|
Association of Indian Medical Device
Industry
Report on the issue of the reprocessing of medical devices
in the European Union, in accordance with Article 12a of Directive 93/42/EEC.
This report addresses the issue of the reprocessing of
medical devices in the European Union. The reprocessing of a medical device, for
the purpose of this report, includes steps needed such as routine maintenance,
disassembly, cleaning, disinfection and/or sterilisation to allow safe reuse.
CONCLUSION
In the absence of quantitative data, it is not possible to
quantify the risk associated with the use of reprocessed single use medical
device. The number of documented incidents is very small, although it can be
speculated that the reporting of incidents is incomplete. Regarding adverse
events there may be a “grey” area for which the recognition and reporting of
incidents is difficult. In addition, long-term effects may not be identified and
attributed to the use of reprocessed medical devices.
Three major hazards were however identified by the SCENIHR
i.e. a remaining contamination, the persistence of chemical substances used
during the reprocessing process and the alterations in the performance of the
single use medical devices due to the reprocessing.
In addition, not all single use medical devices are suited
for reprocessing in view of the characteristics (e.g. material used, geometry),
their complexity and their intended use (non critical, semi-critical, critical).
In order to identify and reduce potential hazards associated with the
reprocessing of a specific single use medical device, the whole reprocessing
cycle starting with the collection of these single use medical devices after
(first) use until the final sterilisation and delivery step, including its
functional performance, needs to be evaluated and validated.
It must be noted that the SCENIHR expressed specific concern
about the potential contamination with transmissible agents such as prions, for
which elimination and inactivation is not possible, or the procedure is not
compatible with the materials generally used for a single use medical device.
It is not disputable that reprocessing single use medical
devices leads to a waste reduction to some extent and offers the possibility of
dividing the purchasing costs of these devices over multiple patients. However,
to date, no comprehensive study clearly demonstrates that reprocessing single
use medical devices is globally a cost effectiveness and environmental friendly
practice when done under high quality standards.
In the light of the above, taking into account the potential
hazards and risks identified by the SCENIHR in terms of the remaining
contamination, persistence of chemical residues and alteration of the
functionality, the Commission will assess which are the appropriate measures to
be put forward in the context of the Recast of the Medical Devices Directives
with regards to the reprocessing of single use medical devices in order to
ensure a high level of protection for patients. This assessment will also take
into account potential economic, social and environmental consequences that any
envisaged measure may have.
Contact: Forum Co-ordinator
Association Of Indian Medical Device Industry, (AIMED)
GL-3, Ashoka Estate,
24, Barakhamba Road,
New Delhi - 110001 Intas Pharma: Enters Medical Devices Market
Intas Pharmaceutical Ltd signs a marketing deal with California based Insightra
Medical Inc. Intas Pharmaceutical Ltd. aspires to foray into
the medical devices sector and plans to market medical products in India and
Nepal. Jayesh Shah, Chief Financial Officer of Intas Pharma
said, “A separate subsidiary called Intas Medi Device was floated in April this
year, and we will source and market devices used in cardiovascular therapies
like coronary stents and gynaecological surgeries etc”
However, Shah added that it is quite early to discuss the annual amount of
medical devices that it would source, but said they are confident as the medical
device market is a fast growing one. To forge the deal, the company has invested
close to $1-2 million, he informed. Insightra Medical Inc is a
noteworthy surgical device manufacturer in the US. The company’s main focus is
on medical products for general surgery, uro-gynaecology, cardiology, cardiac
surgery and therapeutic colonoscopic surgery. Apart from the US, the company
also has presence in Europe and Asia along with sales and marketing offices
across Europe and South Africa. At present, it sells its products across 50
markets. Intas, conversely, has offices in Latin America and
CIS nations – besides their presence in the European and African markets. “This
is an important strategy for Intas. It allows us to approach our customers with
a broader offering of products covering a wider spectrum of treatment options.
The lines between pharmaceutical therapies and medical device therapies are
starting to overlap. Having access to both technologies will be important for
our future growth, “said Nimish Chudgar, Managing Director, Intas.
This alliance will allow Intas to have direct access to a range of IAB
catheters, stents and other cardiovascular products. They are also entitled to
access new hernia products for both ventral and inguinal hernia, which is an
enormous multimillion dollar market globally. A range of new duel drug eluting
stents, which is a growing market in India, is also in the company’s pipeline.
Intas has registered a net sales of Rs 1500 crore in 2009-10. (Ref:
http://www.healthcare-digital.com/sectors/medical-devices-products/intas-pharma-enters-medical-devices-market) |
