Creation and maintenance of a safe environment for patient care in all healthcare settings through application of infection control principles and practices for cleaning, disinfection, and sterilization. (updated guideline)

Application of accepted infection control principles helps maintain a safe environment for both patients and healthcare workers. This includes proper use of Standard Precautions and an understanding and ability to apply proper techniques for cleaning, disinfection, sterilization, and reprocessing of medical equipment.

Microorganisms are abundant in moist, organic environments; however, many significant pathogens can persist and remain viable on dry, inanimate surfaces (fomites) for extended periods. Contaminated environmental surfaces serve as reservoirs and are associated with the transmission of healthcare-associated infections—especially multi-drug -resistant and highly transmissible organisms such as C. diff, norovirus, and MRSA.

The transfer of microorganisms from an environmental surface to a patient or healthcare worker occurs predominantly via direct or indirect hand contact. Because of this dynamic, addressing both human vectors and environmental reservoirs is essential to breaking the chain of infection.

While strict adherence to hand hygiene is critical, it is most effective when paired with comprehensive environmental control practices. Cleaning and disinfecting environmental surfaces, particularly high-touch surfaces in patient-care areas, is fundamental in reducing the facility's microbial burden and lowering the incidence of HAIs.

5.1 Environmental Cleaning

All work areas must be maintained in a clean and sanitary condition. The employer is required to determine and implement a written schedule for cleaning and disinfection based on the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed.

All equipment, environmental, and working surfaces must be properly cleaned and disinfected after contact with blood or OPIM. Contaminated broken glassware must be removed using mechanical means, like a brush and dustpan or vacuum cleaner.

Chemical germicides and disinfectants must be used to decontaminate environmental surfaces. Consult the Environmental Protection Agency (EPA) lists of registered sterilants, tuberculocidal disinfectants, and antimicrobials with HIV/HBV efficacy claims to ensure that the disinfectant is appropriate.

5.2 Laundry

Contaminated laundry is laundry that has been soiled with blood or other potentially infectious materials or may contain sharps. Contaminated textiles and fabrics often contain high numbers of microorganisms from body substances, including blood, skin, stool, urine, vomitus, and other body tissues and fluids.

Disease transmission attributed to healthcare laundry involves contaminated fabrics that are handled inappropriately (e.g., the shaking of soiled linens). Bacteria, viruses, fungi, and ectoparasites such as scabies can be transmitted from contaminated textiles and fabrics to workers either via direct contact or via aerosols of contaminated lint generated from sorting and handling contaminated textiles.

Fabrics, textiles, and clothing used in healthcare settings are disinfected during laundering and generally rendered free of vegetative pathogens (hygienically clean), but they are not sterile. The antimicrobial action of the laundering process results from a combination of mechanical, thermal, and chemical factors.

Dilution and agitation in water remove substantial quantities of microorganisms. Soaps and detergents function to suspend soils and exhibit some microbicidal properties. Hot water provides an effective means of destroying microorganisms. Chlorine bleach is an economical, broad-spectrum chemical germicide that enhances the effectiveness of the laundering process.

Laundry that is or may be soiled with blood or OPIM, or may contain contaminated sharps, must be treated as though contaminated. Contaminated laundry must be bagged at the location where it was used and should not be sorted or rinsed in patient-care areas. It must be placed and transported in bags that are labeled or color-coded.

Laundry workers must wear protective gloves and other appropriate personal protective clothing when handling potentially contaminated laundry. All contaminated laundry must be cleaned or laundered so that any infectious agents are destroyed.

5.3 Appropriate Ventilation

Engineering controls to contain or prevent the spread of airborne contaminants center on local exhaust ventilation, general ventilation, and air cleaning. General ventilation encompasses: (a) dilution and removal of contaminants via well-mixed air distribution of filtered air; (b) directing contaminants toward exhaust registers and grilles via uniform, non-mixed airflow patterns; (c) pressurization of individual spaces relative to other spaces; and (d) pressurization of buildings relative to the outdoors and other attached buildings.

5.4 Waste Management

The most practical approach to medical waste management is to identify wastes that represent a sufficient potential risk of causing infection during handling and disposal and for which some precautions are likely prudent.

Although any item that has had contact with blood, exudates, or secretions may carry pathogens, treating all such waste as infective is neither practical nor necessary. Federal, state, and local guidelines and regulations specify the categories of medical waste that are subject to regulation and outline the requirements associated with treatment and disposal. The categorization of these wastes has generated the term regulated medical waste, which is defined as any of the following:

• liquid or semi-liquid blood or other potentially infectious materials (OPIM)
• contaminated items that would release blood or OPIM in a liquid or semi-liquid state, if compressed
• items that are caked with dried blood or OPIM and can release these materials during handling
• contaminated sharps
• pathologic and microbiologic wastes that contain blood or OPIM

Medical wastes require careful disposal and containment before collection and consolidation for treatment. Measures for discarding regulated medical-waste items are designed to protect the workers who generate medical wastes and who manage the wastes from point of generation to disposal. A single, red, leak-resistant biohazard bag is usually adequate for containment of regulated medical wastes, provided the bag is sturdy and the waste can be discarded without contaminating the bag’s exterior. If the outside of the primary bag is contaminated or punctured, it must be placed into a second biohazard bag. All bags should be securely closed for disposal.

Puncture-resistant containers located at the point of use are used to discard sharps, including needles and syringes, scalpel blades, unused sterile sharps, and discarded slides or tubes with small amounts of blood. To prevent needlestick injuries, needles and other contaminated sharps should not be recapped, purposefully bent, or broken by hand.

Transporting and storing regulated medical wastes within the healthcare facility while awaiting terminal treatment is often necessary. Both federal and state regulations address the safe transport and storage of on- and off-site regulated medical wastes. Healthcare facilities are required to dispose of medical wastes regularly to avoid accumulation.

Medical wastes requiring storage should be kept in labeled, leakproof, puncture-resistant containers under conditions that minimize or prevent foul odors. The storage area should be well ventilated and be inaccessible to pests. Any facility that generates regulated medical wastes should have a regulated medical waste management plan to ensure health and environmental safety as per federal, state, and local regulations.

Regulated medical waste, microbiologic waste such as untreated cultures, stocks, and amplified microbial populations, poses the greatest potential for infectious disease transmission, while sharps pose the greatest risk for injuries.

5.5 Sterilization and Disinfection

In the United States, nearly 50 million surgical procedures and even more invasive medical procedures—including more than 5 million gastrointestinal endoscopies—are performed each year (Bicket et al., 2024). Each procedure involves contact by a medical device or surgical instrument with a patient’s sterile tissue or mucous membranes.

A major risk of all such procedures is the introduction of pathogens that can lead to infection. Failure to properly disinfect or sterilize equipment carries not only risks associated with the breach of host barriers, but also the potential for person-to-person transmission and the spread of environmental pathogens such as Pseudomonas aeruginosa (Josephs-Spaulding & Singh, 2021).

Depending on the intended use, healthcare policies must identify whether cleaning, disinfection, or sterilization is indicated. Instruments and devices are categorized as critical, semi-critical, and non-critical according to their level of tissue or mucous membrane contact and the associated infection risk.

Recent studies have documented a lack of compliance with established guidelines for disinfection and sterilization. This non-compliance and the increasing prevalence of multidrug-resistant (MDR) pathogens have led to numerous outbreaks and healthcare-associated infections (Josephs-Spaulding & Singh, 2021).

Sterilization is a comprehensive process used to destroy or eliminate all forms of microbial life—including bacteria, viruses, fungi, and highly resistant bacterial spores—through physical or chemical methods (Al-Otaibi et al., 2025).

Disinfection is a process that eliminates on inanimate objects many or all pathogenic microorganisms, except bacterial spores (Rowan et al., 2023). In healthcare settings, objects are usually disinfected using liquid chemicals or wet pasteurization. When selecting a disinfectant, its properties, toxicity, and material compatibility must be considered.

Products used for sterilization and disinfection must be cleared or licensed by the FDA for their intended purpose. Because all disinfectants are inherently toxic, use the lowest effective level of disinfectant required.

5.6 Cleaning and Decontamination

Cleaning is done to remove visible contaminants from objects and surfaces. This is usually done manually or mechanically using water with detergents or enzymatic products. Thorough cleaning is essential prior to high-level disinfection and sterilization because remaining organic and inorganic materials can interfere with the effectiveness of these processes (Rowan et al., 2023).

Decontamination removes pathogenic microorganisms from objects, so they are safe to handle, process, use, or discard (Rowan et al., 2023).

5.7 Medical Device Reprocessing

Healthcare facilities must adhere to the manufacturer's Instructions for the proper cleaning, disinfection, and sterilization of all reusable medical equipment.

Facilities must designate personnel responsible for maintaining and overseeing proper reprocessing procedures. Designated staff members must be thoroughly trained in reprocessing each specific piece of equipment, with documentation verifying competency. Maintaining an accurate log of all equipment reprocessing cycles ensures compliance and traceability.

5.7.1 Special Pathogen Procedures

Instruments, medical devices, and equipment must be managed and reprocessed using recommended methods regardless of the patient’s diagnosis, except for suspected prion disease.*  Special handling procedures apply to brain, spinal, or nerve tissue from patients with known or suspected prion disease (such as Creutzfeldt-Jakob disease). Consultation with infection control experts is required prior to performing procedures on such patients.

*Prion disease: occur when proteins in the body misfold and cause brain damage and other symptoms.

Industry guidelines as well as equipment and chemical manufacturer recommendations should be used to develop and update reprocessing policies. Written instructions must be readily available for each instrument and device.

Factors Influencing Contamination Potential

The risk and potential for contamination depend on several key factors:

• type of device or environmental surface
• potential for external or internal contamination
• frequency of hand contact with the device or surface
• potential for contamination with body substances or environmental sources of microorganisms
• level of contamination

5.7.2 Reprocessing Steps

Reprocessing of medical equipment involves three sequential steps:

1. Pre-cleaning removes soil, debris, and lubricants from internal and external surfaces and should be done as soon as possible after use.
2. Cleaning can be performed manually (scrubbing with brushes) or mechanically using automated washers. Cleaning solutions must be changed according to the manufacturer’s guidelines.
3. Disinfection or sterilization is done once cleaning is completed. The item must be disinfected or sterilized depending on its intended use.

Disinfection requires sufficient contact time with a chemical solution. Sterilization requires sufficient exposure time to heat, chemicals, or gases.

At any point in reprocessing or handling, breaks in infection control practices can compromise the integrity of instruments, medical devices, or equipment. Specific factors include:

• failure to reprocess or dispose of items between patients
• inadequate cleaning, disinfection, or sterilization
• contamination of disinfectant or rinse solutions
• improper packaging, storage, and handling
• inadequate or inaccurate record-keeping of reprocessing requirements

Differing levels of disinfection and sterilization methods and agents are based on the area of professional practice, setting, and scope of responsibilities. Professionals who practice in settings where handling, cleaning, and reprocessing is performed elsewhere should understand core infection control concepts and principles. A thorough understanding of Standard Precautions, personal protective equipment, and principles of cleaning, disinfection, and sterilization are essential.

Designation and physical separation of patient care areas from cleaning and reprocessing areas is strongly recommended by NYSDOH. Each medical facility must determine appropriate reprocessing practices and select appropriate methods, taking into consideration:

• antimicrobial efficacy
• time constraints and requirements for various methods
• compatibility of equipment and materials
• toxicity
• residual effect (the product’s antimicrobial effect when used repeatedly over several days)
• ease of use
• stability (concentration, potency, efficacy of use, and effect of organic material)
• odor
• cost
• monitoring requirements

5.7.3 Single Use Devices

A single-use device (SUD) is a device that is intended for one use or on a single patient during a single procedure. Approximately 20% to 30% of U.S. hospitals report that they reuse at least one type of SUD (Hennein et al., 2022).

The reprocessing of certain SUDs is permitted in the United States under the Food, Drug, and Cosmetic Act. Federal regulations require that all reprocessed SUDs be clearly labeled as “reprocessed” and contain the name of the reprocessor (Hennein et al., 2022).

The Food and Drug Administration considers SUD reprocessors to be device "manufacturers," requiring them to comply with the same rigorous regulatory standards as original equipment manufacturers. Reprocessors are also subject to premarket review, and must submit data demonstrating effective cleaning, sterilization, and functional performance to ensure that the reprocessed device is substantially equivalent to the original device (Hennein et al., 2022).

The reuse of SUDs is controversial due to concerns about the potential risks of infection, cross contamination, material fatigue, and device failure. While many healthcare facilities in the United States use reprocessed SUDs for their cost and environmental savings, institutions such as the Department of Veterans Affairs continue to restrict or prohibit their use entirely to eliminate risk to patient safety (Hennein et al., 2022).