There’s no underestimating the importance of Instructions For Use (IFU) documents. In a life-or-death situation, the most current instructions are critical for patient safety.
Without the latest IFUs, you increase the risk of Hospital Acquired Infections. Remove the guesswork and the risk, and have access to the latest IFUs anytime, anywhere.
Healthcare product manufacturers are required to produce and provide Instructions for Use (IFU) documents for their reusable surgical instruments, medical devices and equipment and implantable biologics, materials and devices.
To minimize healthcare-associated infections (HAIs) and adhere to accreditation standards, your Sterile Processing and Operating Room technicians continually refer to these documents as they maintain and prepare equipment.
The first step in this process is to ensure validated IFUs are easily accessible to everyone throughout your facility who needs them. oneSOURCE offers IFU-related libraries for two primary categories of products:
Surgical and Equipment
Surgical Instruments & Equipment Library
CMS has very clear expectations regarding manufacturer IFU’s in maintaining device sterility – “If manufacturers’ instructions are not followed, then the outcome of the sterilization process is guesswork, and the practices should be cited as a violation…”
The oneSOURCE Surgical Instruments & Equipment Library contains validated manufacturer IFU’s for reusable surgical instruments, devices, and equipment, so your team can be confident that they have the most recent decontamination and sterilization guidelines to remain complaint with CMS standards.
More than 85% of U.S. hospitals, including HCA, Ascension Health, Mayo Clinic and Community Health Systems, subscribe to the oneSOURCE Surgical Instruments & Equipment Library with IFUs from over 4,500 manufacturers.
The oneSOURCE Biomedical Library assists your technicians with the maintenance and performance of biomedical equipment, by providing access to detailed service information on how often to maintain and repair complex equipment – including preventative maintenance and repair guidelines.
Your biomedical equipment technicians (BMET) and clinical engineers will be able to refer to key equipment information quickly and efficiently including:
- Service Manuals
- Preventative Maintenance Frequency
- Preventative Maintenance Information
- Parts Lists and Schematics
- End of Life Notifications
- Letters of Obsolescence
The oneSOURCE Dental Library is the industry’s most comprehensive source of dental Instructions for Use (IFU’s) for all dental products, as well as required SDS/MSDS documentation. Our team consistently updates this information, so your dental team has access to the latest technical guidance for cleaning and sterilization, while maintaining compliance with such regulatory bodies as OSHA and CMS.
The Dental library includes:
- OSHA-required SDS/MSDS sheets
- Dental Instrument IFUs
- Dental Equipment IFUs
- Dental Consumable IFUs
- Owners and Users Manuals for Dental Equipment
Facilities Maintenance Library
As of January 2019, The Joint Commission (TJC) has joined the Centers for Medicare & Medicaid Services (CMS) and the Center for Improvement in Healthcare Quality (CIHQ) accreditation organization in requiring hospitals to strictly adhere to manufacturers’ preventive maintenance recommendations (or the facility’s alternative equipment maintenance (AEM) program) for non-medical equipment maintenance and repairs.
It’s more important than ever that members of your healthcare facility management (HFM) team have quick access to hundreds of documents including facility maintenance plans, service manuals, parts lists, and the other public and proprietary information related to your facility’s non-medical systems. Easy access to this material for everyone who needs it is critical – not only to promote effective, efficient maintenance, but to demonstrate compliance.
Just as we support your HTMs and BMETs by providing online access to the latest manufacturer documentation for surgical devices and biomedical equipment, we also offer this cost-effective solution to help your HFM technicians meet regulatory and accreditation mandates regarding non-medical system maintenance and care.
Tissue & Implants
Tissue & Implants Library
Our Tissue & Implant Library provides your sterile processing and operating room technicians with IFUs that include critical information regarding the storage, handling, and preparation of sterilized human, bovine, and porcine derived materials. IFUs for nonbiological implants include similar preparation instructions for prostheses and devices, as well as re-sterilization instructions for certain materials (i.e., screws or rods) for reusability.
Tissue Certificates allow your facility to maintain regulatory compliance with current and consistently updated IFU’s for:
- FDA Registrations
- State Registration / Licenses
- AATB and EBAA Accreditations
The oneSOURCE Safety Data Sheet (SDS) Library provides your team with 24/7 access to a fully searchable collection of thousands of current and archived SDS’ via computer, tablet, or mobile device.
The SDS Library:
- Helps your team meets or exceed all OSHA compliance standards
- Grants access to archived versions of SDS’ for 30 years
- Allows unlimited views and document requests
- Provides unlimited access across your facility
- Supports full training for your staff
The Consumables Library contains a robust collection of single-use medical devices (SUD) and pharmaceutical item documentation designed to provide health care organizations with important instructions for use (IFU)
- IFU documentation and labeling helps facilities confirm if an instrument can be reused and reprocessed (i.e., not labeled for single use)
- Obtain access to critical information for:
- Guidelines and packaging insert documentation for sterility status, contraindications, precautions, and storage/handling conditions
- Pharmaceutical packaging inserts describing dosage and administration, contraindications, adverse reactions, use in specific populations, and storage/handling information
- Consumables such as gloves, needles, wraps, catheters, syringes, feeding tubes, cleaners, etc.