IV Sets
- Posted by CERC India
- Posted in Pharmaceuticals
We tested 15 brands of IV sets against the specifications in the BIS and the DIN (German Standards). None of them could conform to all the parameters specified by the BIS though most of them claimed to meet the IS standards. Except Corelife, Hema-flo, Safti and Intrafix Eco, all other brands had the IS mark. Intrafix Eco claimed to be sterilised as per IS.
November-December 1999
KEY FINDINGS
15 brands Tested
All Found Unsafe
We tested 15 brands of IV sets against the specifications in the BIS and the DIN (German Standards). None of them could conform to all the parameters specified by the BIS though most of them claimed to meet the IS standards. Except Corelife, Hema-flo, Safti and Intrafix Eco, all other brands had the IS mark. Intrafix Eco claimed to be sterilised as per IS.
- It is very important for IV sets to be sterile as microbial contamination may lead to blood poisoning, causing fever, pain, nausea, etc. JMS, Hemo-flo and Max were found to be contaminated, and hence could not conform to this parameter.
- None of the brands had the 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 the set may lead to loss of fluid being given to the patient. Corelife, Aroset, JMS and Intrafix Eco were found with air leakage and hence did not conform to the parameter on integrity.
- The sets should be able to withstand a certain amount of force. If they can’t, they may break open leading to air leakage. Only Green Cross, Care-fix, Medico, Hemo-flo and Max conformed to this parameter.
- Flowel did not have any filter. Filter is important to prevent the entry of micro-organisms into the fluid
- The length of the tube should not be less than 1500 mm. A short tube may get stretched and separate leading to loss of fluid and medication to the patient. Medico tube was found to be only 1260 mm and hence could not conform to this parameter.
- The drip chamber and the tube need to be of the required specification for proper flow rate of the fluid. Hema-flo, Care-fix, Medico, Hemo-flo and Max could not meet the specifications laid down by the BIS.
- The injection site should get resealed on its own after the injection has been given. Otherwise, it may cause leakage of fluid. Green Cross could not conform to this parameter.
- Ammonium and chloride ions can be present in the set if it has not been cleaned properly. These substances can reach the blood and may cause disturbances in the electrolyte balance of the blood. Since the BIS has not specified any limits for these, we tested them against the German standards (DIN). Aroset, Deniset, Flowel, Flowking, Hema-flo, Hemo-flo and Green Cross were found with ammonium ions while chloride ion was detected in Care-fix.
- M.R.P. of the brands ranged between Rs.20 to 36. However, for most of the sets we purchased, we paid less than the M.R.P. In some cases like Carefix, Green Cross and Max we paid almost half the Theprice.
