|
INSIGHT is published
bimonthly by Consumer Education and Research Society (CERS), a non-commercial
membership organisation promoted by Consumer Education and Research Centre
(CERC), Ahmedabad.
15 brands of IV sets were tested against 21 parameters set by
the Bureau of Indian Standards (BIS). Wherever required, the Indian
Pharmacopoeia (IP) was referred. They also referred to the German Standard (DIN)
for 2 parameters. None of the brands could conform to all the parameters
specified by the BIS though most of them claimed to meet the IS standards.
KEY FINDINGS
Except few, all other brands bore the IS mark. One brand
claimed to be sterilised as per the IS specifications.
It said most of the sets were purchased on price less than
the printed maximum retail price (MRP). For some brands CERS paid only half the
price, "We wrote to the manufacturers but did not get any response on this
issue," Said a spokesman.
It is important for IV sets to be sterile as microbial
contamination may lead to blood poisoning, causing fever, pain nausea and other
such diseases. Few brands were found to be contaminated and hence could not
confirm to this parameter.
None of the brands had the proper dimensions of the closure
piercing device as specified in the BIS. The correct dimensions ensure
convenient usage of the set and adequate flow of the fluid.
Leakage in an IV set may lead to contamination as well as
loss of fluid being given to the patient. Some brands did not conform to the
parameter on integrity.
The sets are required to withstand a certain amount of force.
"If they can’t , they may break open leading to air leakage. Only few
conformed to this parameter. One brand did not have an air-filter. A filter is
important to prevent the entry of micro-organism into the fluid.
The length of the tube should not be less than 1500mm. A
short tube may get stretched and separate, leading to loss of fluid and
medication for the patient. The tube of one set was found to be only 1260 mm and
hence could not conform to this parameter.
The drip chamber and the tube need to meet the required
specification for proper flow rate of the fluid. Some brands could not meet the
BIS specifications.
The injection site should get resealed on its own after
administering and injection as otherwise it may cause leakage of fluid. One
brand could not conform to this parameter.
Ammonium and chloride ions can make its presence felt in the
IV set if it has not been cleansed properly. These substance may reach the blood
and disturb its electrolyte balance. "Since the BIS has not specified any
limits for these, we tested them against the DIN. Many revealed ammonium ions
while chloride ion was detected in one".
MANUFACTURERS’ RESPONSE
As a policy, "INSIGHT" conveys the test results to
all the manufacturers, irrespective of whether their brand has passed or failed
the test. The results are posted to their Registered Offices under registered
A.D. The manufacturers receive only the result of their own product and are
given two weeks from the date of receipt to respond.
We reproduce herewith the responses from the manufacturers
alongwith the respective notes from "INSIGHT" as published in their
Nov.-Dec. 1999 issue. For obvious reasons, we have excluded the company names.
Response 1
The company thanked for testing their product and assured
them of making necessary changes in the label as per the BIS requirement. They
even sent a sample set for testing.
INSIGHT : "As a Policy,
we do not accept and test samples sent by the manufacturers. We buy samples,
like any other consumer; from the market".
Response 2
The Company agreed to rectify the design of the closure
piercing device as per the standard. They also said that they are going for
newly printed pouch mentioning all mandatory labelling information as per the
BIS.
INSIGHT : "Regarding the presence of ammonium ions,
they said that they would now inspect every set for the filter placement.
"The company is responsible for whatever material it
supplies under its name".
"Regarding the absence of filter, they said that filter
may have fallen off. They said that they would now inspect every set for the
filter placement".
"We checked 300 sets of the same batch and we did not
find filter in any of them".
Response 3 :
The company wrote to "INSIGHT" that they have
improved their product which now meets all relevent standards. They sent new
samples to test and said that the samples tested were two years old.
INSIGHT : "The samples we have tested are still
available in the market, and their expiry date is in 2000. So it would not be
fair on our part to test the product of the same company again".
Response 4 :
The company sent a letter disagreeing with their results and
said that their inhouse testing revealed that the products meets BIS and ISO
limits. However, according to our test results, their product does not meet all
the BIS specifications. They wanted to know the instrument used to check the
connections.
INSIGHT : "The test was performed as per the BIS using
electro pneumatic sensor".
"Some of the manufacturers called "INSIGHT" to
convey that the ISO standard has been revised for the closure piercing device.
We looked into the revised standards and found the brands still not conforming.
However, we feel that since all brands are not complying to this particular
parameter, it’s time for the BIS to look into the matter".
ACTIONS FROM BIS NECESSARY
Based on detailed study and close interactions with the
Industry, "INSIGHT"
has suggested actions required from BIS in following areas :
-
There should be a suitable test and a limit laid down in
the BIS for particulate matter within the IV set.
-
The BIS does not have any standards for ammonium and
chloride ions. They should be included in the BIS as they have health
implications.
-
The latex particles for fluid filter test are very
difficult to procure though the test has been prescribed by the BIS. The BIS
should either suggest an alternative or have some suppliers for these test
requisites.
-
When sets are sterilised by elthylene oxide (Eto) they
need to be tested for ethylene oxide residues or its degradation products
since they are health hazards. They also need to be tested for leaching of
plasticisers in the tubing. The BIS should include methods and limits for
these tests.
-
The BIS should clarify whether infusion sets are included
under the term ‘Perfusion Sets’. They also should specify whether the
standards are mandatory or voluntary.
|
MEDICAL PLASTICS DATA SERVICE invites the Indian
Medical Devices Industry to offer their views/opinions regarding the
survey carried out directly to "INSIGHT" to their following
address :
Consumer
Education and Research Society
Suraksha
Sankool, Thaltej, Ahmedabad-Gandhinagar Highway, Ahmedabad-380 054,
Gujarat, India
Phones:
079-7489945/46, 7450528, 7451097
Fax:
079-7489947 • E-mail: cerc@wilnetonline.net |
|
