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Page updated 9 October 2006
1. Never reuse medical devices designated for single-use
2. Anyone who reprocesses or reuses a single use device bears full responsibility for its safety and effectiveness
3. Anyone who reprocesses a device intended for single use has the same legal obligations under the Medical Devices Regulations as the original manufacturer of the device.
Studies have show that due to the nature of the design of matrix bands, files and reamers they cannot be successfully decontaminated by cleaning and sterilisation and proteinaceous material continues to adhere to the surface, which can harbour microbes and prions. Therefore most manufacturers sell these items for single use only . To avoid the problems associated with reprocessing of hard other to clean and sterilize instruments such as devices with lumens (e.g. aspirators) the best practice alternative is to replace them whenever feasible with single use disposable items.
Use single use disposable instruments whenever possible, including amongst others:
Steel burs, matrix bands, endodontic files and reamers, saliva ejectors, aspirators, 3-in-1 plastic syringe-tips, scalpels, demonstration toothbrushes, rubber prophy cups, bristle brushes, impression trays, plastic mouthwash cups, absorbent patient bibs, and surface wipes. D isposable paper towels should be used for cleaning and drying.
Virtually all dental hand instruments are now available in a single use disposable format either for purchase as single instruments or in kits and are priced to be a realistic alternative to decontaminating reusable instruments.
Files and reamers designated for single-use or any other piece of dental equipment or device designated as single use by the manufacturer should not be reused and should be discarded after single patient use. If single use items are re-used, product liability is transferred from the manufacturer to the dentist. If the device after reprocessing is not fit for the intended purpose then the reprocessor and the professional user may be committing an offence under one of more of the following acts; Health and Safety at Work Act 1974, Part 1 of the Consumer Protection Act 1987, The General Product Safety Regulations 1994 and The Medical Devices Regulations 1994 (see for further information on legal aspects MDA DB 2000(04) ( www.mhra.gov.uk )
Guidance from the MHRA (MDA DB2000 (04) clearly states that devices intended for single use should never be re-processed. Potential hazards include the following:
The status of the reprocessed device can become unclear as a result of inadequate labeling.
Source: MDA DB 2000 Single-Use Medical Devices: Implications and Consequences of Reuse. London : www.tso.co.uk
Manufacturers' instructions will always state if an item is for single use only. The standard symbol for single use items is shown below.