What Does The Devices Division of The MHRA Do?
The Devices Division of the MHRA
Medical technology has expanded and progressed greatly in recent years. Treatments for a number of conditions now involve medical devices. Many of these devices are complicated and extremely high tech. With medical devices taking such a large share of medical care, safety and regulation has become an important focus for the Medicines and Healthcare Products Regulatory Agency. The wing of the MHRA that is in charge of medical device compliance in the EU is called the Devices Division. The function of this division is to ensure that all medical devices available as treatment options are safe and effective options. The devices division has the authority to declare medical devices safe or unsafe based on independent testing and field data.
What are medical devices?
The term ‘medical device’ covers a large portion of healthcare in the United Kingdom. These items include high tech diagnostic equipment such as the Magnetic Resonance Imaging machines used in hospitals to simple over the counter products such as bandages and splints. Virtually any item that is used to treat or help correct a medical condition falls under the category of medical devices. Medical devices are becoming more and more common in our hospitals and at our doctors’ offices.
Why is it important to regulate medical devices?
Medical devices offer the potential to help heal and correct many medical conditions. They can also create great amounts of damage if they are unsafe or create side effects. Diagnostic machines that allow us to see inside the body are of great use and a wonderful tool for doctors. However, if they are not proven safe and regulated the radiation these machines produce could cause a host of other problems for patients as well as practitioners. The same issues exist for implants and devices designed to correct bone fractures or other problems. If a back brace causes other problems while correcting a back problem its effectiveness is not very good. As medical devices become more and more complicated it’s important to have a central agency overseeing their safety because the testing they will require will be specialized and high tech in nature. Testing new x-ray machines and heart regulators will require special equipment and advanced scientific knowledge. The devices division of the NHRA has this technology and some of the best scientific minds working to safeguard the public.
Where does the devices division get its data?
One of the ways that the devices division helps to keep the public safe from dangerous medical devices is by tracking problems associated with them. The devices division of the NHRA gets its data from a number of sources. The NHS is a big source of data regarding problems with medical devices. Much of this information is available through the Clinical Practice Research Datalink. The NHS has far-reaching access to this type of data and can be very helpful for the devices division. Private hospitals and care homes also provide data to the devices division. When these institutions see patients coming in with problems caused by their medical devices a report is made by the attending physician and then relayed to the devices division of the MHRA so that they may file it with other similar reports to monitor the frequency of these happenings. Manufacturers also report to the devices division. In cases of defects or recalls manufacturers are often obliged to contact the devices division so that they can take the appropriate action to safeguard the public. The final way that the devices division receives information regarding problems with medical devices is directly from the public itself. The public can report issues to the devices division through the MHRA website or through other traditional channels. All of this data is collected so that trends of problems with medical devices can be identified and corrected.
Testing
The devices division does its own testing of a variety of medical devices to ensure that they are safe for the public to use. These devices need to be certified as safe before they can be used for patients and the devices division is in charge of handling this process. Without their approval medical devices may not be sold to consumers. When the devices division finds defects or other problems with devices, it often will report these issues to the manufacturers. The devices department also relays information from the public to manufacturers so that they may make corrective action. The devices department will make recommendations to device manufacturers as well when deemed necessary.
What are medical devices?
The term ‘medical device’ covers a large portion of healthcare in the United Kingdom. These items include high tech diagnostic equipment such as the Magnetic Resonance Imaging machines used in hospitals to simple over the counter products such as bandages and splints. Virtually any item that is used to treat or help correct a medical condition falls under the category of medical devices. Medical devices are becoming more and more common in our hospitals and at our doctors’ offices.
Why is it important to regulate medical devices?
Medical devices offer the potential to help heal and correct many medical conditions. They can also create great amounts of damage if they are unsafe or create side effects. Diagnostic machines that allow us to see inside the body are of great use and a wonderful tool for doctors. However, if they are not proven safe and regulated the radiation these machines produce could cause a host of other problems for patients as well as practitioners. The same issues exist for implants and devices designed to correct bone fractures or other problems. If a back brace causes other problems while correcting a back problem its effectiveness is not very good. As medical devices become more and more complicated it’s important to have a central agency overseeing their safety because the testing they will require will be specialized and high tech in nature. Testing new x-ray machines and heart regulators will require special equipment and advanced scientific knowledge. The devices division of the NHRA has this technology and some of the best scientific minds working to safeguard the public.
Where does the devices division get its data?
One of the ways that the devices division helps to keep the public safe from dangerous medical devices is by tracking problems associated with them. The devices division of the NHRA gets its data from a number of sources. The NHS is a big source of data regarding problems with medical devices. Much of this information is available through the Clinical Practice Research Datalink. The NHS has far-reaching access to this type of data and can be very helpful for the devices division. Private hospitals and care homes also provide data to the devices division. When these institutions see patients coming in with problems caused by their medical devices a report is made by the attending physician and then relayed to the devices division of the MHRA so that they may file it with other similar reports to monitor the frequency of these happenings. Manufacturers also report to the devices division. In cases of defects or recalls manufacturers are often obliged to contact the devices division so that they can take the appropriate action to safeguard the public. The final way that the devices division receives information regarding problems with medical devices is directly from the public itself. The public can report issues to the devices division through the MHRA website or through other traditional channels. All of this data is collected so that trends of problems with medical devices can be identified and corrected.
Testing
The devices division does its own testing of a variety of medical devices to ensure that they are safe for the public to use. These devices need to be certified as safe before they can be used for patients and the devices division is in charge of handling this process. Without their approval medical devices may not be sold to consumers. When the devices division finds defects or other problems with devices, it often will report these issues to the manufacturers. The devices department also relays information from the public to manufacturers so that they may make corrective action. The devices department will make recommendations to device manufacturers as well when deemed necessary.
