FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
Today, the U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands).
“For some patients with parathyroid disease, treatment may mean a surgical procedure,” said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health.  “Real-time identification of parathyroid tissue during surgery can provide surgeons… Continue reading.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624982.htm?utm_campaign=11022018_PR_FDA%20authorizes%20devices%20to%20detect%20parathyroid%20tissue%20in%20during%20surgery&utm_medium=email&utm_source=Eloqua

November 2, 2018

Release

Today, the U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands).

“For some patients with parathyroid disease, treatment may mean a surgical procedure,” said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health. “Real-time identification of parathyroid tissue during surgery can provide surgeons with valuable information to help preserve healthy tissue or to remove diseased tissue.”

Disorders in the parathyroid tissue, which is tissue that borders the thyroid gland, are usually treated by surgeries to remove part of the thyroid gland or parathyroid tissue. Hyperparathyroidism, or the overproduction of parathyroid hormone, is the most common of parathyroid disorders and is diagnosed in approximately 100,000 Americans each year. For surgeons treating hyperparathyroidism or other disorders, parathyroid tissue can be visually difficult to locate and distinguish from nearby tissues during a surgery.

The Fluobeam 800 Clinic Imaging Device is used to assist in the imaging of parathyroid glands and can be used as a companion method to assist surgeons in locating parathyroid tissue visually during surgery. Parathyroid tissue emits a fluorescent glow when exposed to the device’s light source, avoiding the need for a contrast agent. The device was previously cleared as an imaging system used to capture and view fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion.

The Parathyroid Detection PTeye System aids in detecting parathyroid tissue during surgery by using a probe that emits fluorescence light. Tissue detection is based on how the parathyroid tissue reacts to the fluorescent light. When parathyroid tissue is detected, the system provides an audio and visual display to indicate its presence.

Use of either device is intended to assist, not replace, experienced visual assessment in identifying the parathyroid tissue along with a biopsy to confirm thyroid tissue per standard of care. The systems are not intended to be used to confirm the absence of parathyroid tissue or glands and are only to be used to assist the surgeon in locating potential parathyroid tissue or glands.

For the Fluobeam 800, the FDA reviewed data from five peer-reviewed published studies, including one study that compared the rate of postoperative hypocalcemia (PH), or a temporary reduction in calcium in the blood, that occurs when healthy parathyroid tissue is inadvertently removed. In 93 patients who had surgery using the device, 5 percent experienced fluctuating PH following surgery compared with 21 percent of the 153 patients who had surgery without the device.

For the PTeye System, the FDA reviewed data from a single-blinded study of 81 patients who had surgery using the device. Results demonstrated that the PTeye could correctly identify the presence of parathyroid tissue as compared to histology 93 percent of the time and correctly identify the absence of parathyroid tissue as compared to intraoperative visualization by an expert 97 percent of the time, with an overall accuracy of 96 percent.

The Fluobeam 800 and the PTeye were reviewed separately but concurrently under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

The FDA granted marketing authorization of The Fluobeam 800 Clinic Imaging Device to Fluoptics.

The FDA granted marketing authorization of Parathyroid Detection PTeye System to AiBiomed.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks

tatement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks

Earlier this year, we experienced the largest E. coli O157:H7 outbreak the country has seen in the last decade, leaving hundreds sick and claiming the lives of five people who consumed contaminated romaine lettuce.
We’re committed to taking necessary actions to prevent future outbreaks like this and to improving the safety of leafy greens available in the marketplace. Since the next romaine growing season for the Yuma region is underway, it’s critical for all of us to understand what happened so we can identify the changes that can prevent future outbreaks and reduce the scope of any problems that could arise.
Since the first signs of the outbreak appeared…Continue reading

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624867.htm?utm_campaign=11012018_Statement_findings%20from%20the%20romaine%20lettuce%20E.%20coli%20O157%3AH7&utm_medium=email&utm_source=Eloqua

November 1, 2018

Statement

Earlier this year, we experienced the largest E. coli O157:H7 outbreak the country has seen in the last decade, leaving hundreds sick and claiming the lives of five people who consumed contaminated romaine lettuce.

We’re committed to taking necessary actions to prevent future outbreaks like this and to improving the safety of leafy greens available in the marketplace. Since the next romaine growing season for the Yuma region is underway, it’s critical for all of us to understand what happened so we can identify the changes that can prevent future outbreaks and reduce the scope of any problems that could arise.

Since the first signs of the outbreak appeared, our team has collaborated closely with our state, federal and local partners to determine the root cause of the outbreak. Today, the U.S. Food and Drug Administration is sharing an environmental assessment that details final findings from this investigation.

One of the investigation’s main objectives was to identify factors that potentially contributed to the introduction and spread of the strain of E. coli O157:H7 that contaminated the romaine lettuce associated with this outbreak. The FDA, the Centers for Disease Control and Prevention, and the Arizona Department of Agriculture launched an investigation of the outbreak, leading to the collection of samples in Yuma in order to help gather evidence needed to identify the source of the outbreak.

The environmental assessment issued today confirms the presence of E. coliO157:H7 in three samples of irrigation canal water collected as part of this investigation in the Yuma region. It considers that the most likely way the romaine lettuce became contaminated was from the use of water from the irrigation canal, since the outbreak strain was not found in any of the other samples collected in the region. How the water contaminated the lettuce is uncertain. But based on interviews with growers and pesticide applicators, possible explanations include direct application of irrigation canal water to the lettuce crop or the use of irrigation canal water to dilute crop-protection chemicals applied to the crops through both aerial and land-based spray applications. We cannot rule out other ways the lettuce became contaminated. It’s important to note that we have no evidence that any other product grown in Yuma was contaminated by this water.

When and how the irrigation canal became contaminated with the outbreak strain of E. coli O157:H7 is also uncertain. We know that a large concentrated animal feeding operation (CAFO) is located adjacent to this stretch of the irrigation canal where the samples were collected. This is one potential source. However, the investigation did not identify an obvious route for contamination of the irrigation canal from this facility. In addition, samples collected at the CAFO did not yield E. coli O157:H7. The investigation did not exclude other ways the irrigation canal could have become contaminated with this outbreak strain.

With the growing season underway in Yuma, we know just how important it is to continue collaborating closely with industry and our regulatory partners to ensure that leafy greens are safe. To assist with these efforts, our environmental assessment recommends a number of steps that can be taken to reduce the likelihood of another tragic outbreak from occurring in the future. Working with the produce industry to further reduce the risk of outbreaks is a key priority for the FDA.

Fully implementing the Food Safety Modernization Act (FSMA) is critical to these efforts. We must continue to advance FSMA’s Produce Safety Rule in collaboration with our state regulatory partners and ensure that we craft agricultural water standards that work across the incredible diversity of commodities and growing conditions. The FDA has resources available to help industry comply with FSMA requirements, including produce safety experts regionally located as part of the FDA’s Produce Safety Network and growers in the Yuma region can find the contact information for their area at this website.

Because leafy greens are a highly perishable commodity, the ability to traceback the route of a food product as it moves through the entire supply chain, or traceability, is critical to removing the product from commerce as quickly as possible, preventing additional consumer exposures, and properly focusing any recall actions. During the romaine investigation we found the typical traceback process to be particularly challenging because much of the finished lettuce product contained romaine that was sourced from multiple ranches As a result, our investigation involved collecting documentation from each point in the supply chain to verify the movement of product back to the Yuma area. Complicating this already large-scale investigation, the majority of the records collected in this investigation were either paper or handwritten.

Going forward, both FDA and industry need to explore better ways to standardize record keeping and determine whether the use of additional tools on product packaging could improve traceability.

We strongly encourage the leafy greens industry to adopt traceability best practices and state-of-the-art technologies to help assure quick and easy access to key data elements from farm to fork. We also strongly encourage the leafy greens industry to explore modern approaches to standardized record keeping and the use of additional tools or labels on product packaging that could improve traceability. We urge all segments of this industry and our government partners to review the findings of our environmental assessment and make necessary changes. For our part, the FDA is exploring ways to best tap into new technologies to significantly reduce the time needed for traceback investigations.

The agency is taking steps to improve our response times and provide actionable information to consumers as quickly as possible. We are also looking at our regulatory options and considering appropriate enforcement actions against companies and farms that grow, pack, or process fresh lettuce and leafy greens under insanitary conditions. We continue to explore additional ways to improve these processes and urge all segments of the leafy greens industry to review their operations in the same way.

As a next step, the FDA plans to collect and analyze romaine lettuce samples through a new special surveillance sampling assignment for contamination with human pathogens. This will help us determine whether products are safe to enter the U.S. marketplace. If samples are found to be contaminated, the FDA will follow-up with fresh-cut leafy greens processors and their growers or suppliers to determine if these foods were produced under insanitary conditions that render them harmful to consumers and take the appropriate action to remove them from the market.

We recognize and appreciate the efforts that the leafy greens industry has taken to date. But we know more must be done on all fronts to help prevent future foodborne illness outbreaks. I remain committed to investing in the FDA’s food program and applying our food safety expertise as we work to better safeguard the U.S. food supply. We want food to be safe because it promotes the American industries that grow and produce these products. That’s part of our dedication to these efforts. But first and foremost, we pursue food safety measures as key parts of our public health mandate to protect American consumers

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FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner, warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Roche Diagnostics issued a voluntary recall of certain test strip lots used with its CoaguChek test meter devices. The recall involves more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from Jan. 12, 2018 to Oct. 29, 2018. Today, the FDA announced this action as…Continue reading 

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624904.htm?utm_campaign=11012018_PR_FDA%20warns%20of%20inaccurate%20test%20results%20for%20device%20to%20monitor%20warfarin&utm_medium=email&utm_source=Eloqua

 

November 1, 2018

Release

The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner, warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Roche Diagnostics issued a voluntary recall of certain test strip lots used with its CoaguChek test meter devices. The recall involves more than 1.1 million packages of CoaguChek XS PT Test Strips that were distributed nationwide from Jan. 12, 2018 to Oct. 29, 2018. Today, the FDA announced this action as a Class I recall, the most serious type of recall, which means use of these devices may cause serious injuries or death.

The FDA is warning patients and health care professionals that they should not rely on these test meter devices to monitor warfarin levels if they’re using test strips affected by the recall. Instead, they should have blood drawn from a vein and have their levels measured by a laboratory test or use an alternative meter device.

“These strips are widely used and we are working diligently to warn health care providers and the public about the dangers associated with this recall. Using faulty strips can lead to serious errors in medication dosage that could cause serious harm or death in some patients,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “We are also working with the company on the swift removal of the recalled strips and to ensure the new corrected strips are distributed to patients and health care providers as quickly as possible.”

Millions of Americans take the blood thinner warfarin (also known by the brand names Coumadin and Jantoven) to prevent and treat blood clots. The drug may be prescribed for patients with certain types of irregular heartbeats, blood clots in the legs or lungs, or certain medical device implants such as artificial heart valves. Achieving the correct warfarin dosage is crucial, and patients need regular monitoring to test how long it takes their blood to clot. The response is measured by a blood test to check the International Normalized Ratio, or INR. This test can be performed by an accredited laboratory on blood drawn from a vein or with a fingerstick blood draw using an INR test meter at home or in a doctor’s office.

The FDA’s warning concerning the CoaguChek XS PT Test Strips is based on medical device reports submitted by Roche Diagnostics to the agency indicating that the test strips may provide results that are higher than the actual INR. As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or instructed to interrupt warfarin use, which may increase the risk for dangerous blood clots. Approximately 90 medical device reports and two serious patient injuries involving strokes were reported to the FDA.

Incorrect INR results are of particular concern for individuals at an increased risk of blood clots including those with mechanical heart valves, atrial fibrillation (irregular heartbeat) who are at a high risk of stroke, or those who had a recent blood clot. It is important to note that problems with the CoaguChek XS PT test strips are not likely to be evident to the patient.

Roche Diagnostics attributes the cause of the problem to a recent re-calibration of the test strips to a different international standard that occurred earlier this year. They plan to provide new batches of re-calibrated test strips, based on the previous international standard, to their customers by the end of November; the FDA reviewed validation data submitted by the company for these recalibrated strips. The test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST and CoaguChek Vantus test meter devices.

Patients who are using CoaguChek meters should contact their health care provider to get information about alternative test methods and to address questions regarding their individual testing schedule. Patients should also contact their patient self-testing service providers to find out when they will be getting their corrected test strips. Health care providers and patients may contact Roche Diagnostics to learn more details about the recall.

All health care providers, patients and caregivers, are strongly encouraged to voluntarily report INR test meter problems directly to the FDA through MedWatch, the FDA’s voluntary reporting program. Problems should be reported whenever one suspects that there may be an issue with an INR test meter such as a malfunction or incorrect result, or that the meter caused or contributed to a serious injury or death.

The FDA is committed to continuing to communicate publicly on this issue and will provide updates related to this recall when available.

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