public access to Global Unique Device Identification Database
The FDA, in partnership with the National Library of Medicine (NLM), is
pleased to announce that data submitted to FDAâ€™s Global Unique Device
Identification Database (GUDID) is now publicly available through a website
Through AccessGUDID, anyone can search or download information that device
labelers have submitted to the GUDID about their medical devices.
Because the UDI system is being phased in over the next several years,
labelers are currently submitting data on only the highest risk medical
devices, a small subset of marketed devices. But as the system is
implemented according to the UDI
compliance timeline, the records of all medical devices required to have
a UDI will be included.
As we launch this beta version of AccessGUDID, we encourage everyone
---health care systems, clinicians, patients, researchers, industry and
others--- to explore its contents, assess its functionality and provide us
with feedback. This feedback will shape future enhancements, including
advanced search and web services.
You can submit feedback through the Contact Us link at the bottom of the AccessGUDID landing
page or the FDA
UDI Help Desk.
Pure Processing Technologies add new capabilities to pre-cleaning, flushing
Pure Processing LLC is exhibiting its newest instrument flushing
technologies at the International Association of Healthcare Central Service
Materiel Management 50th Annual Conference & Exposition. Pure Processing, a
developer of ergonomic instrument pre-cleaning technologies and accessories
designed to enhance worker and patient safety, will exhibit in Booth 121.
Among the many Pure Processing cleaning innovations visitors will see at the
IAHCSMM exhibit, some featured products to look for this year are:
New Ergonomic stainless steel reprocessing sinks. These custom-designed,
height-adjustable systems are specifically intended for safe, efficient,
The FlexiPump Independent Flushing System. This compact and highly
flexible lumen-flushing device helps departments improve flushing
ergonomics, boost overall flushing capacity and
improve process standardization and consistency.
New ProSpray one-step, ready-to-use disinfectant cleaner, specifically
validated for disinfecting Pure Station and FlexiPump systems
The Pure Station Dedicated Eye Sink, a compact, lightweight, all-in-one
system that enables separate, safe, effective and standardized cleaning
and flushing of eye instruments
For more information, please visit
Sterilizer/Aerator GS series kills microorganisms on instruments safely,
efficiently, and cost effectively
Recent CRE outbreaks traced to inadequately processed duodenoscopes have
highlighted the need for healthcare facilities to review cleaning and
sterilization processes. In the case of a facility in northeastern Illinois,
after the hospital changed its reprocessing procedure from automated
high-level disinfection to ethylene oxide sterilization, no additional cases
of CRE transmission were identified. Ethylene Oxide (EO) sterilization
provides an overkill sterilization process which means that there is a large
safety margin built in to the cycle.
For facilities looking for effective reprocessing methods for heat- and
moisture-sensitive equipment, the new 3M Steri-Vac Sterilizer/Aerator GS
Series may be the solution. Instruments made of sensitive materials require
sterilization solutions that are both budget-friendly and effective at
killing microorganisms; sterile processing managers require solutions to
help them effectively manage the increasing complexity of instrument
The 100 percent Ethylene Oxide (EO) sterilant used in the Steri-Vac
sterilizer GS series effectively penetrates the complex geometries of
instruments, such as long-lumen flexible endoscopes; many instruments that
require low temperature sterilization can be sterilized using EO (always
refer to the instrument manufacturersâ€™ Instructions for Use (IFU) for
validated sterilization modalities and cycles).
EO is gentle on materials, which may extend the life of instruments or
reduce the frequency or cost of repairs. EO has been safely used in the
health care industry for more than 50 years, and EO has also been used in
medical device, government, and other industries for decades. In fact, over
half of all sterilized single-use medical products are sterilized with
ethylene oxide, according to the Global Industry Analysts.
3M also provides the elements of a strong sterilization quality control
system utilizing biological, chemical, and physical monitors for every
To monitor cleaning efficacy prior to sterilization, particularly for
difficult to clean flexible endoscopes, sterile processing managers may
establish a quality control protocol using the 3M Clean-Trace ATP Cleaning
Monitoring System. The Clean-Trace system provides a quantitative measure of
contamination at established test points to help facilities verify cleaning
For more information about the 3M Steri-Vac Sterilizer/Aerator GS Series,
For more information about the 3M Clean-Trace ATP Cleaning Monitoring
System, visit go.3M.com/ATPmonitoring.
works to change surgery across the U.S.
ReadySet Surgical, mission is to change the way surgery is done across the
United States. Yet the company and its founders arenâ€™t selling a new type of
product or surgical instrument. Instead, theyâ€™re working to ensure that
every surgeon from New York to Alaska has the right instruments for every
surgery that they perform.
Founded by Keerthi V. Kanubaddi and Shawn Studdard in the summer of 2014,
ReadySet Surgical is a company that is dedicated to improving surgical
â€śI have been witness to hundreds, if not thousands of surgical procedures
that were negatively impacted by poor communication and coordination of
surgical case needs with external vendors,â€ť said Kanubaddi. â€śAt its heart,
ReadySet is a surgical coordination platform. It consolidates logistics and
communication through one dashboard accessible by all members of the
What this means for surgeons, surgical departments and sterile processing is
that with ReadySet Surgical, they no longer have to suffer from poor vendor
coordination and its effects on patient outcomes.
â€śSurgeons tell us there are countless delays related to issues with surgical
equipment, operating room team members tell us that many hours each week are
dedicated to vendor coordination and sterile processing staff tell us that
department resources are regularly stretched thin to accommodate the variety
and irregularity of vendor equipment,â€ť said Studdard. â€śWhat we aim to
accomplish with ReadySet is the elimination of all of these headaches so
that surgical teams can focus less on the logistics and more on the patient.
Visit them in booth #835 at IAHCSMM, or visit
New research could
provide new and completely effective blood test for determining cancer
A group of researchers has recently developed a new test which, they claim,
can determine if a person will develop cancer within 13 years; and, more
importantly, that this test has 100 percent accuracy.
The researchersâ€”out of Northwestern University and Harvard Universityâ€”say
that a small but very significant physiological change occurs over a ten
year period before the diagnosis of cancer. Thus, finding this shift helps
them note a marker for potential cancer diagnosis.
â€śUnderstanding this pattern of telomere growth may mean it can be a
predictive biomarker for cancer,â€ť explains lead study author Dr. Lifang Hou.
The professor of preventive medicine with Northwesternâ€™s Feinberg School of
Medicine goes on to say, â€śBecause we saw a strong relationship in the
pattern across a wide variety of cancers, with the right testing, these
procedures could be used to eventually diagnose a wide variety of cancers.â€ť
The study authors indicate that they look for damage in telomeres. These are
the protective caps on the ends of chromosomes which protect DNA. They say
that when you find telomere damage it usually means that cancer is on its
The good news, then, is that these findings could lead to more effective
cancer research and even prevention. It has the potential to become the type
of test you might get at a simple checkup as part of, say, a blood screen.
Visit Pioneer News for the story.
The key to
reducing pain in surgery may already be in your hand
Imagine a hand-held electronic device â€“ accessible, portable and nearly
universal â€“ that could reduce pain and discomfort for patients, and allow
doctors the freedom to use less powerful and potentially risky medications
to complement anesthesia. Now reach in your pocket, because chances are you
already own one.
According to new research from a team led by Communication and Information
Science Professor Jeff Hancock and Cornell doctoral student Jamie Guillory
(now at RTI International), the simple act of texting someone on a mobile
phone during a minor surgical procedure done under local anesthetic can
significantly reduce a patientâ€™s demand for narcotic pain relief. Make that
text buddy a stranger, and the odds a patient will ask for medications to
take the edge off could be as little as one-sixth of those who go under the
knife with empty hands.
â€śThese findings suggest that the simple act of communicating with a
companion or stranger provides an analgesic-sparing effect,â€ť the authors
write in the journal Pain Medicine. â€śThe data also suggest that
text-based communication with a stranger is more effective.â€ť
Building on research that has shown social support before and during medical
procedures can reduce anxiety and perceptions of pain, Hancock and his team
decided to test whether mobile phones that allow patients to send text
messages or play games could bring that support benefit into settings where
the company of family members or friends is not possible.
Together with Hancock and Guillory, physicians Christopher Woodruff and
Jeffrey Keilman from McGill University working at LaSalle Hospital in
Montreal used an experiment to track four groups â€“ patients receiving
standard mobile phone-free perioperative treatment, those using a mobile
phone to play the game Angry Birds, patients using a mobile phone to text
with a close friend or family member, and others invited to text with a
research assistant instructed to focus on â€śgetting to know youâ€ť
When the research team analyzed the results, they found that patients
receiving â€śstandard therapyâ€ť â€“ meaning those not using mobile phones during
surgery â€“ were almost twice as likely to receive supplemental pain relief as
patients who played the game Angry Birds before and during the procedure.
The same patients were more than four times as likely to receive additional
analgesic as those texting a companion and â€“ most notably â€“ more than six
times as likely to receive additional narcotic relief as patients who
engaged in a texting conversation with a stranger.
To verify that latter effect and explore its source, the team took the
additional step of analyzing the language of the two groups allowed to text
during their surgeries. Hancock and his team found that, while the text
conversations with companions related more to biology, the body and negative
emotions; the texts with a stranger included more words expressing positive
emotions, with patients writing more often about self-affirming topics.
The authors say this study provides the first evidence that texting offers
this benefit beyond traditional treatment or even â€śdistractionâ€ť methods such
as playing a video game. The team called for new work to explore exactly
what type of conversations work best, and how far this benefit can be
developed to assist patients and doctors.
Visit Cornell for the study.
Ebola now being spread by unprotected sex
Health officials believe that survivors of Ebola can spread the virus
through having unprotected sex up to twice as long as was previously
believed. Officials are telling male survivors of Ebola to avoid any
unprotected sex for an indefinite period. Scientist thought the virus could
remain for three months in the semen of an infected person. However,
recently a case took place in West Africa that suggests infection through
unprotected sex could happen for up to five months or longer.
Using that case as an example, officials are telling male survivors of Ebola
to avoid any unprotected sex for an indefinite period. The officials said
that they previously had advised that the men wore condoms for up to three
On Friday, a report was released that detailed the case of a Liberian woman
who was 44 and whose infection is likely to have come from a man who is 46
and who had symptoms of Ebola in September of 2014.
She became ill during March in just a week following sex with the man and
died. Another woman that he had sex with close to the same time was tested
and her results were negative.
The virus spreads via direct contact with the blood or other bodily fluids
of an Ebola patient, such as saliva, urine, sweat or semen.
Once a patient recovers, health officials have said they are not contagious
except there remains a chance it remains in the semen.
Investigations of recent cases of Ebola in Sierra Leone, Guinea and Liberia
have pointed toward sexual transmission from Ebola survivors, but there has
been no confirmation on those cases.
However, there have been less than 10 of these cases, said a Center for
Disease Control spokesperson. It has been difficult pin pointing that sexual
relations was the only way that they might have been infected with the
Visit the Times Gazette for the story.
Almost half of
Obamacare exchanges face financial struggles in the future
Nearly half of the 17 insurance marketplaces set up by the states and the
District under President Obamaâ€™s health law are struggling financially,
presenting state officials with an unexpected and serious challenge five
years after the passage of the landmark Affordable Care Act.
Many of the online exchanges are wrestling with surging costs, especially
for balky technology and expensive customer call centers â€” and tepid
enrollment numbers. To ease the fiscal distress, officials are considering
raising fees on insurers, sharing costs with other states and pressing state
lawmakers for cash infusions. Some are weighing turning over part or all of
their troubled marketplaces to the federal exchange, HealthCare.gov, which
now works smoothly.
The latest challenges come at a critical time. With two enrollment periods
completed, the law has sharply reduced the number of uninsured and is
starting to force change in the nationâ€™s sprawling healthcare system. But
the law remains highly controversial and faces another threat: The Supreme
Court will decide by the end of June whether consumers in the 34 states
using the federal exchange will be barred from receiving subsidies to buy
If the court strikes down subsidies in the federal exchange, the states that
are struggling financially might be less likely to turn over all operations
to the federal marketplace, because they will want to make sure their
residents do not lose subsidies to help them buy insurance. If the court
upholds subsidies for the federal exchange, some states might step up
efforts to transfer operations to HealthCare.gov.
Most exchanges have operating budgets of $28 million to $32 million. One of
the biggest cost drivers is call centers, where operators answer questions
and can sign people up. Enrollment can be a lengthy process â€” and in several
states, contractors are paid by the minute. An even bigger cost involves IT
work to correct defective software that might, for example, make mistakes in
In Vermont, where the systemâ€™s cost is projected to balloon to almost
$200 million by the end of the year, officials are eyeing a move to the
federal marketplace if things donâ€™t improve. Officials from Vermont, Rhode
Island and Connecticut met recently to explore banding together in some sort
of regional effort.
In Maryland, where the exchangeâ€™s technology problems were so daunting that
officials turned to Connecticut for help, officials expect to have enough
revenue to cover operations for the fiscal year that begins July 1. If not,
the exchange would need to ask the governor for more funds.
In Colorado, Connecticut, Kentucky, Maryland and the District, fees to
support the exchange are imposed on plans sold on and off the marketplaces.
In the District, about $25 million of the exchangeâ€™s $28 million budget
comes from user fees assessed on insurance products not offered on the
exchange. The exchange budget would increase to $32.5 million in the budget
year beginning in September under the mayorâ€™s proposed plan. Debra Curtis,
deputy director of the exchange, said the marketplace estimates it will
raise about $28 million from the assessments and â€śuse existing federal
grants for ongoing implementation.â€ť
Even if some state exchanges wind up handing the reins to HealthCare.gov,
doing so is not free. Each exchange would have to be made compatible with
the federal marketplace at a cost of about $10 million per exchange, Jim
Wadleigh, executive director of Connecticutâ€™s exchange said.
Visit the Washington Post for the story.
chemicals come under new scrutiny
A top federal health official and hundreds of environmental scientists
voiced new health concerns about a common class of chemicals used in
products as varied as pizza boxes and carpet treatments.
The concerted public campaign renews a years-old debate about a class of
chemicals known as poly- and perfluoroalkyl substances, or PFASs. After
studies showed that some PFASs lingered in peopleâ€™s bodies for years, and
appeared to increase the risks of cancer and other health problems, the
chemical manufacturer DuPont banned the use of one type of PFAS in its
popular Teflon products, and other companies followed suit.
At issue now are replacement chemicals developed by those manufacturers
and used in thousands of products, including electronics, footwear, sleeping
bags, tents, protective gear for firefighters and even the foams used to
The companies assert that the alternatives are safe and vehemently contest
the scientistsâ€™ contentions, pointing to extensive studies conducted in the
last decade or so. But two separate salvos fired on Friday question whether
enough research has been done to justify the chemical industryâ€™s confidence
in the safety of this crop of PFASs.
The journal, published by the National Institutes of Health, devoted several
pages to the issue, with articles from researchers and from the industry
trade group. A statement signed by 200 international scientists â€”
environmental health experts, toxicologists, epidemiologists and others â€”
urged countries around the world to restrict the use of PFASs.
In a counterpoint, the American Chemistry Council, the industry trade
association, argued that the statement ignored the fact that such chemicals
use â€śessential technology for many aspects of modern life,â€ť and that tests,
reviewed by the Environmental Protection Agency, concluded that these
alternatives were safer than the chemicals they were replacing.
The PFAS family of chemicals represents an important part of DuPontâ€™s $34.7
billion in sales last year. Thomas H. Samples, the companyâ€™s head of risk
management for the division that manufactures these chemicals, rejected the
This class of chemicals is known for its durability. PFASs have strong
water-resistant properties. Cardboard pizza boxes treated with the
chemicals, for example, stay sturdy even when grease seeps into them.
But some of these same features worry environmental health specialists
because traces of the chemicals linger and have been detected in the
bloodstream of a large segment of the population, although typically at low
levels. In some cases, detectable levels of the older class chemicals have
been declining as major manufacturers have developed alternatives they say
Some researchers cite lingering concerns about a chemical spill more than a
decade ago. The health of residents of Parkersburg, WV, is still monitored
related to a spill of an older form of PFAS from a nearby chemical plant. A
class-action lawsuit accused DuPont, which owned the plant, of knowingly
contaminating the residentsâ€™ groundwater, and the company faces new
accusations, in a separate report being issued Friday by the
nonprofit Environmental Working Group, that it is not living up to the terms
of a court settlement.
Visit the New York Times for the article.