Feature: Connectors
Table 3: The company achieved further savings through using most cost-effective materials
Figure 2: ODU MEDI-SNAP disposable connector and receptacle
least one type of single-use device. Reuse of single-use devices involves regulatory, ethical, medical, legal and economic issues, and has raised controversy. In August 2000, the FDA released
a guidance document on single-use devices reprocessed by third parties or hospitals. It states that hospitals or third-party re-processors will be considered “manufacturers” and regulated in the same way; i.e., a reused single- use device must comply with the same regulatory requirements as an originally- manufactured device.
Disposable solutions More recently, a wide range of sub- categories has been introduced to that of disposable cable assemblies. Tese are now subdivided into true single-use assemblies, single patient use, disposable and limited- use assemblies. A different category has also been developed for lower-cost cables but with limited sterilisation cycles and reusability, informally referred to as “re- sposable” cables. In the end, the OEM must make a
risk assessment against the product’s intended use, actual use and the requirements for safety and quality in the selected interconnects. To achieve lower cost, the disposable connector and receptacle housings used in such cables are made of an alternative plastic such as polysulfone (PSU) rather than metal or a higher-cost, more-durable plastic such as polyetherimide (PEI) or polyetheretherketone (PEEK). For example, the ODU MEDI-SNAP disposable connector and receptacle (Figure 2) are rated at 25 mating cycles,
whereas the more durable and reusable members of the family are rated up to 5,000 mating cycles on the receptacle side. Te importance of longevity when selecting connectors for medical use should be included into any evaluation of lifetime mating cycles. ODU’s wide range of products also
includes another family of disposable connectors and receptacles specifically designed for medical applications – the ODU MINI-MED family of integrated cable/connector assemblies; see Figure 3. Te primary difference between the
ODU MINI MED and MEDI-SNAP disposable families lies in the number of contacts each can support: 2-6 for MINI MED and 2-8 for MEDI-SNAP. Te MEDI-SNAP is compliant with the IEC 60601-1 standard for maximum protection of both patients and operators – 2 MOPP and 2 MOOP. ODU MINI-MED connectors are not
available as standalone components but as pre-terminated cable assemblies, to reduce overall costs. Te company achieved further savings through using most cost-effective materials; see Table 3. Te connectors are rated at over 1,000 mating cycles. ODU MINI-MED products can be
either disposable or reusable; in the latter case, the cables can be sterilised between uses, using the ETO gas sterilisation method.
Reliable and sterile Equipment used in hospitals and emergency sites must be extremely reliable and as sterile as possible, since a patient’s life may depend on it. Until a few years
Figure 3: ODU MINI-MED disposable connector and receptacle
ago, that meant the cables and connectors used in medical systems had to fall into one of two categories – disposable or reusable. For them to be reusable, they must be suitable for sterilisation and autoclave between uses, and offer thousands of mating cycles. Tose requirements made reusable cables and connectors substantially more expensive than their disposable counterparts. Recently, a third category was
introduced, that of “limited use”, offering the cost advantages of disposable devices, but with a limited level of reusability. Cables and connectors in this category are sometimes referred to as “re-sposable”. They can be sterilised and used with an autoclave but with less harsh methods, and their mating cycles are limited to hundreds rather than thousands. ODU has pioneered the development
of limited-use cables and connectors, and partners with many medical equipment companies as a supplier of interconnect solutions. ODU’s high-quality connectors, some with up to 5,000 mating cycles, can be sterilised up to 200 times. And, to further lower costs, the products can be fully assembled by ODU.
www.electronicsworld.co.uk July/August 2023 43
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