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Select Your Area of Interest to Learn More

Healthcare regulatory requirements (mandates from the FDA, ONC, and CMS) are complex and becoming more intricate as advancements occur in healthcare IT. Hospitals and device manufacturers currently employ teams of people who have a collective focus to ensure compliance with these regulatory requirements. One area that often falls through the cracks is medical device tracking. This is a shared responsibility among the device manufacturer, various distributors and healthcare providers, and lapses in communication can result in patient injury and even death.

CAREier relieves the burden of device tracking requirements impacting manufacturers, hospital systems, and providers, while also delivering support across the device continuum to improve patient outcomes related to all medical devices. CAREier eliminates current manual processes, relying on paper and fax, through seamless and automated processes embedded in existing workflows. Our innovative approach to this longstanding problem protects brands, reduces costs, avoids complications, eases administrative burdens, improves patient satisfaction and safety, and complies with all device tracking and tracing requirements. In the 21st century, it is long past time to take advantage of modern technology to solve this critical communication problem!

A medical device implanted in a patient should be tracked for its useful life, which could be 15 years or more. This is an FDA requirement for certain devices—but, more important, it’s the right thing to do. If a problem with the device necessitates a recall, time is of the essence. Which specific devices must be recalled? Are they in the manufacturer warehouse, in a hospital storeroom, or already in a patient? How can we communicate with the hospital and patients?

Today, often manufacturers rely on regular mail to communicate these urgent messages. Yes, snail mail. That adds days or weeks to the process. Recipient information must be collected and letters prepared and physically mailed—that is if the manufacturer has the patient contact information. Hospitals are required to provide it when the device is implanted, but frequently fail to do so. Often, there is no process to keep contact information updated. When patients move or change email addresses or phone numbers, they become lost to the system. The result: large numbers of recall notices never arrive.

There is a solution. CAREier has created a complete ecosystem that connects manufacturers, hospitals, physicians and patients for the immediate, secure delivery of patient alerts. CAREier tracks medical devices from the initial manufacturer through sales channels to the patient. Using our system, a manufacturer can issue a recall in minutes and notifications are delivered immediately to the hospitals and patients. Message Sent. Message Delivered. Every Time.

Highly specialized devices have specific use cases and associated best practices to provide patients with the optimal outcomes. It is important to adhere to these standards, as deviations can lead to complications and adverse events. For medical devices, these Standards of Care can range from specified maintenance to an identified timeframe for device removal when no longer needed.

One example is inferior vena cava (IVC) filters, which are small metal devices implanted to prevent dangerous blood clots from traveling to the lungs. IVC filters can increase risks of new blood clot formation in the legs and abdomen. Certain filter types have also been found to fracture and/or cause symptoms if the filter legs penetrate the wall of the inferior vena cava. The U.S. FDA recommends filter removal when no longer required. Unfortunately, ineffective communication processes often result in the patient failing to receive the proper clinical follow-up. A recent study found that 55.3% of patients who received these filters were “lost to follow-up.”

Leveraging CAREier’s services, you can directly engage and provide communication to ensure patients return for their needed follow-up appointments to receive the recommended care, avoiding potential complications. Our focus is facilitating communication so healthcare professionals can spend more time practicing and less time on these administrative tasks.

In the end, it comes down to keeping the patient informed. When a problem is discovered that potentially affects a patient, a message must be sent quickly and securely to that patient. It must be received and acknowledged. The patient’s health, and even their life, may depend on the successful delivery. To that end, a manufacturer or healthcare provider must know how to reach that patient. Considering that devices may be recalled 10 to 15 years or longer after the implant date, likely the original patient address is incorrect, along with the email address and phone number. Every year thousands of messages sent to patients are never delivered. The patient remains unaware of a pending problem until it is too late and an emergency response is required.

A second major issue is the volume of messages to be delivered. In a major recall, tens of thousands of patients may have to be alerted. This is an enormous challenge for most manufacturers and healthcare providers.

CAREier solves these issues. We establish an ongoing relationship with patients through regular messages. We proactively update our systems if these messages are not delivered. We know how to reach the patients. Our systems are fully automated and in minutes can deliver millions of messages via email, text or automated phone call to patients, providers, and health systems.