SYRINGES
Key Findings : Syringes
9 brands of
5ml syringes and 10 brands of 2ml syringes were tested Dr.
Safe was the top scorer in the 5ml category, while Dispovan was
the top scorer in 2ml category All brands passed in the
critical parameters of sterility, toxicity and pyrogens
Among the 5 brands, only two and among the 2ml brand, only four
were found clean Lubricants were visible as particles in
most of the brands Few brands of 5ml and 2ml had leakage
problems Only 2 brands were confirming to all the
requirements for graduations Some brands of 5ml and 2ml did
not have the required length of the plunger. |
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32 samples of each of
the 40 brands of needles syringes and insulin syringes were tested
against the specifications of the Indian Standards, which are
mandatory.
Disposable syringes
and needles are sterile and ready to use. Glass syringes have to be
sterilised by boiling in water. However, the sterilisation may not
always be enough and chances of contacting HIV and hepatitis through
them remain. Although syringes of various capacities are available in
the market, the most commonly used are the 2 ml and 5 ml capacity
ones.
Not Clean
It is very important
for any medical device to be clean. Because of the static charge on
plastic syringes, they may attract extraneous particles, dust, etc.
The injection fluid coming into contact with unclean syringes absorbs
all the unclean matter and travels into the body. This may cause
harmful effects and if the particles are contaminated, the situation
could be life threatening.
Lubrication
Syringes at the time
of manufacture, are lubricated for greater ease of movement of the
plunger in the barrel. However, excess lubricant remaining after
manufacture interferes with the free flow of injection fluid through
the needle. It may also affect the stability of the injection fluid.
The Indian Standards advise that the quantity of lubricant should be
minimum and should not be visible as droplets or particles in the
syringes. Only six companies complied with the IS specifications.
Syringe Dimensions
The syringe
components include the piston, the plunger, barrel and nozzle. The IS
lays down certain guidelines for the design and functioning of each of
the above components for greater convenience and efficiency in the
operation of the syringe.
Assembly
The length of the
plunger should be adequate to allow the piston to traverse the full
length of the barrel. Once the plunger has traversed its full length,
the projection should be long enough to allow space for the fingers
and ease of operation. The IS advises that the preferred length of the
projection should be at least 12.5 mm for 5 ml syringes and 9 mm for 2
ml syringes.
The finger grips
should be smooth and not have any sharp edges which would be harsh on
ones fingers when operating the syringe. Dead space, a component of
the performance parameter, is the space occupied by the injection
liquid in the barrel and nozzle when the piston is fully inserted.
Lesser the dead space, greater is the economy on the medicine used.
Do they Leak?
Leakage in the syringe, either of air
or syringe liquid would not only mean a waste of medicine but also
delivery of an inaccurate does which could delay the therapeutic
effect. The leakage could happen because of an improper inner
diameter of the
barrel and outer diameter of plunger or piston. In the 5 ml category,
some brands were found to be vulnerable to leakage and not conforming
to the performance parameters.
Graduated Scale
The visibility, uniformity and
dimensions of the graduation markings are very important, especially
at ill-lu places. The IS lays down detailed guidelines with respect to
the graduations to make syringes more convenient, safe and efficient.
The guidelines range from the size of the graduated markings to
distance between them and their prominence. Non-conformity with the
above requirements could lead to a wrong dose being delivered.
The Indian Standards also recommend
specific lengths for the long and short graduation lines. It is
disappointing though that even the larger brands failed to follow the
IS recommendations in this regard. Any error in the marking of the
total volume could also lead to either an insufficient or an overdose
of the drug. In both the cases, the result could prove fatal. The
Indian Standards permit an error of four percent for 5 ml and five
percent of 2 ml in volume labelling. Few brands did not comply with
the standards...[More]
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