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July 26, 2016
FDA issues draft guidance on the Unique Device Identification System: Form and Content of the UDI
Today, the U.S. Food and Drug Administration released a draft guidance document, "Unique Device Identification System: Form and Content of the
Unique Device Identifier (UDI)."
The Unique Device Identification System Rule (UDI Rule) requires the label and device packages of most medical devices to bear a unique device
identifier (UDI) in both easily readable plain-text and automatic identification and data capture (AIDC) technology forms. UDIs must be issued under
a system operated by FDA-accredited issuing agencies (IAs).
This draft guidance is intended to assist both labelers and FDA-accredited IAs better ensure the UDIs developed under IA systems are in compliance
with the UDI rule. It includes clarification on:
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Two forms of a UDI;
Content of the UDI (including data delimiters that identify specific data elements within the UDI); and
Order of data in a UDI and UDI carrier (the means to convey the UDI and any non-UDI elements in easily readable plain-text and AIDC
forms).
Visit FDA for the draft guidance.
The mall of the future will offer dinner, movies, and a colonoscopy
The Runway at Playa Vista in Los Angeles recently added a Whole Foods, a movie theater, and upscale shops and restaurants—retail center
staples intended to attract affluent shoppers, condo-buyers, and tech companies to the mixed-use development. The next big tenant slated to move
in, however, is a little different: A 32,000-square-foot doctors' office, where the Cedars-Sinai Health System plans to house outpatient services,
including cardiology and orthopedics.
While urgent-care centers have been strip-mall staples for decades, the chance to catch dinner, a movie, and a surgical procedure under the same
roof is new—and coming soon to a mall near you. The reason is commerce: Mall operators are looking for tenants that trade in entertainment and
services to replace the brick-and-mortar retailers slowly being strangled by Amazon.com and its online competitors. Rents, particularly at older malls,
are a bargain.
The healthcare industry, meanwhile, is moving away from centralized campuses to bring services closer to patients at a time when two key
demographics are entering prime years for consumption. Boomers are hitting an age when they can expect to use more healthcare services;
millennials are starting families and beginning to make doctors appointments for their kids.
Put those factors together, and voila: You can get your blood pressure checked just steps from the steakhouse.
Chris Isola, vice president in the healthcare service group for CBRE, says the idea of putting medical clinics in malls is one that landlords are just
starting to come around to. “I think from Cedars’ perspective, that’s how you capture the younger demographic,” he explains. “The challenge is
convincing the landlord of a highly desirable center that there should be a medical clinic. It’s like, ‘This is why you should put Cedars here and not
break up the space for five or six boutiques.’”
Gauging just how rapidly healthcare companies are absorbing retail space is difficult, because the industry is composed of regional and local
players, many of which are using only small amounts of space. CoStar, a commercial real estate data and analytics firm, has begun tracking
healthcare companies as retail tenants only in recent years, making it hard to measure the industry's footprint. But the consensus among observers
is that it's the wave of the future.
Cedars-Sinai isn’t the only healthcare provider to take a large space in a retail mall. Others include the Prime Healthcare, which operates a 23,500square-foot ambulatory care facility at the Plymouth Meeting Mall outside Philadelphia. Last year, UCLA Health put a dozen doctors in a new medical
office at the Village at Westfield Topanga, a high-end mall in Woodland Hills, CA.
Then there's Vanderbilt University Medical Group, which occupies the entire second level at the 100 Oaks Mall in Nashville, TN, where patients can
pick up a pager when they check in at a clinic, then browse the outlet shops on the lower level while they wait. It used to be that only restaurants
would give you a pager to let you know when your table was ready. Now it means the results of your CT scan are in.
As this transformation has begun to take shape, strip malls seem to be more popular than traditional malls because they offer medical tenants an
appealing prospect: parking spaces directly in front of their stores so the elderly and infirm don’t need to cover large distances, let alone navigate
stairs or escalators.
While outpatient facilities and doctors offices make the move from hospitals and medical suites to the mall, about one-third of the 7,200 urgent-care
centers in the U.S. are already there, said Steve Sellars, president of the Urgent Care Association of America. The industry is adding a few hundred
new urgent-care centers a year, leading operators to try out new locations. Care Here!, a Brentwood, TN-based health and wellness company, even
opened a walk-in clinic in the Nashville airport.
For the healthcare companies, softness in the retail market has helped them negotiate favorable leases, including improvement allowances. Medical
facilities also look good financially as tenants, with credit profiles that stack up well compared with nail salons and fast-food restaurants.
Visit Bloomberg for the story.
Alzheimer's experts call for end to under-treatment of disease
Several physicians recognized for their contributions to clinical research and advances in the treatment of people with Alzheimer's disease today
called for immediate changes to how healthcare professionals approach the management of the disease.
Citing statistics that show a lack of diagnosis and use of currently available prescription medicine proven to have important positive clinical impact,
Gary Small, M.D., and Rachelle Doody, M.D., Ph.D., said that better education of primary care doctors to eliminate misconceptions is a critical first
step to give people with Alzheimer's disease a "fighting chance."
They emphasized that drugs that affect the cholinergic system are the only drugs shown to have a positive impact on all stages of Alzheimer's
disease – this has been established by two decades of clinical trials and real world observational studies. Furthermore, they also pointed out new
data published by Dr. Harald Hampel, M.D., Ph.D., supporting important, new information on the role medicines targeting the cholinergic system may
have in Alzheimer's patients.
According to the Alzheimer's Association and published research:
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46.8 million people worldwide and 5.4 million people in the United States are thought to be suffering from Alzheimer's disease, with the
numbers expected to reach 120 million globally by 2050.
Less than 50% of affected individuals are correctly diagnosed with Alzheimer's disease.
Less than 25% of the diagnosed patients receive treatment.
If prescribed treatment, less than 50% of people suffering from Alzheimer's disease remain on therapy after 4 years.
"It is unfortunate that only a minority of primary care doctors believe they have received sufficient training to diagnose the disease," commented Dr.
Small, Director of Geriatric Psychiatry at UCLA's Semel Institute for Neuroscience and Human Behavior.
"We see patients regularly for whom the diagnosis of Alzheimer's was missed. Unfortunately, the result is people with the disease are not getting
treated. This robs them of the ability to perform everyday tasks independently and maintain quality of life. We must change this now. We know that
research to find a cure is important. But so, too, is clinical research of medicines that can make an impact sooner."
"Results of our recently published brain imaging studies add to the growing amount of clinical and scientific evidence that supports the importance of
the cholinergic system in the treatment of Alzheimer's disease. Hopefully, we will soon get additional innovative compounds and therapies that will
further enhance the cholinergic brain system.
Companies like Axovant and others are in the late-stage development process of such novel compounds. If they are successful with the
development of these compounds, then we believe they could be used in combination with standard of care therapies that we have today. That's
really good news for patients and caregivers," said Dr. Hampel, Professor at the Department of Neurology, Marie Curie University and AXA
Research Fund Excellence Chair (Sorbonne Universities), and representative of the Hippocampus Study.
In summary, some of the most prominent physicians in the field of Alzheimer's disease call for immediate action: patients consulting their physicians
about possible early signs of Alzheimer's disease, physicians carefully assessing these patients, and in case of positive diagnosis – prescribing
appropriate medications targeting the cholinergic system to ensure maximum benefit.
Visit PR Newswire for the release.
Lifelong care, heartaches ahead for babies born with Zika in the U.S.
At least 12 babies in the United States have already been born with the heartbreaking brain damage caused by the Zika virus. And with that number
expected to multiply, public health and pediatric specialists are scrambling as they have rarely done to prepare for the lifelong implications of each
case.
Many of Zika’s littlest victims, diagnosed with microcephaly and other serious birth defects that might not immediately be apparent, could require
care estimated at more than $10 million through adulthood. Officials who have been concentrating on measures to control and prevent transmission
of the virus are now confronting a new challenge, seeking to provide guidance for doctors and others who work with young children with
developmental problems.
The White House and Centers for Disease Control and Prevention are holding regular talks with experts and nonprofits about the array of services
the infants and their families will need well into the future. Advocacy groups are seeking to raise awareness among parents and day-care providers,
and some high-risk states are streamlining existing programs so that they can rapidly connect Zika babies with physical, occupational and other
therapies.
On Thursday and Friday, CDC and the American Academy of Pediatrics convened a special meeting in Atlanta to establish guidelines on how to
evaluate and care for infants whose mothers were infected with the virus during pregnancy. They heard ophthalmologist Camila Ventura of Brazil,
the epicenter of Zika in the Americas, describe how extremely irritable, even inconsolable, the newborns with microcephaly are.
Just as daunting is the question of how to best monitor those exposed in utero but without obvious abnormalities at birth. Vision and hearing
problems can surface, as can seizure disorders.
The urgency of these discussions increased after Congress adjourned in mid-July without taking action on additional Zika funding. Lawmakers will
not return to Washington until September.
Federal and local health officials are monitoring at least 400 pregnant women with Zika in the 50 states and the District, up from 346 a week ago,
and another 378 pregnant women in the U.S. territories, most of them in Puerto Rico. In addition to the babies already born with Zika-related
problems — the latest was announced Friday by New York City health officials — at least six women have lost or terminated pregnancies because
their fetuses suffered brain defects from the virus.
Florida is investigating two possible cases of locally transmitted Zika — the first in any state. Should the virus spread there or elsewhere in the
region, it would be the first outbreak linked to serious birth defects since the 1964 rubella outbreak that killed 2,100 babies and left 20,000 others at
risk of deafness, heart damage and microcephaly.
But unlike with rubella, the vast majority of people with Zika have no symptoms. That poses enormous diagnostic challenges because the most
accurate tests need to occur within the first two weeks of infection. Also unlike rubella, researchers do not truly know the magnitude of risk for a
pregnant woman passing Zika to her fetus.
In addition to microcephaly, a rare condition usually characterized by an abnormally small head and underdeveloped brain, Zika can cause
neurological harm affecting vision, hearing, muscle and bone development, research shows. The range of impairment can be vast. Some babies lack
the most basic sucking reflex, which means they might never develop the ability to swallow.
Even in babies who look “absolutely fine” at birth, ongoing screening may be necessary to detect subtle changes that could signal serious problems.
Abnormal movement and prolonged staring, for example, could indicate an emerging seizure disorder.
Federal law requires every state to have an early intervention program that offers services to eligible infants and toddlers up to 36 months old who
have significant developmental delays or conditions likely to result in such delays. The programs, typically funded with state and federal dollars,
represent a critical support system for children with complex needs.
In Florida, which has 46 pregnant women with Zika, officials recently decided that any child with a confirmed Zika diagnosis automatically qualifies
for early screening and intervention.
With Zika, that support will be harder. It is a new disease. No one knows how a child’s development will be affected in the long-term. Parents of a
child with autism or Down syndrome can turn to well-established organizations offering resources and showcasing successes, but Zika-affected
families have no such help. At least not yet.
Visit the Washington Post for the article.
Class I Recall: Stryker Sustainability Solutions Flush Angiographic Catheter due to tip separation
Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions), is recalling Angiodynamics Soft Vu Omni Flush Angiographic Catheters due
to reports of separation of the tip of the catheter from the main body. Tip separation leads to loss of device function, possible surgical intervention to
retrieve a separated segment, or other complications such as blocking blood flow to bodily organs.
Tip separation can also lead to internal organ injury and cause stroke, kidney failure, and intestinal failure among other serious adverse health
consequences, including death.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The Soft-Vu Omni Flush Angiographic Catheter is used to inject contrast dye into blood vessels in preparation for a cardiac angiogram, a type of Xray used to diagnose heart conditions. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel.
On June 1, 2016, Stryker Sustainability Solutions sent a Customer Notification letter to customers informing them of the high possibility of tip
separation during use. The letter also asked customers to:
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Discontinue use of the affected lots of the recalled products
Check their inventories for affected lots of the unused products
Ship all affected products found back to Stryker
Visit FDA for the full recall notice.
MEDICAL FAIR ASIA 2016 posts strong growth
MEDICAL FAIR ASIA in Singapore, the International Exhibition on Hospital, Diagnostic, Pharmaceutical, Medical & Rehabilitation Equipment &
Supplies, continues its sustained growth course in 2016 thereby providing impressive proof of its role as South East Asia’s leading showcase for
medical device technology and healthcare.
For the 11th edition of this trade fair from August 31 to September 2 at The Sands Expo and Convention Center, Marina Bay Sands in Singapore,
1,000 exhibitors from 45 countries and 40% more exhibition space are expected than at the previous event in 2014. The number of country pavilions
from throughout the world will reach record numbers.
As part of these joint participations the leading industrial nations of the EU, North America with Canada, China, Japan, Taiwan, South Korea as well
as the ASEAN states Malaysia, Singapore and Thailand will present themselves. Saudi Arabia and Turkey have announced their first-time
participation.
The ten ASEAN states alone are home to some 625 million people and they continue investing in their medical care in order to overcome the lag with
western standards. This is clearly reflected in the extremely positive development of MEDICAL FAIR ASIA.
This economic region offers particularly high potential for the segments healthcare IT, telemedicine, patient monitoring and digital applications that
network and efficiently manage patient data. There is also growing interest in prevention and rehabilitation care that focuses on largely retaining the
self-determination of people affected.
At MEDICAL FAIR ASIA 2016 visitors can obtain an overview of current solutions and developments in these growth areas. The trade fair will
dedicate a Special Show with the theme of rehabilitation care.
Celebrating a premiere will be MEDICINE + SPORTS CONFERENCE ASIA, which will be held concurrently with MEDICAL FAIR ASIA on
September 1, 2016. The event sheds some light on South East Asia’s booming market for sports and preventive medicine and will discuss the
region’s health policy challenges.
According to studies, this market segment is expected to grow by seven percent annually to reach a volume of US$ 3.85 billion by late 2019. At the
same time, the region registers a dramatic rise in cardio-vascular diseases, in respiratory tract diseases but also in chronic diseases such as
diabetes.
For more information visit www.medicalfair-asia.com/.
FDA evaluation of automatic Class III designation (De Novo) summaries
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option as an alternate pathway to classify
novel devices of low to moderate risk that had automatically been placed in Class III after receiving a “not substantially equivalent” (NSE)
determination in response to a premarket notification [510(k)] submission
Section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), on July 9,
2012, to allow a sponsor to submit a de novo classification request to the FDA for novel low to moderate risk devices without first being required to
submit a 510(k).
There are two options for de novo classification for novel devices of low to moderate risk.
Option 1: Any person who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE
determination, submit a de novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.
Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may
submit a de novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and
receiving an NSE determination.
Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.
Since 2010, the FDA has begun releasing summary documents for devices classified through the de novo process. The de novo summary is
intended to present an objective and balanced summary of the scientific evidence that served as the basis for the decision to grant a de novo
request.
The de novo summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device
manufacturers that may wish to use the device as a predicate for future 510(k) Submissions
Visit FDA for the release.
The 7 types of cancer that alcohol might actually 'cause'
If there was ever a research area to inspire confusion in the public, it’s the alcohol-and-health debate. Some studies suggest that alcohol may be
good for us in certain ways, while others find that it’s decidedly bad. Much of the discrepancy may have to do with the quantity of alcohol consumed,
and the other lifestyle habits that go, or don’t go, along with it.
Now, a new paper in the journal Addiction suggests that alcohol is not only linked to, but may actually cause, seven different types of cancer. But as
always, the dose makes the poison.
Lead researcher Jennie Connor of the University of Otago in New Zealand found that drinking alcohol was routinely linked to cancer of the
oropharynx, larynx, esophagus, liver, colon, rectum and, in women, the breast.
“There is strong evidence that alcohol causes cancer at seven sites, and probably others,” says Connor. It’s important to point out that the study
doesn’t actually “prove” that alcohol causes cancer, but Connor argues that the whole body of literature taken together gets about as close to
showing causation as one can, without randomly assigning people to drink alcohol or abstain over the course of their lifetimes.
“Ongoing research will elucidate mechanisms more clearly and increase confidence in the epidemiology,” says Connor. “At the same time there will
be orchestrated attempts to discredit the science and the researchers, and to confuse the public. The stakes are high for alcohol industries when
there is no argument, on current evidence, for a safe level of drinking with respect to cancer.”
It used to be that drinking moderately seemed like the safe bet–but in recent years, the research suggests, we may have to go a little lower. Drinking
lightly, or even sparingly, may be the new normal, at least if we look at the science. But the beverage industry may not be ready to hear that.
Visit Forbes for the article.