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Too Many New Medical Devices Leave Doctors At Sea
Last Summer, rival cardiologists in Rock Hill, South Carolina, decided to
learn how to perform a lucrative new procedure, implanting a defibrillator, a
device that protects against fatal heart rhythms.
One doctor attended weekend classroom sessions sponsored by a professional
medical organisation, passed a daylong written test given by that group and
implanted defibrillators in 10 patients while an expert observed. But by then,
four other doctors at a competing practice had left him in the dust, implanting
75 devices. They chose a separate training programme, provided free and tailored
to their liking by a little known device maker, Biotronik. Only one of the four
doctors so far has taken the recommended competency test.
The different training regimens like the ones followed by the Rock Hill
physicians are at the centre of a growing and often contentious debate. As
companies develop more sophisticated devices, medical experts are asking how
doctors should best be trained and who should train them to implant such devices
without compromising patient safety.
The growing use of the costly defibrillators is drawing particular attention.
Until recently, such units were typically implanted by highly trained heart
device specialists. But since last year, when the US government agreed to pay
for tens of thousands more patients annually to get such devices, many new
practitioners have entered the field. One result is that patients do not realize
that the training and experience of doctors can very widely. "A patient does not
know whether they are a doctor's third implant or their 300th" said Charles E
Swerdlow, a heart device expert in Los Angeles who advocates rigorous
training standards.
To meet patient demand, the Heart Rhythm Society, a professional group that
represents experts like Swerdlow, adopted so called fast-track training
guidelines two years ago for doctors who had not implanted defibrillators
before. But those guidelines are voluntary. No one knows what percentage of
physicians who have recently begun to put in defibrillators are following the
guidelines.
At the same time, makers of the devices have jumped into the mix by offering
free schooling. That has promoted concerns about possible conflicts of interest,
since doctors may return the favour when deciding which company's units to plant
in patients.
Separately, federal officials started collecting data last year to determine,
among other things, if the rate of complications from implant surgery differs
between heart device specialists and other doctors. The reporting has just
started. Patients deaths during defibrillator implants are extremely rare.
Recent US government data indicates they occur at a rate of about 0.03%.
The scramble by doctors to get quickly trained in defibrillator use was
accelerated in January 2005 when the government sharply increased the number of
patients for whom it will pay to get such a device, potentially bringing the
figure to 5,00,000 people.
(Ref : The Times of India dated August 5, 2006)
TTK & Co Acquires 20% Holding of TTK Healthcare Through 'Open Offer'
The management of TTK & Co is acquiring 16,22,083 equity shares of TTK
Healthcare Ltd. (THL), 20 per cent of the fully expanded voting equity capital,
at a price of Rs 73 per share from open market Inga Advisor Pvt Ltd. will act as
'Manager to the Offer' on behalf of TTK & Co. The Offer will open from Sept 18,
2006 and close on Oct 7, 2006.
TTK & Co is in the business of trading, distribution, warehousing, clearing
and forwarding and promotion of business in the field of consumer products,
consumer durables, healthcare and pharmaceuticals, rubber contraceptives and
services. The company achieved revenue of Rs 13.94 crore and earned a net profit
of Rs 5.48 crore for the year ended March 2006.
(Ref : Chronicle Pharmabiz dated August 3, 2006)
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