FDA to Address Challenges of Using Complex Medical Devices in the Home

/PRNewswire/ -- The U.S. Food and Drug Administration today announced a new initiative to ensure that caregivers and patients safely use complex medical devices in the home.

Hemodialysis equipment to treat kidney failure, wound therapy care, intravenous therapy devices, and ventilators are among the medical products that have migrated to the home in recent years. And more hospital patients of all ages are being discharged to continue their medical treatment at home.

"Using complex medical devices at home carries unique challenges," said Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health. "Caregivers may lack sufficient training, product instructions may be inadequate or overly technical, and the home environment itself may pose environmental or safety hazards that can affect the product's functioning."

According to an FDA white paper, the initiative will develop guidance for manufacturers who intend to market a device for home use, provide for postmarket surveillance, and put in place other measures to encourage safe use of these products. In addition, the FDA is developing educational materials on home use of medical devices.

"The FDA's Home Use Initiative will help address the potential challenges, providing greater protection and awareness for patients who are being cared for in the home," Shuren said.

Currently, the FDA does not have a clear regulatory pathway for devices intended for home use that describes the unique factors that manufacturers should take into consideration when designing, testing, and labeling such products. The new home use guidance document that FDA intends to develop will:

-- make recommendations for actions manufacturers should take to support
premarket approval or clearance of these devices, including device
testing with at-home caregivers and patients in a non-clinical
setting,
-- define circumstances under which the FDA may exercise its authority to
require that certain devices cleared for marketing carry a statement
in the labeling that the device has not been cleared for use in the
home,
-- recommend postmarket surveillance to identify and address adverse
events that may occur in the home.


In addition to developing the guidance document, the FDA will launch a 10-month pilot program beginning in the summer of 2010 in which manufacturers of home use devices may voluntarily submit their labeling to the agency for posting on a central Web site repository. Posting medical device labeling in the repository will help home care patients and caregivers to quickly and conveniently access important information about the safe use of their devices.

The Home Use Initiative also contains measures for enhanced postmarket surveillance through HomeNet, a subnetwork of the FDA's Medical Device Surveillance Network, an adverse event reporting program that includes more than 350 health care facilities nationwide.

Understanding issues experienced by home users will help the FDA develop appropriate actions to address those issues in the future. It may also identify cases in which devices intended solely for use in a health care facility are being used at home. The FDA already has collected information on safety concerns related to home hemodialysis and is now collecting similar information on the use of some wound therapy devices.

The FDA is partnering with the Community Health Accreditation Program and the Joint Commission, which evaluates and accredits 17,000 U.S. health care organizations and programs, to strengthen home health agency accreditation criteria that relate to medical device safe use practices.

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UGA Study finds significantly worse outcomes in cancer patients with cognitive impairment

A new study published by researchers from the University of Georgia and the Moffitt Cancer Center in Tampa, Fla., has found that cancer patients with dementia have a dramatically lower survival rate than patients with cancer alone, even after controlling for factors such as age, tumor type and tumor stage.

But the study, published in the early online edition of the journal Critical Reviews in Oncology/Hematology, also argues that a diagnosis of dementia shouldn’t discourage the use of cancer screenings and appropriate cancer treatments.

“As the population ages and as treatments improve, we’re going to see more patients with both dementia and cancer,” said lead author Claire Robb, assistant professor in the UGA College of Public Health. “And right now there are no guidelines for oncologists as to how to treat these patients.”

Robb and her co-authors in the Senior Adult Oncology Program at Moffitt compared the outcomes of 86 cancer patients with cognitive impairment to a control group of 172 patients with cancer alone. They found that cancer patients with dementia survived an average of four fewer years.

Robb, who is also a researcher in the UGA Cancer Center, said that the reason for the disparity is unclear. She notes that the patients in both groups received similar treatment and that the survival gap persists even after controlling for age, tumor type and tumor stage.

But Robb pointed out that within the cognitively impaired group, there was a dramatic difference in survival time between those with mild cognitive impairment and those with moderate to severe impairment. People with mild cognitive impairment often have problems with thinking and memory yet can still live independently; those with moderate to severe dementia forget details about current events, lose awareness and have difficulty with basic tasks such as preparing meals or choosing proper clothing. The researchers found that while patients with moderate to severe dementia had an average survival time of eight months, those with mild dementia had an average survival time of nearly four and a half years.

“Some people would argue against treating patients with mild cognitive impairment because they’re going to have a shorter survival,” Robb said. “But, you know, 53 months—almost 4 and a half years—is a pretty significant amount of time to live.”

The patients in the UGA/Moffitt study generally received the same treatment regardless of cognitive status, but other studies have found that patients with dementia often receive fewer cancer screenings and undergo less aggressive treatment. One study found that physicians were significantly less likely to recommend a mammogram for a woman with dementia than without, while another found that patients with dementia were twice as likely to have colon cancer reported only after death. Another study of breast cancer patients found that those with dementia were 52 percent less likely to have the tumor removed surgically, 41 percent less likely to undergo radiation therapy, 39 percent less likely to undergo chemotherapy and nearly three times more likely to receive no treatment.

“The fact that cognitively impaired patients seen in our Senior Adult Oncology Program received treatments similar to unimpaired patients while epidemiologic data show a marked difference in treatment provides food for thought,” said study co-author Dr. Martine Extermann, associate faculty member at Moffitt. “Although this might reflect a referral bias in which those who volunteered to participate in the study are different from the general population, it might also indicate that such patients benefit from a specialized evaluation and management in a geriatric oncology program.”

Robb emphasized that she does not advocate overly aggressive treatment for patients who are in the late stages of dementia, but urges the creation of guidelines to help ensure that cognitively impaired cancer patients receive appropriate treatment.

“People have thought about the impact of the aging population on rates of cancer and dementia, but not much attention has been paid to what happens when the diseases coincide,” Robb said. “We’re going to be seeing more cases like these, and, if anything, I hope our research raises awareness of this situation.”

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Why Bladder Cancer Is Deadlier for Some

/PRNewswire-USNewswire/ -- Bladder cancer is much more likely to be deadly for women and African-Americans, but the reasons long believed to explain the phenomenon account for only part of the differences for such patients compared to their white and male counterparts, according to results published in the Jan. 1 issue of the journal Cancer.

The results present a stark question for doctors and patients: If age, tumor type, and stage of the disease upon diagnosis don't account for all the increased lethality of the disease in women and African-Americans, then what does?

It's a gaping question facing researchers who have long confronted an irony of bladder cancer, the fifth-most-common type of cancer in America. The disease is more lethal in those patients who are less likely to get it.

Men are more than three times as likely as women to get the disease, and white people are nearly twice as likely to get the disease as African-Americans. Yet, once the disease is present, it's far deadlier in women and in African-Americans -- anywhere from 73 percent to 114 percent more deadly in the first year after diagnosis, depending on the group.

In the Cancer paper, scientists and physicians at the University of Rochester Medical Center show for the first time that the factors traditionally thought to be responsible for the differing course are responsible for only about one-third of the difference between white men and women, and up to two-thirds of the difference between African-Americans and their white counterparts.

"We've known that the disease is likely to be more advanced in women and African-Americans by the time they're diagnosed," said corresponding author Edward Messing, M.D., a surgeon well known for his expertise in treating patients with bladder cancer. "Like many doctors, I long assumed that the delay in diagnosis was the reason why the disease is more deadly for these patients.

"I was surprised to find that recognized factors like a delay in diagnosis explain only part of the difference. There are clearly other important factors at work that make these patients more likely to die from the disease. There could be something different about the cancer itself, or there could be differences in the ways these groups are treated," said Messing, who is professor of Urology and Oncology as well as leader of the Prostate Cancer and Genitourinary Oncology team at the James P. Wilmot Cancer Center.

To do the study, scientists analyzed the records of more than 100,000 patients who were diagnosed with bladder cancer from 1990 to 2003. Their records are part of a national cancer registry known as SEER (Surveillance, Epidemiology, and End Results). The 101,249 patients came from 16 different regions: Atlanta, rural Georgia, Connecticut, Detroit, Seattle, Hawaii, Iowa, New Mexico, San Francisco, Los Angeles, San Jose, rural California, Kentucky, Louisiana, New Jersey, and Utah.

The statistical analysis was done by first author Emil Scosyrev, a graduate student in epidemiology; Katia Noyes, Ph.D., associate professor of Community and Preventive Medicine; and Changyong Feng, Ph.D., assistant professor of Computational Biology and Biostatistics. The work was funded by the Ashley Family Foundation.

The team found that in the first year after diagnosis, women were anywhere from about 80 percent to 114 percent more likely to die from the disease than their male counterparts. That increase was a bit lower in year two, when women were about 52 to 55 percent more likely to die.

When it came to race, the researchers found that African-Americans were about 73 percent to 103 percent more likely than their white counterparts to die from the disease within the first two years after diagnosis, and about 40 percent to 117 percent more likely to die three or four years after diagnosis.

Then the team sifted through the data to try to uncover the reasons behind these differences. The team found that the factors traditionally thought to be responsible for the differences -- stage of the disease upon diagnosis, tumor type, and age -- accounted for only about 30 percent of the difference between the genders among white people, and about 50 to 70 percent of the differences between the races and between the genders among African-Americans.

"The current study by Scosyrev et al elegantly demonstrates that, even after controlling for tumor characteristics, inferior outcomes remain for African-American patients and women," write physicians Mark Katz, M.D., and Gary Steinberg, M.D., of the University of Chicago Medical Center in an editorial accompanying the findings.

The authors speculate about other factors that might be responsible for the differences, though they say that further study is necessary to know for sure. Some of the other issues that might play a role include the choice of treatment chosen, differences among tumors that were not taken into account in the study, and access to health care.

Messing believes that poorer access to health care is a clear cause of the higher mortality rates for African-Americans. He says African-American patients and their doctors need to be aware of the increased chance of death for these patients, who should be treated as aggressively as possible.

When it comes to gender, some of the differences are likely caused by factors that are not currently understood, such as hormonal differences, says Messing. But a factor that is known to play a key role is people's reaction when they see blood in their urine. Men are more likely than women to notice blood in their urine, to think it's abnormal, and to report it to doctors -- and even then, when it is reported, doctors are 65 percent more likely to refer men than women to urologists.

The authors say that women who find blood in their urine need to be vigilant about having the cause checked as quickly as possible. In women with bladder cancer, sometimes treatment is delayed while doctors investigate other potential causes of blood in the urine. While that is often a sign of a urinary tract infection or something other than cancer, Messing says it's crucial for doctors to consider bladder cancer as a potential cause right from the start.

"People need to be especially vigilant about blood in the urine," said Messing. "Be sure to report it to your doctor, and be sure the doctor investigates the cause thoroughly."

The American Cancer Society estimates that in 2007, 67,000 people in the United States were newly diagnosed with bladder cancer, and 13,700 patients died of the disease.

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FDA Creates Web Page with Drug Safety Information for Patients, Health Care Professionals

Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs. The Web page, http://www.fda.gov/cder/drugSafety.htm, provides links to information in these categories:

* Drug labeling, including patient labeling, professional labeling, and patient package inserts;
* Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that their benefits outweigh their risks;
* A searchable database of postmarket studies that are required from, or agreed to by, drug companies to provide the FDA with additional information about a drug's safety, efficacy, or optimal use;
* Clinicaltrials.gov, a searchable database of clinical trials, including information about each trial's purpose, who may participate, locations, and useful phone numbers;
* Drug-specific safety information, including safety sheets with the latest information about the drug as well as related FDA press announcements, fact sheets, and drug safety podcasts;
* Quarterly reports that list certain drugs that are being evaluated for potential safety issues, based on a review of information in the FDA's Adverse Event Reporting System (AERS);
* Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety Alerts;
* Regulations and guidance documents;
* Consumer information about using medications safely and disposing of unused medicines;
* Instructions how to report problems to the FDA through its MedWatch program;
* Consumer articles on drug safety; and
* The FDA's response to the Institute of Medicine's 2006 report on the future of drug safety.

"By placing Web links to these up-to-date resources on a single page, we're helping consumers and health care professionals find drug safety information faster and easier," said Paul Seligman, M.D., M.P.H., associate director of Safety Policy and Communication in the FDA's Center for Drug Evaluation and Research. "This type of communication is aimed at helping consumers and health care professionals make well-informed decisions about medication use."

Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007, and is among FDA's many efforts to address the safe use of drugs throughout their lifecycle.

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Custom-Fit OtisKnee™ May Impact Early Success of Total Knee Replacement Surgery, Study Finds

BUSINESS WIRE--A new study from the University of Alabama at Birmingham indicates that the OtisKnee Custom Fit Knee™ Replacement system may have a positive impact on length of hospital stay, range of motion, pain level and patient satisfaction immediately following total knee replacement surgery. The study abstract, titled “MRI-Guided Custom-Fit Total Knee Replacement: The First Six Weeks,” was presented at the joint Alabama Orthopedic Society and Mississippi Orthopedic Society annual meeting on May 3, 2008 in Sandestin, Fla. by Herrick Siegel, M.D., associate professor of surgery at the University of Alabama at Birmingham and lead investigator of the study.

Designed to evaluate the impact of OtisKnee on the early success of total knee replacement, the study involved 25 total knee replacements performed in 19 patients using the custom-fit OtisKnee technology. Each patient was followed for six weeks, a crucial period for predicting ultimate satisfaction with the procedure. Results showed that OtisKnee had a positive influence on length of hospital stay, range of motion, pain and patient satisfaction, as seen by the following data.

• Average length of hospital stay for single and bilateral (both knees) OtisKnee patients was 2.2 and 3.5 days, respectively.
• At two weeks, 17 of the 19 OtisKnee patients were walking with only a cane, and by 6 weeks all patients were walking without assistance.
• Sixteen of the 19 OtisKnee patients reported that they only needed prescription pain medication for 10 to 14 days post-op, and all patients were off prescription pain medication completely by four weeks post-op.

In addition, the study results indicated that OtisKnee is useful to the surgeon in pre-determining ideal implant size as well as defining proper rotation and positioning during the total knee replacement procedure.

“While total knee replacement has been a successful surgery historically, studies have shown that nearly 14 percent of patients have reported being dissatisfied or very dissatisfied with their surgery,” said Dr. Siegel. “Preliminary results with OtisKnee indicate that this unique, custom-fit approach may lead to a more predictable, reproducible and optimal result for patients.”

Since its limited U.S. launch in June of 2007, the OtisKnee technique has been performed by more than 400 surgeons on more than 7,000 patients. Initial clinical data demonstrating the value of OtisKnee in total knee replacement has been presented at the American Academy of Orthopaedic Surgeons annual meeting and has been accepted for publication in a peer-reviewed orthopedic trade journal.

Students' Device Allows ICU Patients to Get Back on Their Feet

Johns Hopkins undergraduates have designed and built a device to enable critically ill intensive care unit patients to leave their beds and walk while remaining tethered to essential life-support equipment. The invention allows doctors to better understand whether carefully supervised rehabilitation, as opposed to continuous sedation and bed rest, can improve the recovery of intensive care patients.

Some clinicians believe that allowing ICU patients to get out of bed and walk could avert some of the muscle weakness, bedsores and depression that typically develop when these patients are kept heavily sedated and confined to bed. Because such patients usually must remain connected to an artificial breathing machine, heart monitors and intravenous lines with essential medications, a simple walk down the hall can require four staff members to accompany the patient.

To reduce this staffing demand and improve this new ICU rehabilitation program, a physician at Johns Hopkins Hospital last year asked students in a biomedical engineering design team course to devise a mobility aid for ICU patients. Over two semesters, the students, supervised by faculty members and graduate students and advised by hospital staff, produced a device called the ICU MOVER Aid. This device has two components: a novel mobility aid that combines the rehabilitative features of a walker and the safety features of a wheelchair, and a separate wheeled tower to which important life-support equipment can be attached.

"The finished product is truly outstanding," said physician Dale Needham, an assistant professor in the Division of Pulmonary and Critical Care Medicine at the Johns Hopkins School of Medicine. "The most recent version of the MOVER is far beyond a rough prototype. The students exceeded everyone's expectations in designing a device that we could routinely use in the Medical ICU."

To help him improve the new Medical ICU rehabilitation program at Johns Hopkins, Needham had challenged the students to produce a device that would meet three key criteria. First, it had to provide physical support for the patient during walking. Second, it had to safely house all necessary monitoring and therapeutic equipment for critically ill patients. Finally, it needed a safety backup system for patients who must immediately sit down because of fatigue or a sudden change in their medical condition.

"We ended up building three versions," said Joshua Lerman, a senior biomedical engineering student who served as team leader. "First, we used PVC pipes to work on the basic design. Then, we made an aluminum version. We made the final prototype mostly of steel. All through the process we got feedback from the hospital's ICU staff, who told us what we needed to change to make it better suit patients' needs. All of the staff involved in the ICU rehabilitation program were very happy with the final version."

This final version features a walker type framework, similar to devices that some frail or elderly people use to get around. Immediately behind the patient, however, a fabric seat is attached to the frame so that a tired patient can sit down. The seat can also "catch" a patient who abruptly collapses because of a medical problem. "We made the seat out of ballistic nylon because we didn't want it to rip," said Lerman, 22, from Delray Beach, Fla. "It's durable, and it's easy to clean for infection-control purposes."

As a separate component, the prototype features a tower designed to accommodate two oxygen tanks and three medical devices: a cardiac monitor, intravenous infusion pumps to provide medications, and a ventilator to support breathing. Despite all of the equipment attached to it, the MOVER prototype was small enough to maneuver through the Medical ICU's narrow hallways, although using it in the ICU patient rooms, which are particularly small, proved to be more challenging. In terms of improved efficiency, the inventors said, the MOVER requires only two hospital staff members to accompany the walking patient, compared with four staff under the earlier system.

Needham, the project's faculty sponsor, said, "We've tried this device on one MICU patient so far, and we are certainly keen to continue using it as part of our physical medicine and rehabilitation program in the Medical ICU at Johns Hopkins. The MOVER worked as well with the real patient as it did when we tested it with the biomedical engineering students serving as simulated patients."

At a recent competition for Johns Hopkins biomedical engineering design projects, the MOVER's team took second-place honors. The student inventors and their faculty mentors have obtained a provisional patent for the device and are exploring commercialization opportunities. Needham said much will depend on how quickly other hospitals adopt new therapies in the ICU setting to improve patient recovery. "With the increasing interest in early mobility for ICU patients and the emerging scientific evidence supporting the benefit of this approach," he said, "I think there is a strong commercial future for the MOVER device."

In addition to Lerman, the undergraduates who worked on this project were Ravy Vajravelu, Derrick Kuan, Jeremy Elser, Erica Jantho, Jinjie Chen, Hanlin Wan and Swarnali Sengupta. The design course is taught by Robert Allen, an associate research professor and senior lecturer in the Department of Biomedical Engineering.

New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care

HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.

“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” Secretary Leavitt said. “We are moving from reactive dependence on voluntary reporting of safety concerns -- to proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of health care services.”

In a white paper released by the FDA today, the agency describes plans for the Sentinel Initiative, which will include the development of a new electronic system that will enable FDA to query a broad array of information to identify possible post-market adverse events. That Sentinel System will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.

A CMS final regulation published today will make it possible for federal agencies, states, and academic researchers to use claims data from the Medicare prescription drug program (Part D) -- subject to protections for beneficiary privacy and commercially sensitive data -- for public health and safety research, quality initiatives, care coordination and other research and analysis.

The Sentinel System is an important example of how electronic health records and other electronic health information, such as the Medicare data, can help move the nation toward a system that delivers safer and better quality health care. President Bush has set the goal of most Americans having access to an interoperable electronic health record by 2014.

FDA’s Proposed Sentinel System Will Strengthen Safety Monitoring of Drugs and Other Medical Products

The new FDA white paper, titled “The Sentinel Initiative -- A National Strategy for Monitoring Medical Product Safety,” describes the proposed Sentinel System and calls for a public-private collaboration to develop and implement it. The report is available at: http://www.fda.gov/oc/initiatives/advance/reports/report0508.html. The system would enable FDA to analyze significantly more information than it can today by tapping into vast databases of health information to detect early signs of emerging safety problems.

“With the Sentinel System we will no longer have to wait years to see how a drug or medical device is affecting millions of people,” said FDA Commissioner Andrew C. von Eschenbach, M.D. “The era of ‘wait and see’ is going to become the era of ‘tell me right now.’ By harnessing the world’s most powerful information technologies, and by partnering with CMS, the VA and DoD, and an array of private health care organizations, we will have the ability to monitor a product’s performance in millions of patients in real time. The Sentinel System will give us an unprecedented ability to detect problems as they first begin to surface.”

Creating an active surveillance system such as the Sentinel System was one of the recommendations made by the Institute of Medicine in a 2006 report on ways to improve the safe use of drugs. The recently passed Food and Drug Administration Amendments Act of 2007 (FDAAA) includes provisions that call for the development of such a system. As planned, the Sentinel System will fulfill some requirements of FDAAA while also meeting additional FDA needs.

Access to CMS Data Will Facilitate Public Health and Safety Research and Quality Initiatives

“We look forward to working with the FDA on the Sentinel Initiative,” said CMS Acting Administrator Kerry Weems. “There’s a clear nexus between the data collected through Medicare’s prescription drug program and the FDA’s role in protecting the public from adverse events. The public health and safety benefits from this cooperative venture with the FDA will be substantial.”

Weems noted that CMS’s most recent survey of beneficiaries indicates that people with Medicare use more than twice as many medications in a year as do other Americans. Medicare beneficiaries use an average of 28 prescriptions in a year, while those who consider themselves in poor health have about 45 prescriptions in a year (source: Medicare current beneficiary survey, 2004). In contrast, other Americans use about 13 prescriptions a year, according to a 2007 study by the Agency for Healthcare Research and Quality (http://www.ahrq.gov/news/nn/nn051607.htm). Medicare beneficiaries’ high usage of medications, coupled with numerous chronic health conditions, puts this population segment at higher risk of adverse drug events than other Americans and makes them the group most likely to see benefits from the FDA’s new Sentinel Initiative.

The Medicare Prescription Drug Benefit data, linked to Medicare inpatient and outpatient claims data, will allow the creation of a highly robust HHS database as the prototype for the Sentinel System. Publication of the Medicare Part D Claims Data Rule enables the FDA to use Part D claims data as the FDA explores drug safety questions related to particular products. Medicare’s Part D prescription drug program, implemented in January 2006, has generated claims data on medications used by the more than 25 million beneficiaries with prescription drug coverage under the benefit. Linking these data on prescription drug use to other Medicare claims information, including diagnoses, medical treatments, hospitalizations, and physician services, will provide the FDA, other agencies, and researchers with a powerful new tool to investigate potential drug safety problems and questions about health outcomes. With approximately 1 billion claims per year, the Medicare Part D database is unprecedented in size and scope and will be a valuable resource for patient safety analyses that will benefit not only Medicare beneficiaries but the entire nation.

Publication of the final rule today will enable CMS to use Medicare Part D claims data for research, program oversight and evaluation, care coordination, quality improvement, and performance measurement initiatives. In compliance with beneficiary privacy protections, as required by the Federal Privacy Act and HIPAA regulations, and while protecting commercially sensitive data, Medicare drug claims will be linked to other Medicare information on patient care, such as hospitalizations and physician visits, and made available to other federal agencies, state Medicaid programs, researchers, and beneficiaries for their personal health records.

CMS will be developing guidelines and workshops to inform researchers on how they can request these data.

The CMS final rule and a related fact sheet may be viewed at www.cms.hhs.gov/PrescriptionDrugCovGenIn/08_PartDData.asp

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PIEDMONT PHYSICIANS AT TATE COMMUNITY CLINIC

The Piedmont Physicians at Tate Community Clinic welcomes Michael A. Suarez, M.D., to its healthcare team.

Dr. Suarez is board-certified in family medicine and has been in practice for over eight years. He earned his medical degree from The Ohio State University College of Medicine in Columbus, Ohio and completed his residency training in family medicine from the University of Florida North Broward Hospital District in Coral Springs, Florida.

Following completion of his residency, Dr. Suarez joined the Watson Clinic in Lakeland, Florida. After two years in Lakeland, he returned to Ohio where he joined Memorial Physicians, Inc. in Marysville. Prior to joining the Piedmont Physicians at Tate Community Clinic, he treated patients at the Doctor’s Office in Hilliard, Ohio.

“We are pleased to welcome such an exceptional physician to the Piedmont family," said Berney Crane, CEO of Piedmont Medical Care Corporation, the administrative parent corporation of the Piedmont Physicians Group. "Dr. Suarez will provide excellent care to our patients.”

Dr. Suarez accepts most major insurance plans and is available for immediate appointments. Office hours are Monday through Thursday, 8 a.m. to 5 p.m. and Fridays, 8 a.m. to noon. The office is located at 89 Clinic Road, in Tate, Ga. For an appointment, call 770-737-3333.