Safety
Medical Product Safety Educational Resources
Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products. |
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 Healthcare Professionals
Reporting Adverse Events to FDA's MedWatch Program (FDA Patient Safety News, December 2009)
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.
Click the video to play, or use the following link to read the transcript of the video and get links for the video presented in wvm, Real, and mpeg formats: FDA Patient Safety News, Show #93, December 2009
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Reporting Product Problems to FDA: Video For Consumers
Your Guide to Reporting Problems to FDA (FDA Consumer Update)
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. |
Safety Information Resources for Health ProfessionalsLearn about medical product safety information available from FDA. | ||
Video, approximately 11 minutes Windows: 300k | 150k Choose 150k bit rate videos for slower
| "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.
| " ... 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
| "[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 | "Well-placed information can assist a busy physician in locating new drug safety information at the point of care." Dr. Norman Marks, 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. | "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
Older Articles
- Post-marketing Surveillance for Adverse Events After Vaccination: The National Vaccine Adverse Event Reporting System (VAERS), November 1998 (PDF format)
- Improving Patient Care by Reporting Problems with Medical Devices, September 1997 (PDF format)
- The Clinical Impact of Adverse Event Reporting, October 1996 (PDF format)
- Communication Dynamics: A Resource in Assuring Drug Quality, 1998
- Clinical Therapeutics and the Recognition of Drug Induced Disease, June 1995 (PDF format)
Use 8 1/2" x 14" paper to print this PDF document.