Why You Should Know What an MDR Is
“MDR” has two different meanings, both of which have some significance in the field of healthcare. The following is an explanation of both definitions of MDR.
Medical Device Reporting (MDR)
Every year, the Food and Drug Administration (FDA) receives several hundred thousand reports of malfunctions, serious injuries, and deaths suspected to be associated with medical devices. Medical Device Reporting (MDR) is a post-market surveillance tool FDA uses to:
- Monitor medical device performance;
- Detect potential device-related safety issues; and
- Perform benefit/risk assessments of medical devices.
Mandatory and Voluntary Medical Device Reporting
Manufacturers, importers, and facilities that use medical devices are required to submit various reports for adverse events and problems with the medical devices. Healthcare professionals, caregivers, patients, and consumers are also encouraged to submit voluntary reports of any serious usage errors, therapeutic failures, adverse events, or product quality issues. These reports provide critical information to improve patient safety and health.
MDRs on Surgical Staplers
The potential of surgical staplers for malfunction and misuse, and the resulting harm to patients, makes them the number one health technology hazard in hospitals, as reported in an article on Medscape. In March 2019, the FDA issued an alert to physicians concerning an increase in the number of MDRs regarding the use of surgical staplers. Between January 1, 2011 and March 31, 2018, the FDA received more than 41,000 MDRs on surgical staplers and staples for internal use. This included reports of 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions.
Multi-Drug Resistant (MDR) Bacteria
Multi-drug resistant (MDR) bacteria are one of the greatest threats to human health worldwide, as reported in an article published by the Infectious Disease Clinics of North America. Although they are typically associated with infections originating in the hospital, some MDR bacteria have become prevalent as causes of infections acquired in the community. The spread of MDR bacteria into the community is a critical development associated with increased morbidity, mortality, antibiotic use, and healthcare costs.
How Are Hospitals Responsible for Dangerous Devices and Multi-Drug Resistant Bacteria?
Under the law, manufacturers and importers of medical devices are required to submit a Medical Device Report (MDR) for any sign of malfunction or injury caused by a device. Hospitals and other facilities that use medical devices are required to report associated serious injuries and fatalities. They are not required to report device malfunctions, but are encouraged to do so. However, lack of training on how to recognize defective medical devices and how to submit an MDR may represent a snag in the medical device reporting system. Hospital staff’s fear of being held personally responsible for bad outcomes caused by defective medical devices may also inhibit reporting.
Hospital Reporting and the Spread of Drug-Resistant MDR Bacteria
Hospitals are key in the spread of multi-drug resistant (MDR) bacteria. Two key factors contributing to the spread of MDR bacteria are hand contamination among hospital personnel and hand contamination among patients. Researchers found that patient hand hygiene protocols could reduce transmission of MDR bacteria and help prevent serious infections, in a study published in Clinical Infectious Diseases.
Hospitals have a responsibility to safeguard the health and safety of their patients. When they fail to do so, they may be liable for the resulting harm. If you or your loved one has been injured by a medical device or contracted an infectious disease in a hospital, contact Grant Law Office at (404) 995-3955. Our Atlanta personal injury lawyers can tell you if you have a case and what damages you may be entitled to claim.
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