Any prudent sterile processing professional knows you must follow the manufacturers’ validated instructions for use (IFU) in order to verify that items can be effectively sterilized.  Manufacturers have very strict rules and regulations that they must follow in order to get approval and clearance to take their products to market.

According to the FDA, if a healthcare facility sterilizes a product to be used on a patient without having or following the validated and written IFUs, they become the manufacturer who is subject to the FDA rules and regulations.  In August of 2000, The FDA announced Enforcement Priorities for single-use devices (SUD), and reprocessed devices.  The FDA provides guidance to third-party and hospital reprocessors about their responsibilities as manufacturers engaged in reprocessing devices labeled for single use under the Federal Food, Drug, and Cosmetic Act. Third-party and hospital reprocessors of SUDs are subject to all the regulatory requirements currently applicable to original equipment manufacturers, including premarket submission requirements .

Knowing many consultants in the industry, we've heard of hospitals and ambulatory care centers reprocessing items without having or following the manufacturer’s instructions for use. This is especially true when it comes to what is known as “put-ups” - things like, cotton-tipped applicators, gauze, rubber bands, pencils, trach tape etc. When asked why they are packaging and sterilizing these things without the IFUs, the standard answer is “we have always done it”, or I was told to do it. These are excuses and are blatantly against the Food and Drug Administration (FDA), The Centers for Medicare and Medicaid Services (CMS) and The Joint Commission (TJC).

The CMS tells us that healthcare facilities infection control policies and procedures must be based on nationally recognized guidelines and applicable state and federal laws.  CMS also states “if manufacturers’ instructions are not followed, then the outcome of the sterilizer cycle is guesswork, and the ASC’s practices should be cited as a violation of 42 CFR 416.44(b)(5).” (CMS, 2009).

TJC’s infection control standard IC.02.02.01 states, “The hospital reduces the risk of infections associated with medical equipment, devices and supplies.”  Many facilities have been cited for non-compliance for lack of quality control, not following manufacturers’ IFUs, and using nonvalidated conditions.

Besides the legal and regulatory issues, organizations should also consider all of the costs of packaging, labeling, chemical indicators, sterilization, monitoring and productivity time it takes to process these items.  However, the majority of these single-use “put-ups” can be purchased already sterilized and ready to use at a much lower cost and much less risk to the facility and even more importantly the patient.  So do not be one of those facilities that are pennywise- and pound foolish by processing “put-ups” inefficiently or incorrectly.

Resources and References:

• ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
• Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals. 
• CMS Pre-Decisional worksheet. 
• CMS Manual System, Pub 100-07 State Operations Provider Certification.