Safety

Medical Product Safety Educational Resources

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MedWatch Tips & Tools for Health Professionals

FDA needs to know when a serious problem with a medical product is suspected or identified in clinical use. FDA Drug Info Rounds pharmacists discuss how FDA’s MedWatch program makes it easy to get important safety information directly from you to us. Run time 3 min 14 sec

 

MedWatch for Nurses: Clinically Important Reporting and Safety Resources for Practice

FDA's MedWatch Program is a valuable resource for nurses in any practice setting, providing important information on all medical products as well as for reporting problems with them. Run time 2 min.

 

Safety Information Resources for Physicians

Busy doctors need a quick method of finding up-to-date and science-based new safety information on the human medical products that they use, prescribe or administer in patient care. MedWatch delivers free Safety Alerts to doctors, either online or delivered to the doctor at the point-of-care via email or text message to their computer or smartphone. Run time 5 min.

 

Reporting Product Problems to FDA: Video For Consumers

Reports of problems submitted to FDA by consumers are an important part of the agency’s strategy for identifying risks with products after they’ve reached the market. These reports help FDA protect the health and safety of all Americans—and can ultimately save lives. MedWatch Medical Director Norman Marks explains how the public can submit reports and how the agency uses this information. Run time 3 min.

 

Reporting Product Problems to FDA: Video For Healthcare Professionals

What to report to FDA when you suspect that a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure may be associated with the use of an FDA-regulated human medical product. Run time 3 min 50 seconds. 

FDA Patient Safety News, Show #93, December 2009

Transcript of video

 

Bad Reactions to Cosmetics? Tell FDA!

From styling our hair to showering before bed, Americans love cosmetics. Most are safe, but some cause problems, and that's when the Food and Drug Administration gets involved. Run time 1 min 34 sec.

 

BeSafeRx: Know Your Online Pharmacy

A national campaign to raise awareness of the dangers of buying prescription medicines from fake online pharmacies.

 


 

Safety Information Resources for Health Professionals

Learn about medical product safety information available from FDA.

Video, approximately 11 minutes

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SIR Video screenshot featuring FDA Director Dr. Janet Woodcock

"Busy healthcare professionals need the best safety information at the right time to help manage their patients' care."

Dr. Janet Woodcock, FDA

 


 

FDA MedWatch and Patient Safety

A self-learning tutorial covering the MedWatch program goals of broadcasting safety information and encouraging adverse event reporting.

  • Video, approximately 24 minutes. 
  • Powerpoint presentation [25 slides]
  • Transcript
  • Self-administered quiz with answers

MedWatch tutorial screenshots 

" ... Even a few voluntary reports ... can become the signal that leads to a label change or other FDA actions to improve the safe use of a medical product."

Dr. Norman Marks, FDA

 


 

MedWatch: Safety Information and Adverse Event Reporting

In this expert column, Norman Marks, MD, Director of the FDA's MedWatch program, discusses the role of MedWatch in adverse event reporting and in disseminating timely and targeted safety information.

Medscape Pharmacists-Expert Column, March 11, 2009 

screenshot of Medscape article

"[MedWatch is] a trusted source of safety information as you provide the best care for your patients."

Dr. Norman Marks, FDA

 


 

Boxed Warnings and Other FDA Communication Tools

In this editorial, FDA Medical Officers Norman Marks and Karen Weiss discuss the risk communication tools used by the FDA to provide science- based, credible, and timely information that make a physician's job easier and patients safer.

American Family Physician, February 1, 2010, Volume 81, Number 3

Boxed Warnings and Other FDA Communication Tools, Amer Family Physician, Vol81, No 3

"Well-placed information can assist a busy physician in locating new drug safety information at the point of care."

Dr. Norman Marks, FDA
Dr. Karen Weiss, FDA

 


 

Safe Disposal of Medications and Sharps in the Home Setting

A joint presentation by FDA and the American Nurses Association provides information on safe disposal of unused or expired treatments, medications, and devices used in the home setting.

Safe Disposal of Medications and Sharps in the Home Setting

"As healthcare has shifted from the hospital setting to the home, so have nurses who often provide the care. This webinar educates nurses and their patients on how to handle these risks."

Christine Merenda, RN, FDA  

 


 

Introducing MedWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems, JAMA, June 2, 1993, Vol 269, No 21. David Kessler, MD.

Original article announcing the implementation and rationale for the MedWatch program.

 

Managing the Risks from Medical Product Use: Creating a Risk Management Framework

Report to the FDA Commissioner From the Task Force on Risk Management, May 1999


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Page Last Updated: 02/04/2016
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