Blog: Footstep Following: A Sure-Fire Route to Medical Device Compendia Success
August 9, 2018
Unfortunate Scenario 1: An Interventional radiologist needs to start intravenous (IV) lines in a pediatric patient. This involves trying various types of IV catheters in different places – arm, neck, leg – with the young patient. Unfortunately, the trial-and-error process results in pain and suffering. What’s frustrating is that this scenario repeats itself the next time the patient comes to the hospital, as the process — and subsequent pain starts all over again. If only the electronic medical record (EMR) contained information on which device worked and which didn’t, then the clinician could provide a better, pain free experience.
Unfortunate Scenario 2: A patient with a pacemaker needs to undergo an MRI to explore another potential health problem. However, the patient doesn’t know what type or model of pacemaker he had implanted. As such, the clinicians are pretty much in the dark as to whether the pacemaker will react badly to the imaging exam. They don’t know if they have to adjust wires in the pacemaker or set the MRI machine to a particular setting to prevent an adverse event. So, the patient walks away – and doesn’t get the much-needed imaging exam. If only the EMR contained information on this individual’s pacemaker and how to handle it during imaging exams, then the patient would get the care he needs.
The problem: medical device information within information systems currently is unstructured, incomplete, and in many cases simply unavailable.
Fortunately, we are on the precipice of eliminating these unfortunate if onlys. In fact, the device identification challenge can now be addressed, as the Food and Drug Administration’s unique device identification system requires that all devices include a unique device identifier (UDI) in human- and machine-readable form and that certain information about each device is submitted to the FDA’s Global Unique Device Identification Database (GUDID).
Now, if only we, as an industry, could easily leverage this information to optimally track, utilize and manage devices in a manner that will improve safety, support the delivery of high quality care and lower costs. Well, I’ve got good news. We can – and the industry doesn’t have to recreate the wheel, as established drug compendias can serve as models for the development and utilization of similar medical device databases. As someone who was involved in the creation of these drug compendia, I have witnessed how these electronic drug “encyclopedias” have opened up opportunities for improving clinical decision support, drug utilization, care outcomes, cost savings and the quality of patient care. And, perhaps more importantly, I believe that similar compendia can make it possible to more efficiently and safely use medical devices.
A medical devices compendia could serve as a “source of truth” by providing structured, complete, and readily available information about a full array of products from those that are implanted in patients such as hip replacements, pacemakers, and stents as well as surgical instruments and medical supplies. The compendia could go beyond providing the identification data currently available in the GUDID and add information that healthcare organizations need in a format that makes it easy to use.
As a result, medical device compendia could not only help healthcare organizations identify devices but also:
Track the effectiveness of devices by answering questions such as did the device shorten the patient’s stay in the hospital? Did it require patients to come back and get an updated device implanted? Did the device enable the patient to experience positive care outcomes? Did the device fail to perform as needed?
Provide additional clinical information by enabling clinicians and others to access specific information related to devices. For example, physicians who are performing catheterizations will want to know the length, size and volume of the catheters.
Facilitate recalls by making it possible to quickly identify which patients have had faulty devices implanted. As such, staff members can quickly identify these patients and inform them of the problem with the device and the need to see their physician for follow-up care. Without the device compendia in place, manufacturers simply inform provider organizations that they sold the faulty devices to them and staff members then need to laboriously flip through their charts and figure out if the specific product with a specific UDI was given to a specific patient. With a medical device compendia, information about recalled devices is sent in real time, through push notifications in your information system. So, organizations can identify what patients received the devices – and also manage and purge recalled device inventories quickly and cost effectively.
Streamline the work of registry staff by eliminating the need to collect device information manually from a medical record. Instead, this information would be captured as a device is scanned prior to being used with a specific patient. As such, registry staff could simply pull the information off of the computer system and provide it directly to the various registries.
These are just a few of the benefits that could be achieved through a medical device compendia. In the final analysis, having easy access to this device information is bound to enable healthcare organizations to experience the overall quality and cost improvements similar to those that have been achieved through the use of a drug compendia.
About Julie Suko, PharmD
Julie Suko is senior director of editorial content services for FDB where she is responsible for overseeing the identification and acquisition of relevant drug and drug?related data from identified primary sources, development and maintenance of drug pricing information, coordination with manufacturers and regulatory agencies and supervision of editorial and data structure modules within FDB MedKnowledge. Connect with Julie on LinkedIn.