In a survey, conducted in 2015-2016, only 58% of the World Health Organization members have implemented a regulation for medical products. Medical products as defined by the Food and Drug Administration is “an instrument, machine, or implant that is intended for use in the diagnosis for disease, or treatment in man or other animals.” Examples can range between significant risks such as (catheters, surgical tools, rebreathing devices, pacemakers, etc) and non significant risk devices, which only pose minimal risks (contact lens solutions, digital mammography, MRI, menstrual pads, etc). The regulation of medical devices promotes safety, effectiveness, health, as well as reducing harmful reactions caused by a device. Organizations such as the International Medical Device Regulators (IMDF), the Asian Harmonization Working Party (AHWP), and the 17th International Conference of Drug Regulatory Authorities (ICDRA) work to ensure safe and effective devices for patients. Also, The U.S. Department of Health and Human Services are developing programs such as digital prescribing programs, electronic decision-support programs.
The overall goals for Healthy People 2020 are to help people live their lives free of preventable diseases and injuries, and improve and promote good health by creating special programs.
It can be difficult to make sure the medical devices do not malfunction and cause more problems than intended. To prevent these from occurring, one primary prevention would be to research the device that will be used and then speak with a doctor in regard to, if this device is necessary. This can forestall the onset of any complications. If a patient notices unusual symptoms after a procedure where a medical device was implanted, reporting to their doctor would be a secondary prevention. This prevents any further advancement of reactions from a device. It’s important to be informed about the different kinds of medical products that can improve health in the future, keeping in mind the significant and non significant risks products.
Devices are listed as significant and/or non significant risked products, to inform patients about the potential affects their devices could bring. The FDA tests and approves these devices only through clinical trials and it is common that a few medical devices can result in failure after a procedure. A few of the most high-risked devices are transvaginal mesh, which is a surgical net used to support organs in a pelvic organ prolapse and can result in painful swelling or infection; metal hip replacements, which is a metal on metal ball on socket device used to alleviate hip pain and arthritis and can result in serious metal poisoning or other injuries; Da Vinci Robot which is used as another operating arm during a surgery and can result in system failures; and guidant defibrillator, also known as pacemakers, which is implanted inside patients with heart diseases and side effects are premature battery depletion. A study for the cause of failure in medical devices show that “most failures are due to preventable causes, inadequate medical equipment technicians and engineers, data deficiencies, and lack of predictive maintenance”.
After speaking with Donna Headlee, from the Division of Industry and Consumer Education (DICE) of Center for Devices and Radiological Health (CDRH), a branch from the U.S. Food and Drug Administration (FDA), the vision to improve the safeness of medical products was very clear. Across the United States, there are an abundance of high-quality, secure, and useful medical technologies. Before they are distributed to hospitals, medical products are tested for effectiveness and then approved. The responsibility of the CDRH is to facilitate device approval, as well as manage the performance and safety of devices. Their overall plan is to assure and improve the public health. The CDRH make sure that patients have easy access to safe medical
products. These plans are implemented with the help of a collaborative community. In their words, a collaborative community is where “private- and public-sector members, including the FDA, work together on medical device challenges to achieve common objectives and outcomes.” The FDA have generated a premarket approval (PMA) application to determine whether it consists of valid evidence that supports the effectivity and safeness of a certain medical device for its intended use.
As technology continues to rise, medical devices will advance as a result. The Center for Devices and Radiological Health plans to continue their goals in medical product safety currently and in the years to come. However, there are a few challenges when it comes to providing easy access to patients. The CDRH have taken steps to reduce the time and expense for generating clinical evidence. It takes a wealth of evidence to bring a medical product to the marketplace, especially one that is incredibly innovative or high-risked. Another issue that the CDRH are faced with is that they are underfunded which prevents them from regulating products as efficiently. As a result of lack of funding as well as highly innovative products, patients have been waiting for their access to these products that can potentially save their lives. Upon that, it takes time, money, and evidence to clear a product safe for the market.
