Every Year, 1000s of Patients are Harmed or Die Due to Critical Healthcare Messages Never Received This Stops Now! Introducing Mission-Critical Messaging Across the Entire Healthcare System Message Sent.
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We provide ultra-reliable, immediate communications for regulatory issues, device recalls, updates and any other mission-critical information.
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Medical Device Manufacturers

As a medical device manufacturer, you make devices designed to improve quality-of-life and longevity. However, even with the best intentions and dedication to quality, complications can arise. These might be a malfunctioning part, design flaw, or simply a required device software update. Regardless of the issue, it is incumbent on you, the manufacturer, to address the problem. You will potentially be required to communicate field notices, recalls, or warnings to mitigate potential harm. This is not only the right thing to do, but, in certain cases, is required by federal regulation and law. The tracking provisions of section 519(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 360i(e), were added in 1990 by the Safe Medical Devices Act (SMDA) and amended in 1997 by the Food and Drug Administration Modernization Act (FDAMA).

When a recall or field notice becomes necessary, there could be a significant negative impact to your brand as well as costly legal ramifications if not handled properly. The primary factors to the success of a recall are the speed of notification and accuracy of data pertaining to everyone associated to those devices. Patients as well as purchasers of the device must be notified immediately to avoid potential adverse events—this would not be a good time to find that you lack all the pertinent information needed for reaching these parties. Incomplete records of purchasers, providers, and patients make contacting these parties nearly impossible. Moreover, even if you do have contact information, it may be out-of-date. As a result, you face a serious risk of failing to notify many interested parties when initiating a recall.

Post-manufacture device tracking and the subsequent alerting is necessary throughout the device’s entire useful life, which can exceed 10 or 15 years. Rather than maintaining a costly, ineffective administrative process in-house, you can turn to Patient Alerting Logistics. We track all your devices, from manufacture through the useful life of the device. When communication is necessary, our comprehensive services will handle the logistics. We maintain contact with your patients and keep their ever-changing information updated. We sustain device relationships to patients so you can immediately send out thousands or even millions of alerts within seconds, while also receiving acknowledgement of delivery. We provide a fully automated communication ecosystem for healthcare that solves this problem once and for all.

Download Our Informative FAQ Sheet

Medical Device Manufacturers

As a medical device manufacturer, you make devices designed to improve quality-of-life and longevity. However, even with the best intentions and dedication to quality, complications can arise. These might be a malfunctioning part, design flaw, or simply a required device software update. Regardless of the issue, it is incumbent on you, the manufacturer, to address the problem.

You will potentially be required to communicate field notices, recalls, or warnings to mitigate potential harm. This is not only the right thing to do, but, in certain cases, is required by federal regulation and law. The tracking provisions of section 519(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 360i(e), were added in 1990 by the Safe Medical Devices Act (SMDA) and amended in 1997 by the Food and Drug Administration Modernization Act (FDAMA).

When a recall or field notice becomes necessary, there could be a significant negative impact to your brand as well as costly legal ramifications if not handled properly. The primary factors to the success of a recall are the speed of notification and accuracy of data pertaining to everyone associated to those devices.

Patients as well as purchasers of the device must be notified immediately to avoid potential adverse events—this would not be a good time to find that you lack all the pertinent information needed for reaching these parties.

Incomplete records of purchasers, providers, and patients make contacting these parties nearly impossible. Moreover, even if you do have contact information, it may be out-of-date. As a result, you face a serious risk of failing to notify many interested parties when initiating a recall.

Post-manufacture device tracking and the subsequent alerting is necessary throughout the device’s entire useful life, which can exceed 10 or 15 years. Rather than maintaining a costly, ineffective administrative process in-house, you can turn to Patient Alerting Logistics. We track all your devices, from manufacture through the useful life of the device.

When communication is necessary, our comprehensive services will handle the logistics. We maintain contact with your patients and keep their ever-changing information updated. We sustain device relationships to patients so you can immediately send out thousands or even millions of alerts within seconds, while also receiving acknowledgement of delivery. We provide a fully automated communication ecosystem for healthcare that solves this problem once and for all.

Hospitals and Surgery Centers

As a hospital or surgery center, your focus is on treating your patients. As part of doing that, it is often necessary to implant medical devices such as pacemakers, spinal stimulators, heart valves among others into your patients.  Your job is to treat the acute issue and that’s what you are good at doing.  After that, the patient returns to their regular provider for ongoing care.

Depending on the Product Code of the medical device, it may have to be tracked for its entire useful life.  Title 21 specifies what you must do when a patient gets an implant and, more important, after they leave your facility.  Specifically, as a Final Distributor you must send data regarding the patient, device, provider, facility and follow-up providers to the device manufacturer promptly.   This often results in hospitals resorting to manual methods of data capture and submission using spreadsheets, word documents or even paper documents.  As a Multiple Distributor, you are required to be able to supply information to the manufacturer upon request within 5 days and to the FDA within 10 days.

The processes to do this, while important, are usually outside of your normal workflow and are ancillary to the core focus of immediate patient care.  That’s when you turn to Patient Alerting Logistics. Device and patient tracking are central to our mission. And delivering patient alerts regarding these devices is so central to us, it’s our name!  There are many other uses for our messaging services that will help you drive revenue, lower costs and improve patient care.  Click here to download an informative FAQ sheet regarding the regulations as well as a copy of Title 21.

Download Our Informative FAQ Sheet

Hospitals and Surgery Centers

As a hospital or surgery center, your focus is on treating your patients. As part of doing that, it is often necessary to implant medical devices such as pacemakers, spinal stimulators, heart valves among others into your patients.  Your job is to treat the acute issue and that’s what you are good at doing.  After that, the patient returns to their regular provider for ongoing care.

Depending on the Product Code of the medical device, it may have to be tracked for its entire useful life.  Title 21 specifies what you must do when a patient gets an implant and, more important, after they leave your facility.  Specifically, as a Final Distributor you must send data regarding the patient, device, provider, facility and follow-up providers to the device manufacturer promptly.   This often results in hospitals resorting to manual methods of data capture and submission using spreadsheets, word documents or even paper documents.  As a Multiple Distributor, you are required to be able to supply information to the manufacturer upon request within 5 days and to the FDA within 10 days.

The processes to do this, while important, are usually outside of your normal workflow and are ancillary to the core focus of immediate patient care.  That’s when you turn to Patient Alerting Logistics. Device and patient tracking are central to our mission. And delivering patient alerts regarding these devices is so central to us, it’s our name!  There are many other uses for our messaging services that will help you drive revenue, lower costs and improve patient care.  Click here to download an informative FAQ sheet regarding the regulations as well as a copy of Title 21.

Download Our Informative FAQ Sheet

Primary Care Providers

As a primary care physician, you have a unique challenge of managing the overall health and wellbeing of each member of your patient population. This challenge is complicated further by primary care providers often not having a wholistic view of all the variables of a patient’s medical history. One such area where an information gap has persisted is around a patient’s specific device information after receiving an implanted medical device. This was an area of focus for CMS and the ONC as 2015 CEHRT requirements for hospitals asserted an electronic health record’s capability to capture and record unique device identifier (UDI). The inclusion of the UDI criterion was aimed at delivering information to all clinicians so they can know what devices their patients have and to leverage that information to deliver safer and more effective care. Once UDIs are recorded in a patient’s chart, they can be exchanged among certified health IT and accessed by users of certified health IT wherever the patient seeks care. Unfortunately, this UDI is not easily accessible by a primary care physician and, therefore, you are often unaware of recalls or product issues and unable to notify your patient.

Patient Alerting Logistics (PAL) works to not only provide this information across different places of service but we also look to make that data actionable. Leveraging our services, primary care physicians are able to not only secure all the specific information on one of their patient’s devices, but they are also able to be notified of a device recall pertaining to their patient population even if they have never purchased that device prior. This is one of the ways we are re-imagining the way communication occurs between all the key stakeholders related to a medical device implant.

Primary Care Providers

As a primary care physician, you have a unique challenge of managing the overall health and wellbeing of each member of your patient population. This challenge is complicated further by primary care providers often not having a wholistic view of all the variables of a patient’s medical history. One such area where an information gap has persisted is around a patient’s specific device information after receiving an implanted medical device. This was an area of focus for CMS and the ONC as 2015 CEHRT requirements for hospitals asserted an electronic health record’s capability to capture and record unique device identifier (UDI). The inclusion of the UDI criterion was aimed at delivering information to all clinicians so they can know what devices their patients have and to leverage that information to deliver safer and more effective care. Once UDIs are recorded in a patient’s chart, they can be exchanged among certified health IT and accessed by users of certified health IT wherever the patient seeks care. Unfortunately, this UDI is not easily accessible by a primary care physician and, therefore, you are often unaware of recalls or product issues and unable to notify your patient.

Patient Alerting Logistics (PAL) works to not only provide this information across different places of service but we also look to make that data actionable. Leveraging our services, primary care physicians are able to not only secure all the specific information on one of their patient’s devices, but they are also able to be notified of a device recall pertaining to their patient population even if they have never purchased that device prior. This is one of the ways we are re-imagining the way communication occurs between all the key stakeholders related to a medical device implant.

Patients

If you’re one of the thousands of patients that receive a medical device every year, you probably have lots of questions. How will the manufacturer communicate with me in the future if there is important information that I need about my device? Who will tell me if there is a problem discovered with my device or a recall is issued? How will I communicate with the manufacturer if necessary? How will I be able to find out the details about my device in 5, 10 or even 15 years from now? These are all good questions and, unfortunately, the answers you are given are usually vague, if they are answered at all.

Unless, that is, your device manufacturer or hospital is a partner with Patient Alerting Logistics. We provide a service that connects the manufacturers, hospitals and physicians to you. When you get your device, you will be added to our alerting system. Your device will be tracked real-time for recalls or urgent messages. All these players involved with your device will have the ability to instantly contact you with any urgent alerts. You will be able to specify how you want those alerts – email, text message or automated phone call. You will be able to acknowledge messages and send messages to them as well. The best part is that this service is free to you. It is being paid for by our partner customers. So, relax, we’re watching out for you.

Patients

If you’re one of the thousands of patients that receive a medical device every year, you probably have lots of questions. How will the manufacturer communicate with me in the future if there is important information that I need about my device? Who will tell me if there is a problem discovered with my device or a recall is issued? How will I communicate with the manufacturer if necessary? How will I be able to find out the details about my device in 5, 10 or even 15 years from now? These are all good questions and, unfortunately, the answers you are given are usually vague, if they are answered at all.

Unless, that is, your device manufacturer or hospital is a partner with Patient Alerting Logistics. We provide a service that connects the manufacturers, hospitals and physicians to you. When you get your device, you will be added to our alerting system. Your device will be tracked real-time for recalls or urgent messages. All these players involved with your device will have the ability to instantly contact you with any urgent alerts. You will be able to specify how you want those alerts – email, text message or automated phone call. You will be able to acknowledge messages and send messages to them as well. The best part is that this service is free to you. It is being paid for by our partner customers. So, relax, we’re watching out for you.

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.

Patient Alerting Logistics (PAL) 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. PAL 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. Patient Alerting Logistics has created a complete ecosystem that connects manufacturers, hospitals, physicians and patients for the immediate, secure delivery of patient alerts. PAL 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 Patient Alerting Logistics’ 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.

Patient Alerting Logistics 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.

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ABOUT US

Patient Alerting Logistics was born out of a simple desire: to improve patient lives. One very important way to do that is to ensure that patients receive the important information that is sent to them by their healthcare providers and medical device manufacturers. Surprisingly, those messages are often not delivered. In fact, thousands of patients every year experience health issues and even death due to not receiving the urgent messages that were sent to them.

Patient Alerting Logistics is headed up by two experienced healthcare executives, Paul Dandrow and Ryan Bass. Paul is the Chairman & CEO. His extensive background in Healthcare IT spans 25 years and with his business background of creating and leading technology companies, he is well positioned to lead our growth. Ryan is our President & COO. He has spent his entire professional career immersed in healthcare regulatory compliance. He is a subject matter expert with many governmental programs and has supported a plethora of hospitals in maintaining and achieving compliance with both existing and new regulations.

Our Vision

A world where every critical message sent to a patient is received and acknowledged securely and quickly.

Our Mission

To create a complete communication ecosystem between medical device manufacturers, healthcare providers, and physicians to transmit urgent messages in near real-time to their patients with confirmed receipt and acknowledgement.

ABOUT US

Patient Alerting Logistics was born out of a simple desire: to improve patient lives. One very important way to do that is to ensure that patients receive the important information that is sent to them by their healthcare providers and medical device manufacturers. Surprisingly, those messages are often not delivered. In fact, thousands of patients every year experience health issues and even death due to not receiving the urgent messages that were sent to them.

Patient Alerting Logistics is headed up by two experienced healthcare executives, Paul Dandrow and Ryan Bass. Paul is the Chairman & CEO. His extensive background in Healthcare IT spans 25 years and with his business background of creating and leading technology companies, he is well positioned to lead our growth. Ryan is our President & COO. He has spent his entire professional career immersed in healthcare regulatory compliance. He is a subject matter expert with many governmental programs and has supported a plethora of hospitals in maintaining and achieving compliance with both existing and new regulations.

Email us: info@patientalerting.com

Our Vision

A world where every critical message sent to a patient is received and acknowledged securely and quickly.

Our Mission

To create a complete communication ecosystem between medical device manufacturers, healthcare providers, and physicians to transmit urgent messages in near real-time to their patients with confirmed receipt and acknowledgement.

CONTACT US FOR MORE INFORMATION







    Patient Alerting Logistics

    1100 Sycamore St., Floor 1
    Cincinnati, OH 45202
    info@patientalerting.com
    513.570.4314

    Reach out to us through our social channels:

    CONTACT US FOR MORE INFORMATION

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      FOR ANY QUESTIONS:

      Patient Alerting Logistics

      1100 Sycamore St., Floor 1
      Cincinnati, OH 45202
      info@patientalerting.com
      513.570.4449

      Reach out to us through our social channels:

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