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Questions can be sent
to:jakridge@hpnonline.com
called in to Jeannie Akridge at HPN:(941) 927-9345 ext.202
or mailed to:
HPN CS Questions, 2477 Stickney Point Road, Suite 315B,
Sarasota, FL 34231
Names and hospital identification will be withheld upon
request. |
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Filing down needle tips; micro fiber wraps; CS/SPD
certification entities
by Ray Taurasi
Q One of the
anesthesiologists at our hospital came to me requesting that I file
down the tips of some disposable hypodermic needles to dull the tips.
I told him that I could not do this as it would alter the
manufacturer’s design and functionality of the needles. He said it was
not an issue as the needles were not going to be used directly on the
patient. I told him that did not matter and refused to do it. He
became irate and stormed out of my office. Moments later I received a
call from his director followed by another call from my boss both
telling me I was being uncooperative and to just do as I was asked
claiming there was no patient risk associated with it. After arguing
my case and getting nowhere I finally succumbed to the pressure from
my superiors and filed the needles down. I feel very uncomfortable
about doing this and I would prefer not to do so again. I feel my
superiors are basically ordering me to do something that is wrong. Do
you think I am over reacting?
A Under no circumstances
should you alter the design of a medical device of any kind including
needles. When you do so you are taking on the full legal
responsibility and become the manufacturer of the device. As a
manufacturer you must follow Good Manufacturing Practice regulations (GMPs),
have FDA clearances and the like. Even though they claim the needle is
not going to be used in direct patient care, you or they cannot
guarantee that it will not happen. A patient’s safety and welfare
could be at stake and you as the person who altered the device could
be held legally responsible in a court of law.
I would suggest that you address this issue with your
superiors prior to another such request coming your way again. Set up
a meeting with your boss, the director of anesthesiology and risk
management. Prior to the meeting, gather all the documentation you can
find relative to the reprocessing, recycling and/or reuse of single
use devices. Also obtain data from FDA regarding 510ks, GMPs, etc.
Prepare a statement of reasoning and rationale of why you should not
alter the devices include the supporting documentation and circulate
prior to the meeting. In advance, schedule an appointment with your
risk manager and/or legal department to discuss the situation; it
would be very unlikely they would find this practice to be acceptable.
You should also try to gain an understanding of how they plan to use
these needles and why they need to be altered. Once you have a better
understanding you can research other alternatives and possibly find a
ready made device that fills the need or even find a manufacturer that
could offer a solution.
Q We still use a lot of
fabric packs and wraps. Recently our materials manager ordered a new
kind of micro fiber wrap without consulting me. The wraps have a very
different look and feel to them. When I asked him about it, he said
they’re made from a new synthetic textile that is much stronger and a
lot less expensive than what we had been using. I have never heard of
the brand name or manufacturer, and the materials manager had no
literature or technical information on the product. He said the
representative told him it is the next generation of reusable wrap and
that studies demonstrate it performs better than what we were using
and/or competitive products. Can you provide information on using
micro fiber wraps?
A There are many different
types and/or blends of synthetic fabrics and materials, both reusable
and single use, that can be classified as "micro fibers" or have micro
fibers as part of the material. I therefore cannot provide you
information on the material you have without knowing more about it,
e.g. manufacturer, brand name, technical data, etc. Microfibers, also
known as microdeniers, are now very popular in the garment and
upholstery industry due to their ability to repel moisture and their
strength and durability. The fibers are so small that they can be
tightly woven together, and as a result are strong enough to repel
moisture and are more durable. Certainly such characteristics could
have significant advantages as a sterile packing device. However
microfibers that are too tightly woven together may not provide
sufficient breathability to allow for sterilant permeation. Be mindful
that sterilization packaging materials are classified as a Class II
medical device and therefore must have FDA 510k clearance prior to
marketing. You should not under any circumstances purchase or utilize
any form of sterile packaging that has not been cleared by FDA. Insist
that your materials manager obtain a copy of the FDA 510k
documentation from the manufacturer of your new "microfiber" wraps,
request copies of all relative technical and performance data,
instructions for use, and care and handling. Until you obtain this
information do not use the new product.
Q I am the clinical nurse
educator for perioperative services at a large community hospital.
Changes in organizational structure have placed Sterile Processing
under perioperative services and I am now responsible for SPD
education as well. One goal is to get all staff certified. I
understand there are two entities that offer certification for SPD. I
find this confusing. Should SPD be certified by both? What is the
difference? Is one certification superior to the other?
A There are two professional
entities that offer certification credentials for Sterile Processing
personnel: The International Association of Central Service Materiel
Management (IAHCSMM) and the Certification Board for Sterile
Processing and Distribution (CBSPD). Both offer various levels of
certification for sterile processing practitioners, technicians,
supervisors and/or managers which are recognized internationally. Most
SPD professionals seek and maintain certification through only one of
these bodies. Many employers that require certification will accept
certification from either entity, but this is not always the case.
Certain states, geographic locations, hospitals and healthcare systems
may have a preference for one source over the other. Prior to
determining your certification policy, it is a good idea to speak to
other professionals in your area as well as any regional CS
associations to learn what program they support or endorse and why.
Contact IAHCSMM (800-962-8274 or
www.iahcsmm.org)
and CBSPD (908-236-0530 or
www.sterileprocessing.org/about_cbspd.htm) to learn more about
their philosophy, educational and credentialing programs.
Ray Taurasi is Eastern Regional Director of Clinical Sales and
Services for Healthmark Industries. His healthcare career spans over
three decades as an Administrator, Educator, Technologist and
Consultant. He is a member of AORN, AHA, SGNA, AAMI and a past
president of IAHCSMM and has served on and contributed to many
national committees with a myriad of professional organizations,
manufacturers, corporations and prestigious healthcare networks.
Taurasi has been a faculty member of numerous colleges teaching in the
divisions of business administration and health sciences. In addition
to this column he has authored several articles and has been a
featured speaker on the international scene. |
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