Medical Device Safety Standards

Medical transcription, including IME Transcription, often includes information about medical devices. How is the data from these devices used?

Researchers often use data from electronic health records to determine the safety of certain types of devices. However, certain information must first be redacted or de-identified before it can be used.

Medical devices are thoroughly tested by the Food and Drug Administration or FDA before they are used by the general public. This testing is just the first step of the process. After the devices hit the market, a number of things can happen. Researchers use real world data from actual patients to determine if the device will continue to be marketed and used by the public. In many cases, artificial intelligence is used to obtain the information to make those decisions.

Obstacles Obtaining the Information

There are a number of obstacles to obtaining the information. Logistics is a huge obstacle. Patient records are often located on many different databases in many different systems, and each system is different. This makes it difficult to locate the records and consistently evaluate the effectiveness of a device.

Privacy

Privacy is another concern. Researchers have had success using artificial intelligence systems that strip the medical files of personal identifying information, and then gather the data that is left. There is an incredible amount of information available in the records, which are available in staggering numbers. In such quantities, these records are able to show which devices are the most reliable.

In order to determine which devices are the most reliable, researchers use an algorithm to link certain traits.

For example, researchers might link infection rates and pain along with hip replacements. Hip replacement data is often used simply because there is so much data available. This algorithm method has shown that pain is an excellent predictor of complications later on. By using the data from many patients that spoke of pain, researchers could see what specific complications arose and note the type of device that was used in the patient.

Studies such as this are increasingly important in today’s world where people are getting hip replacements at younger ages. Researchers are using algorithms to see if certain hip replacement devices are better for younger patients than they are for older patients or if the same devices work equally well in both population segments.

Eventually, the hope is to be able to use the data obtained to create a tailor made treatment plan to each patient using their previous medical history. In order to do that, researchers need more data. Currently, researchers are starting to use the data algorithms at the Veterans Health Administration to see how their model works.

As more data is obtained and changes how medical records are encoded, accessed, and written, this will no doubt change IME transcription and medical transcription practices as well.