FDA Public Health Notification (formerly known as Safety Alert/ Public Health Advisory) Readership survey

Form Approved: OMB No. 0910-341 Expiration Date: xx/xx/xxxx. See OMB Statement at the end of the survey

FDA Public Health Notification: <insert PHN title> <insert date of PHN release>

PLEASE HELP US (TO HELP YOU)...

We need to hear from you so we can evaluate and improve the format of our Public Health Notifications as well as the overall effectiveness of the Safety Notification program. Please take a few minutes to answer the questions below. We will publish a summary of the results. All questions relate to this Public Health Notification.

Your responses will be kept confidential. Thank you for your assistance.

1. A. Is the problem addressed in this Notification clearly identified?  Yes

 No

B. If no, why not?

2. A. Is the problem addressed in this Notification easily understood?  Yes

 No

B. If no, why not?

3. A. Are the actions for reducing risk clearly explained?  Yes

 No

B. If no, why not?

4. A. Did you find the information contained in this Notification useful?  Yes

 No

B. If no, why not?

5. Did you find the information contained in this Notification to be timely?  Yes

 No

6. A. Were you aware of the problem addressed in this Notification prior to receiving it?  Yes

 No

B. If yes, how did you first become aware of the problem?

a____ personal experience e____ manufacturer recall

b____ coworkers f____ manufacturer notification

c____ professional bulletin g____ your organization’s management

d____ professional symposium h____ Other (please specify)___________________

7. A. Have you taken any actions to eliminate or reduce the risk as a result of the information in this Notification?

 Yes

• No

2. If yes, what actions did you take?

C. If no, why not?

a_____ already took action prior to Notification

b_____ actions planned prior to Notification but not yet taken

c_____ actions planned based on Notification but not yet taken

d_____ risk was never applicable to our operation

e_____ felt risk did not warrant action

8. A. Have you signed up to receive future Notifications electronically?

 Yes

• No

B. If no, why not?

9. My title is:

a____ Hospital Administrator f____ Quality Assurance Manager

b____ Risk Manager g____ Home Health Care Administrator

c____ Director of Nursing h____ Nursing Home Administrator

d____ Biomedical/Clinical Engineer I____ Hospice Administrator

e____ Safety Director j____ Other (please specify)_____________________________

10. In my organization, the most appropriate individual(s) to Notifications is(are): (Check as many as needed)

a____ Hospital Administrator f____ Quality Assurance Manager

b____ Risk Manager g____ Home Health Care Administrator

c____ Director of Nursing h____ Nursing Home Administrator

d____ Biomedical/Clinical Engineer I____ Hospice Administrator

e____ Safety Director j____ Other (please specify)_____________________________

11. I have the following suggestions for improving the FDA Safety Notification process:

Public reporting burden for this collection of information is estimated to average .25 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:

DHHS Reports Clearance Officer

Paperwork Reduction Project (0910-xxxx)

Room 531-H, Hubert Humphrey Building

200 Independence Avenue, SW

Washington, DC 20201

Insert FDA office to send the response to.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.