Pharmabiz
 

CERC cautions about unclean, unsafe syringes in market, manufacturers put weak defenses

Our Bureau, MumbaiThursday, February 28, 2002, 08:00 Hrs  [IST]

Following a voluntary quality test conducted at the in-house laboratory of the Ahmedabad-based Consumer Education and Research Centre (CERC), the Centre has cautioned the public about the unsafe and unclean syringes sold and available in the Indian market. Recently, the laboratory had tested nine brands of 5 ml and ten brands of 2 ml syringes; seven brands of 23 G and six brands of 22 G needles; three brands of U-100 and five brands of U-40 insulin syringes. Shockingly, of the total 19 brands of syringes picked up from the market tested, the result showed 13 as unclean. Since the test results showed such large number of brands defective, the consumer agency has expressed its concern about health impacts of the same in the society. Cautioning about the impact of using unclean syringes, the CERC sources alarmed that the injection fluid may absorb the unclean matter, which then travels into the body. If the particles are contaminated, the situation could be life - threatening. The major brands of syringes tested by the Centre included Mediflo, B-D Pricon, Medisafe, Doctor, Corelife, Dispovan, Injecto, (all of 5 ml and 2 ml) Getwel, Healthcare (both of 2 ml) and Dr. Safe (5 ml). The laboratory test observed that lubricant was observed as droplets in all syringes except B-D, Dispovan, Dr. Safe (all 5 ml), B-D, Dispovan, Healthcare, Injecto, Medisafe and Pricon (all 2 ml). Excess lubricant interferes with the free flow of injection fluid and affects its stability. The Indian Standards (IS) lay down detailed guidelines for the length, position, spacing and prominence of the graduation marks to ensure the accuracy of the dose being delivered. Only Dispovan (2 ml) and B-D (2 ml and 5 ml) met all the above specifications. Doctor, Mediflo (both 5 ml); Healthcare, Mediflo and Medisafe (all 2ml) did not have the required plunger length which would be adequate to allow the piston to traverse the full length of the barrel. Medisafe (5 ml) and Healthcare (2 ml) did not have accurate making for the total volume. This could mean delivery of an inaccurate dose. Dr. Safe, B-D, Medisafe, Doctor, Mediflo (all 5 ml) and Pricon, Medisafe, Mediflo (all 2 ml) had leakage problems. This would mean not only a waste of medicine but also delivery of an inaccurate dose, which could delay the therapeutic effect. Whereas, Mediflo, Medisafe, Doctor, Dispovan and Dr. Safe (all 5ml) had more than the permissible dead space, i.e. the space occupied by the injection fluid in the barrel after the piston has been fully inserted into it. More dead space moans wastage of medicine. And Mediflo, Doctor, Dispovan, Dr. Safe (all 5ml) and Doctor, Mediflo (both 2 ml) did not satisfy the IS requirements for packaging as well. At the same time it showed that all brands of syringes passed the critical parameters of sterility, toxicity and pyrogens. The lab had also tested 13 needle brands available in the market which included Sterican, Dispovan, Safti, Medisafe, B-D, Corelife, Mediflo (all 23 G); B-D, Sterican, Safti, Corelife, Dispovan and Mediflo (all 22 G), in which, the lab found only Mediflo (23 G) to be unsterile. The cleanliness of Mediflo (22 G) too was not found to be up to the mark. All the brands passed the critical parameters of toxicity and pyrogens. Excess lubricant remaining on the needle affects the stability of the injection fluid. Corelife (23 G) and Mediflo (22 G) did not conform to the IS specifications for lubrication. Regarding needle assembly, the joint between the hub and the needle tube should be strong enough to resist breakage. Dispovan, Mediflo, Corelife, Medisafe (all 23 G), Dispovan, Corelife and Mediflo (all 22 G) could not resist the pressure applied on them as specified by the ISI. It is also found that B-D, Medisafe (both 23 G), Dispovan and Mediflo (both 22 G) did not meet the ISI requirements for needle tube dimensions. The hub sockets of Safti, Mediflo, Corelife and Medisafe (all 23 G) and Mediflo (22 G) had foreign particles clinging to them. B-D, Medisafe, Sterican, Safti, Mediflo (all 23 G), and Safti and Mediflo (both 22 G) did not conform to the marking requirements of the IS. B-D (23 G) did not meet the packaging requirements of the IS. In the category of insulin syringes the laboratory tested three brands of U-100 insulin Syringes (B-D, Dispovan, Omnican) and five brands of U-40 insulin syringes (Dispovan, B-D, Nipro, Omnican, Medisafe). It showed that none of the brands met all the marking requirements as specified by the IS. Medisafe (U-40) did not conform to the packaging requirements as prescribed by the IS. While, Omnican (U-100) and Medisafe (U-40) did not conform to the IS specifications for graduate scale, Dispovan (U-100); Nipro, Omnican (both U-40) did not conform to the test for bond between the hub and the needle tube. Medisafe, Omnican and Nipro (all U-40) did not conform to the IS specifications for needle tube dimensions. Interestingly, when laboratory sent the test results to the various brand manufacturers, they responded with mixed reactions. While the manufacturers of Dispovan brand of syringes, needles and insulin syringes, Hindustan Syringes, said that results of tests of counter samples at their laboratory showed that the 5 ml syringes passed the parameters of cleanliness, graduated scale, piston plunge assembly and performance. The needles also passed the parameters for needle assembly (22 G and 23 G) and needle tube (22 G), it also disagreed to the test findings that the packaging of the 5 ml syringes was not designed to maintain sterility. They felt that the conformance of Dispovan to the sterility test was contradictory to the CERC findings. Hindustan Syringes differed with the findings on packing requirements for insulin syringes saying that their category was in the multiple unit pack and hence the test was not applicable to them. By IS definitions Dispovan insulin syringes are both self-contained packs and multiple unit packs. As for marking of insulin syringes, Hindustan Syringes said that corrective measures had been taken on two points a year back and a request had been made to the IS for revision of standards for two other requirements. But the CERC states that while they appreciate the corrective measures, the test results still stand since they relate to products purchased from the market before the measures were implemented and are as per current IS requirements. Core Healthcare, the manufacturers of Corelife, after checking the samples picked up by the Centre stated that the batch of syringes tested by CERC as manufactured in 1999. "The products had since been corrected on the cleanliness, graduation scale and lubrication parameters to comply with the IS requirements. Hence the findings are not relevant," the added. However, the CERC sources said that they are unable to comment on the quality of Core's current products since they have not tested them. However, the batch of products tested by the lab had an expiry date of 2004 and hence are valid even today. Products of the above batch are even available in the market today, the CERC sources said. While ISCON Surgicals, the manufacturers of Pricon syringe, fully agreed with the test results, Sharp Medical Products, the manufacturers of Mediflo, thanked the lab for the results. They said that their products were released after tests for compliance with relevant standards. However, they assured that they would take greater care in the future for better quality products. Interestingly, Getwel Syringes has closed its operations and hence there was no response from the company. Manoj Surgicals, the manufacturers of Medisafe, said that keeping in mind the wordings of the various clauses of the IS such as 'recommended', 'preferred' etc, certain amount of flexibility should be given for readings. Manoj Surgicals observed that they were confident that their products could not be deficient in parameters such as lubrication, tolerance on graduated capacity and performance. Becton and Dickinson, the manufacturers of B-D brand of syringes and needles, did not agree with the results on cleanliness and leakage in the 2 ml and 5 ml syringes; requirements for marking in insulin syringes and requirements for size designation, range of size, colour coding for needle hub, size of needle tube and colour code for packaging in the 23 G needles. B-D further contended that its markings satisfy international and British requirements.

 
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