Objective: The effective decontamination of reusable dental instruments is essential to reduce the risks from onward transmission of infectious diseases. There are therefore a number of legislative requirements placed upon manufacturers of medical devices (which includes dental instruments) to provide validated methods for the reprocessing of such devices. The aim of this study was to determine the availability and content of manufacturer's instructions for the reprocessing of reusable dental instruments.
Materials And Methods: A database of reusable dental instruments with details of their manufacturers was collated from information received from three dental hospitals. A questionnaire was sent to all the manufacturers requesting information about the reprocessing instructions for their products. The response from each manufacturer was assessed for the quality of the information and compliance with the British, European and International Standard, BS EN ISO 17664 (2004).
Results: The database from the three dental hospitals included over 800 items supplied by 54 different manufacturers/suppliers. Forty protocols were available for assessing compliance with BS EN ISO 17664 (2004). These protocols accounted for 25 (46%) manufacturers covering 300 devices. The majority (90%) of the returned questionnaires did not comply with the required standard and provided insufficient information to allow for the effective decontamination of the instruments.
Conclusions: Manufacturers of medical devices are legally required to supply the user with validated instructions to enable effective decontamination of these devices. The information must be in a format as specified in BS EN ISO 17664 (2004). The information obtained in this survey demonstrated that the manufacturers' instructions fall short of the required regulatory requirements. The absence of such instructions increases the risk of cross-infection arising from inadequate cleaning, decontamination and sterilisation.
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