Communication: New duodenoscope Model TJF-Q180V by Olympus reprocessing
Olympus has issued new, validated manual reprocessing instructions for the
TJF-Q180V duodenoscope to replace those provided in the original labeling.
The FDA has reviewed these new reprocessing instructions and the validation
data as part of its ongoing review of the 510(k), and recommends that any
facilities that are using Olympusâ€™ TJF-Q180V duodenoscope train staff on the
new instructions and implement them as soon as possible.
Visit here for more information.
The FDA is closely monitoring the possible association between reprocessed
duodenoscopes and the transmission of infectious agents, including multidrug-resistant
bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae
(CRE) such as Klebsiella species and Escherichia coli. If not
properly reprocessed, residual body fluids and organic debris may remain in
microscopic crevices of the device following an attempted cleaning and high
The FDAâ€™s investigation into the possible association between inadequately
reprocessed duodenoscopes and patient infections, including the agencyâ€™s
recommendations for healthcare facilities, is more fully discussed in the
following recent communications:
February 2015 Safety Communication and
FDAâ€™s Updated Information for Healthcare Providers Regarding Duodenoscopes
issued March 4, 2015.
FDA has been working with duodenoscope manufacturers as they modify and
validate their reprocessing instructions to further enhance the safety
margin of their devices and show with a high degree of assurance that their
reprocessing instructions, when followed correctly, effectively clean and
disinfect the duodenoscopes.
In September 2014, Olympus initiated testing to validate new reprocessing
instructions. The cleaning validation reports were provided to FDA in
October 2014. While FDA found Olympusâ€™ cleaning validation data acceptable,
initial high level disinfection reports did not demonstrate an adequate
safety margin, and so Olympus conducted additional testing.
At the end of February 2015, Olympus submitted new high level disinfection
validation data to FDA. The agency has reviewed this data and believes that,
when followed, the new, validated reprocessing instructions for the Olympus
TJF-Q180V duodenoscope are robust, and demonstrate consistent and reliable
cleaning and high-level disinfection. At FDAâ€™s request, Olympus has issued
the new, validated instructions for reprocessing the TJF-Q180V duodenoscope.
To validate reprocessing instructions for duodenoscopes, manufacturers
should soil their device with bacteria to simulate use in a procedure and
then demonstrate that the device can be adequately disinfected through a
sufficient reduction in microbes when the reprocessing instructions are
correctly followed. To support high level disinfection of duodenoscopes, the
disinfectant should result in a six-log reduction in the number of microbes
at each of several locations on the scope â€“ that is a one million-fold
reduction; or a reduction of 99.9999%.
Olympus sent letters dated March 26, 2015 to healthcare facilities and other
users of the TJF-Q180V outlining the new, validated reprocessing
instructions, and will soon be distributing revised user manuals. Key
changes have been made to the Precleaning, Manual Cleaning, Manual High
Level Disinfection reprocessing procedures for Olympusâ€™ TJF-Q180V
In addition, FDA has the following recommendations for facilities and staff
that use and reprocess the Olympus TJF-Q180V: Implement the new manual
cleaning and high level disinfection procedures for the Olympus TJF-Q180V
duodenoscope in accordance with the manufacturerâ€™s reprocessing
instructions; Train appropriate staff on Olympusâ€™ new reprocessing
instructions and implement them as soon as possible.
Read the MedWatch Safety Alert, including links to the FDA Safety
Ebola more deadly
for young children
Ebola progresses more quickly and is more likely to be fatal for children
under five, according to new research. An international group of scientists
led by Imperial College London and the World Health Organization analyzed
data on Ebola cases in children under 16 during the current outbreak in
Guinea, Liberia and Sierra Leone, comparing them to cases in adults.
The results show that although the rate of infection is lower in children
than adults, young children who get the disease have a lower chance of
As of March 2015, nearly 4,000 children under 16 have been affected by Ebola
in the current epidemic, around a fifth of all confirmed and probable cases.
The proportion of cases made up by children has been gradually increasing
over the course of the epidemic, but the explanation for this is unclear.
Ebola has affected young children most severely, killing around 90 percent
of children aged under a year and around 80 per cent of children aged one to
four years who are infected. Older children are much more likely to survive
the disease â€“ it has killed 52 percent of children infected aged 10 to 15.
For adults aged 16 to 44, the case fatality rate is 65 percent.
The incubation period â€“ the time between becoming infected and showing
symptoms â€“ was 6.9 days in children under a year, compared with 9.8 days in
children aged 10 to 15. Younger children also had shorter times from the
onset of symptoms to hospitalization and death.
There were also differences in the symptoms experienced by children.
Children were more likely to have a fever when they first see a doctor, and
less likely to have pain in the abdomen, chest, joints, or muscles;
difficulty breathing or swallowing; or hiccups.
The findings are published in the New England Journal of Medicine.
Visit the Imperial College of London for the article.
of Surgeons hails U.S. House passage of Medicare Access Bill
The American College of Surgeons (ACS) is optimistic that much-needed
Medicare program reforms are within reach following Thursdayâ€™s vote in the
U.S. House of Representatives on H.R.
2, the Medicare Access and CHIP Reauthorization Act of 2015. ACS
congratulates representatives for working together to develop a bill that
implements meaningful reforms to the Medicare program, including permanent
repeal of the broken sustainable growth rate formula (SGR) used to calculate
â€śThe American College of Surgeons commends the U.S. House of Representatives
for their pivotal vote today passing the Medicare Access and CHIP
Reauthorization Act,â€ť said David B. Hoyt, MD, FACS, Executive Director of
the American College of Surgeons. â€śSpeaker Boehner and Minority Leader
Pelosi have demonstrated admirable leadership in working across the aisle to
usher through legislation that ensures seniors have uninterrupted access to
the medical care they need. The College calls on the U.S. Senate to follow
the House example and pass the bipartisan Medicare reform bill before
adjourning for its two-week break.â€ť
Visit ACS for the announcement.
chain talent recognized with Visionary Award
SCM World, the supply chain talent development partner for the worldâ€™s
leading companies, recently honored Vance Moore, senior vice president of
operations for Mercy, and current board chairman for ROi (Resource
Optimization & Innovation), Mercyâ€™s supply chain company, with its inaugural
Supply Chain Visionary Award.
â€śVanceâ€™s contributions to supply chain in healthcare go back a long way,â€ť
explained Kevin Oâ€™Marah, chief content officer and head of research, SCM
World. â€śHe is part of a history at ROi that has produced exceptional,
visionary leadership in healthcare and will no doubt continue to influence
the sector for years to come.â€ť
Moore joined ROi in 2002 and served as president and CEO from 2007 to 2011
before transitioning to his current role within Mercy.
The Supply Chain Visionary Award is part of SCM Worldâ€™s Power of the
Profession awards program, which, according to Matt Davis, SCM Worldâ€™s
senior vice president of research, was created to recognize supply chain
leaders that are not only driving breakthrough innovations, but also sharing
their practices to advance the entire supply chain profession.
â€śIt is such an honor to see ROi and its leadership recognized by SCM World,â€ť
said Gene Kirtser, president and CEO of ROi. â€śWe are very proud of our
continued heritage of visionary leaders, starting from our three founders
Lynn Britton, Mike McCurry and Shannon Sock, elevating the strategic role of
supply chain in health care, and continuing today with our current
Visit ROI for the release.
battling the worst HIV outbreak in its history
The HIV epidemic that now grips Austin, IN, seemed to come out of nowhere.
Since the first diagnosis in mid-December, the number of infected there and
in the surrounding region has skyrocketed â€” 26 by the beginning of March, 72
as of this Wednesday. Itâ€™s the worst HIV outbreak in state history, and has
local and federal officials scrambling to stem the spread of the disease.
But to William Cooke, who runs the only doctorâ€™s office in this city of
about 4,300, this epidemic has been years in the making. â€śWe identified long
ago there was an undercurrent there that was very unhealthy,â€ť he told NBC.
Poverty and drug addiction in Austin created â€śa recipe for disaster.â€ť
Long before the first HIV diagnosis, the city has been coping with another
epidemic: intravenous drug use. Used needles can be found strewn across
yards and roadsides, but just as often wind up in the hands of other users,
contributing to the spread of infection.
In the 10 years since he established his family practice here, Cooke has
watched drugs and disease take hold â€” first the opiate addiction, driven by
the trafficking of painkillers up nearby Interstate 65, then the increased
rate of overdoses, then the spread of hepatitis C, another blood-borne
On Monday, investigators from the Centers for Disease Control and Prevention
were dispatched to Scott County, where Austin is located, to investigate the
outbreak and determine whether the virus is a new strain or one that has
been circulating for a while.
They agreed with Cookeâ€™s assessment that this epidemic is driven by drug
use, epidemiologist Pam Pontones told the Associated Press. Intravenous drug
use has been identified as the mode of infection in nearly all of the 72
confirmed cases, she added â€” the vast majority of those infected shared a
syringe with someone else while injecting a liquid form of a prescription
painkiller called Opana.
Indiana Gov. Mike Pence (R), said he would consider implementing a targeted
needle exchange program to combat the diseaseâ€™s spread. Such programs, which
allow people to trade-in used hypodermic needles for clean ones, are
currently illegal in Indiana.
But a needle exchange isnâ€™t the only program Scott County needs, Cooke said.
He is petitioning for an addiction treatment center â€” right now, the nearest
such facility is in the next county over, and many residents lack the means
to get there â€” and for more infectious-disease experts, addiction
councilors, cardiologists and pulmonary doctors. He also wants more funds
and training for his staff to serve the growing number of HIV patients.
Visit the Washington Post for the story.
Spectra254 ultraviolet light system 99.9 percent effective in killing Human
Spectra254, a developer of UVC light decontamination systems, announced that
results from an independent laboratory study finds Spectra254â€™s 1000 Series
ultraviolet light system to be 99.9 percent effective in killing the Human
Enterovirus, the virus that causes known diseases such as hand foot and
mouth disease, conjunctivitis and Aseptic Meningitis.
The study, by Antimicrobial Test Laboratories, found the ultraviolet light
system is 99.9 percent effective at killing the Human Enterovirus on
surfaces at a distance of up to 10 feet in five minutes. The laboratory
measured efficacy at distances of five, 10 and 15 feet, both vertically and
The study tested the microorganism Human Enterovirus 68 (EV68), a
non-enveloped, single-stranded RNA member of the Picornavirus family. Once
considered rare, outbreaks of this virus appear to be on an upswing as the
United States experienced a national outbreak in 2014 that resulted in an
unusually high number of respiratory illness hospitalizations.
The Spectra 1000 Series UVC light decontamination systems use high-intensity
UVC light to eliminate pathogens on surfaces. The companyâ€™s devices are
currently in use at hospitals throughout North America, as well as
ambulatory care, medical clinics and education facilities.
Multiple analyses performed for Spectra254 in further independent scientific
testing documented that UVC light from the Spectra Systems was also highly
effective (greater than 99 percent) in killing MRSA and C. difficile spores
on solid surfaces and in inhibiting the growth over a range of exposure
times and distances.
Visit Spectra254 for the study.
contest may accelerate warehouse automation
Packets of Oreos, boxes of crayons, and squeaky dog toys will test the
limits of robot vision and manipulation in a competition this May. Amazon is
organizing the event to spur the development of more nimble-fingered
Participating robots will earn points by locating products sitting somewhere
on a stack of shelves, retrieving them safely, and then packing them into
cardboard shipping boxes. Robots that accidentally crush a cookie or drop a
toy will have points deducted. The people whose robots earn the most points
will win $25,000.
Amazon has already automated some of the work done in its vast fulfillment
centers. Robots in a few locations send shelves laden with products over to
human workers who then grab and package them. These mobile robots, made by
Kiva Systems, a company that Amazon bought in 2012 for $678 million, reduce
the distance human workers have to walk in order to find products. However,
no robot can yet pick and pack products with the speed and reliability of a
human. Industrial robots that are already widespread in several industries
are limited to extremely precise, repetitive work in highly controlled
Pete Wurman, chief technology officer of Kiva Systems, says that about 30
teams from academic departments around the world will take part in the
challenge, which will be held at the International Conference on Robotics
and Automation in Seattle (ICRA 2015). In each round, robots will be told to
pick and pack one of 25 different items from a stack of shelves resembling
those found in Amazonâ€™s warehouses.
Some teams are developing their own robots, while others are adapting
commercially available systems with their own grippers and software.
The challenge facing the robots in Amazonâ€™s contest will be considerable.
Humans have a remarkable ability to identify objects, figure out how to
manipulate them, and then grasp them with just the right amount of force.
This is especially hard for machines to do if an object is unfamiliar,
awkwardly shaped, or sitting on a dark shelf with a bunch of other items. In
the Amazon contest, the robots will have to work without any remote guidance
from their creators.
The contest could offer a way to judge the progress that has been made in
the past few years, when some cheaper, safer, and more adaptable robots have
emerged thanks to advances in the technologies underlying machine dexterity.
Visit Technology Review for the story.
From pills that
snitch to Xbox sensors, drugmaker goes high tech
A decade ago, Joe Jimenez was peddling ketchup and baked beans. Now heâ€™s
using Microsoft Corp.â€™s gaming technology and embedding Google Inc. sensors
in contact lenses to reinvent the worldâ€™s biggest drugmaker.
As Novartis AGâ€™s chief executive, Jimenez is barreling down untested paths
at the frontier of biology and digital technology to prepare for a future in
which the use of smartphones and other digital devices to monitor health
will be the key to getting paid.
Jimenez is also taking an axe to the empire built by his flamboyant
predecessor, Daniel Vasella, with a complex asset swap worth more than $30
billion that closed this month. By offloading vaccines and adding cancer
drugs, the 55-year-old former competitive swimmer is preparing Novartis for
the loss of patents on medicines that make up a fifth of its sales.
â€śOur view has to be based on how healthcare is going to change,â€ť Jimenez
said in an interview at the companyâ€™s headquarters in Basel, Switzerland.
â€śIf you look at what led to the transformation that we just went through, it
was a view of whatâ€™s going to happen in 10 years externally.â€ť
Projects and products include pills and inhalers with sensors that tell on
patients who miss a dose; clinical tests that rely on Microsoftâ€™s Kinect,
the motion-sensing technology used with Xboxes, to measure walking speed and
balance in people with multiple sclerosis; and Google contact lenses that
focus automatically and can deduce diabeticsâ€™ blood-sugar levels from their
tears -- a gamble that Jimenez says could transform eyesight.
Thereâ€™s more to come. Novartis and U.S. chipmaker Qualcomm Inc. in January
agreed to invest up to $100 million to find and fund startups that enable
devices such as smartphones to monitor a patientâ€™s health remotely.
Vasella built Novartis with acquisitions and a handful of blockbusters like
Gleevec, a leukemia drug that garnered $4.7 billion in sales last year but
will face a generic contender next February. Jimenez, who took over as CEO
in February 2010, started out with prudent steps as long as Vasella remained
as chairman, buying out the Alcon eye-care unit and trimming costs.
Jimenez has boosted research and development spending in the pharma unit by
25 percent in his five years at the helm, an increase second only to Johnson
& Johnsonâ€™s 64 percent among the worldâ€™s five biggest drugmakers. Besides
ensuring Novartis researchers get funds and autonomy, Jimenez says heâ€™s
working to foster an environment in which they feel safe to take risks --
even if that means admitting defeat.
For Jimenez, the digital initiative is about bracing for the day when public
health spending will be so stretched that drugmakers will get paid only when
they can show a patientâ€™s condition improved. That means delivering
technology to show the treatment works. Novartis is planning about 10 pilot
projects, including one in the U.K. with Google designed to experiment with
conditional reimbursement for heart failure by using remote patient
monitoring systems in conjunction with its LCZ696 drug.
Visit Bloomberg for the story.