RISKS DUE TO THE RE-USE OF “SINGLE-USE” DEVICE
Implantable Device*
The “SINGLE-USE” implantable device* of Orthofix is identified through symbol
reported on the product label. After the removal from the
patient, the implantable device* has to be dismantled. The re-use of implantable device* introduces contamination risks for users and patients.
The re-use of implantable device* can not guarantee the original mechanical and functional performances, compromising the effectiveness of
the products and introducing health risks for the patients.
(*): Implantable device. Any device intended to be totally / partially introduced into the human body through surgical intervention and intended
to remain in place after the procedure for at least 30 days.
Non Implantable Device
The “SINGLE-USE” non implantable device of Orthofix is identified through symbol
reported on the label or are indicated in the “Istructions
For Use” supplied with the products. The re-use of “SINGLE-USE” non implantable device can not guarantee the original mechanical and
functional performances, compromising the effectiveness of the products and introducing health risks for the patients.
INSTRUCTIONS FOR REPROCESSING OF REUSABLE DEVICES FOR SUBSEQUENT RE-USE
General
• Unless supplied sterile, all Orthofix devices must be sterilized prior to surgical use.
• PRODUCTS LABELED FOR SINGLE-USE MUST NOT BE REUSED.
• Repeated reprocessing has minimal effect on reusable instruments. End of life is normally determined by wear
and damage due to use.
Recommended
The following sequence of decontamination processes is recommended for
reprocessing re-usable Orthofix
decontamination
Fixation System medical devices
and rendering them safe for subsequent clinical use.
process
1. CLEANING
2. DISINFECTION
3. STERILIZATION
Preparation
• All
used
surgical instruments should be regarded as
contaminated.
Their handling, collection and transportation
at the point
should be strictly controlled to minimise any possible risks to patients, personnel and any area of the healthcare facility.
of use
• It is recommended that instruments are reprocessed as soon as is reasonably practicable following use.
of used devices
•
Ensure that items are securely and safely packaged during transport to the decontamination area.
Preparation
• All components should be inspected, since damage to the surface of metal components can reduce the strength
for cleaning
and fatigue resistance and may lead to corrosion.
of used devices
• Wherever possible, all parts of disassembled devices should be kept together in one container.
• For disassembly/reassembly, the specific instrumentation should be used as described in detail in the Operative Manuals.
STEP 1:
• Cleaning is an essential pre-requisite to ensure effective disinfection or sterilization.
Cleaning
• The preferred method of decontamination of used devices is mechanical cleaning followed by disinfection.
of used products
• Where an automated washer-disinfector is not available, manual cleaning may be used, followed by disinfection.
MANUAL CLEANING (BY IMMERSION)
Equipment required:
- a sink (not hand wash basin) or receptacle which will hold enough detergent so that the item of equipment to be
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