The Hindu : SCTIMST plans national diagnostic testing centre

Online edition of India's National Newspaper
Monday, Jun 09, 2003

Southern States

Southern States - Kerala-Thiruvananthapuram

SCTIMST plans national diagnostic testing centre

By M. Dinesh Varma

THIRUVANANTHAPURAM June 8. The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) is working towards establishing a national testing centre for a whole range of bio-materials and medical devices, it is learnt.

While the tertiary care institution, which deals with the cardiology and neurology streams, already has investigative facilities that are on a par with international standards, there is now a growing need for coining a gold standard so as to benefit both the industry as well as the patient community, sources say.

The lack of standardised calibration of low-to-high-end diagnostic machines could have a telling effect on the way a medical condition is managed, it is pointed out. False values that could emerge during investigations are bound to mislead clinicians. There is also no way of knowing whether, say, the catheter, has been designed in a proper way.

A preliminary audit of the quality system implementation, conforming to the ISO 17025 norms, was completed in 2001. An inspection team, which is part of an accreditation agency based in France, is expected to visit the institution in the first week of July to determine whether the diagnostic facilities here measure up to ISO 17025 norms.

According to the SCTIMST Director, K. Mohandas, the institution would also press for the enactment of a Medical Devices Regulatory Act which would ensure quality control in a bio-material and bio-medical device industry which is at present an ill-regulated sector.

The situation as of now is that the lack of such a Regulatory Act has spawned medical devices which may not match up to stringent standards.

According to G. S. Bhuvaneswar, Head, Biomedical Technology Wing at Poojappura, the demand for medical devices has been increasing by leaps and bounds. The main reason for this has been the mushrooming of corporate/private hospitals across the country that cater to a middle class population.

While an estimated 80 per cent of bio-materials and bio-medical devices are imported, the economic might of this market in India, according to at least one survey, is to the tune of a mind-boggling Rs. 10,000 crores.

The SCTIMST management had, as early as in the mid-1990s, forwarded a proposal on quality system implementation, to the Department of Science and Technology. The President, A.P.J. Abdul Kalam, is reported to have evinced keen interest in the establishment of a national centre for certifying medical devices.

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