# CE2004070EN.01024401.xml

| 20.3.2004 | EN | Official Journal of the European Union | CE 70/244 |
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20.3.2004

EN

Official Journal of the European Union

CE 70/244

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(2004/C 70 E/264)

WRITTEN QUESTION E-3245/03

by Erik Meijer (GUE/NGL) to the Commission

(3 November 2003)

Subject:   Increased costs of hospital treatment and waste-disposal arising from restrictions on cost-saving re-use of surgical instruments

Subject:

| 1. | Can the Commission confirm that the way in which the distinction has been made in the EU since 1993 between ‘single-use’ and ‘multiple-use’ surgical instruments that are placed temporarily in the human body during surgery prevents certain expensive instruments from being re-used after an operation, so that, for example, a catheter pump costing between EUR 8 000 and EUR 13 000 that has been placed in the heart has to be thrown away after use? |
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1.

Can the Commission confirm that the way in which the distinction has been made in the EU since 1993 between ‘single-use’ and ‘multiple-use’ surgical instruments that are placed temporarily in the human body during surgery prevents certain expensive instruments from being re-used after an operation, so that, for example, a catheter pump costing between EUR 8 000 and EUR 13 000 that has been placed in the heart has to be thrown away after use?

| 2. | Is the Commission aware that such ‘single-use’ instruments are recovered, cleaned and repaired in Europe not only for the benefit of the Third World, but also for use in Europe itself, in particular in Belgium and Germany? Is it further aware that, in Germany, the Vanguard company has recycled one and a half million instruments from 400 hospitals, resulting in savings in hospital costs of EUR 1-2 billion per year? |
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2.

Is the Commission aware that such ‘single-use’ instruments are recovered, cleaned and repaired in Europe not only for the benefit of the Third World, but also for use in Europe itself, in particular in Belgium and Germany? Is it further aware that, in Germany, the Vanguard company has recycled one and a half million instruments from 400 hospitals, resulting in savings in hospital costs of EUR 1-2 billion per year?

| 3. | Has the Commission considered the position of the ‘European Association for Medical Device Reprocessing’ (EAMDR) to the effect that hospitals would save millions of euro every year if more surgical material was recycled, and that, over the last two years, the association tested some 20 000 single-use instruments for suitability for re-use? |
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3.

Has the Commission considered the position of the ‘European Association for Medical Device Reprocessing’ (EAMDR) to the effect that hospitals would save millions of euro every year if more surgical material was recycled, and that, over the last two years, the association tested some 20 000 single-use instruments for suitability for re-use?

| 4. | How does the Commission assess the EAMDR position to the effect that existing provisions governing single use now appear in practice to protect the interests of the industry (united under its Eucomed association) rather than those of patients, and that continuing with this practice results principally in an adverse impact on the environment and/or waste of money spent on disposing of the waste created by compulsory discarding? |
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4.

How does the Commission assess the EAMDR position to the effect that existing provisions governing single use now appear in practice to protect the interests of the industry (united under its Eucomed association) rather than those of patients, and that continuing with this practice results principally in an adverse impact on the environment and/or waste of money spent on disposing of the waste created by compulsory discarding?

| 5. | Is the Commission prepared to take the initiative of extending multiple use to the extent that can now be shown to be responsible practice, thereby helping to reduce the soaring costs of healthcare, without reducing the quality of service to the patient or over-stretching health-care workers? |
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5.

Is the Commission prepared to take the initiative of extending multiple use to the extent that can now be shown to be responsible practice, thereby helping to reduce the soaring costs of healthcare, without reducing the quality of service to the patient or over-stretching health-care workers?

Source: ‘De Morgen’ (Belgium), for 17 October 2003.

Answer given by Mr Liikanen on behalf of the Commission

(1 December 2003)

(1 December 2003)

The Commission would like to refer the Honourable Member to the background information contained in the answer given to written question E-3177/03 of Mrs Corbey (1).

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| 1. | No The Commission would consider that the question whether or not particular devices could be re-used depends entirely on the question whether health is sufficiently protected. The issue of re-use of single use devices is not specific to the introduction of the medical devices directive, and is subject of debate in other countries as well, such as the United States, Australia and Canada. |
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1.

No The Commission would consider that the question whether or not particular devices could be re-used depends entirely on the question whether health is sufficiently protected. The issue of re-use of single use devices is not specific to the introduction of the medical devices directive, and is subject of debate in other countries as well, such as the United States, Australia and Canada.

| 2. | The Commission is aware that re-use of single use medical devices takes place. Some Member States have either regulation or guidance on the re-use of single use medical devices. It has no knowledge of detailed market data. |
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2.

The Commission is aware that re-use of single use medical devices takes place. Some Member States have either regulation or guidance on the re-use of single use medical devices. It has no knowledge of detailed market data.

| 3. and 4. | The Commission has no knowledge of positions taken by the European Association for Medical Device Reprocessing (EAMDR). The Commission has been requested, and it has accepted, to meet EAMDR. |
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3. and 4.

The Commission has no knowledge of positions taken by the European Association for Medical Device Reprocessing (EAMDR). The Commission has been requested, and it has accepted, to meet EAMDR.

| 5. | The introduction on the market of particular device categories is determined by various factors, such as technology, health protection considerations and national reimbursement schemes, consideration of which belongs mainly to manufacturers, health care institutions and Member States. Consequently, the Commission sees no reason at this stage to develop an initiative to promote the marketing of reusable devices. |
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5.

The introduction on the market of particular device categories is determined by various factors, such as technology, health protection considerations and national reimbursement schemes, consideration of which belongs mainly to manufacturers, health care institutions and Member States. Consequently, the Commission sees no reason at this stage to develop an initiative to promote the marketing of reusable devices.

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(1)  See page 232.

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