All facilities are FDA regulated. GMPs (Good Manufacturing Practices/QSRs (Quality System Regulations) the FDA guidelines for the production of medical devices are reflected in NOVO’s quality systems and robust SOP’s. Novo’s processes fully comply with the ANSI/AAMI ST65 standard – Processing of reusable surgical textiles for use in health care facilities.
Products are delivered and retrieved daily by NOVO employed drivers. Returned soiled carts are sorted exclusively by hospital origin for discovery of hospital owned items. Product is sorted by class and weighed for optimum processing before washing and disinfecting using our proprietary formulas.
Hospital instruments that are inadvertently tossed in our hampers along with our soiled products are retrieved, decontaminated, catalogued, and returned to the hospital.
Separate soiled and clean docks are maintained to prevent cross contamination, as cleanliness is a top priority!
We built our reprocessing facilities with sustainable innovative custom designed equipment and workstreams to decrease our impact on the planet.
- Unique water management system reclaims 76% water 43% of all processed water is reuse water
- Efficient direct-fire water heater reduces energy usage and costs by 35%
- Back-up CAT diesel generator for emergencies, completely automated to operate with minimal intervention
- Heat exchanger reduces heating costs by 40-60%
- Heat is stripped from the waste water to reduce thermal shock to municipal water systems
- Direct-fired gas water heaters
- Computerized mixing and dispensing of chemicals
- Proprietary wash formulas
- Controlled access for security
- Disaster relief programs
In our pack room, each linen product is hand-inspected on a light table and tested if required. Linens in need of repair are identified and repaired on site, and rejected linen is removed from inventory. Our patented RFID technology chips are sewn into each product to ensure appropriate testing occurs at specified cycle intervals.
Our linen is folded for proper donning in the OR, then packs are built to the surgeon or procedure specifications.
We have a comprehensive PM program for proper functioning and consistent performance of our sterilization operations and equipment. All sterilizers are validated, calibrated and recommissioned.
Our sterilization process is pre-vac steam with parametric release of product. Every load must meet specified sterilization parameters and are only released if they meet strict QA requirements. Our Quality Systems ensure we follow a thorough inspection for wet packs and allow for sufficient dry time.
RFID Product Fulfillment
Each pack is put in a dust cover to protect the product during transport. Our unique patented RFID technology assigns packs to the customer location and creates an inventory tracking report. The process includes multi-read capability for all components in a reusable pack.
Transfer carts assigned to the customer location are stocked and prepared for distribution.