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CHANGE
THEORY
Gloria,
MS, MSH, RN
For anyone who
studied "change theory" as we did in grad school at NIU,
you will remember that before significant and lasting change can take
place, there must be a "felt need". When I hear how
terrible conditions are becoming in health care, I feel sorry for
those involved, but I feel hopeful that change is just around the corner.
One of the ways
that hospitals and nursing homes are coping with the shortage is for
all personnel to wear scrubs. Each department wears different
color scrubs and name badges, but it does tend to keep patients and
families from realizing how few nurses there are in the
facility. They see many employees with scrubs running around
them and feel secure. I finally realize why many of the
"old timer nurses" were so reluctant to give up their
nursing caps with the stripes. Patients back when nurses wore
caps could easily identify a nurse from housekeeping, dietary, lab
techs, and other technicians. The patients' families could tell
within a few minutes how many nurses were on duty by counting
caps. Maybe it's something nurses should return to and have it
in the contracts of nurses, who are fortunate enough to have a union
contract, that ONLY nurses could wear caps.
Unlicensed
personnel are used for direct patient care under the supervision of a
single nurse who is responsible for an entire floor or anywhere from
20 to 40 patients. Some nursing homes have a single nurse for
from 75 to 150 skilled care patients with unlicensed personnel
practicing under the "extended arm" of the professional nurse.
Gloria, Illinois
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FLORENCE
PROJECT ANNUAL DINNER
The Florence Project, Inc.
extends to the membership an invitation to attend its annual dinner
meeting. The meeting will be held
Saturday evening,
November 18, 2000
Long Beach Island, New Jersey.
Arrangements are
yet to be finalized. If you are interested in attending please
contact me via email.
Thank you,
Catherine Snyder,
RN, BSN
President
email: catsnyder@aol.com
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FIRST
DECLINE IN NUMBER OF
UNINSURED
AMERICANS SINCE 1987
by Ron Pollack,
Executive Director, Families
USA
The new Census
Bureau numbers showing the first decline in the number of
uninsured Americans since 1987 is welcome news but is no cause for
celebration. It is like a morning drizzle after a prolonged drought.
Some specific
aspects of the new report are heartening. Perhaps most significantly,
the number of uninsured children has dropped from 11.1 million to 10
million. This demonstrates that the new Children's Health Insurance
Program (CHIP) is beginning to work - and, since 1999 marked the
earliest stages of CHIP implementation, it augurs well for continued
enrollment improvements in CHIP and Medicaid. Similarly, the increase
in employer-based coverage is a sign the nation's strong economy is
now producing increased health coverage in the workplace.
But there are very
troubling signs as well, especially for low-wage working families.
Today, almost half of low-income, full-time workers are
uninsured. Approximately one-third of the people with incomes
below the federal poverty line continue to be uninsured. Part of this
problem, no doubt, is because many people lost health coverage when
they moved from welfare to entry-level jobs that have no health care benefits.
Most sobering is
that this report comes at a time when the economy is doing
extraordinarily well. It should, therefore, be a call to national
action so that expanded health coverage, especially for low-wage
working people and families, gets immediate attention before
unemployment, inflation and health costs increase once again.
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MILLION
NURSE MARCH
Karen O'Hara RN, BSN
Let your mouse click to the
following web site to find more information re the Million Nurse
March ---a Internet interest group of nurses from all walks of life
that is concerned about todays healthcare climate Nursing
Bulletin Boards for all Nurses.
Mission statement:
"We are a
grassroots effort, started by nurses online. We are concerned
about the continued deterioration in our work environments. Our
chief priority is to raise public awareness to the issues confronting
nurses that detract from and/or diminish our ability to give the
excellent quality care that all patients deserve. We believe
these issues can adversely affect the health of our patients, as well
as our own. We have identified our two top issues as
1.)
Inadequate staffing
2.)
Mandatory overtime
By bringing these
issues to the forefront of public attention we hope to begin the
dialogue necessary to find solutions to these problems, and expose
any others that negatively impact the delivery of excellent health
care. We invite all nurses of any type of credentials, from
PhD. to CNA, to join us in this effort. We invite any concerned
citizens to also join us. We strongly believe that united we
can impact the future direction of health care.
The March
organizing committee conducted a poll and over 70% respondents
wished to March in each state Capital to Rally for safe patient care.
My political
activism has been stirred by my membership in PSNA and especially
Florence posts so I am helping to spearhead the March in
PA. Click here: PSNA
agrees to assist with March - Nursing Bulletin Boards for all Nurses
Please consider
joining the March and if possible consider assisting on a state
committee. Click here: Million
Nurse March-State Roll Call - Nursing Bulletin Boards for all Nurses
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NEW
MEDICATIONS RECEIVING FDA APPROVAL
Oxycodone
& Acetaminophen
Generic
Tylox Approval
Barr Laboratories received
approval for oxycode with acetaminophen 5mg/500mg capsules.
This is a generic capsule equivalent to McNeil Pharmaceuticals
Tylox(R). Used for relief of moderate to moderately severe
pain. Tylox sales last year equaled nearly $10,000,000.00.
Novantrone
Medication
To Treat Advanced M.S.
The FDA has approved the use of
Novantrone (mitoxantrone), an approved cancer drug, for treating
patients with advanced or chronic MS. In two randomized
studies, with about 200 patients, Novantrone reduced the number of
relapses decreases progression of disability. Novantrone has
not been studied in nor approved for treatment of primary progressive MS.
Some patients
treated with Novantrone experience very serious heart disease.
This risk increased with cumulative dosing. Ordinarily patients
being treated for MS should not receive more than 8-12 doses over two
to three years. Patients will be advised by their physician
that regular testing of their heart and blood is needed to help avoid
these side effects. Other side effects include nausea, hair
loss, loss of menstruation, UTIs and mouth sores. Novantrone is
manufactured for Immunex Corporation, Seattle, Wash., by Lederle Labs.
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FDA
APPROVES NEW
MEDICAL
DEVICES / TREATMENTS
FDA
REPORT ON NEW MEDICAL DEVICES APPROVED IN FY 2000
Millions of people
stand to benefit from new medical devices approved by the Food and
Drug Administration during Fiscal Year 2000, which ended Sept. 30.
FDA's Center for Devices and Radiological Health approved or cleared
more than 3,600 new products. Many are first-of-a-kind medical
devices representing breakthrough technology; many others offer
significant advances over existing technology.
Devices were
approved to treat hearing loss, gall bladder disease, vision
problems, diabetic foot ulcers, and female sexual arousal disorder.
Products were also approved to monitor fetal oxygen, to seal air
leaks in lungs following lung cancer surgery, and to test cholesterol
at home. And almost 800 laboratory test kits were approved,
including some that help detect the early stages of alcoholism.
One of the most
significant approvals--one that could eventually change the practice
of surgery--is a robotic arm that enables a surgeon to perform
laparoscopic gall bladder and reflux disease surgery while seated at
a console with a computer and video monitor. The product--the
first of its kind--represents the first step in the development of
new robotic technology.
In another
"first," FDA approved a digital mammography system for
breast cancer screening in women. Studies showed that the
digital system was comparable to the standard use of radiographic
film in screening and diagnosing breast cancer. However, the
new technology offers several potential advantages over film/screen
mammography, including electronic storage and transfer, manipulation
of image area, and large dynamic range.
In another
significant action, taken after extensive deliberation and review,
FDA approved the continued marketing of saline-filled breast implants
made by two firms. The manufacturers were required to conduct studies
to show that the implants were safe and effective and, as a condition
of approval, provide information to patients on risks and
benefits. That information is now available on FDA's web site
and in patient brochures developed by the companies.
FDA also granted
humanitarian device exemptions to six companies to make devices
available after only limited testing for patients with rare medical
conditions. Included is an implanted device to control chronic
nausea and vomiting of patients with a gastrointestinal disorder
called gastroparesis. HDEs are intended to benefit patients who have
a disease or condition that affects fewer than 4,000 people annually
in the United States. Preparation of the U. S. medical device
industry for rollover into the Year 2000 (Y2K) was a premier
achievement of the Center for Medical Devices and Radiological
Health. CDRH surveyed the entire industry about its Y2K readiness,
established a national clearinghouse database of information on each
company, and followed up with audits of priority companies. As a
result, Americans entered the 21st century with the assurance that
the medical devices they needed would function properly.
Another singular
accomplishment was the development of "guidance" on the
practice of reusing medical devices intended for only one use. The
guidance, which governs third party reprocessors and hospitals that
engage in reprocessing, protects the public health by assuring that
the practice of reprocessing and re-using "single-use"
medical devices is based on good science.
Preliminary
figures show that altogether in FY 2000, FDA approved 43 new medical
devices under the pre-market approval (PMA) process, cleared 3,567
others for marketing through the 510k process (for devices that are
substantially equivalent to legally marketed products), and approved
1,909 supplements to marketing or clinical study applications. It
also approved the design and start of 213 new studies to test the
safety and effectiveness of a variety of experimental medical devices
in humans, and monitored 1,061 ongoing device studies. In addition,
the agency continued to monitor the ongoing safety and performance of
approximately 80,000 medical devices already on the market.
Case
studies conclude that Acticoat(R) dressings are effective
for chronic wounds, which affect millions annually
The Westaim
Corporation's subsidiary (Nasdaq: WED), Westaim Biomedical Corp.,
today announced that it has received clearance from the U.S. Food and
Drug Administration (FDA) and Canada's Health Protection Branch for
Acticoat(R) 7 dressing, a new product that delivers a sustained
seven-day release of antimicrobial silver nanocrystals, for acute and
chronic wounds.
Chronic wounds are
severe, persistent, painful wounds such as diabetic foot ulcers,
pressure ulcers and venous insufficiency leg ulcers. They are prone
to infection, which can lead to dire consequences such as severe
pain, an inability to stand, and in the case of foot and leg ulcers,
amputation of limbs. Chronic wounds affect more than four million
people in North America every year.
Westaim Biomedical
also released three new case studies from independent wound care
professionals in the United States and Canada describing clinical
results using Acticoat(R) Burn Dressings on various chronic wounds.
Acticoat(R) dressings were first used to treat burn wounds, graft
sites and donor sites and are now used in more than 100 burn centers
in North America. In its first full year on the market, Acticoat(R)
Burn Dressing generated sales of US$3.2 million. The new Acticoat(R)
7 dressing can be left on wounds for a longer period of time, seven
days, which is beneficial for the chronic wound market.
"Westaim
Biomedical is translating the success of Acticoat dressings in
managing burn wounds to the much larger chronic wound market,"
said Scott H. Gillis, President of Westaim Biomedical. "This
success puts us in an excellent position to introduce our technology
more widely into the chronic wound market and quickly establish the
Acticoat brand with chronic wound caregivers."
Westaim
Biomedical's Acticoat(R) barrier dressings use a proprietary
nanocrystalline coating of pure silver. Laboratory tests have shown
that this unique delivery system has lowered proteolytic enzymes in
chronic wounds. Many physicians believe that the reduction in
proteolytic enzymes is a key factor in moving non-healing wounds into
a progressing healing state.
Acticoat(R)
dressings also deliver antimicrobial activity considerably faster
than other forms of silver, providing the optimal healing
environment. Acticoat(R) dressings have demonstrated effectiveness
against more than 150 pathogens, including antibiotic-resistant
superbugs such as Methicillin-resistant Staphylococcus aureus (MRSA)
and Vancomycin-resistant Enterococcus (VRE).
Clinical results
Anecdotal case
studies conducted by independent wound care professionals in Toronto
and London, Ontario, and Baltimore, Maryland examined the use of
Acticoat(R) dressings for the treatment of a variety of chronic
wounds including a venous insufficiency ulcer, an infected surgical
wound and TENS, a disease which causes blistering of most of the
body's skin.
"The wound we
treated did not respond to other treatments," said Louanne Rich-vanderBij,
a Clinical Nurse Specialist at Sunnybrook and Women's College Health
Sciences Centre in Toronto. "The Acticoat dressings appear to
have 'kick started' the wound healing process. The Acticoat dressing
we used was effective in reducing infection in the wound with a
concurrent reduction in the amount and type of wound fluid. Once the
wound bio-burden was reduced we observed a proliferation of healthy
tissue growth."
Strong customer demand
Westaim
Biomedical's strategy is to establish strategic partnerships with
medical product companies that have specialized sales forces and
marketing expertise in the chronic wound market. However, strong
demand for Acticoat(R) brand products among chronic wound care
professionals has led the company to begin distributing Acticoat(R) 7
dressings in North America using its existing sales force.
Acticoat(R) 7 dressings will be distributed along with Westaim
Biomedical's other FDA-cleared wound products.
In focus groups of
nurse practitioners and doctors at the 15th Annual Clinical Symposium
on Advances in Skin & Wound Care held in Nashville, Tennessee in
early October, several chronic wound professionals revealed that they
were already using Acticoat(R) antimicrobial dressings to treat
chronic wounds despite the fact that Westaim Biomedical had not yet
marketed a product specifically designed for the chronic wound
market. The nurse practitioners and doctors who took part in the
focus groups identified ease of use, fewer dressing changes, the need
for a broad spectrum of antimicrobial activity and the need for a
dressing to help move chronic wounds into a progressive healing state
as key attributes of a superior chronic wound dressing.
"We are
encouraged that so many chronic wound professionals are already aware
of Acticoat dressings," said Gillis. "The new Acticoat 7
dressings are even better suited for chronic wounds, because they
only need to be changed every seven days."
About Westaim
Biomedical Corp.
Westaim Biomedical
Corp. develops medical devices based on its Acticoat(R) antimicrobial
technology, a patented method of applying a thin layer of
antimicrobial silver to base materials. The first commercial product
based on this technology is the Acticoat(R) Burn Dressing, launched
into the burn wound market in 1998. Future applications based on
Acticoat(R) antimicrobial technology include additional specialized
wound dressings, catheters, orthopaedic implants and other surgical devices.
About The Westaim Corporation
The Westaim
Corporation is a technology accelerator that launches exceptional
technologies into the marketplace. In addition to its investment in
Westaim Biomedical, Westaim's technology investments include iFire
Technology Inc., which has developed a revolutionary low-cost flat
panel display and Savvion, a leader in e-business management
software. Westaim's common shares are listed on Nasdaq under the
symbol WEDX and on the Toronto Stock Exchange under the trading
symbol WED.
Westaim Legal
Notice Regarding Forward-Looking Statements
This news release
may contain forward-looking statements. These statements are based on
current expectations that are subject to risks and uncertainties, and
the Company can give no assurance that these expectations are
correct. Various factors could cause actual results to differ
materially from those projected in such statements, including
financial considerations and those predicting the timing and market
acceptance of future products. The Company disclaims any intention or
obligations to revise forward-looking statements whether as a result
of new information, future developments or otherwise. All
forward-looking statements are expressly qualified in their entirety
by this Cautionary Statement.
FDA
APPROVES NEW IMPLANTED HEARING DEVICE
FDA today approved
a new brain stem implant designed to restore some hearing in people
who experience total hearing loss when the removal of tumors damages
their cranial hearing nerves.
The device made by
Cochlear Corporation of Englewood, Colo., restores the ability to
detect certain sounds and speech, although it does not restore normal
hearing. In clinical studies, the device worked for most, but
not all, patients.
FDA expedited
review of the product, the first of a kind, and approved it within
six months of receipt of the manufacturer's application.
The product is an
auditory brain stem implant system. It is surgically implanted
into the brain and electrically stimulates the area that normally
receives the electrical signal from the ear. The patient wears a
pocket-size speech processor that picks up sound and changes it into
electrical pulses that are transmitted to the implant.
The device was
approved for use in teenagers and adults who have a rare disease
called neurofibromatosis type 2 in which tumors growing on cranial
nerves need to be surgically removed. Removal of tumors on the
auditory nerve requires severing or cutting the nerve, which results
in total loss of hearing. These patients cannot be helped by
hearing aids or cochlear implants.
Approval was based
on a review of clinical studies of safety and effectiveness conducted
by Cochlear Corp. and on the recommendation of the Ear, Nose and
Throat Devices Panel of FDA's Medical Devices Advisory Committee
which met in July to evaluate the device.
In the studies,
the device was implanted in some 90 people between the ages of 12 and
67 with neurofibromatosis type 2. The device was implanted
during surgery to remove auditory nerve tumors. Sixty patients
were evaluated for effectiveness after six months of use. (The
remaining 30 had yet to reach their 6-month evaluation.)
Results varied:
82% of the 60 patients were able to detect certain familiar sounds,
such as honking horns and ringing doorbells; 85% were able to hear
and understand conversation with the aid of lip reading; and 12% were
able to hear well enough to use the phone. Of the 90 patients
who received this implant, 18% were not able to hear any sound.
This was due either to migration of the implant after surgery or
misplacement of the device during surgery.
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THE
NURSING SHORTAGE
GETTING
MORE PRESS
On October 10th,
the Philadelphia Inquirer ran a front page story entitled "Major
Nurse Shortage Feared In Years Ahead". The story was
written by Inquirer staff writer Stacey Burling, who we think did an
excellent job both with her story and the investigation. The
story adequately describes the climate nurses and our patients face
and will encounter in the years to come. With expert
testimonials from the likes of frustrated recruiters, AHA
representatives, PSNA executive administrator, RN professor and
economist and many more. This article is excellent reading and
is likely to give you and the general public lots to think
about. To read the article simply click
here.
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FEDERAL
MANDATORY OVERTIME LEGISLATION FILED IN U.S. CONGRESS
Saturday
September 16 6:34 PM ET
BILL
WOULD BAN MO FOR HEALTH CARE EMPLOYEES
Nurses
Applaud Federal Proposal, Saying Public Safety at Issue
CONTACT:
Michael Byrne (202) 331-3700
WASHINGTON
- Mandatory overtime for licensed health care employees (excluding
physicians) would be prohibited under a bill introduced in the U.S.
House of Representatives Thursday by U.S. Reps. Tom Lantos (D-Calif.)
and James McGovern (D-Mass.). The legislation recognizes the growing
danger to patient safety posed by forced overtime practices in
hospitals nationwide.
"Hospitals
across the nation are requiring nurses to work overtime on a regular
basis," said Jill Furillo, RN, national outreach coordinator for
the California Nurses Association. "Nurses frequently complain
that at the end of their shift, they no longer have the stamina and
mental alertness to deliver the quality of care patients need."
At
least 1,720 hospital patients have been accidentally killed and
9,584 other injured since 1995 because of the actions or inaction of
registered nurses across the country, according to an investigative
report by the Chicago Tribune, which attributed the problem to cuts
in staff and other belt-tightening in U.S. hospitals.
In
recent months, mandatory overtime has been a major factor in
lengthy, high-profile nurses' strikes in Massachusetts, California
and New York, and has been a rallying cry for exhausted RNs and other
health care workers across the nation.
"Forced
overtime is a prescription for disaster," said Teri Evans, RN,
president of the Pennsylvania Association of Staff Nurses and Allied
Professionals. "Patients are placed at greater risk when the
professionals caring for them are exhausted and not sufficiently
alert. Increased medication errors and errors in judgment result."
The
Lantos-McGovern bill amends the Fair Labor Standards Act to bar
mandatory overtime beyond 8 hours in a work day or 80 hours in any 14
day work period, except in the case of a natural disaster or in the
event of a declaration of emergency by federal, state or local
government officials. Voluntary overtime is also exempted."Our
bill would give nurses the relief they need," Lantos said.
"America's nurses put their hearts and souls into caring for
individuals and their families. We need to ensure that they have time
to care for their families as well. It's inhumane the way hospitals
treat nurses."
McGovern
pointed to a recent 49-day strike at St. Vincent/Worcester Medical
Center in Massachusetts, where mandatory overtime was the primary
issue that led more than 600 nurses to walk out. "Health care
professionals have drawn the line against mandatory overtime, and for
good reason," he said. "No one should be asked to work the
kind of hours that jeopardizes patient care."
"No
patient deserves a nurse in her fifteenth or sixteenth hour working,
especially after she has said 'I can't do this,' " said Sandy
Ellis, RN, of the Massachusetts Nurses Association, who was among
those who struck St. Vincent. "If you are forced to do it, your
license is not protected and you've been mandated to put your
patients at risk."
Rosalind
Hunter, RN, a Contra Costa County (Calif.) Regional Medical Center
nurse, points to the "horrible staffing situations" and the
"abuse of mandatory overtime" by California hospitals.
"If this (ban on mandatory overtime) becomes law, I predict it
will be a real lifesaver for both nurses and patients."
Mandatory
overtime actually has contributed to the national nursing shortage,
Furillo added, pointing to surveys and anecdotal reports showing that
nurses are refusing to work in hospitals with unsafe conditions,
including when they are forced to work unplanned overtime hours.
"Without a curb on this reckless practice, more nurses will
leave the profession and we will experience a deeper and longer-term
nursing shortage," Furillo said.
This
bill was initiated by the following nursing organizations:
California
Nurses Association
Massachusetts
Nurses Association
Maine
State Nurses Association
Pennsylvania
Association of Staff Nurses and Allied Professionals
Already
signing on in support of this bill are:
Congressman
Robert Brady (Democrat, Pennsylvania)
Congressman
Luis Gutierrez (Democrat, Illinois)
Congressman
Moakley (Democrat, Massachusetts)
Congresswoman
Grace Napolitano (Democrat, California)
Congressman
Barney Frank (Democrat, Massachusetts)
Congressman
Bob Filner (Democrat, California)
Congresswoman
Juanita Millender-McDonald (Democrat, California)
Interviews
with members of the California Nurses Association, Massachusetts
Nurses Association, Maine State Nurses Association and Pennsylvania
Association of Staff Nurses and Allied Professionals are available by
contacting Tamil Perry or Suzanne DeMass at (202) 331-3700.
Rep.
Lantos may be contacted at (202) 225-3531. Rep. McGovern is
available at (202) 225-6101.
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NMAHP
UK
Gateway to High Quality 'Net Sources for Nurses, Allied Health Professions
We are pleased to announce the
success of a joint bid by the Universities of Nottingham and
Sheffield and the Royal College of Nursing to develop NMAHP, a
gateway to evaluated Internet resources relevant to the needs of
Nurses, Midwives and Allied Health Professionals. This freely
available gateway will be an integrated component of the
well-established OMNI service (Organising Medical Networked
Information), http://omni.ac.uk/
which is now part of BIOME - the Resource Discovery Network's health
and life sciences Internet service. http://biome.ac.uk/
The project is
currently seeking institutions operating in the field to become
contributors, evaluating Internet resources against established and
published criteria, to help build the service for the Spring 2001 launch.
The project has
initially been awarded funding for 2 years starting from the first of
August 2000 by the Joint Information Systems Committee (JISC).
Notes &
further information
BIOME is a health,
medical and life sciences Internet gateway designed to enhance
learning, research and professional development by equipping Internet
users with simple and effective access to high quality Internet
resources, together with support and guidance in how to use
them. BIOME is part of the RDN (Resource Discovery Network -
see below). Visit BIOME at http://biome.ac.uk/
The Resource
Discovery Network is a federated network of subject-based Internet
services funded by JISC (the Joint Information Systems Committee -
see below). The service is committed to enhancing learning, teaching,
research and professional development by providing free, effective
access to high quality Internet resources selected and described by
specialists throughout UK academia or closely affiliated
organisations. Visit the RDN home page at http://www.rdn.ac.uk/
The JISC (Joint
Information Systems Committee) is a strategic advisory committee to
the UK higher and further education funding bodies. The JISC is
currently funded by the Higher Education Funding Council for England,
the Further Education Funding Council, the Scottish Higher Education
Funding Council, the Scottish Further Education Funding Council, the
Welsh Funding Councils and the Department of Higher and Further
Education, Training and Employment. The JISC works in partnership
with the Research Councils. For further information visit the JISC
website at http://www.jisc.ac.uk/
BIOME
http://biome.ac.uk/
Further
information is available from Rod Ward on rw@biome.ac.uk.
Or Telephone Lisa
Gray on 0115 9249924 ext 42050
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