[Legal aspects of reuse and re-sterilization of disposable products in the hospital].
What consequences may follow if the hospital administration decides to introduce recycling and resterilisation of disposable medical products? While some consider the chief executive administrators and doctors to be seriously endangered by the legal implications of the German Medical Products Act (MPG), others consider recycling and resterilisation to be clearly admissible. A closer look at what constitutes an offence as described in sec. 43, para 1 No. 1 of the MPG reveals that mere presumptions do not suffice to incur the respective penalties; rather, a concrete, scientifically sound basis for assuming an endangerment of safety or health are required for penal measures to be justified. The manufacturer's designation "for once-only use" may not be considered "intended purpose" as stipulated in sec. 4, para 1 No. 1 of the MPG. If recycling or resterilisation be confined to self-made disposables, there is no necessity for CE marking. Information of the patient and individual documentation must be extended to cover the use of recycled or resterilised disposable products only if the use of the latter may constitute a significant additional danger to the patient.
Rechtsanwälte Dierks & Bohle, Berlin.
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D004209:Disposable Equipment; D017743:Equipment Reuse / Q000331:legislation & jurisprudence*; D004865:Equipment and Supplies, Hospital; D005858:Germany; D006801:Humans; D008318:Malpractice / Q000331:legislation & jurisprudence; D013242:Sterilization / Q000331:legislation & jurisprudence*