The bulk of these second-hand equipment — from flexible endoscopes to MRI machines — are sold online by third-party traders, ill-equipped to provide reliable maintenance services.
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Implant Files: From endoscopes to MRI machines, patients can’t verify and law is silent.
Nobody has kept an exact count, but it is estimated that 50-70
per cent of medical equipment in use in India’s private healthcare facilities —
from unregulated path labs to some of the super speciality hospital chains —
are pre-owned.
The bulk of these second-hand equipment — from flexible
endoscopes to MRI machines — are sold online by third-party traders,
ill-equipped to provide reliable maintenance services.
An investigation by The Indian Express, in collaboration
with the International Consortium of Investigative Journalists (ICIJ), into the
big, unregulated medical bazaar has found that no regulator ever checks these
pre-owned machines, before or after sale. And that for most tests and
procedures, patients have no means to verify if the equipment is hazardous,
faulty or if the test results are inaccurate.
The National Accreditation Board for Testing &
Calibration Laboratories (NABL) is there to ensure quality but accreditation is
voluntary and not even two per cent of the country’s estimated 1 lakh
diagnostic laboratories have opted for it. The Medical Device Rules 2017 too is
silent on pre-owned machines which are 35-50 per cent cheaper than new
products.
Niti Aayog member V K Paul accepts that a “policy gap
exists” on the use of pre-owned and refurbished medical equipment. “As the BIS
(Bureau of Indian Standards) sets the benchmark for 1,000 medical devices, we
should be able to also address the refurbished sector soon,” he said.
With nobody watching, it is difficult to tell how widespread
the use of pre-owned equipment is. Dr Deepak Mishra, Director (Laboratory
Sciences) at Kolkata’s Tata Medical Centre, and president of Indian Association
of Pathologists & Microbiologists, said: “Only 20 per cent of India’s labs
are in the organised sector and many of them use second-hand units. Nobody
knows what the other 80 per cent are using.”
NABL CEO Anil Relia, underlining that only 1,038 medical
labs out of an estimated one lakh were accredited to NABL as of August this
year, said: “Pathological and diagnostic laboratories are required to provide
details of all major equipment while applying for accreditation and we verify
during on-site assessment if the equipment comply with quality requirements of
ISO 15189.”
Nothing is illegal
In New Kondli on the outskirts of Delhi, a narrow, dark
stairway leads to the first floor of a four-storeyed residential block. There
is no nameplate on the door and the woman in the flat is not very helpful:
“What service centre? I don’t know what you are talking about. Go check the
other 15 flats in this building.”
On the phone, the proprietor of the company that uses the
New Kondli address for its Delhi service centre is not apologetic. He runs a
diagnostic centre not far from Lucknow and sells pre-owned equipment such as
MRI machines online.
“I import these machines, use some at my lab, rent some to
other local labs, and sell online. I can do the installation and basic
maintenance myself. I have technicians on salary in Roorkee. This address is
for customers in and around Delhi,” he said.
He declined to speak on the qualifications of his
technicians. “There is no minimum requirement in law. Why single me out for
interrogation? Show me one illegal thing I do in my business,” he said.
Another proprietor also banked on the lack of regulations
when he contacted his “sources” in a leading hospital chain to “pick up a few
used machines” for his soon-to-be launched diagnostic centre near Meerut. “I
was working on a good deal, but they shifted their old machines to a branch
hospital in (a district headquarters). So, I had to buy an MRI machine online,”
he said.
He did not mind the gamble. “I know there is no guarantee
backup but my competitors in the locality have already bought second-hand
machines, and I had to go online for cheaper options for better margins. I just
hope there are no major service issues,” he said.
He played down the safety issue. “Just because we have not
gone to NABL does not mean we don’t care about our patients. From basic to
elaborate, there are different standards of safety. Would these machines be
allowed if they were dangerous?” he argued.
Under the Directorate General of Foreign Trade rules, import
of second-hand machinery and used capital goods need a valuation certificate
from a chartered engineer — primarily to determine duty fees. To safeguard
against radiation, equipment such as X-ray and CT scan machines need clearance
from the Atomic Energy Regulatory Board. Any other medical equipment — new or
pre-owned — can be imported and sold in India without any safety check.
Regulate and how
There are two types of pre-owned equipment — those restored
to original safety and effectiveness by Original Equipment Manufacturers (OEM)
as well as Certified Refurbishing Companies (CRC), and those sourced and sold
as-is by third-party traders. In the developed market, the OEM and CRC industry
has taken off in the last decade.
In the developing world, third-party vendors, with little or
no technical expertise initiated the trade in pre-owned medical equipment, and
by 2002, several countries banned such imports due to poor after-sale services
and non-availability of spare parts.
In the last decade though, shrinking healthcare budgets and
better technologies have led to increasing use of second-hand equipment even in
the developed countries. Most equipment come with a buy-back promise. As bigger
hospitals purchase the latest models, their used units often remain suitable
for certain applications. Big brands started selling these units after
re-calibration.
However, third-party traders of varying credibility and
expertise continue to operate in the market. The World Health Organisation
feels it is important for developing countries to ensure that companies
supplying refurbished equipment fulfil after-sale obligations including the
continued availability of technical support and maintenance services.
But, according to Medical Technology Association of India
(MTaI) dominated by the MNCs, an estimated 95 per cent of pre-owned equipment
imported to India belong to the CRC or refurbished category. MTaI
representatives, who did not wish to be named, reiterated the Association’s
stand that import of only OEM products should be allowed.
“Given the rising cost of healthcare, the price benefit of
refurbished products plus the safety and service guarantees make them a
rational choice, particularly in Tier 2 and Tier 3 cities,” a MTaI member said.
But the proprietor of a third-party trading company had a
counter view: “The MNCs want to weed out small players like us, take over the
second-hand market and control price. Calibration and servicing need skilled
manpower which is nobody’s monopoly. Yes, unaccountable online traders are a
nuisance. But why target bona fide companies like ours? Let’s have strong
regulations and let all who can comply compete equally.”
The Association of Indian Medical Device Manufacturers
(AiMeD) dominated by domestic companies, is also sceptical of MTaI’s stand.
Rajiv Nath, Forum Coordinator, AiMeD, said: “There is no mechanism to verify if
even the OEM products are properly calibrated as claimed. Until we have robust
regulations in place to ensure patient safety, we should stop importing all
pre-owned equipment.”
According to Nath, the price benefit of using second-hand
machines is rarely passed on to the patients while risks remain very real. No
reseller, including global OEMs, have any obligation to conduct post-marketing
surveys. There is just no record of adverse incidents specific to pre-owned
equipment.
“The regulatory regime has to be practical to be effective.
Since it is virtually impossible for a regulator to monitor every pre-owned
machine, the emphasis should be on training and capacity-building so that a
certain service quality can be maintained,” said M Balasubramaniam, an industry
expert.
Until then, the patient’s only option is to trust the
healthcare facility and hope that its integrity matches its reputation.
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