» Compliance » The GREEN Process HLD  

High level disinfection is an inherently GREEN process. ReNu's HLD uses a natural water-based process with no harmful chemicals and no dangerous air emissions.

 

High-level Disinfection (HLD)

High-level disinfection is not sterilization. HLD utilizes only high temperature water and time to render medical devices free of bacteria, viruses, and numerous other potentially dangerous microbes. This method, also referred to as pasteurization technology, has been a standard in industry since Louis Pasteur discovered its benefits in the 19th century.

The simplicity of the process revolves around the high thermal conductivity of water and the ability to transfer heat to product to kill pathogens. This entire process is completed without the use of chemicals that could degrade product, leave injurious residue, produce dangerous air emissions, or expose patients and caregivers to potential carcinogens.

Consider the benefits of HLD for non-sterile, single use devices (SUD):

  1. Extensive study by regulatory agencies and academia since Nelson and Ryan's definitive 1971 study (Respiratory Care, May-June 1971)
  2. Extended functional life for each device. HLD offers more cycles per device than sterilization
  3. HLD is more cost effective
  4. The environment benefits from less medical waste disposal, less frequent waste burning helps the ozone, and HLD does not give off air emissions
  5. HLD technology allows fast turn around time because devices do not have to be aerated

Sterilization

Medical devices can be bulk sterilized in numerous ways. Choices include steam such as autoclaving and chemical methods with ethylene oxide (EtO) being the most common. Plasma and ozone technologies are currently being researched but neither method is currently approved by the FDA nor is it presently cost effective.

Point of use sterilization is often utilized by physicians' offices or hospitals to render devices sterile for specific immediate use. Point of use methods often employ chemicals such as peracetic acid and ortho-glutaraldehyde.

Consider the following:

  1. The government considers many sterilization chemicals such as EtO dangerous and toxic. Federal, state, and local government are charged with highly regulating its use
  2. Chemicals such as EtO compromise human health and safety. Patients, caregivers, and sterilization employees are particularly at risk
  3. EtO kills microorganisms by alkylation of proteins and DNA. Humans are composed of proteins and DNA
  4. The manufacture and use of sterilization chemicals such as EtO involves the release of said chemicals into the air and water
  5. Why choose sterilization for devices that do not have to be sterile? Many SUDs such as blood pressure cuffs, sequential compression sleeves, and transducers are delivered non-sterile from the OEM, are normally not used in sterile environments, and do not require sterilization for re-use.
  6. Danger Ethylene Oxide - Supporting Article regarding the dangers of EtO

ReNu Medical believes EtO is necessary and appropriate for critical medical devices that require sterilization. ReNu promotes the re-use of single use devices (SUD).

 

Below are additional resources on the subject of HLD and sterilization.

High Level Disinfection (HLD)

Garner, J.S. and Favero, M. S., "Guideline for Handwashing and Hospital Environmental Control: Supersedes Guideline for Hospital Environmental Control Published in 1981," CDC Guidelines for the Prevention and Control of Nosocomial Infections, 1985

Rutala, W.A. et al., "Efficacy of a Washer-Pasteurizer for Disinfection of Respiratory-Care Equipment," Infection Control and Hospital Epidemiology, 21, May 2000, p. 333

"Pasteurization Provides Efficient Cleaning for Hospitals," Infection Control Today, September 1998

"Conversion from Disposable Anesthesia and Respiratory Care Equipment to Reprocessing Reusables," Infection Control Today, September 1998

Nelson, E. and Ryan, K., "A New Use for Pasteurization Disinfection of Inhalation Therapy Equipment," Respiratory Care, May-June 1971

Sterilization

Yong, L. C., et al., "Hemoglobin Adducts and Sister Chromatid Exchanges in Hospital Workers Exposed to Ethylene Oxide: Effects of Glutathione S-Transferase T1and M1 Genotypes," Cancer Epidemiology, Biomarkers & Prevention, 10, 2001, p. 539

Cardenas-Camarena, L., "Ethylene Oxide Burns form Improperly Sterilized Mammary Implants," Annals of Plastic Surgery, 41, 1998, p. 361

Rowland, A. S., et al., "Ethylene Oxide Exposure May Increase the Risk of Spontaneous Abortion, Preterm Birth, and Postterm Birth," Epidemiology, 7, 1996, p. 363

Bolt, H. M., "The Carcinogenic Risk of Ethene (Ethylene)," Toxicologic Pathology, 26, 1998, p. 454

Schulte, P., et al., "Molecular, Cytogenetic, and Hematologic Effects of Ethylene Oxide on Female Hospital Workers," JOEM, 37, 1995, p. 313

Shaham, J., et al., "Hematological Changes in Hospital Workers due to Chronic Exposure to Low Levels of Ethylene Oxide," Journal of Occupational and Environmental Medicine, 42, 2000, p. 843