Quality Check: Overcoming the Challenges of Remote Care Compliance
By Toni Ellis, Director of Quality – Medioh
While remote health innovates and expands how patients receive care, it is still medical care. Because of this, remote care kits comprised of medical devices and medical technologies need to be handled according to the appropriate regulatory standards.
This means that remote health assets, kits, and those who create them all fall under the same regulatory oversight that clinical devices and organizations would.
These regulations come from bodies such as the FDA, CFR, CMS, and other health bureaus, such as Health Canada, to ensure patient safety and care quality.
As remote care models continue to expand across North America at transformative scale, so grows the regulatory eye of these governing bodies, all of whom dictate the standards that remote care technology must meet to be made available to consumers.
Providers are now tasked with navigating these regulatory waters to provide remote care to the patient populations who need and want it, all while ensuring compliance and safety throughout.
But, when scaling remote care programs, maintaining medical-grade compliance is no easy task.
Among many crucial compliance regulations, those delivering care remotely must be able to comply with numerous international standard operating procedures to properly manage remote care assets within a program.
This also includes standards related to reprocessing or refurbishing medical devices used in remote care, which require physical facilities to calibrate, test, disinfect, and perform other activities that keep these devices compliant and safe for patient use.
In addition, standards from HIPAA and ISO27001 strictly regulate how data and protected health information must be secured during RPM.
The process to be certified and compliant with these standards is difficult, requiring extensive time and investment in a specialty that simply falls outside of the core mission of healthcare organizations, which is providing care to patients.
Testing of Remote Patient Monitoring Devices – 2021 Medioh
To manage these added layers of service, and maintain their focus on care, health providers partner with logistics and technology experts who fill in these gaps; designing solutions that enable program scalability without ever sacrificing quality or compliance for volume.
We Need a System
Given the number of managed assets within remote health programs, a deliberately-designed Quality Management System (QMS) is required to keep track of the status, functionality, and safety of each device for each patient in a program.
Leading logistics and technology support partners engineer comprehensive QMS platforms to manage partner programs. This advanced approach to Quality Management allows for seamless workflows that ensure quality, compliance, and patient support are always met to precise standards.
This quality management system controls each activity spanning from the manufacturing and procurement of remote care devices themselves, all the way to the end of a patient’s health program to device return and reprocessing.
Ensuring quality and compliance throughout the entire RPM process requires advanced capacities in logistics, as well as regulated facilities capable of properly and safely managing and processing these assets. It also requires the expertise to manage both remote care technology and patient experience with it.
Logistics and technology support partners are helping healthcare providers overcome these service scalability gaps, designing tailored solutions that help them seamlessly scale their remote care programs.
Find out more about how Medioh enables remote care at transformative scale.