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Stents : Quality Control Is A Must
(A Report By the Forum For Medical Ethics )
A forum for Medical Ethics study indicates that a frighteningly large number of doctors makes their
prescriptions based on kickbacks rather than quality. The government, meanwhile, does not even pretend to regulate the manufacture and sale of medical equipment in India.
"The situation is shocking," said J.V. Vaidya, vice-chairman of the Confederation of Indian Industry's medical equipment division. All you need to manufacture medical equipment today is a garage and some machinery. There's nobody to monitor or even ask questions."
Added Dr. Mathew Samuel Kalarickal, the father of angioplasty in India, "You cannot sell an aspirin without a
license, but you can sell coronary stents, hips and knees without a single regulation."
Peculiar as this seems, the authorities have a ready explanation. Said Uttam Khobragade, the commissioner of Maharashtra's Food and Drug Administration, "Medical instruments are neither food nor drugs, so they don't come under this office."
In the vacuum, nobody addresses vital questions. Are screws used to mend fractures made more precisely than those sold in Lohar Chawl? Is the equipment used for surgical diathermy manufactured in sterile conditions? Have coronary stents priced at Rs. 1 lakh undergone even basic animal and human trials before hitting the market?
"Quality control is a must when implanting a device permanently in a patient," said Renu Virmani, a US based cardio-pathologist and expert on coronary stents. "It's essential, for example, to show safety in animals before anything is implanted in man."
The absence of such guidelines has resulted in a free-for-all especially with big profit devices. The most glaring example is of stents, especially the drug-coated variants, which are inserted into arteries to ward off heart attacks. These are becoming big business given that about one lakh angioplasties are conducted in the country in a year.
But not everybody is convinced. "Often, these are not drug-coated stents, but money-coated stents," said Dr. Kalarickal.
"They only sell because manufacturers entice doctors with incentives." Added a disgusted distributor, "The rot is so deep that kickbacks and foreign trips are handed out, not only to the doctor who performs the angioplasty, but also the referring cardiologist."
Unsterilised implants could cause mysterious infections, stents coated with immuno-suppressant drugs could destroy the body's immunity.
[Ref : Times of India Oct. 23/2003]
New cobalt stent implanted in three cardiac patients in Hyderabad.
The US based Medtronics Inc., one of the leading manufacturers of medical devices, has successfully launched Driver, a coronary stent developed out of a cobalt alloy by implanting the device in three coronary patients at Usha Mullapudi Cardiac Centre in Hyderabad last week. The implant procedure of the new device was done for the first time in India by Dr. B Chevalier, eminent interventional cardiologist from Paris.
Though both the drug coated stent made of stainless steel and the new stent made of cobalt were life-long, the new device was a good compromise for the patients in terms of clinical outcome and cost. Also it was a good intermediate choice between drug coated and uncoated stainless steel stents, Dr. Chevalier said.
Replying to a question on the standard of theatres and medical support in Indian hospitals, Dr. Chevalier said they were as good as any foreign hospitals, maintaining very high international quality standards.
Launching the product in Hyderabad, Dr. Narsing Rao, Medical Advisor to Medtronic, said, " The Driver stent has a very low profile and excellent trackability, flexibility and radial strength, which makes it uniquely, suited for direct stenting, which means lower rist of complications, reduced radiation exposure and lower costs of the procedure."
The Driver Stent's advanced cobalt alloy surpassed the limitations of stainless steel strents by making possible very strong, ultra-thin struts that offered flexibiltity and excellent vessel support, he said.
Dr. Nbarsing Rao said about 35,000 to 36,000 ordinary stents and drug-coated stents were being used in India every year, with some 25 suppliers in the field. Asked whether the new device would phase out the stainless steel stents, he said it would be a combination of both for some time.
The cobalt alloy had been chosen for its biocompatibility, strength, non-ferro magnetism and high resistance to fatigue and corrosion, he said.
Research trials conducted on 300 patients in the US using Driver coronary stents indicate as low as 3 percent Target Lesion Revascularisation (TLR) rate in patients with diseased coronary arteries. TLR is the need for a repeat angioplasty or artery bypass surgery following a stent implant. The TLR results of Driver coronary stent is comparable to some of the studies done with drug-coated stents," Robert Young said.
Interestingly, the product has not been launched in the country of its origin so far, though Meditronic had filed an application before the UD FDA for its approval to launch the stent in US. The company currently is in the process of launching the device across several centers in
Indial.
[Ref : Pharmabiz
Hospital Review July 16/2003]
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