CHPSO periodically releases urgent information regarding patient
safety. Members subscribed to our mailing list will
automatically receive alerts via email.
This supplement to the original alert serves as a reminder to
clinicians that they should always check and recalibrate air
mattress settings to the patient’s settings when reconnecting.
Mattresses, when unplugged, may revert to a default
setting.Additionally, though not mentioned in the first alert, on
occasion caregivers may use a mattress control unit for a new
patient without remembering to change the settings that were used
for the prior patient.
Due to the broad scope of the recall, we felt it was important to
distribute this alert. Note that the product may be labeled with
the name of the distributor rather than the manufacturer
(“Triad”).Other names used were: Cardinal Health, PSS Select,
VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS and
Conzellin.
H & P Industries, Inc., a manufacturer of over-the-counter
products, is voluntarily recalling all Povidine Iodine Prep Pads
due to concerns of contamination with the pathogenic bacterium
Elizabethkingia meningoseptica. Use of contaminated
Povidine Prep Pads could lead to life-threatening infections,
especially in at-risk populations, including neonates, immune
suppressed patients and surgical patients. Treatment options are
limited for Elizabethkingia meningoseptica infections.
US
Marshals raided H&P Industries, which makes alcohol wipes
and other products distributed by Triad Group. This company was
the source of several recent large-scale recalls and CHPSO
Patient Safety Alerts. The manufacturer ceased production after
yesterday’s raid. Below is a partial listing of the recalled
items.
An outbreak of fungal endophthalmitis, first identified in
California, has raised concerns about the sterility of products
from Franck’s Compounding Lab: a Florida compounding pharmacy.
This cluster of cases was in patients who had undergone
vitrectomy with epiretinal membrane peeling using a dye called
Brilliant Blue-G (BBG). All lots of BBG produced by Franck’s have
been recalled.
Franck’s Compounding Lab today issued a recall of all sterile
human and veterinary compounded prescriptions dated November 21,
2011, and later. The notice states that “it is essential that you
do not use them and that employing appropriate practices, you
destroy all such sterile preparations and all remaining portions
of such sterile preparations.” This recall resulted from the
FDA’s discovery of microorganisms and fungal growth in Franck’s
clean room.The recall notice is posted at www.francks.com.
The cap needs to be removed for safe use in patients receiving
continuous flow therapy.
CHPSO periodically reviews California Department of Public Health
(CDPH) citations for opportunities to improve patient safety and
prevent future events.In reviewing the following event, CHPSO
identified a recurrent issue (as evidenced by reports in the FDA
device event database).
Interested counsel may join a discussion group that offers
support and an opportunity to learn about the new legal
privileges and challenges of the Patient Safety and Quality
Improvement Act of 2005. You can request to join the
group by
clicking here. This group generally holds conference calls
quarterly.
