Call for EU-wide law on re-use of disposable devices

THE question of whether ophthalmologists should re-use single-use knives and other disposable devices may soon receive a pan-European answer.
The European Union Health Policy Forum, a high-powered consultation group headed by the European Commissioner for Health and Consumer Protection, Mr David Byrne, is considering whether to support a new EU law to regulate or even ban the re-use of disposable medical devices and products.

The Forum, which was scheduled to meet in Brussels late last month, is to focus on a new manifesto from EUCOMED, the European Medical Technology Industry Association.
In the manifesto, EUCOMED has urged the EU to regulate the re-processing of single-use medical devices as a matter of urgency.

A matter of safety and health
"The reuse of medical devices intended for single use is widespread throughout the EU, presenting significant risks to the health and safety of patients and healthcare workers," EUCOMED has charged in its manifesto.

The call for regulating such re-use follows increasing worries about the spread of such infections as hepatitis and non-variant Creutzfeldt Jakob Disease (CJD) - the human form of so-called 'mad cow' disease - from medical devices.

Existing EU law, which dates to the Medical Device Directive of 1993, ignores the reprocessing and re-use of medical devices intended for use once, says the head of the EUCOMED Reuse Task Force, Mr Peter Schroër.

Politicians, too, have so far refused to get involved, Mr Schroër adds. He is also European Director of Quality Systems and Regulatory Affairs for Ethicon.

Many ignoring re-processing issue
"Everyone is trying to ignore this and say, 'This is not on my plate,'" Mr Schroër says. "Now we are hoping to get the EU to take ownership of this issue."
Although EUCOMED is opposed to any re-use of one-time use products, EUCOMED will only propose a total ban on re-use if the EU cannot establish some regulatory framework for the re-processing of disposable medical devices and products.

"We are asking for full regulation," Mr Schroër says. "But if regulation is not possible, we will request a ban."
The lack of an EU-wide law on the reprocessing of single-use devices is exacerbated by the fact that fewer than half the EU's 15 member countries have national laws to guide physicians, manufacturers and hospitals about the re-use of disposable devices within their own borders, Mr Schroër notes.

Even in those countries, the laws on single-use devices differ widely - from banning re-use, such as in France and Britain, to permitting re-use in certain circumstances, like in Germany.

Not only are the laws themselves different. So too is the level of their enforcement - from strict to lax, he says.
In addition to the health and safety issues, there's a financial one, too. EUCOMED estimates the reprocessing of one-time use products robs medical technology companies of hundreds of millions of euro worth of sales each year.

EUCOMED says it is optimistic that the EU will involve itself in the reprocessing issue. For one, the EU's so-called 'New Health Strategy' commits the EU to preserve public health by complementing the efforts of individual EU countries.

"The Community's role in public health is to complement their efforts, to add value to their actions and in particular to deal with issues that member states cannot handle on their own," the strategy reads. "Infectious diseases, for example do not respect national borders."

Infection control a priority
For EUCOMED, preventing the transmission of infection should be the priority of any new law regulating the re-use of one-time use products.
"Re-use of single-use devices may introduce infectious organisms into the patient's blood stream, due to the difficulty (and often impossibility) of cleaning single-use devices," EUCOMED says in its manifesto.

"In many cases it is not possible to guarantee that all blood, tissue and body residues have been removed," EUCOMED adds.
"If cleaning is not achieved, inactivation of all micro-organisms can not be guaranteed. Infections acquired in hospitals are an increasingly serious problem, putting the health and lives of patients and hospital staff at risk, putting pressure on waiting lists and adding sizeable costs to the member state budgets."

In addition, EUCOMED alleges that without proper safeguards, the devices themselves may fail.
"Reprocessing a single-use device is contrary to the manufacturer's design and may alter the nature of the device," the association claims. "Research has shown that significant damage can be caused with consequent impairment of performance and safety.

Informed consent necessary
Also an EU law is necessary to ensure that patients know more about the medical devices used on them, EUCOMED says. For instance, patients often do not know they are being treated with reprocessed devices, the association says.

"It is a basic principle of medical treatment that the patient should consciously agree to the form of treatment, particularly if it involves surgery and puts the patient at risk without any patient benefit," EUCOMED says in the manifesto.

"That consent should be 'informed,' which means that the patient should be clearly told of all relevant factors, including the fact that he is to be treated with a reused single-use device contrary to the manufacturer's instructions and that this may expose the patient to infection and/or device malfunction."

EU law should be founded on protecting public health
THE EU's most important laws, contained in the European Treaty, provide an appropriate legal foundation for a new law on the re-processing of single-use medical devices, according to EUCOMED, the European Medical Technology Industry Association.

The European Treaty, commits the EU to preserving the public health of all its citizens.
"A high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities," reads Article 152 of the Treaty.
"Community action, which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases and obviating sources of danger to human health."

The Treaty also commits the EU to protect consumers. "In order to promote the interests of consumers and to ensure a high level of consumer protection, the Community shall contribute to protecting the health, safety and economic interests of consumers, as well as to promoting their right to information and education," reads Article 153 of the Treaty.

In carrying out the objectives of Articles 152 and 153, the Treaty commits the executive of the EU, the European Commission, to monitor public health as a priority.
"In its proposals concerning health, safety, environmental protection and consumer protection (the Commission) will take as a base a high level of protection, taking account in particular of any new development based on scientific facts," reads Article 95 of the Treaty.

CONTACT DETAILS

EUCOMED
Tel: +32 277 22 212
Website: www.eucomed.org

European Union Health Policy Forum
Website:www.europa.eu.int/comm/health/ph/health_forum/index_en.html

If you have any suggestions for future Regulatory Matters columns, please contact Paul McGinn at +353 1 628 9747 or email paulrmcginn@eircom.net.

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