
MedSun Reporting
MAUDE Database
Submit
Disclaimer --- The views taken here are those of
MedSun Hospitals and not the FDA, Center for
Devices and Radiological Health
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MDEN De-identify and Clarify

• FDA receives problem
• If needed, contacts submitter with questions
• Posts question to the web site

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Home
Home
Submit a New Issue
Latest Issues on Devices
Respond to an issue
Search Lessons Learned
Premarket Approval (PMA)
Premarket Notification (510K)
MedSun Reporting
MAUDE Database
Enter Your Response
Disclaimer --- The views taken here are those of
MedSun Hospitals and not the FDA, Center for
Devices and Radiological Health
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Home
Respond to an Issue Select from below
Submit a New Issue
Respond toan Issue
Respond to an Issue
Search Lessons Learned
Premarket Approval (PMA)
Premarket Notification (510K)
MedSun Reporting
MAUDE Database
Disclaimer --- The views taken here are those of
MedSun Hospitals and not the FDA, Center for
Devices and Radiological Health
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Home
Submit a New Issue
Enter Your Response

• Manufacturer Samsan
• Brand Name Cardiac Monitor
• My experience/suggestion with this issue
• I had a similar problem and found that there was
  EMI interference occurring with the radio
  transmissions from the warehouse. I recommend
  conducting an analysis to rule out EMI emissions.

Respond to an Issue
Respond to an Issue
Search Lessons Learned
Premarket Approval (PMA)
Premarket Notification (510K)
MedSun Reporting
MAUDE Database
Enter your response
Disclaimer --- The views taken here are those of
MedSun Hospitals and not the FDA, Center for
Devices and Radiological Health
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MDEN Solutions

• MDEN members share their stories, related
  problems and solutions
• FDA collects stories, de-identifies, and posts

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Home
Lessons Learned
Submit a New Issue
Manufacturer Samsan Device Brand Name Cardiac
Monitor Device Problem/Malfunction Increase in
frequency of reports from clinical staff that
monitors are blinking. Solution 1 Check for
EMI interference occurring with the radio
transmissions from the warehouse. Try conducting
tests to rule out EMI emissions. Solution 2
Respond to an Issue
Search Lessons Learned
Search Lessons Learned
Premarket Approval (PMA)
Premarket Notification (510K)
MedSun Reporting
MAUDE Database
Disclaimer --- The views taken here are those of
MedSun Hospitals and not the FDA, Center for
Devices and Radiological Health
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Home
Search Lessons Learned
Submit a New Issue
Enter your search terms below
Respond to an Issue
Search Lessons Learned
Search Lessons Learned
Type of Search
Manufacturer Device Brand Name Device
Problem/Malfunction Environment of Use How issue
identified
Premarket Approval (PMA)
Premarket Notification (510K)
MedSun Reporting
MAUDE Database
Submit
Disclaimer --- The views taken here are those of
MedSun Hospitals and not the FDA, Center for
Devices and Radiological Health
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Conclusion

• Assist to respond to device issues not normally
  reported
• Create a forum for sharing
• Store the knowledge for future public use
• Iterative development process

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What can you do?

• Volunteer to help with the design
• Identify your problems
• Identify your solutions
• PARTICIPATE!

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MDEN

• Contact information
• Terrie Reed 301-827-7535 txr4_at_cdrh.fda.gov
• Jay Crowley 301-594-1161 jjc_at_cdrh.fda.gov
• Michael Dumais 617-732-5586 mdumais_at_partners.org