Four steps to balance disinfectant standardization with medical equipment IFU compliance
Hospitals manage hundreds of types of medical equipment, each with specific cleaning and disinfection requirements outlined in their manufacturer’s Instructions for Use (IFUs) documents. While infection control teams often seek to standardize cleaning products for efficiency, safety and cost effectiveness, many IFUs specify exact cleaning formulations or brands, leaving little flexibility.
Adhering to IFUs is critical, as deviations can jeopardize patient safety, void warranties and result in non-compliance with accrediting bodies like The Joint Commission and governmental agencies such as Centers for Medicare & Medicaid Services. If an IFU does not align with a facility’s disinfectant, hospitals should seek written manufacturer approval for an alternative. Some manufacturers provide lists of additional tested and approved disinfectants and may offer guidance on safe alternatives.
If no alternative is provided, hospitals should document all compliance efforts as evidence of due diligence during regulatory surveys. Assuming a chosen disinfectant is sufficient without manufacturer validation is risky and may lead to regulatory findings. Instead, hospitals should implement these steps for a structured process to align with IFUs while prioritizing patient safety.
1. Conduct a comprehensive inventory
It is essential to recognize that any item requiring high-level disinfection or sterilization must strictly follow IFU guidelines without exception; these items are not subject to risk assessment or substitution decisions. Hospitals should conduct a comprehensive inventory to identify and document all other instruments and patient care equipment requiring intermediate- or low-level disinfection. This involves identifying devices used across various departments, reviewing their intended use and evaluating the IFUs for cleaning and disinfection recommendations.
2. Perform a risk assessment
Hospitals should assess the risks associated with equipment that does not align with standardized disinfectants. This assessment should focus on the following three key factors to determine the appropriate compliance approach and ensure patient safety.
- Determine whether the equipment comes into direct contact with a patient. Devices involved in direct patient care pose a higher risk and require stricter compliance measures.
- Evaluate the prevalence of these items within the facility. If a device or piece of equipment is widely used or exists in large quantities, ensuring compliance becomes a higher priority.
- Lastly, determine how closely the available disinfectant aligns with IFU requirements.
3. Categorize equipment and implement compliance measures
Once the risk assessment is complete, hospitals should categorize equipment by risk level and prioritize high-impact devices. Addressing items that pose the greatest patient safety risk, lack an approved alternative disinfectant or are widely used should take precedence. By systematically evaluating and documenting this process, organizations demonstrate due diligence in compliance efforts while making informed decisions about alternative disinfectants.
4. Provide staff training
In addition to selecting appropriate disinfectants, hospitals must ensure frontline staff receive comprehensive training to maintain compliance. Cleaning protocols should specify when strict IFU adherence is required and when facility-approved disinfectants are permissible. Improper disinfectant use, whether due to substitution or lack of awareness, can result in equipment damage, increased infection risks and non-compliance with The Joint Commission standards.
Disinfectant standardization offers clear operational benefits — efficiency, cost savings and reduced complexity. But those benefits can never come at the expense of compliance with manufacturer IFUs, especially for devices requiring high-level disinfection or sterilization. In these cases, adherence is absolute — no substitutions, no risk assessments, no exceptions. For all other equipment, a structured approach grounded in risk assessment allows facilities to make informed decisions when a perfect match between IFU and available disinfectants isn’t feasible. Categorizing equipment, documenting alternatives and engaging manufacturers when needed reflects the level of due diligence expected by regulatory bodies.
Ultimately, the path forward isn’t either/or between standardization and compliance — it’s a strategic balance. By conducting robust inventories, assessing risk where appropriate, training staff effectively and fostering collaboration across teams, healthcare organizations can uphold patient safety, protect their equipment and stay prepared for survey readiness.