Feature: Connectors
Table 1: Spaulding’s classification of devices
Table 2: The main decision factors to consider when choosing disposable vs reusable cables in the medical field
integrate two means of protection (MOP) into their products, by implementing two separate measures or apply a single measure twice. Overall, the specified protection level 2 MOPP (Means of Patient Protection) or 2 MOOP (Means of Operator Protection) must be achieved. In addition, manufacturers must introduce a development process by which they not only investigate all protection-relevant aspects, but also document their results in detail. For these reasons, the approval processes for medical electrical equipment and systems are becoming more and more complex, with each subsequent version of IEC 60601-1. To simplify the risk management
process and save time and costs during the implementation of protective measures, manufacturers should involve their
component and system suppliers from the start of their product development process. Ideally, those components would already be fully compliant with IEC 60601-1. If the implemented components, such as connectors, already fulfill 2 MOPP and 2 MOOP (say, through mechanical measures), product development costs can be reduced, and the necessary time for approval procedures substantially shortened.
Disposable vs reusable Another consideration when choosing between disposable and reusable connectors is the function of each connector half. In most instances there is a “permanent” part that is not disposable, but reusable. Tis illustrates the wide range of system requirements from the
42 July/August 2023
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capital side, to in-line, to the device side. Table 2 lists the decision factors to be
considered in making such a selection. In any case, the chosen product, whether a component or cable assembly, must meet the safety and effectiveness regulations specified by the FDA. ANSI/AAMI/ISO 17664:2017 lists
requirements for processing that consist of some of the following activities: • Preparation at the point of use; • Preparation, cleaning, disinfection; • Drying; • Inspection, maintenance and testing; • Packaging; • Sterilisation; • Storage. Over the years, the US Centers for
Disease Control (CDC) has found that up to 30% of American hospitals reuse at
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