News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Enforcement of FDA’s Unique Device Identification Law Begins as Hospitals, ASCs, and Nursing Homes Must Now Report Adverse Patient Events from High-Risk Medical Devices

Some clinical laboratory and pathology equipment are Class III (high-risk) medical devices and may be eventually subject to FDA adverse patient event reporting rules

Effective on September 1, 2014, providers using Class III (high-risk) medical devices are required to report adverse patient events involving such devices. That reporting is to include the unique device identification (UDIs) labels of the Class III device.

The primary goal of the new regulation is to have specified providers report patient deaths that involved high-risk medical devices, such as stents and heart valves, for example. Specified facilities include hospitals, ambulatory surgery centers, and nursing homes. Manufacturers must also report adverse patient events involving their Class III medical devices.

All Class III in vitro diagnostic systems used by clinical laboratories and pathology groups here in the United States will now have a UDI label. (more…)

New Handheld Imaging Device Can Diagnose Melanoma in Physicians’ Offices, Potentially Reducing the Volume of Skin Biopsies Referred to Pathology Labs

This diagnostic instrument would be preferred by patients and physicians alike because it is noninvasive and provides immediate results

Dermapathologists will be interested to learn about a new handheld, point-of-care (POC) device that images melanoma tumors and enables the in vivo diagnosis of melanoma.

Because this diagnostic technology is noninvasive and provides immediate results, it is likely to be preferred by patients and doctors alike and could thus substantially reduce the volume of skin biopsies referred to dermapathologists and pathology laboratories. (more…)

Ochsner Becomes First Health System to Interface Apple’s HealthKit App to its Epic EHR; Will It Help Patient’s Monitor Their Medical Laboratory Test Results?

electronic health recordNew products are expected to radically change the wearable fitness device game by allowing physicians and patients and even pathologists to see the same data

If Apple Inc. can succeed with its latest wearable health device, experts predict that physicians may soon begin using it to monitor the health of their patients. This may be auspicious for pathologists and clinical laboratory scientists if physicians ask them to monitor that patient data and provide consultative support.

It was in September when Apple (NASDAQ: AAPL) unveiled its new smartwatch. When combined with Apple’s HealthKit software platform, the Apple watch might well the most powerful wearable health-tracking device to hit the market yet. (more…)

Specialist Physicians Launch Patient-Centered Medical Homes, Creating Opportunities for Clinical Pathology Laboratories to Deliver Value-Added Medical Lab Testing

Specialist physicians will benefit from enriched medical laboratory consultations involving pathologists and other clinical laboratory scientists

Increasing numbers of medical specialists are launching patient-centered specialty practices (PCSP). This trend has implications for clinical laboratories and pathology groups because these office-based physicians will want tighter clinical and operational integration with other healthcare providers who treat the same patients.

Specialist physicians are watching the growth of patient-centered medical homes (PCMHs) and how PCMHs are organized to provide proactive clinical services and maintain access to patients. In adopting this care model for specialty medical practices, these specialists will typically utilize a more extensive menu of medical laboratory tests and anatomic pathology professional support from their laboratory providers. (more…)

Cheap, Disposable Biometric Patch to Monitor Stress and Fatigue in Military Personnel May Be Adapted to Monitor Biomarkers Used by Clinical Pathology Laboratories

The U.S. Air Force Research Laboratory tapped nanotechnology experts at the University of Massachusetts Amherst to develop a patch that targets stress biomarkers in sweat

One potential disruptor of medical laboratory testing, as it exists today, are wearable biometric devices. These are already popular with athletes and health-conscious people. To meet this demand, a continual stream of innovative biometric gear is hitting the marketplace.

Foremost among the consumers for this technology is the U.S. military. Military leaders recognize the importance of monitoring the physical condition and health of armed forces personnel in the field. Wearable biometric devices are a perfect solution to meet this need. (more…)

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