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References - Call for Safety Improvements in Design of Domestic Paper Shredders
The US Consumer Product Safety Commission (CPSC) carried out an nvestigation of reported finger injuries, including amputations, and the characteristics of domestic paper shredders that might have contributed to those injuries. The National Electronics Injury Surveillance System (NIESS) database collected
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
23 reported finger injuries attributable to domestic paper shredders. The ages of the victims ranged from 14 months upwards. Of the 23 reported finger injuries caused by a domestic paper shredder mechanism, fifteen involved children aged 5 years and under. However, finger injuries from domestic paper shre
; 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
dders have been reported in victims of 20 years old and even 65 years old. This report was published in
December 2004.
The most severe injuries, amputations, involved children. Injury occurred even when a child was feeding paper into a shredder under adult supervision but did not release the paper in t
The most severe injuries, amputations, involved children. Injury occurred even when a child was feeding paper into a shredder under adult supervision but did not release the paper in t
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ime to prevent their fingers from entering the shredder
opening. As the paper shredder continued to pull the paper into the shredder opening, it also pulled in the children's
fingers.
Since most paper shredders have auto start features, a child can be at risk even when an adult is present. A child may
Since most paper shredders have auto start features, a child can be at risk even when an adult is present. A child may
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
insert a piece of paper into the shredder opening and activate the shredder mechanism, allowing it to pull the paper (and
possibly the child's fingers) into the shredder. Children are not conscious of hazards to themselves and may not let go of
the paper as it is being pulled in.
Paper shredders can pos
Paper shredders can pos
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e a risk of finger injury to children as young as 15 months because of their small finger size. With
no force applied, a child's finger would be unlikely to penetrate the shredder opening since their finger diameter is
typically larger than a paper shredder opening. However, depending on the design of th
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
e shredder, the shredder opening may enlarge as the shredder pulls in the paper and child's fingers. The height of a 15-month-old can be more than twice the
height of a domestic paper shredder, putting them within easy reach of the paper shredder opening.
The International standard that applies to paper
The International standard that applies to paper
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
hredders is IEC (International Electrotechnical Commission). The methods
of testing the safety of shredders has in the past involved the use of a probe which was meant to represent the dimensions
of the fingers of a twelve year old child. The probe was not designed or intended to determine the risk of
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
injury to
younger children.
The shredders that were tested prior to the report produced by the U.S. Consumer Product Safety Commission were on sale for between $20 and $70. The design characteristics of domestic paper shredders that may contribute to the danger to toddlers include the width of the o
The shredders that were tested prior to the report produced by the U.S. Consumer Product Safety Commission were on sale for between $20 and $70. The design characteristics of domestic paper shredders that may contribute to the danger to toddlers include the width of the o
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
pening or "throat", the stiffness of the material from which the shredder "throat" is
constructed, the distance from the opening to the cutting mechanism and the pulling power of the shredding mechanism. In
general, the crosscut shredders tested allowed larger diameter probes to pass through the shredde
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
r "throat" than the strip
cuts shredders that were tested. Since crosscut shredders require more power to shred paper the motors were consistently
more powerful and this would pull a child's fingers in more easily. None of the shredders tested had a separate On/Off
switch separate from the Auto / Forw
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
ard / Reverse functions. Critical safety information was not universally displayed on
all models and some had no warnings at all at the shredder "throat". Some shredders did not show contrasting colours for the switches which may be a safety concern if it should become necessary to turn off a shredder o
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
r put it into reverse in an emergency.
Some of the observations given by the U.S.CPSC can be summarised as follows:-
• Crosscut shredders allowed thicker rigid rods to enter the shredder throat than did strip cut shredders
• Cross cut shredders were more powerful and thus more likely to pull in a
Some of the observations given by the U.S.CPSC can be summarised as follows:-
• Crosscut shredders allowed thicker rigid rods to enter the shredder throat than did strip cut shredders
• Cross cut shredders were more powerful and thus more likely to pull in a
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
child's fingers
• Crosscut shredders allowed the smallest compressible probe to enter the shredder throat
• Crosscut shredders allowed larger compressible probes to enter the shredder throat
• Only some shredders had an OFF position on the function switch
• No shredder tested had a separate ON/OFF swi
• Crosscut shredders allowed the smallest compressible probe to enter the shredder throat
• Crosscut shredders allowed larger compressible probes to enter the shredder throat
• Only some shredders had an OFF position on the function switch
• No shredder tested had a separate ON/OFF swi
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
ch separate from the Auto/Forward/Reverse functions
• Not all shredders carried the same hazard markings at the shredder "throat"
• Some shredders did not have contrasting colours for the hazard markings
• Some shredders did not have contrasting colours for the function markings
The CPSC came to
• Not all shredders carried the same hazard markings at the shredder "throat"
• Some shredders did not have contrasting colours for the hazard markings
• Some shredders did not have contrasting colours for the function markings
The CPSC came to
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
some conclusions on the samples tested, but pointed out that this was not a statistical sampling or a
sample of all types of paper shredders:-
• Paper shredders pose the greatest threat of finger injuries to children between the ages of 15 months and 2? years (based on incident data)
• The level of ri
• Paper shredders pose the greatest threat of finger injuries to children between the ages of 15 months and 2? years (based on incident data)
• The level of ri
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
sk depends on the design of the shredder opening or "throat"
• Current testing (as at December 2004) did not relate to hazards involving small children
• The design of the shredder "throat" determines the amount of force required to insert a probe into the shredder. These factors include width of openin
• Current testing (as at December 2004) did not relate to hazards involving small children
• The design of the shredder "throat" determines the amount of force required to insert a probe into the shredder. These factors include width of openin
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
g, stiffness of opening, distance from opening to shredder mechanism, compressibility of fingers and the pulling force of the shredder involved.
The researchers called for domestic paper shredder manufacturers to redesign the shredders to improve safety aspects and for them to carry clear warnings directl
The researchers called for domestic paper shredder manufacturers to redesign the shredders to improve safety aspects and for them to carry clear warnings directl
.
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
y on the machines. The authors also recommended that paediatricians ask parents whether they have a paper shredder in the home and if so to advise them to leave it unplugged and out of reach and to never allow a child to use the shredder, even when an adult is present.
David Jenkins, of the Royal Society
David Jenkins, of the Royal Society
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
for the Prevention of Accidents in the UK was recently quoted by Sarah Womack, of The Daily Telegraph as saying "I am not aware of a problem in this country yet but with the increasing popularity of paper shredders - and if similar designs are available here as in America - accidents are likely to happen"
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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