HEALTH ALERTS Archive
Community Health Connections
The Bantam Commons
Phone: (724) 283-0990
Fax: (724) 283-1012
Website: www.hcqu.org
ResMed S8 Flow Generators (Continuous Positive Air Pressure or CPAP):
S8 Compact, S8 Escape, S8 Elite, and S8 AutoSet Vantage
April 24, 2007
ResMed and FDA notified consumers and healthcare
professionals of a worldwide recall of approximately 300,000 S8 flow generators
(Continuous Positive Air Pressure or CPAP) used for the treatment of
obstructive sleep apnea. In Model S8 devices manufactured between July
2004 and May 15, 2006, there is a potential for a short circuit in the power
supply connector. ResMed plans to work with its distribution partners globally
to provide a replacement device to patients who have an affected S8 flow
generator. See recall notice for serial numbers for affected S8 models.
Patients may continue to use their S8 flow generators
until they receive a replacement device. As with any electrical device,
patients should make sure that it is placed on a hard clean surface and that
the area around the device is clear during use. Patients should discontinue use
of the device if there are any signs of electrical failure such as intermittent
power, cracking sounds, sparking or charred smell. Patients should not use
supplemental oxygen with an affected device; patients using supplemental oxygen
should immediately contact their home healthcare provider for a replacement.
Read the complete MedWatch 2007 safety summary, including
a link to the manufacturer's Recall Notice, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#ResMed
Pertussis Health Advisory
April 16, 2007
It has come to the attention of the Pennsylvania
Department of Health that residents in various regions of
For more information on this alert you may link to the
Department of Health Alert Advisory on Pertussis at http://www.dsf.health.state.pa.us/health/cwp/view.asp?A=171&Q=247467
The Department of Health is requesting that all suspected
or confirmed cases be immediately reported to the Pennsylvania Department of
Health at 1-877-PA-HEALTH or to the local health department where the patient resides.
Zelnorm Health Alert
Product Market Withdrawal - Study Results Showed Patients on Drug Had Higher
Risk of Serious Cardiovascular Adverse Events
March 30, 2007
FDA notified healthcare professionals and patients that
Novartis has agreed to discontinue marketing Zelnorm, a drug used for the
short-term treatment of women with irritable bowel syndrome with constipation
and for patients younger than 65 years of age with chronic constipation. FDA analysis
of safety data pooled from 29 clinical trials involving over 18,000 patients
showed an excess number of serious cardiovascular adverse events, including
angina, heart attacks, and stroke, in patients taking Zelnorm compared to
patients given placebo. Patients taking Zelnorm should contact their healthcare
professional to discuss treatment alternatives and seek emergency medical care
if they experience severe chest pain, shortness of breath, sudden onset of
weakness or difficulty walking or talking, or other symptoms of a heart attack
or stroke. Healthcare professionals should assess their patients and transition
them to other therapies as appropriate.
Read the complete MedWatch 2007 Safety summary, including a
link to the FDA Public Health Advisory regarding this issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm
Zanaflex Health Alert:
Zanaflex, a drug used to treat spasticity
March 5, 2007
Acorda Therapeutics and FDA informed healthcare
professionals of changes to the CONTRAINDICATIONS and WARNINGS Sections of the
product labeling for Zanaflex, a drug used to treat spasticity, In
pharmacokinetic studies where tizanidine was coadministered with either
fluvoxamine or ciprofloxacin (CYP1A2 inhibitors), the serum concentration of
tizanidine was significantly increased and potentiated its hypotensive and
sedative effects. Although there are no clinical studies evaluating the
effects of other CYP1A2 inhibitors on tizanidine, coadministration of
tizanidine with other CYP1A2 inhibitors (zileuton, other fluroquinolones,
antiarrythmics, cimetidine, famotidine, oral contraceptives, acyclovir and
ticlopidine) should be avoided.
Read the complete MedWatch 2007 Safety summary, including
a link to the manufacturer's Dear Healthcare Provider Letter regarding this
issue at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zanaflex
Health and Safety Alert issued by
February 2007
What are some examples of potential incidents of neglect?
An individual being left alone in a vehicle while staff
run in “just for a minute” for something in a store;
An individual being left alone while taking a shower when close supervision is
necessary, or;
An individual being left alone in their home while staff grab the mail.
Is there adequate staffing?
If individuals are left alone in the above examples or
similar situations, they could possibly be victims of neglect. Neglect could
take many forms; both intentional and unintentional. Regardless of the reason,
neglect is dangerous and has zero tolerance with the Office of Developmental
Programs. Assurance should be made so that staff understand explicitly (and
that supervisory/program staff define explicitly) what “one-to-one” or other
forms of enhanced supervision means with regard to the person they are
supporting.
Has your agency adopted a “zero tolerance” policy?
Staff should be educated and dedicated to Everyday Lives.
Assurance of safety is one of the Everyday Lives principles. Persons receiving
services in
Does your agency have a staffing coverage policy?
Flexibility is important when assuring adequate coverage
is available. There should be a plan in place for unanticipated absences;
including “fill-in” when necessary by management staff. This is important to
assure that the required services for the individuals are met. Responsibility
must be shared to assure that we have in place what is needed to keep each
individual safe and healthy.
Ways to Avoid Leaving Someone Unsupervised:
Health Alert
Toxic Shock Syndrome
Office of Mental Retardation
December 13, 2006
What is Toxic Shock Syndrome?
Toxic Shock Syndrome (TSS) is an infection caused by
bacteria. It is a serious, but relatively uncommon infection. It is
caused by two different bacteria, staphylococcus and streptococcus, which
produce somewhat different symptoms.
Where does Toxic Shock Syndrome come from?
It generally occurs from two types of situations. In
women it can be related to the use of tampons or barrier contraceptives such as
the sponge. It also can be a complication of skin infections and surgery.
Who is at risk for Toxic Shock Syndrome?
Women using the products listed above can be at
risk. People that have skin abscesses can also get TSS as can anyone that
has had recent surgery and developed an infection. People that have had
nose surgery or sinusitis seem to be at higher risk for this. People with
chronic heart or lung problems or diabetes are also at higher risk.
What are the symptoms of Toxic Shock Syndrome?
Why is it important to know this?
There have been some recent cases of TSS in
Additional information can be found at the website: http://www.toxicshock.com/