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New FDA Guidelines for Reusable Medical Devices

 Posted on March 19, 2015 in FDA

In an effort to increase safety and prevent disease, the United States Food and Drug Administration (FDA) released new recommendations regarding reusable medical devices. The announcement from the FDA was made following an outbreak of a bacterial superbug linked to the design of a specific piece of reusable medical equipment.

At least seven patients at Ronald Reagan UCLA Medical Center in Los Angeles were infected over the last several months with carbapanem-resistant enterobacteria, or CRE, while undergoing minor gastrointestinal diagnostic procedures. Two of patients later died from complications of the CRE infections, which antibiotics struggle to combat. The procedures at UCLA all involved a reusable medical device called a duodenoscope.

Hospital officials have determined that the device had been maintained and serviced in accordance with manufacturer guidelines, and claim that design flaws allowed the bacteria to be transmitted between patients despite the efforts of hospital staff. While the manufacturer continues to stand behind its products, the company is currently facing several lawsuits related to the outbreak.

Last week, the FDA issued new guidelines regarding reusable medical devices and reprocessing them for each subsequent use. Under the new rules, manufacturers will be expected to provide clear labeling and reprocessing instructions for their products to minimize the risk of contamination and illness. The administration lists six criteria that must be addressed by the manufacturers:

  • Labeling should clarify the device's intended use;
  • Instructions should specify the device must be thoroughly cleaned;
  • Instructions should indicate the recommended sterilization process;
  • Reprocessing should be feasible, using only legally available equipment or supplies;
  • Instructions for reprocessing should be thorough; and
  • Instructions should be clear and understable.

The FDA also recommends that consideration of the reprocessing cycle and its difficulties be included from the initial design stages for future devices. The new guidelines apply only to new devices seeking FDA approval, so currently marketed equipment, such as the duodenoscope at UCLA, would not necessarily be required to maintain compliance.

An improperly reprocessed reusable medical device can be extremely dangerous to patients or, as shown in recent months, possibly fatal. As federal regulators take steps to improve the safety of new equipment, devices currently in use at medical facilities around the country may continue to infect patients.

If you or a family member has suffered an infection potentially related to a reusable medical device, you may be entitled to seek damages from the hospital or manufacturer. Contact an experienced Illinois defective medical device attorney for a consultation today and put our team to work for you.

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