Description #
Medical Device Reprocessing. Differentiate between cleaning, disinfection and sterilization. Introduce Spaulding’s classifications of medical devices. Review the contents of a departmental reprocessing manual. Requirements of an approved decontamination/reprocessing area.
Learning Objectives #
- 1. Define reprocessing
- 2. Identify the difference between cleaning, disinfection, and sterilization
- 3. Describe good cleaning practices
- 4. Identify medical devices according to Spaulding’s classifications
- 5. Describe the contents of a departmental reprocessing manual
- 6. Identify the necessary requirements for a decontamination area in a healthcare setting
Medical Device Reprocessing – an Introduction #
“When used on different patients, reusable devices become soiled and contaminated with microorganisms. To avoid any risk of infection by a contaminated device, reusable devices undergo “reprocessing,” a detailed, multistep process to clean and disinfect or sterilize them. When the labeling instructions for reprocessing are completely and correctly followed, reprocessing results in a medical device that can be safely used for more than one patient. Adequate reprocessing of reusable medical devices is vital to protecting patient safety.” (www.fda.gov. 2014)
Most large hospitals have entire departments dedicated to the reprocessing of medical devices. These are often called Sterile Processing (SPD) or Medical Device Reprocessing Departments (MDRD). However, many smaller clinical settings or satellite areas of healthcare facilities do not have access to these large departments and must be able to reprocess their own medical devices.
**Should we add the MDRD video here? its 7 minutes long **
Reprocessing medical devices between patients always involves careful cleaning and usually involves either disinfection or sterilization. All reusable devices that are involved in a patient procedure must be fully reprocessed, even if they did not contact the patient. In other words, if the device is brought into a procedure room with a patient but not used, that device must be reprocessed.
Cleaning/Disinfection/Sterilization – what is the difference?
Cleaning physically removes soil and many micro-organisms. Cleaning is the most vital step in reprocessing any medical device. If a device is not clean, no disinfection or sterilization process will make it safe for use on a patient. Organic and inorganic matter can have an effect on disinfectants; either by causing chemical reactions that can counteract the disinfectant, or by the development of a physical barrier which can protect an organism from disinfecting or sterilizing agents.
Good cleaning practice involves soaking a device to loosen soil; the use of friction such as brushing or rubbing with a cloth; and very careful rinsing to remove soil and detergent. In medical device reprocessing we use chemical detergents which often contain special enzymes. These are commonly referred to as “enzymatic” detergents. It is important to note that enzymatics do not disinfect, they only aid the cleaning process.
Any detergent used to clean a medical device must be approved for that use. For example, household cleaners or dishwashing detergents are not approved for medical use and must never be used on medical devices without specific, detailed instruction from the manufacturer of the device. The manufacturer’s instructions for use are the best source of cleaning information for any medical device and should always be carefully followed.
For more information on Cleaning see the unit Decontamination in this series.
Disinfection is a process that is distinct and separate from cleaning. Cleaning removes many micro-organisms; disinfection kills most remaining micro-organisms. Chemicals are commonly used to disinfect medical devices and work areas.
There are 3 different “levels” of disinfection used in healthcare. These levels are based on the type and number of microorganisms that are killed. The level of disinfection needed on any medical device is determined by how the device is used on patients. In 1972 Dr. Earle H Spaulding classified medical devices according to how they are used, and what type of tissue or body parts they come in contact with. This classification system is now used to determine how medical devices are reprocessed between patients.
Spaulding’s Classifications:
Non-Critical Devices: do not touch the patient or only contact intact skin. These devices do not come in contact with mucous membranes or non-intact skin and have a low risk of transmission of infection. Examples are IV pumps, blood pressure cuffs, bedpans/urinals, environmental surfaces such as counter tops. These items require washing with a detergent and are often disinfected with a Low-level disinfection process. Low-level disinfection reduces the number of micro-organisms to a safe level for a non-critical device. Some devices may require Intermediate-level disinfection which offers a slightly higher level of microorganism kill. The difference is the equipment may come in contact with known or unknown chemically resistant organisms. Equipment that may require Intermediate –level disinfection are hydrotherapy tubs, and bedpans in high risk areas
Semi-Critical Devices: do not penetrate skin but do contact mucous membranes such as the mouth and throat, and the rectum and colon. Examples would be flexible endoscopes, laryngeal blades, and anaesthetic equipment. Sterilization is recommended if possible for these devices but is not mandatory. High-level disinfection (HLD) is the minimum process required for semi-critical devices. High-level disinfection kills or inactivates most forms of micro-organisms.
For more information on all levels of disinfection and on common disinfection procedures please see the unit Disinfection in this series.
Critical items: these come in contact with sterile areas of the body, such as the bloodstream. Examples would be surgical instruments, and intravenous catheters. Biopsy forceps that are used during flexible endoscopy procedures must be sterilized as they bite into tissue and contact the bloodstream.
Disinfection is not appropriate for any critical items. All critical items must be sterilized and stored sterile for future use. This means they must be packaged in approved packaging that can withstand the sterilization process and provide protection after sterilization.
Sterilization is the only method that kills all microorganisms. It is achieved in healthcare facilities by exposure to high pressure steam, or through chemical processes.
For more information in Sterilization see the units Sterilization General, Sterilization Steam and Preparation for Sterilization in this series.
All staff responsible for reprocessing medical devices should be trained in the use of cleaning agents, disinfecting chemicals and any machines used to assist with reprocessing. Many of the chemicals that are used in reprocessing are ineffective if not used correctly, or can even be dangerous if instructions for use are not carefully followed. All staff should have easy access to instructions for all devices, chemicals, and machines as they reprocess any device. Posting instructions on the wall where reprocessing is done can be helpful. Laminating any posted material allows for easy cleaning and can protect instruction sheets from water damage.
In addition to posting instructions for easy reference developing a “Reprocessing Manual” can be an important tool for departments which are reprocessing medical devices. The manual should contain:
- instructions for reprocessing- cleaning and disinfection – for the medical device provided by the manufacturer
- instructions for use of any cleaning solutions or disinfecting chemicals including dilution and temperature if necessary. These instructions should also be posted in your reprocessing area for quick reference.
- Workplace Hazardous Materials Information System (WHMIS) information on all solutions and chemicals used. This information comes from the manufacturer in the form of Material Safety Data Sheets (MSDS) and includes chemical composition, first aid, and spill cleanup information.
- instruction for use of any machines used for washing or disinfecting, and for any monitoring devices that track the process
- sterilization instructions for medical devices if applicable, as well as instructions for how to use, monitor, and test the sterilizer.
Records of training and orientation to the work of reprocessing are important and can be included in your department Reprocessing Manual. Some examples of these types of records are:
- training checklists for new employees and employees with newly assigned tasks
- a list of functions that each employee is authorized to perform
- training obtained prior to implementation of new/ revised procedures. This would include:
- confirmation of training sessions attended
- the aim of the training session
- any alternative evidence of training
- records of annual reviews of SOPs (standard operating procedures)
- records of annual WHMIS (Workplace Hazardous Materials Information Sheet) review
- records of attendance at workshops, seminars etc.
The Reprocessing Area
The area where you clean and disinfect or sterilize reusable medical devices must be appropriate for this use. Harsh chemical cleaners and soil, in the form of body fluids or tissue, can cause contamination of the area during the cleaning process. As well, other uses of a sink such as dishwashing, meal preparation etc. can cause contamination of any medical devices being reprocessed. Therefore, sinks in staff rooms or kitchen areas are not suitable for cleaning medical devices.
The BC Ministry of Health Best Practices Guide outlines these requirements for an area where medical devices are cleaned – commonly called the Decontamination area. These areas must:
- have restricted access – only those people who are doing the work of reprocessing should be in the area
- ensure “one-way workflow” – moving from the dirtiest area to the cleanest and not moving back into a dirty area.
- have adequate space for the work being done – too small a space can interfere with one-way-workflow patterns
- be distinctly separate from areas where clean/disinfected or sterilized items are handled or stored – this helps prevent “cross- contamination” of soil from dirty items onto clean items
- have surfaces that are easily cleaned and disinfected
- have slip-proof flooring that can withstand wet mopping and disinfecting
- negative air flow – this type of ventilation prevents the movement of air born contaminants from the decontamination or dirty area to clean and/or sterile areas