Instructions for Use
24/7 access to updated manufacturer documents for a safer organization
- oneSOURCE Complete gives your team easy access to Instructions For Use, cleaning protocols, service manuals and Safety Data Sheets across departments.
- Protect your patients and staff from HAIs and other risks by following proper equipment sterilization protocols and up-to-date manufacturer guidelines.
- Save up to 2,000 staff hours annually when you use oneSOURCE Complete to keep manufacturer documents up to date.
With oneSOURCE Complete, access all six databases below in one centralized location to keep you in compliance.
Surgical Instruments and Equipment
Manufacturers’ IFU documents for sterilizing, high level disinfection and cleaning reusable surgical instruments, devices and equipment.
TJC’s Standard IC.02.02.01 (Reducing the risk of infections associated with medical equipment, devices, and supplies) includes the following accreditation element: “Location and accessibility of manufacturers’ instructions-for-use (sterilization related equipment, devices, and supplies).”
Preventive maintenance, service and repair manuals for biomedical equipment.
The CMS’s Interpretive Guideline for regulatory standard §482.41 (c)(2) (Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality) states: “Hospitals comply with this regulation when they follow the manufacturer-recommended maintenance activities and schedule… When equipment is maintained in accordance with the manufacturer’s recommendations, the hospital must maintain documentation of those recommendations and the hospital’s associated maintenance activity for the affected equipment.”
Tissue and Implant
IFUs for implanted biologic and non-biologic tissues and devices.
TS.03.01.01.05: “The hospital follows the tissue suppliers’ or manufacturers’ written directions for transporting, handling, storing, and using tissue.”
TJC’s Standard TS.03.02.01.06 (The organization uses standardized procedures to acquire, receive, store, and issue tissue) includes the following element: “The hospital retains tissue records for a minimum of 10 years beyond the date of distribution, transplantation, disposition, or expiration of tissue (whichever is latest). If required by state and/ or federal laws, hospitals may have to retain tissue records longer than 10 years”
Safety Data Sheets (SDSs) for chemicals stored in the facility as well as IFUs for dental instruments, consumables and equipment.
Dental health facilities (NAICS 621210) are subject to the OSHA Hazard Communication Standard found in 29 C.F.R. 1910.1200(g)(8): “The employer shall maintain in the workplace copies of the required safety data sheets for each hazardous chemical and ensure that they are readily accessible during each work shift to employees when they are in their work area(s).
IFUs and service manuals for non-medical equipment and systems in healthcare facilities.
CMS’s State Operations Manual – Appendix A Survey Protocol (Regulations and Interpretive Guidelines for Hospitals) states that: “The hospital’s Facility Maintenance and hospital departments of services responsible for the hospital’s buildings and equipment (both facility equipment and patient care equipment) must be incorporated into the hospital’s QAPI program and be in compliance with the QAPI requirements…. This includes ensuring that proactive and preventive maintenance and testing activities are performed as necessary, in accordance with … manufacturer’s recommendations.”
Safety Data Sheets
Manufacturer SDSs with information about the safe handling of the chemicals typically found in a healthcare setting and the appropriate response to a spill or release.
OSHA’s Safety and Health Management Systems: A Road Map for Hospitals September 2013, states: “Where possible, employers should offer employees every piece of information they can use to understand safety and health hazards and risks and identify protective measures… This information may include Safety Data Sheets; chemical and equipment manufacturers’ safety recommendations; …”