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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)

Other News

Cost Advantage Of Imported Medical Devices Against Domestic Players Rose By 20% Last Year: AIMED
DSM, Dupont form JV In Surgical Biomedical Materials

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