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Main Subject - OSHA Infection Control Training For Blunt-Tip Suture Needles
In the ongoing task of OSHA infection control training and education OSHA (Occupational Safety and Health Administration) and NIOSH (National Institute for Occupational Safety and Health) have collaborated together to help your organization with bloodborne path
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
ogens exposure control plans. As to your obligations to provide a safe work environment for you and the people around you the intent of this document is to help with your infection control monitoring as they fit into your health and safety practices.
As of the
As of the
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
date of this memo these implications by OSHA/NIOSH are not regulatory standards that must be implemented. This OSHA infection control training is being provided to help your organization provide a safer work place in the form of information you could put into
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
your bloodborne pathogens exposure control plans.
As a business owner you must provide a safe and healthy workplace for you and your employees. When it comes to infection control monitoring and safety work practices concerning precutaneous injuries that may oc
As a business owner you must provide a safe and healthy workplace for you and your employees. When it comes to infection control monitoring and safety work practices concerning precutaneous injuries that may oc
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
cur from penetrating the skin with sharp surgical instruments there is some new information available to help with possible bloodborne pathogens exposure.
It is the intent of this article to help you investigate day to day operations and see where you can impl
It is the intent of this article to help you investigate day to day operations and see where you can impl
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ement these OSHA infection control training changes to provide a safer work environment. This would allow for safer work practices for your surgical staff along with providing a good quality level of attention to the medical procedures in question. As you and y
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
our personnel know your business practices better then anyone it may be a good idea to study which surgical duties can safely switch from the use of sharp-tip suture needles to blunt-tip needles.
Surgical personnel are exposed to the possibility of precutaneou
Surgical personnel are exposed to the possibility of precutaneou
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
injuries through the use of the traditional sharp-tip needles in surgical procedures. OSHA’s ongoing infection control training program has come up with data that shows through the use of blunt-tip suture needles the risk of precutaneous injuries can be reduce
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
d dramatically where it is shown that the use of blunt-tip suture needles is acceptable in the certain medical procedures.
OSHA infection control training studies have shown that blunt-tip suture needles reduce injury occurrences to medical personnel who
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
may be subject to skin penetration injuries through daily work procedures. This has been supported by such organizations as the American College of Surgeons (ACS) and the Association of Perioperative Registered Nurses (AORN).
Skin penetration injuries can
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
occur in work procedures such as the following:
Load or reposition the needle into the needle holder;
Pass the needle hand-to-hand between team members;
Sew toward the surgeon or assistant while the surgeon or assistant holds back other tissue;
Tie the t
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
issue with the needle still attached; Leave the needle on the operative field;
Place needles in an over-filled sharps container; or
Place needles in a poorly located sharps container.
Blunt-tip suture needles can greatly reduce injury when used in the
Blunt-tip suture needles can greatly reduce injury when used in the
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
appropriate situations such as procedures involving muscle and fascia as these are not very dense tissue. It has been shown that almost 60% of suture needle injuries occur during muscle and fascia tasks. It may be the case that at the time of the surgical proce
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
dure a decision can be made as to which type of suture needle is to be used. This decision should take into consideration the task at hand and any problems that may occur by using a blunt-tip suture needle instead of a sharp-tip needle. The main consideration s
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ould be for the safety of the surgical procedure as opposed to the possibility of a skin penetration injury.
The use of blunt-tip suture needles has been shown to reduce the risk of percutaneous injuries and is being supported by both OSHA and NIOSH. Employers
The use of blunt-tip suture needles has been shown to reduce the risk of percutaneous injuries and is being supported by both OSHA and NIOSH. Employers
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
have the responsibility to provide a safe work environment as to the Bloodborne Pathogens standard and the implementation of OSHA infection control training. The use of blunt-tip suture needles is one method of helping to achieve safer medical practices when a
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ppropriate. The introduction of the use of blunt-tip suture needles in certain medical procedures should be investigated as to how the switch from the use of sharp-tip needles will affect the quality and safety of the procedure in question. By implementing inte
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
rnal investigations in your work practices it can be established if the use of blunt-tip suture needles will help with your organization’s infection control monitoring and bloodborne pathogens exposure control plans.
I hope that this paper has helped somewha
I hope that this paper has helped somewha
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
t for your safety procedures work practices when it comes to the safety of your personnel when it comes to possible percutaneous injuries in medical procedures. Please note that this memo is the personal view point of the author and is copyrighted material prod
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
uced by Safety Protection Warehouse. This information is for general guidance only and neither Safety Protection Warehouse nor the author Terry Smeader makes any warranty expressed or implied and assumes no liability what so ever for the use of this information
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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