Device Legislation and Application

The state of legislation and control concerning electrochemical disinfection devices in environmentally oriented applications is not satisfactory. Only in the USA, first attempts for perchlorate... 

There is a large number of available guidelines. These cover a very wide range of topics, and the company submitting an application for a pharmaceutical product should be aware of the contents of these documents and how they interact with other guidelines as well as the interpretation of the legislative requirements. It is necessary to be aware of the impact of guidelines in all areas within the pharmaceutical sector and, in some cases, within the medical device sector. Some of these effects are not obvious from the titles of the documents. 

Disinfectants for the skin of patients, such as chlorhexidine in alcohol, are regarded as medicines for humans. When the same preparation is used in the hospital for disinfection of the hands of nurses and other staff, it is considered as a biocide and falls under the applicable EC legislation [22]. Disinfectants that are used in combination with specific medical devices fall xmder the regulation for medical devices and should have a CE identification mark. Disinfectants for inanimate surfaces fall under the legislation for biocides. When delivering such a disinfectant the pharmacist has to comply with this regulation, that is with the following requirements. 

In the future, we can expect further developments in the field of requirements for safety of especially complex mechanical devices due to the application of a form of integrated approach coming from legislative requirements for safety and health protection of employees and affected populations during risk assessment. 

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