Any parent or caregiver whose child depends on safe medical devices for children has probably wondered about the safety and efficacy of that device, especially with all the press surrounding defective medical devices for adults. The FDA\u2019s MedWatch \u2018adverse event\u2019 reporting program makes it easy for adults to report concerns regarding medical devices for children.<\/p>\n
While most children do not question if the medical device they are using is a safe medical device for children, their parents and caregivers may, and need a direct link to the agencies that ensure consumer safety. For this reason, the FDA created the MedWatch program. As with their adult device counterparts, all safe medical devices for children on the consumer market have undergone clinical trials and garnered approval by the U.S. Food and Drug Administration.<\/p>\n
However, according to Dr. Dianne Murphy of the FDA\u2019s Office of Pediatric Therapeutics (OPT), \u201cMost pediatric clinical trials involve a relatively small number of patients,\u201d which means that problems with the safe medical devices for children or drugs might not be indentified until they are in widespread use. These problems often remain unknown to the FDA until parents and caregivers inform the agency about them. Still, only about 5 percent of the 900,000 adverse event and medication error reports filed with the FDA\u2019s MedWatch system last year were for children.<\/p>\n
(https:\/\/www.fda.gov\/ForConsumers\/ConsumerUpdates\/ucm339672.htm?source=govdelivery)<\/p>\n
In light of this fact, The Cochran Firm \u2013 Ohio is working to make more parents and caregivers aware of the MedWatch \u2018adverse event\u2019 reporting program in an effort to increase the safety of medical devices and drugs for all children.<\/p>\n
Reporting Issues with Safe Medical Devices for Children<\/p>\n
By filing accurate and detailed reports concerning safe medical devices to the FDA, parents and caregivers play an important role in not only the safety of their own children, but all children who rely on medicines and medical devices for therapies and treatments.<\/p>\n
Parents and caregivers can report \u2018adverse events\u2019 through the FDA\u2019s MedWatch reporting database if any of the following are experienced:<\/p>\n
We encourage parents and caregivers to contact the FDA when something goes wrong or parents have a concern about a medicine or safe medical device for children.<\/p>\n
Reporting Adverse Events<\/p>\n
There are three ways parents and caregivers can report adverse events to the FDA:<\/p>\n