• E-mail
• Print
• RSS

Advice on medical device reporting

Ambulatory Safety Monitor, February 11, 2003

Want to receive articles like this one in your inbox? Subscribe to Ambulatory Safety Monitor!

Your medical device reporting (MDR) provides the Food and Drug Administration (FDA) with critical information about faulty medical devices that cause adverse events so they can be detected and corrected. You also help out your colleagues: Reporting device failures helps others to decide which equipment to purchase.

First, establish a reporting policy, says Marvin Shepherd, a safety engineer and medical device safety consultant out of Walnut Creek, CA.

Reportable adverse events are incidents caused by a medical device that may result in death or serious injury. The FDA requires you to report medical device-related deaths and serious injuries within 10 days. Also include the reason, such as a device failure, malfunction, improper or inadequate device design, labeling, or a user error.

Remember these tips:

• Don't hide user errors. You could put yourself and your organization at risk for a lawsuit.
• Identify in your policy the person in charge of MDR reporting and working with the FDA. Shepherd recommends that this person be the risk manager, or whoever is in charge of risk management responsibilities, such as a quality assurance staff member.
• Detail in your policy how staff investigate adverse events. Keep your policy brief, understandable, and readily available to all staff, Shepherd says. If your organization is part of a larger system, the corporate office can fold MDR procedures into the organization's overall policy and procedure.
• Include in your policies and procedures how you decide when to report an adverse event. You can integrate your MDR policy into your incident reporting system, Shepherd says.
  
  
  

  Want to receive articles like this one in your inbox? Subscribe to Ambulatory Safety Monitor!

  • E-mail to a Colleague
  • Print
  • RSS
  • Archive