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Novation, Alliances Encourage FDA to
Implement ID System for Medical
Devices
Novation, VHA and
UHC jointly submitted a letter to
the U.S. Food and Drug Administration in November to encourage
the agency to implement a regulated, mandatory, unique device
identification -- or UDI -- system for medical devices,
similar to the FDA's National Drug Code system for
pharmaceuticals.
Novation and the
alliances stated that the implementation of a mandatory global
nomenclature would help improve patient safety, reduce medical
errors, facilitate device recalls, improve device adverse
event reporting and positively affect supply chain operational
efficiency.
In addition to the
letter, on Oct. 25, Cathy Denning, Novation senior director,
contract and program services, presented at the FDA's public
meeting on behalf of Novation and the alliances in support of
unique device identification.
Given the
significant effect that a regulated, mandatory UDI system
would have in the health care industry, Novation, VHA and UHC
vowed to work in cooperation with regulatory agencies and
suppliers to further the adoption of a universal
identification system for medical devices.
For more
information, contact Denning at (972) 581-5041 or cdenning@novationco.com
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Registration Deadline Extended for Novation/KCI
Pressure Ulcer Study
The registration
deadline for the 2007 Novation/KCI National Prevalence and
Incidence Study has been extended through Feb. 15.
All VHA and UHC acute and extended care facilities are
invited to participate in the study. You may register online
at: http://www.kci1.com/1036.asp or
by e-mail at teleforms@kci1.com.
Data collected during the past eight years provide a
nationwide database to help the health care industry better
understand community- and hospital-acquired pressure
ulcers. The data must be collected in March to be
included in the national database reports.
In addition, facilities pursuing magnet status or that
are magnet-designated may use the data-collection form for
this study to collect data for the National Database of
Nursing Quality Indicators quarterly prevalence submission.
The NDNQI is a proprietary database of the American Nurses
Association.
For more
information, contact Robin Briones, KCI outcomes process
manager, at (800) 275-4524, ext. 56332, or robin.briones@kci1.com.
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Contract Value
Assessor Adds I.V. Catheter Category
Members can analyze
potential line-item savings with Novation's new I.V. catheter agreements, MS70061
and MS70062, by using the Contract Value Assessor on
Marketplace@Novation®.
For more
information about these contracts, contact Pat Baxter,
Novation product manager, at
(972) 581-5446 or pbaxter@novationco.com; or one of
the following:
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Mölnlycke Offers Wound Care Customized
Protocol
Mölnlycke is
offering members a customized protocol for wound care. The
Mölnlycke Health Care Customized Protocol provides a
good comprehensive guide to direct clinicians on how to manage
wounds based on conditions.
Products are
selected by the facility according to preference and
performance and then integrated into Mölnlycke's wound
management by condition guideline. The flexibility of the
customized protocol allows the addition of products from other
suppliers in addition to the Mölnlycke wound care products.
More information on this supplier
program can be found on Marketplace@Novation®.
Mölnlycke provides its Safetac® soft silicone
technology products to members through Novation contract
MS50280.
To find out more
about how you can develop your facility's customized protocol
and learn more about Mölnlycke Health Care wound care
products, contact your local representative by calling (800)
882-4582 or visit Mölnlycke 's Web sites, www.molnlycke.com and www.safetac.com.
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APIC Grand Rounds and Webinar Series: Elimination of
MRSA Transmission
The Association of
Professionals in Infection Control and Epidemiology is hosting
a series of grand rounds on the topic, "Elimination of MRSA
Transmission." These programs are sponsored by Becton,
Dickinson and Co. and will feature leading experts in
infection prevention, infectious disease and epidemiology.
Upcoming grand rounds are scheduled for:
- March 6
-- St. Louis
- March
27 -- Dallas
- May 1
-- New York City
To register, visit:
www.apic.org/grandrounds.
In addition, BD
will sponsor a series of free webinars on this topic. These
webinars will be available as a recorded event 24 hours after
the live event. Scheduled webinars include:
- Designing a Program to Eliminate MRSA Transmission
Part 1: Making the Clinical Case
(Dec. 6,
recorded)
- Designing a Program to Eliminate MRSA Transmission
Part 2: Making the Business Case (Jan. 10, recorded)
- Achieving Workplace Cultural Transformation for MRSA
Elimination (Jan. 24)
- The
Role of Surveillance in a Successful Program to Eliminate
MRSA Transmission (Feb. 7)
- The
Role of Isolation and Contact Precautions in the Elimination
of MRSA Transmission
(Feb. 21) To register for a
webinar or view a recorded event, visit: https://apic.webex.com/mw0302l/mywebex/-default.do?siteurl=apic.
Novation plans to release a new clinical contract
resource guide this month. This guide will provide an overview
of the issues surrounding MRSA infections, a contract overview
of the antibiotics used in the treatment of resistant
gram-positive infections and results of a 2006 Novation
gram-positive antibiotic survey, which examined key issues
related to the marketed gram positive antibiotics as well as
the treatment of MRSA.
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Joint Commission
Seeks Input on 2008 National Patient Safety
Goals
The Joint
Commission on Accreditation of Healthcare Organizations has
released a list of draft goals and requirements that will be
considered for potential inclusion in the 2008 National
Patient Safety Goals.
The full text of the potential
goals on the list is posted on the Joint Commission Web site.
The deadline for comment is Jan. 26.
For more information about the field review, contact
Jennifer Hoppe, senior research associate, JCAHO Division of
Standards and Survey Methods, at (630) 792-5936 or jhoppe@jcaho.org.
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Latest Novation
Budget Impact Projections Report Now Available
Novation's latest Budget Impact Projections report is
now available on Marketplace@Novation.
This semiannual report provides applicable price change
forecasts of products and services purchased by member health
care organizations, to assist members with planning and
budgeting for their next fiscal year. As in previous editions,
the national market price forecast and the Novation contract
projections are available for several product categories, such
as cardiology, anesthesia, orthopedics, medical-surgical
supplies, nutrition and laboratory.
For more
information, or to receive the report via e-mail, contact Jeff
King, Novation market research project manager, at (972)
581-5074 or jking@novationco.com.
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New and
Emerging Technology Update
Novation is
dedicated to identifying new and emerging technologies. Below
is a list of products and devices that are currently under
review by Novation or being evaluated based on an
innovative-technology claim from a
manufacturer.
| SUPPLIER |
PRODUCT |
DESCRIPTION |
| New Products |
| Johnson & Johnson Wound Management |
BIOPATCH antimicrobial dressing |
Antimicrobial dressing that provides protection
against a broad spectrum of bacteria |
| Medivance |
Arctic Sun 2000 |
Skin-friendly, latex-free energy transfer pads
that can decrease nursing time compared to standard
water blankets and/or ice or circulating air
blankets |
| Qlicksmart Pty Ltd |
Check Clip |
Device that attaches the empty ampule directly to
the syringe and thus avoids potential labeling
errors |
| Products Still Under
Evaluation |
| CAS Medical Systems Inc. |
UltraCheck Colors -- PVC-free |
Reusable cuffs made from comfortable, durable,
coated nylon taffeta. They are latex-free and the only
PVC-free cuff available |
| Ceres Products Inc. |
Sensi-liners |
Glove liners with finger holes for tactile
sensitivity |
| Smart Caregiver Corp. |
Change pad indicator fall alarm monitor |
Fall alarm monitor with change-pad
indicator |
| Viasys Medsystems |
Navigator bionavigation system |
External hand-held locating instrument to permit
accurate tip placement of PICC/CVC catheters by infusion
teams |
| Bard Access Systems |
Sherlock catheter tip location system |
System that quickly locates and confirms the
position of specially designed PICCs and CVCs during
initial placement |
If you are
interested in providing feedback on these or other products,
or would like to recommend a product that Novation should
evaluate as new medical technology, visit the New Medical Technology area on
Marketplace@Novation®.
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Pharmacy E-News Highlights
Dec 14, 2006
- Heparin Prescribing Information Updated to Include
Possibility of Delayed Onset HIT
FDA and Baxter
notified health care professionals of revisions to the
Warnings section of the prescribing information for heparin
to inform clinicians of the possibility of delayed onset of
heparin-induced thrombocytopenia, or HIT, a serious
antibody-mediated reaction resulting from irreversible
aggregation of platelets. HIT may progress to the
development of venous and arterial thromboses, a condition
referred to as heparin-induced thrombocytopenia and
thrombosis, or HITT.
Thrombotic events
may be the initial presentation for HITT which can occur up
to several weeks after the discontinuation of heparin
therapy. Patients presenting with thrombocytopenia or
thrombosis after discontinuation of heparin should be
evaluated for HIT and HITT.
Read the complete
MedWatch Safety summary, including links to prescribing
information for heparin regarding this issue at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#-Heparin
- FDA
Warns of Dangers with Compounded Topical Anesthetic
Creams
The Food and Drug Administration notified
health care professionals and consumers about the serious
public health risks related to compounded topical anesthetic
creams. FDA issued warning letters to five firms to stop
compounding and distributing standardized versions of
topical anesthetic creams, marketed for general
distribution.
Exposure to high
concentrations of local anesthetics, like those in
compounded topical anesthetic creams, can cause grave
reactions including seizures, irregular heartbeats and
death. Compounded topical anesthetic creams are often used
to lessen pain in procedures such as laser hair removal,
tattoos and skin treatments. They may be dispensed by
clinics and spas that provide these procedures, or by
pharmacies and doctors' offices.
Read the complete
2006 MedWatch safety summary, including a link to the FDA
press release at: http://www.fda.gov/medwatch/safety/2006/-safety06.htm#compound.
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