Request for Medical Product Safety Network (MedSun) Qualitative Feedback Generic Clearance about Newsletter Services

Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery

APPENDIX A 4.23

Request for Medical Product Safety Network (MedSun) Qualitative Feedback Generic Clearance about Newsletter Services

OMB: 0910-0697

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MEDICAL PRODUCT SAFETY NETWORK (MEDSUN) FEEDBACK ABOUT NEWSLETTER SERVICES



SURVEY INTRODUCTION

Thank you for taking this survey.

The purpose of this survey is to hear your feedback about the information and materials provided in the MedSun Newsletter, both the PDF version sent via email in addition to updates to the MedSun website. We will use these results to improve the materials we provide you in both MedSun Newsletter versions.

Your participation / nonparticipation is completely voluntary and your responses will not have an effect on your eligibility for receipt of any FDA services. In instances where respondent identity is needed (e.g., for follow-up of non-respondents), this information collection fully complies with all aspects of the Privacy Act and data will be kept private to the fullest extent allowed by law. OMB Control Number: 0910-0697.

ABOUT YOU

1. How long have you been involved in the MedSun program? (Select one.)

  • Less than 1 year

  • More than 1 year to 3 years

  • More than 3 years to 5 years

  • More than 5 years to 10 years

  • Don’t know.

2. What selection most accurately represents your job title? (Select one.)

  • Biomedical Engineer

  • Clinical Engineer

  • Legal Department

  • Materials Management Services

  • Patient Safety Officer

  • Physician

  • Quality Improvement Officer

  • Registered Nurse/Clinician

  • Risk Manager

  • Surgical Services

  • Other

NEWSLETTER SERVICES

3. Do you read the MedSun PDF Newsletter sent via email and/or access the MedSun Website (online at www.fda.gov/medsun) that is updated each month? Please select the most appropriate response.

  • MedSun PDF Newsletter via email ONLY. CONTINUE TO 7.

  • MedSun Website that is updated each month ONLY (online at www.fda.gov/medsun). CONTINUE TO 21.

  • Both CONTINUE TO 15.

  • Neither CONTINUE TO 4.

IF RESPONDENT SELECTED ‘NEITHER’ IN Q3

4. Your previous response indicates you do not take advantage of any Newsletter Services. We are interested in your TOP 3 reasons why you do not read the MedSun PDF Newsletter sent via email. (Please select your TOP 3 choices.)

  • Not enough time to read the information

  • Too much information

  • Information is not relevant to my job

  • Format is not easy to read

  • I can’t find what I am looking for

  • Hospital computer does not support PDF attachments

  • I didn’t know about it

  • I read this information by accessing the Landing Page in the MedSun Reporting Site

  • Other ___________

5. Your previous response indicates you do not take advantage of Newsletter Services. We are interested in your TOP 3 reasons why you do not visit the MedSun Website that is updated each month. (Please select your TOP 3 choices.)

  • Not enough time to read the information

  • Too much information

  • Information is not relevant to my job

  • Format is not easy to read

  • I can’t find what I am looking for

  • Hospital does not support Web browsing

  • I didn’t know about it

  • I read this information by accessing the Landing Page in the MedSun Reporting Site

  • Other __________

6. What other sources do you use to find medical device safety information?

____________.

Thank You for taking this survey [ENDS FOR PARTICIPANTS WHO DO NOT TAKE ADVANTAGE OF NEWSLETTER SERVICES]

MEDSUN PDF NEWSLETTER - -- IF RESPONDENT SELECTED ‘ONLY’ IN Q3

7. A previous response indicates that you read the MedSun PDF Newsletter. How often do you read the MedSun PDF Newsletter that is sent to your email address?

  • Every month

  • Most months

  • Some months

  • On rare occasions

8. Which information provided in the MedSun PDF Newsletter are you MOST likely to read?

1=not likely; 2=somewhat likely; 3=moderately likely; 4=very likely; 5=extremely likely.

  • Welcome Note 1 2 3 4 5

  • Recalls 1 2 3 4 5

  • FDA Safety Communications 1 2 3 4 5

  • Subnetwork Updates 1 2 3 4 5

  • Upcoming Events and Orientations 1 2 3 4 5

  • Paperwork and Security Reminders 1 2 3 4 5

  • Highlighted Reports 1 2 3 4 5

  • Medical Device Problem Summary tables 1 2 3 4 5

  • FDA safety websites 1 2 3 4 5

  • Other ___________ 1 2 3 4 5

9. Do you refer your colleagues in other parts of your hospital to any information provided in the MedSun PDF Newsletter?

  • Always

  • Sometimes

  • Rarely

  • Never (Skip to question 11.)

10. Which information provided in the MedSun PDF Newsletter do you most often refer to your colleagues? Select your TOP 3.

  • Welcome Note

  • Recalls

  • FDA Safety Communications

  • Subnetwork Updates

  • Upcoming Events and Orientations

  • Paperwork and Security Reminders

  • Highlighted Reports

  • Medical Device Problem Summary tables

  • Useful FDA websites

  • Other ___________

11. Do you use any of the information provided in the MedSun PDF Newsletter to assist you in staff training sessions or during staff in-services?

  • Yes

  • No – (Skip to question 13.)

12. (If ‘yes’) Please select the information you use to assist you in staff training sessions or during staff in-services. (Select all that apply.)

  • Recalls

  • FDA Safety Communications

  • Subnetwork Updates

  • Upcoming Events and Orientations

  • Highlighted Reports

  • Medical Device Problem Summary tables

  • Useful FDA websites

  • Other ___________

13. What other sources do you use to find medical device safety information?

_____________

14. What else would you like to tell us to help improve the MedSun Newsletter?

_____________

Thank You for taking this survey [ENDS FOR PARTICIPANTS WHO ONLY READ MEDSUN PDF NEWSLETTER]

MEDSUN PDF NEWSLETTER, CONTINUES TO MEDSUN WEBSITE-- IF RESPONDENT SELECTED ‘BOTH’ IN Q3

15. A previous response indicates that you read the MedSun PDF Newsletter. How often do you read the MedSun PDF Newsletter that is sent to your email address?

  • Every month

  • Most months

  • Some months

  • On rare occasions

16. Which information provided in the MedSun PDF Newsletter are you MOST likely to read?

1=not likely; 2=somewhat likely; 3=moderately likely; 4=very likely; 5=extremely likely.

  • Welcome Note 1 2 3 4 5

  • Recalls 1 2 3 4 5

  • FDA Safety Communications 1 2 3 4 5

  • Subnetwork Updates 1 2 3 4 5

  • Upcoming Events and Orientations 1 2 3 4 5

  • Paperwork and Security Reminders 1 2 3 4 5

  • Highlighted Reports 1 2 3 4 5

  • Medical Device Problem Summary tables 1 2 3 4 5

  • FDA safety websites 1 2 3 4 5

  • Other ___________ 1 2 3 4 5

17. Do you refer your colleagues in other parts of your hospital to any information provided in the MedSun PDF Newsletter?

  • Always

  • Sometimes

  • Rarely

  • Never (Skip to question 19.)

18. Which information provided in the MedSun PDF Newsletter do you most often refer to your colleagues? Select your TOP 3.

  • Welcome Note

  • Recalls

  • FDA Safety Communications

  • Subnetwork Updates

  • Upcoming Events and Orientations

  • Paperwork and Security Reminders

  • Highlighted Reports

  • Medical Device Problem Summary tables

  • Useful FDA websites

  • Other ___________

19. Do you use any of the information provided in the MedSun PDF Newsletter to assist you in staff training sessions or during staff in-services?

  • Yes

  • No – (Skip to question 21.)

20. (If ‘yes’) Please select the information you use to assist you in staff training sessions or during staff in-services. (Select all that apply.)

  • Recalls

  • FDA Safety Communications

  • Subnetwork Updates

  • Upcoming Events and Orientations

  • Highlighted Reports

  • Medical Device Problem Summary tables

  • Useful FDA websites

Other ___________

MEDSUN WEBSITE -- IF RESPONDENT SELECTED ‘ONLY’ IN Q3 -- OR IF RESPONDENT SELECTED ‘BOTH’ IN Q3 (in this case questions continue)

21. A previous response indicates that you access the MedSun Website that is updated each month. How often do you access the MedSun Website?

  • One time per month

  • More often than one time per month

22. Which information provided on the MedSun Website are you likely to read?

1=not likely; 2=somewhat likely; 3=moderately likely; 4=very likely; 5=extremely likely.

  • Class I Recalls 1 2 3 4 5

  • FDA Safety Communications 1 2 3 4 5

  • Highlighted Reports 1 2 3 4 5

  • Medical Device Problem Summary tables 1 2 3 4 5

  • MedSun Reports received in the past 30 days 1 2 3 4 5

  • About MedSun 1 2 3 4 5

  • Educational Materials 1 2 3 4 5

  • MedSun Newsletter Archive Search Tool 1 2 3 4 5

  • MedSun in Action 1 2 3 4 5

  • Search MedSun Reports 1 2 3 4 5

  • Other 1 2 3 4 5

23. How often, if at all, do you send web links directing your colleagues to the information provided on the MedSun Website?

  • Always

  • Sometimes

  • Rarely

  • Never (Skip to question 26.)

24. Which information on the MedSun Website do you most often, if at all, send to your colleagues? (Select up to 5 choices.)

  • Class I Recalls

  • FDA Safety Communications

  • Highlighted Reports

  • Medical Device Problem Summary tables

  • MedSun Reports received in the past 30 days

  • About MedSun

  • Educational Materials

  • MedSun Newsletter Archive Search Tool

  • MedSun in Action

  • Search MedSun Reports

  • Other ___________

  • Not Applicable

25. If in the previous question you selected “Educational Materials,” which materials do you send to your colleagues? (Select all that apply.)

  • Past Audioconference/webinar transcripts and slides

  • Training materials about reporting problems with medical devices

  • Subnetwork Materials

  • Recognize, Remove, Report video

  • Not Applicable

26. Do you use any of the information found on the MedSun Website to assist you in staff training sessions or during staff in-services?

  • Yes

  • No (Skip to question 29)

27. (If ‘yes’) Please select the information you use to assist you in staff training sessions or during staff in-services. (Select all that apply.)

  • Class I Recalls

  • FDA Safety Communications

  • Highlighted Reports

  • Medical Device Problem Summary tables

  • MedSun Reports received in the past 30 days

  • About MedSun

  • Educational Materials

  • MedSun Newsletter Archive Search Tool

  • MedSun in Action

  • Search MedSun Reports

  • Other ___________

28. If in the previous question you selected “Educational Materials,” which materials do you use to assist you in staff training sessions or during staff in-services? (Select all that apply.)

  • Past Audioconference/webinar transcripts and slides

  • Training materials about reporting problems with medical devices

  • Subnetwork Materials

  • Recognize, Remove, Report video

  • Not Applicable

29. What other sources do you use to find medical device safety information?

____________.

30. What else would you like to tell us to help improve the MedSun Newsletter? ____________.

Thank You for taking this survey [ENDS FOR ALL PARTICIPANTS WHO READ BOTH PDF MEDSUN NEWSLETTER AND/OR ACCESS MEDSUN WEBSITE]

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AuthorGittleson, Daniel
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File Created2021-02-01

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