FDA halts blood
collection in South Florida
requesting that blood collection facilities in Miami-Dade and Broward
counties cease collecting blood immediately in consideration of the
possibility of an emerging local Zika virus (ZIKV) outbreak.
FDA requests that blood collection facilities located in the identified
areas ‚Äúcease collecting blood immediately‚ÄĚ until the blood collection
facilities ‚Äúimplement testing of each individual unit of blood collected in
the two counties with an available investigational donor screening test for
Zika virus RNA, or until the blood establishments implement the use of an
approved or investigational pathogen inactivation technology.‚ÄĚ
Further, FDA recommends that blood collection facilities in nearby counties,
including Palm Beach, Hendry, Collier and Monroe, cease collecting blood as
soon as possible and implement testing as described above.
For blood collection facilities located outside of the identified areas, FDA
suggests that donors who have traveled to Miami-Dade and Broward Counties
during the previous four weeks be deferred from donating. Although not
stated in today‚Äôs communication, AABB recommends that donors who have
traveled to an area with active ZIKV transmission be deferred for four weeks
following the departure from that area.
FDA is aware that implementation of these measures will result in additional
questions and is planning to provide updates as more information becomes
available. Those with questions may contact
firstname.lastname@example.org. AABB is working with FDA to address questions about
this ongoing situation.
Centers for Disease Control and Prevention maintains an up-to-date web page
listing areas with active mosquito-borne transmission of Zika virus.
AABB will update the
Tracking Zika Travel Notices table so blood establishments will know the
date of this notice as a reference for management of post-donation
information, donor eligibility, product suitability and product recall.
Association Bulletin #16-04, ‚ÄúZika, Dengue, and Chikungunya Viruses,‚ÄĚ
which is quoted above, focuses on recommendations for members whose
collection activities are NOT in locations currently listed on the CDC‚Äôs
Zika-Affected Areas web page. Recommendations are included for screening
donors for travel to Zika-affected areas using Zika Additional Questions and
pre-donation and postdonation screening
AABB earlier this month applauded the U.S. Department of Health and Human
Services‚Äô plan to spend up to $330 million to advance development of
pathogen reduction technologies that could protect the nation‚Äôs blood supply
from bacteria, parasites, Zika and many other viruses, and other pathogens.
Last month the HHS Office of the Assistant Secretary for Preparedness and
Response (ASPR) announced that the Biomedical Advanced Research and
Development Authority (BARDA), had committed up to $180.5 million to Cerus
Corporation of Concord, California to advance its INTERCEPT system for the
treatment of red blood cells; and up to $169.3 million to Terumo BCT
Technologies of Lakewood, Colorado to further develop its Mirasol system for
Currently, all blood undergoes two different screening tests to detect many
pathogens: serologic (antibody) tests and Nucleic Acid Tests (NAT). If the
pathogen reduction process proves effective for removing impurities, it
could change how blood is screened, and even who can donate.
Visit AABB for the announcements.
New crop of
robots to vie for space in operating room
Even though many doctors see need for improvement, surgical robots are
poised for big gains in operating rooms around the world. Within five years,
one in three U.S. surgeries ‚ÄĒ more than double current levels ‚ÄĒ is expected
to be performed with robotic systems, with surgeons sitting at computer
consoles guiding mechanical arms. Companies developing new robots also plan
to expand their use in India, China and other emerging markets.
Robotic surgery has been long dominated by pioneer Intuitive Surgical Inc.,
which has more than 3,600 of its da Vinci machines in hospitals worldwide
and said last week the number of procedures that used them jumped by 16
percent in the second quarter compared to a year earlier.
The anticipated future growth ‚ÄĒ and perceived weaknesses of the current
generation of robots‚ÄĒ is attracting deep-pocketed rivals, including
Medtronic Inc. and a startup backed by Johnson & Johnson and Google.
Developers of the next wave aim to make the robots less expensive, more
nimble and capable of performing more types of procedures, company
executives and surgeons told Reuters.
Although surgical robots run an average of $1.5 million and entail ongoing
maintenance expenses, insurers pay no more for surgeries that utilize the
systems than for other types of minimally-invasive procedures, such as
Still, most top U.S. hospitals for cancer treatment, urology, gynecology and
gastroenterology have made the investment. The robots are featured
prominently in hospital marketing campaigns aimed at attracting patients,
and new doctors are routinely trained in their use.
Doctors say they reduce fatigue and give them greater precision. But
robot-assisted surgery can take more of the surgeon's time than traditional
procedures, reducing the number of operations doctors can perform.
To gain an edge, new robots will need to outperform laparoscopic surgery,
said Dr. Dmitry Oleynikov, who heads a robotics task force for the Society
of American Gastrointestinal and Endoscopic Surgeons.
New systems also will need to be priced low enough to entice hospitals and
outpatient surgical centers that have not yet invested in a da Vinci, as
well as convince those with established robotic programs to consider a
second vendor or switching suppliers altogether.
Intuitive said it too is looking to improve technology at a reasonable cost,
but newcomers will face the same challenges.
Device maker Medtronic has said it expects to launch its surgical robot
before mid-2018 and will start in India. Others developing surgical robots
include TransEnterix Inc. and Canada's Titan Medical Inc.
An RBC Capital Markets survey found that U.S. surgeons expect about 35
percent of operations will involve robots in five years, up from 15 percent
J&J, which hopes to be second to market with a product from Verb, has said
it sees robotics as a multibillion-dollar market opportunity.
Visit Voice of America for the story.
controlled through treatment compliance, patient education
A new study found that following basic hygienic practices and complying with
protocols for Methicillin-Resistant Staphylococcus aureus (MRSA)
decolonization reduces the time to clearance of the bacteria more quickly
than a treatment regimen of antibiotic ointment and antiseptic body wash.
The findings, published in Infection Control & Hospital Epidemiology,
the journal of the Society for Healthcare Epidemiology of America,
demonstrate the importance of educating patients in hygienic practices, in
addition to encouraging adherence to decolonization protocols in the
treatment of MRSA.
"MRSA is particularly dangerous because it can colonize in others without
causing infection; and those in close contact, such as family members, are
more likely to transmit MRSA to each other," said Valerie Cluzet, MD, an
instructor in the division of Infectious Diseases at the Perelman School of
Medicine at the University of Pennsylvania, and lead author of the study.
"As a result, household members could be an ongoing source of MRSA, leading
to recurring infections."
The three-arm non-blinded randomized control trial was conducted at five
academic medical centers in southeastern Pennsylvania among members of 223
households. It compared three different interventions: education on personal
and household hygiene; education with treatment and reminders with daily
phone calls and text messages; and education with treatment, but no
Researchers observed no significant difference in time to clearance of MRSA
between the group that received only education and the groups of patients
that received antibiotic treatment. However, secondary analyses found that
the biggest impact on decolonization was compliance to treatment (>100%).
When patients followed the antibiotic treatment guidance, the bacteria were
cleared more quickly (23 days) compared with non-compliant households (27
Based on these findings, the researchers recommend clinicians emphasize to
patients the importance of compliance with decolonization treatment for
successfully clearing MRSA, and spend time educating patients with MRSA
about its transmission and measures to control it. Practices such as washing
linens regularly, wiping down high-touch surfaces, avoiding sharing personal
hygiene items, and practicing hand hygiene can reduce household spread.
Visit Medical Xpress for the report.
EHR rollout doesn‚Äôt appear to affect outcomes
Implementation or replacement of electronic health records (EHRs) may be
disruptive, inconvenient and confusing. It may slow down clinicians and even
cause some minor mistakes. But it doesn‚Äôt appear to cause additional deaths,
adverse events or hospital readmissions, a new study suggests.
‚ÄúDespite concerns that implementation of EHRs might adversely impact patient
care during the acute transition period, we found no overall negative
association of such implementation on short-term inpatient mortality,
adverse safety events or readmissions in the Medicare population across 17
U.S. hospitals,‚ÄĚ said the study, which appeared in the BMJ.
‚ÄúOur findings should be reassuring to hospitals and physicians who are
considering or planning the implementation of EHRs,‚ÄĚ wrote the Boston-based
research team, from Harvard, Brigham and Women‚Äôs Hospital, Beth Israel
Deaconess Medical Center and Massachusetts General Hospital.
The researchers examined readmission, patient mortality and rates of adverse
patient safety events in Medicare inpatients at 17 hospitals that
implemented or replaced EHRs in a big bang-style rollout in 2011 and 2012.
‚ÄúThere‚Äôs a well-documented ‚Äėweekend effect‚Äô and ‚ÄėJuly effect'‚ÄĚ on patient
safety,‚ÄĚ Barnett said. In other words, more errors happen when hospitals
reduce staff on weekends and in July, when new classes of residents
typically start. Barnett said that he his Boston colleagues expected vendor
changes to be at least as difficult for hospitals to manage.
Surprisingly, there was not a significant difference on those three metrics
in the 90 days before and after the EHR go-live, according to their analysis
of Medicare data at those hospitals.
The study said that implementation of EHRs would have a negative association
with short-term patient outcomes owing to disruptions in clinical workflow.
Contrary to that hypothesis, the researchers found that before and after a
discrete ‚Äúgo live‚ÄĚ date for EHR implementation across 17 hospitals, there
was no evidence of a significant or consistent negative association between
EHR implementation and short term mortality, readmissions, or adverse
Visit MedCity News for the article.
Cancer found in
ancient human ancestor's foot
The aggressive tumour was found in a 1.7 million-year-old toe from an
ancient human ancestor. The toe belonged to one of the early hominins,
either Homo ergaster or Paranthropus robustus.
The researchers said the findings clearly show cancer is not a disease of
modern society, as some people claim.
Tumours have been detected in remains before - a Croatian Neandertal who
walked the Earth around 120,000 years ago was one of the oldest.
The new discovery was made in a toe bone from Swartkrans cave in the Cradle
of Humankind World Heritage Site near Johannesburg.
Data, published in the South African Journal of Science, showed the
metatarsal had osteosarcoma - a rare and deadly form of bone cancer.
Despite cancers being detected in a wide range of species, some people
believe the disease is a uniquely modern problem.
Edward Odes, one of the researchers at the University of the Witwatersrand,
said: "Modern medicine tends to assume that cancers and tumours in humans
are diseases caused by modern lifestyles and environments. Our studies show
the origins of these diseases occurred in our ancient relatives millions of
years before modern industrial societies existed."
Dr Patrick Randolph-Quinney, from the University of Central Lancashire, told
the BBC News website: "The idea that cancers are recent has come out of work
on Egyptian mummies where they failed to find evidence of cancers in X-rays,
which has skewed our reasoning on this."
However, he added that modern lifestyles do increase the risk of some
tumours: "The rise of colorectal cancer with a Western diet, liver cancers
from alcohol consumption, lung cancer and smoking are all diseases of
"There's lots of different causes of cancer and they change through history
- if you were a chimney sweep in London you were likely to get lung cancer -
a lot is context dependent with new diets and new toxins."
Hannah Birkett, from the Bone Cancer Research Trust, commented: "This
discovery is really exciting for osteosarcoma and the field of primary bone
cancer research as a whole.
"Modern lifestyles and environmental factors loom large in people's
perceptions of the cause of cancer and this finding reconfirms the
importance of considering other factors such as bone growth.
Visit the BBC for the story.
CareFusion recalls AVEA Ventilator due
to an electrical issue which may cause an unexpected shutdown
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.
Dates: November 13, 2016 to January 4, 2016
to December 16, 2016 to February 15, 2016
Devices Recalled in
the U.S. 501 units distributed nationwide
The AVEA ventilator is intended for continuous breathing support for
infants, children and adults. The ventilator is only used in hospitals and
other health care facilities.
CareFusion is recalling the AVEA Ventilator because of a faulty fuse on the
ventilators' alarm board, which may cause the ventilator to unexpectedly
shut down. If the ventilator shuts down, a patient may not receive necessary
oxygen. The use of affected product may cause serious adverse health
consequences, including death.
Visit FDA for the recall
Technologies, Inc. debuts new JumpStock OR Module at AHRMM
Jump Technologies, Inc. announced their new JumpStock OR Module will be
unveiled at the 2016 Association for Healthcare Resource & Materials
Management (AHRMM) conference and exhibition.
With this enhancement to JumpStock inventory management, Jump Technologies
continues to expand its portfolio of cloud-based mobile solutions that may
reduce labor, reduce costs, and enable more automated and accurate supply
With disparate systems, manual processes and incomplete functionality from
legacy technology, OR staff members face challenges including poor
visibility to supplies, limited system integration and data sharing, and
difficulty tracking and managing items inventoried in the OR. The lack of
visibility to inventory inside the hospital and within the OR cause
overstocking issues as well as stock-outs.
Jump Technologies has designed simple interfaces to connect JumpStock with a
hospital‚Äôs OR scheduling and preference card systems, powerfully integrating
current on-hand inventory, on-order inventory and safety stock with
scheduled procedures and physician preference cards.
The JumpStock OR Module helps build accurate supply forecasts needed for one
OR suite, multiple suites or an entire organization, within a specified time
period. In just a few clicks, an OR team member can order required supplies
based on forecast.
Using JumpStock to manage inventory provides ongoing, accurate data about
supply usage, building greater predictability in the OR. By forecasting
supply requirements for scheduled procedures, the JumpStock OR module helps
to decrease or eliminate stock-outs, overstocking and waste ‚Äď and in turn,
reduce rescheduled procedures, helping to build clinical confidence.
Attendees of the AHRMM16 conference can see the new JumpStock OR Module at
the Jump Technologies booth (#1020), August 1-2, 2016, along with other
cloud-based supply management.
Jump for more information.
hospitals fail to score 5 stars in Medicare‚Äôs new ratings
The federal government released its first overall hospital quality rating on
Wednesday, slapping average or below average scores on many of the nation‚Äôs
best-known hospitals while awarding top scores to many unheralded ones.
The Centers for Medicare & Medicaid Services rated 3,617 hospitals on a one-
to five-star scale, angering the hospital industry, which has been pressing
the Obama administration and Congress to block the ratings. Hospitals argue
the ratings will make places that treat the toughest cases look bad, but
Medicare has held firm, saying that consumers need a simple way to
objectively gauge quality.
Just 102 hospitals received the top rating of five stars, and few are those
considered as the nation‚Äôs best by private ratings sources such as U.S. News
& World Report or viewed as the most elite within the medical profession.
Medicare awarded five stars to relatively obscure hospitals and a notable
number of hospitals that specialized in just a few types of surgery, such as
Medicare awarded the lowest rating of one star to 129 hospitals. Five
hospitals in Washington, D.C., received just one star, including George
Washington University Hospital and Georgetown University Hospital, both of
which teach medical residents. Nine hospitals in Brooklyn, four hospitals in
Las Vegas and three hospitals in Miami received only one star.
Some premiere medical centers received the second highest rating of four
stars, including Stanford Health Care in California, Massachusetts General
Hospital in Boston, Duke University Hospital in Durham, N.C., New
York-Presbyterian Hospital and NYU Langone Medical Center in Manhattan, the
Cleveland Clinic in Ohio, and Penn Presbyterian Medical Center in
Philadelphia. In total, 927 hospitals received four stars.
Medicare gave its below average score of two-star ratings to 707 hospitals.
Nearly half the hospitals ‚ÄĒ 1,752 ‚ÄĒ received an average rating of three
stars. Another 1,042 hospitals were not rated, including all hospitals in
Medicare based the star ratings on 64 individual measures that are published
on its Hospital Compare website, including death and infection rates and
patient reviews. Medicare noted that specialized and ‚Äúcutting-edge care,‚ÄĚ
such as the latest techniques to battle cancer, are not reflected in the
The government said in a statement that it has been using the same type of
rating system for other medical facilities, such as nursing homes and
dialysis centers, and found them useful to consumers and patients. Those
ratings have shown, Medicare said, ‚Äúthat publicly available data drives
improvement, better reporting, and more open access to quality information
for our Medicare beneficiaries.‚ÄĚ
A preliminary analysis Medicare released last week found hospitals that
treated large numbers of low-income patients tended to do worse, as did
Visit Kaiser for the report.