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One of the biggest thorns in the side of healthcare organizations—from large hospitals to small, privately owned practices—is the management of paperwork and data. Tight control and organization of medical data—whether digital or on paper—is required by FDA and various compliance regulations including the Health Insurance Portability and Accountability Act. Medical facilities must ensure that records are kept up to date, accessible, and secure in order to meet those government requirements, and medical device manufacturers must keep up with regulatory demands as well.
But organized paperwork and data is not just important to satisfy regulatory bodies. Tidy medical records make for better care quality, and they enable continuity of care—an element that can make or break a patient experience.
Within paperwork and data is a vast array of documents including:
- Hand-written notes taken by current and past healthcare practitioners.
- Lab reports.
- Insurance forms.
- Death certificates.
- And more.
Medical devices and systems are the types of technology that are creating this documentation, so a challenge exists for the medical device manufacturer to create products that help healthcare organizations keep such documentation organized. However, there is software that medical device manufacturers can employ to aid healthcare organizations in managing such data and staying compliant. Read on to learn more.
How Can Medical Device Companies Keep Compliant?
FDA's tendency to adapt and change document control requirements presents complications for medical device companies. But medical device document management software has evolved to address the document management needs of both medical device manufacturers and healthcare organizations, so they can stay compliant and consistent. Such software can be the turnkey solution for organizations that are required to meet regulatory standards across dozens of U.S. government groups.
Which Devices Does This Apply to?
Mobile. Mobile computing devices, including smartphones and tablets, have proliferated throughout the medical field for the last 15 plus years, and these devices' data output is massive. Specifically, the last 10 years have witnessed the explosive growth of the mobile device in medical settings, and surveys of healthcare professionals have showed a high rate of ownership of smartphones and tablets. In some instances, they have replaced desktop systems. Document management software has evolved to keep mobile devices in medical settings compliant with regulations. Examples include the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 and the Food and Drug Administration Safety and Innovation Act (FDASIA).
Imaging. Medical imaging devices produce documentation and data that also needs to stay secure and retrievable. Any technology that is used to create images of various parts of the human body for diagnostic and treatment purposes in digital health falls into this highly regulated category. These machines can include x-ray radiography, magnetic resonance imaging (MRI), ultrasonography, thermography, and more.
Other Diagnostic Equipment. Machines used for monitoring blood pressure, weight, pulse, body temperature, and other body processes also produce data that healthcare organizations need to keep secure and accessible. Items such as scales, stethoscopes, Dopplers, and the imaging machines mentioned above fall into this category.
While all of these types of devices have advanced at rapid rates over the years to improve medical settings, processes, and the patient experience, they all come with risk factors if the documentation and data they produce are not managed properly. Any amount of data generated from mobile, imaging, and diagnostic devices in a medical setting needs to be organized and easily retrievable.
Software is Here to Help
Advances in cloud technology have greatly improved medical organizations' abilities to corral their devices and the data they produce. The right document management software system will perform several crucial functions for keeping medical devices compliant:
- Automate Audits. Document management software can automatically consolidate requested data into reports that tag actions and relevant parties.
- Cull Non-Compliant Devices. Non-conforming end points can be tagged by system controls defined by the organization in order to track incidents and manage non-compliant circumstances.
- Improve Employee Training. The right software addresses the human component of staying compliant with comprehensive training. Modules and customized training processes can help medical staff learn how to reduce non-compliant instances.
As a cloud-based solution, document management software is a budget-friendly technology that can keep medical devices in line with FDA regulations. That way, both hospitals and medtech professionals can remain confident that devices are not presenting data-related risks to the medical field.