US based safety science company Underwriters Laboratories (UL) concluded in a survey that over 60 per cent of products in primary and secondary healthcare centres lack testing and proper quality control procedure. That is why cheap, low quality medical devices are getting circulated in the market in various parts of the globe.

Even as the government has launched the much awaited Materio-Vigilance programme of India to report serious adverse events due to medical devices, industry experts, however, go on to say that there is tremendous lack of regulation in the sector.

Substantiating the view backed by the survey, Peeyush Gupta, director, sales and marketing, South Asia, Underwriters Laboratories says, "The survey found that a lot of fires took place in hospitals due to defective infant baby warmers leading to even infant deaths besides burn injuries. No scrutiny at customs has led to medical devices landing up in clinics and hospitals without being looked for quality, safety and efficacy."

UL is a safety science company based in the US. The company offers about 1,200 courses globally and has trained around 38,000 US FDA inspectors till date.

The survey concluded that incubators, CT -scanners, MRI machines and home use pressure monitoring devices which have completed their life cycle are refurbished without lack of concern for quality and are sold to secondary and tertiary healthcare markets. The serious adverse events due to these products can have long lasting impact on the operators and patients.

"There is a flourishing industry of refurbished equipment which are making their way back into clinics and hospitals. A brand new equipment which probably has gone through its life cycle like an imaging device is refurbished at low- quality substandard workshops. There is some percentage which is taken back by manufacturers but a large part goes through a low quality refurbishment process in India," Gupta explained.

He suggested that in order to ensure quality there is a need to classify medical devices into different categories based on the risk assessment approach. According to this, the product is tested as per the regulatory requirement to notify the risk levels through independent conformity assessment bodies who verify and document the manufacturing processes, design processes, post production experiences, product issues and recalls. It is a continuous process of PDCA process cycle in order to arrive at best in class manufacturing process.

There has been initiative from the government to develop incubation and testing centres for medical devices to make products globally harmonised. There is a Global Harmonisation Task Force (GHTF) to ensure that there is conversion of regulatory practices globally to arrive at safety, efficacy and performance.

"Industry has witnessed several dozen start-ups over a period of two years which shows that indigenisation in medical devices is bound to happen in a big way. There have been recommendations from the industry to frame a policy on preferential market access for ancillary industry in medical devices, draft medical devices bill and a national health policy as an overarching way to build infrastructure in primary and secondary healthcare," Gupta concluded.