The progress of medical equipment is one of the major factors that contributed to the development of the medical world. Modern medical devices can come in simple shapes such as catheters and sutures or in more sophisticated shapes such as resuscitation equipment or incubators. Despite the fact that most equipments are quite trustworthy, it is not uncommon for some of them to fail, resulting in patient injuries and even deaths. Medical equipment failure can come from medical negligence or equipments malfunctions. Though the medical world has advanced greatly it is essential to reduce the device malfunctions as much as possible in order to protect the well being of the patients.
MDR is short for Medical Device Reporting and it is a regulation for all medical devices manufacturers, importers and users. The regulation states that these companies and individuals are obliged to report adverse events to the FDA. This information is used in order to control and prevent the failure of medical devices. Furthermore both patients and medical professionals can use a program called MedWatch in order to report disturbing incidents regarding medical equipment. The manufacturers are forced to report any malfunctions that could endanger a patient’s health. If such an information comes to the importers, they too need to report it. As far as the user facilities go suspect devices need to be reported to the FDA as well as to the manufacturers. Despite the fact that the MDR has been around since 1948, its utility is still debatable as a lot of cases remain unreported even nowadays. Furthermore the latest updates in the MDR politics don’t seem like they were made with improvements in mind. The Manufacturers and distributes are no longer forced to submit annual certification reports. User facilities file annual reports instead of semi annual ones and domestic distributors only keep complaint files without filing reports. The latest upgrades seem rather pointless given the fact that the MDR wasn’t so effective to begin with.
Aside from regular and voluntary reports it is important for the FDA to also assign specialists to analyze the failure. If a device is malfunctioning it is important that it is repaired or replaced. However it is equally important to determine the cause of the malfunction in order to avoid a future similar scenario. There are about 80 000-85 000 reports of medical equipment failure each year. Despite the fact that these numbers are a lot smaller than those related with medical negligence, they are still alarming and need to be dealt with.
It is not uncommon for medical equipment failure to happen due to the fact that the devices were not properly used. These cases can fall under the category of medical negligence. All equipments come with solid instructions and if the healthcare providers don’t respect those instructions, they can be held liable for patient injuries. It is important for hospital administration to provide proper training sessions in order to make sure that the medical specialists know how to use the medical devices. Furthermore the hospital administrations should also make regular inspections in order to make sure that the equipments are used in a proper way.