Medical devices are not safer to use because data needed to identify dangerous devices is not routinely reported in the United States. Health problems caused by medical devices are not uncommon. The number of recalls continues to climb due to several factors. It should be a given that lifesaving devices are closely monitored. That isn’t the case, however.
Medical Devices Can Be Dangerous
The very devices that people rely on to save their lives can instead wreck havoc. The United States Food and Drug Administration (FDA) is responsible for investigating problems. Recent recalls and problem devices include:
- Defibrillators: Nearly 200,000 implanted defibrillators were recalled in 2011 due to a faulty part.
- Power morcellators: Used in hysterectomies, the FDA warned in 2014 that most women should not have surgery using one of these devices.
- Essure birth control: The FDA received more than 5,000 adverse events reports in 2015 but has still not banned the device.
- Transvaginal mesh: Complications were found in 10% of the surgeries, with over 73,000 lawsuits filed by women who were injured.
- Hip and knee replacements: Poorly designed replacements can fail and cause bone fractures, often requiring more corrective surgery. The FDA has reported recalls from several companies in recent years.
The FDA lists information about the most significant medical device recalls. Class I recalls are issued because the device has a reasonable chance of causing serious health issues or even death. Persons affected by a Class I recall should seek the advice of a Reno defective medical device lawyer immediately.
The Number Of Recalls Continues To Climb
Recalls continue to increase year after year. Recalls nearly doubled from 2003 to 2012 according to the FDA. There were 604 recalls in 2003, compared to 1,190 in 2012. Class I recalls, which can result in death, rose in number as well. Seven Class I recalls were issued in 2003, compared to 57 in 2012.
Recalls often come too late for the patients because the faulty devices have already been implanted. There are several reasons for more recalls. The most cited reasons by the FDA include:
- Nonconforming material or component
- Faulty software design
- Faulty device design
- Labeling errors
- Mix-up of materials or components
A Reno defective medical device lawyer can provide another layer of protection for consumers. The growth of technology will see more and more medical devices available. These devices should be properly tested and safe for public use. Tracking medical device use would provide data that could help save money and save lives.
A Monitoring System Can Save Lives
Drugs, vaccines, and medications are watched very closely by the FDA using the Sentinel Initiative. Sentinel is a national electronic system that monitors FDA-regulated products. The Adverse Event Reporting System is a database that contains information submitted to the FDA.
Many medical devices are not included in the Sentinel Initiative because unique identifiers are not required to be on standardized medical claims data. The exact device used is not necessarily listed on the claims. There is no standardized system, so claims data may not integrate with other systems. This is dangerous for patients and makes reporting faulty devices difficult.
Some high-risk devices do include unique identifiers and bar codes that are suitable for tracking. Several members of Congress and FDA Commissioner Robert Califf support device tracking. Health care providers and medical societies also support tracking medical devices.
A monitoring system would make any problems easier to detect. Doctors, hospitals, and care providers could report adverse effects of devices. Patients could also report issues they are having. All reports would go to a database, alerting the FDA in a timely manner. Lives could be saved because an investigation could be launched sooner. A recall could be issued in a fraction of the time.
Not Everyone Agrees With Tracking
The price tag for a medical device surveillance system would be around $50 million per year. Hospitals would also have to pay to adopt the system. Marilyn Tavenner, a former administrator for the Centers for Medicare and Medicaid Services spoke out against a monitoring system due to increased costs.
However, such a database would provide invaluable data that could save many lives. Faulty medical devices cost taxpayers billions of dollars, according to Daniel Levinson, the Inspector General of the Department of Health and Human Services. The cost of the defective defibrillators alone was near $300 million.
Medical Devices Should Not Cause Harm
Medical devices are intended to save lives. A centralized reporting system, similar to what is in place for medications and vaccines, could greatly improve device safety. Until such a system is in place, a Reno defective medical device lawyer can hold manufacturers responsible for faulty products.