D.29- PRE-TREATMENT AND TRANSPORTATION OF SOILED REUSABLE MEDICAL EQUIPMENT , REUSABLE NON-CRITICAL MEDICAL EQUIPMENT.pdf

TRANSPORTATION OF REUSABLE MEDICAL EQUIPMENT / PRE-TREATMENT

REQUIREMENTS

MCP 003SPS - 01

Syracuse VA Medical Center Syracuse, NY 13210

Signatory Authority:

Medical Center Director

Responsible Owner:

Associate Director for Patient/Nursing Services / SPS Chief

Rescinded Document:

None

Effective Date:

January 2021

Recertification Date:

January 2026

1. POLICY

This medical center policy (MCP) establishes the current processes for transportation of sterile /clean reusable medical equipment (RME); and pretreatment and transportation of soiled reusable medical equipment from the point of use to a decontamination area in accordance with professional practice standards.

2. JUSTIFICATION

The Transportation of Reusable Medical Equipment/Pre-Treatment Requirement Protocol is mandated by VHA Directive 1116 (2); Section 14 and VHA Memorandum;

Clarification on Current Processes for Pretreatment and Transportation of Soiled Reusable Medical Equipment, dated April 20,2018. This policy is intended to clarify the process for Transportation of RME in accordance with Department of Transportation (DOT) regulations, OSHA guidelines and the American National Standards Institute/Association for the Advancement of Medical Instrumentation Standards

(ANSI/AAMI ST79).

3. RESPONSIBILITIES

a. VA Medical Facility Director . The VA Medical Facility Director is responsible for:

(1) Ensuring facility compliance (and compliance of affiliated sites, e.g., Community

Based Outpatient Clinics) with critical and semi-critical RME processes, specifically:

(2) Verifying that the transportation of critical and semi-critical RME, which has been cleaned, disinfected or sterilized to areas outside of SPS, is assigned to an appropriate service.

b. Chief, SPS. The Chief, SPS is responsible for:

Attachment D.29 RFP 36C24224R0049

June 2020 MCP 003SPS-01

(1) Providing training in proper handling techniques to any staff member handling soiled containers or who are involved in the collection and/or transport of potentially soiled items. These techniques are defined by Infection Prevention and Control guidelines and are in keeping with the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard, title 29 Code of Federal Regulations (CFR) 1910.1030.

c. Point of Use. Point of use staff is responsible for:

(1) Pre-clean and spraying instruments to prevent soil from drying before transport.

(2) Separating sharp instruments from other instruments to minimize risk of injury to decontamination personnel. Discard disposable sharps in appropriate sharps container.

(3) Contaminated instruments should be handled as little as possible at the point of use and should be immediately contained and transported to the decontamination area. Immediate containment and transport reduce the risk of surgical personnel’s contact with the contaminated instruments.

4. RME TRANSPORTATION AND PRE-TREATMENT PROCEDURE

a. The following standards relate to the transportation of off-site Sterile and Contaminated medical devices. Vehicles used for transportation between health care facilities should provide for the complete separation of Sterile/ clean items from contaminated items. Transport vehicles must be completely enclosed and checked periodically at least annually, more frequently if needed. Environmental conditions such as, temperature and humidity should be kept at levels to protect the integrity of sterile products. Refer to ANSI/AAMI ST-79 Section 8.11.5.

b. DOT regulations for labeling and transporting of contaminated instruments must be followed by Syracuse VAMC. OSHA’s primary role is to protect workers from occupational illnesses and injuries. Both the DOT and OSHA have specific guidelines that must be followed when transporting biohazardous materials, such as contaminated instruments. Transport containers must be enclosed, secure, leak and puncture proof.

Transport containers and carts should be thoroughly decontaminated before each use.

c. The shelf life of a packaged, sterile item is event-related and depends on the quality of the packaging material, the storage conditions, the amount of handling, and the conditions during transport. Sterilized packages are to be considered sterile unless the integrity of the packaging is compromised (damaged) or suspected of being compromised. Packages or containers must be visibly inspected for package integrity prior to distribution and prior to use.

d. Contaminated reusable items must be transported ASAP to the Decontamination area in such a manner as to protect people and the environment from contamination.

e. Reusable collection containers must be biohazard, medical grade, puncture resistant, rigid, made of material that can be properly cleaned and decontaminated and must contain a secured lid. Disposable, impervious plastic bags and sterilization pouches may not be used to transport contaminated RME.

f. All clinic areas are to have a designated soiled utility room. Enclosed containers must be provided in these rooms. All clinical procedure trays and other critical and semi-critical RME must be placed in these containers.

g. Containers are to be exchanged at each pick-up location, and the containers must be cleaned between each use.

h. Soiled biohazard labeled containers are to be dedicated for soiled transport and storage. Soiled biohazard labeled containers are never used to transport clean equipment.

i. Gross soil must be removed from RME at the point-of-use by the user prior to transport. This practice is considered pre-treatment and must contain the following steps:

(1) The reusable devices are placed in a properly sized, biohazard-labeled, closed container.

(2) It is the user's responsibility to dispose of sharps appropriately before returning RME to SPS.

(3) Pretreat with the proper use of an enzymatic pre-treatment product prior to transport to prevent drying.

(4) All RME must be transported within four hours to the Decontamination area of SPS for reprocessing. This includes clinics, Community Based Outpatient Clinics (CBOC’s) using RME outside the main facility.

j. Offsite locations without full onsite sterile reprocessing departments must develop a contingency plan when it is not feasible to return soiled instruments/devices to the sterile processing department at the main facility within four (4) hours. The time between use and reprocessing may be extended to no more than 12 hours with the proper use of an enzymatic pre-treatment product. Reapplication of an enzymatic pretreatment product is not permissible to extend holding time. At any given point if instrumentation is questionable regarding door to door time, it will be assessed upon receipt in decon and based on assessment will be disposed of or soaked for a two hour time frame to rid extreme bio-burden, then reassessed and cleaned per Manufacturers Information for Use(IFU).

k. Under NO circumstances may soiled instruments/devices be left overnight or over the weekend / holidays.

l. A biohazard label is to be placed on containers used for contaminated equipment or RME.

m. The closed, soiled container to be transported to the Syracuse VAMC must be exchanged for a clean container at each scheduled pick up. The closed, soiled container must be placed in a larger container or closed cart for transport. The cart or container must be properly labeled for biohazard transport according to local, state, and federal Department of Transportation regulations. Soiled items must be contained in such a way as not to contaminate the person or persons in the transport vehicle or the vehicle itself.

n. Contaminated items and clean items must be kept separate. Dirty bins will be placed in the back of the transport vehicle. Clean bins are placed in the second row of the vehicle.

o. Cleaning and maintenance of the transport vehicle is important to protect instruments from dust, dirt and other contaminants. Vehicles are sprayed down each morning prior to and after use.

p. Transport personnel should be properly trained in infection control and prevention.

q. Clean transport containers cannot be stored in soiled utility rooms.

r. Reprocessed and soiled items must never be transported together on carts or in the same containers.

5. DEFINITIONS

a. Reusable Medical Equipment (RME). Reusable medical equipment are items that health care providers can reprocess and reuse on multiple patients. Examples of reusable medical devices include surgical forceps, endoscopes, stethoscopes, and dental instruments.

(1) Semi-critical devices: such as endoscopes, come in contact with mucus membranes.

(2) Non-critical devices: such as stethoscopes, come in contact with unbroken skin.

b. Pre-Cleaning. Responsibility of the end user, in which instruments / devices are wiped off and lumens are flushed during the procedure as well as at the end of the procedure, using sterile water to remove all gross debris. This must occur prior to pre-treatment. This is to prevent soil from drying before transport.

c. Pre-Treatment. The application of an enzymatic pre-treatment product to soiled instruments to keep residual organic bioburden and inorganic debris from drying prior to and during transport to the Sterile Processing Services (SPS) decontamination area.

Pre-treatment products are applied in a defined area with minimal instrument handling.

This is the responsibility of the end user and must occur in all point of use areas where Critical and Semi-critical RME is used.

d. Soiled utility room . Located in or near clinical areas and must be secured with designated biohazard labeling. This is the location where soiled instruments / devices are held until they are transported for SPS decontamination, pre-treatment and reprocessing.

e. Designated holding area. When clinical areas do not have soiled utility rooms, an enclosed, secured, biohazard labeled cart may be used.

f. Off-site transport. The process of moving medical devices between healthcare facilities, campuses and cities. Syracuse has several off-site clinics that require reusable medical devices for procedures. It is not cost effective or efficient to install cleaning and sterilization equipment at each location; therefore, reprocessing services are centralized at the Syracuse VAMC location, with items being transported to and from the various clinics.

g. Offsite . Defined as any of the Department of Veterans of Affairs (VA) Community Based Outpatient Clinics (CBOC) and/or outside facility other than the main facility.

6. REFERENCES

a. VHA Directive 1116(2), Sterile Processing Services (SPS), dated March 23,2016

b. Standard 29 CFR 1910.1030. Occupational Safety and Health Administration B

c. ANSI/AAMI ST79:2010&A1&A2 and ST 91. Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

(1) ANSI/AAMI ST79:2010 & A1 & A2 pgs. 49 & 50

d. DUSHOM, Deputy Under Secretary for Health for Operations and Management (10N) Memorandum, 2018-04-29, 10NC6, Clarification on Current Processes for Pre-Treatment and Transportation of Soiled Reusable Medical Equipment (RME), dated April 20,2018. (Operational Memos).

e. Transportation of clinical Instrumentation Internal SPS SOP and Competency, dated August 15, 2018

7. RESCISSION

None

Attachment D.29 RFP 36C24224R0049 https://dvagov.sharepoint.com/sites/NADqms/syrvamc/External%20Documents%20and%20Refrences/Forms/AllItems.aspx https://dvagov.sharepoint.com/sites/NADqms/syrvamc/External%20Documents%20and%20Refrences/Forms/AllItems.aspx https://vaww.va.gov/vhapublications/index.cfm https://vaww.va.gov/vhapublications/index.cfm https://vaww.va.gov/vhapublications/index.cfm https://dvagov.sharepoint.com/sites/NADqms/syrvamc/External%20Documents%20and%20Refrences/Forms/AllItems.aspx https://www.aami.org/ https://www.aami.org/ https://www.aami.org/ https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030 https://vaww.va.gov/vhapublications/index.cfm

8. REVIEW

This MCP must be reviewed, at minimum at recertification and including when there are changes to VHA Directive 1116 (2), Sterile Processing Services (SPS), dated March 23,2016, or if recommended changes are made by the National Program Office of Sterile Processing (NPOSP).

9. RECERTIFICATION

This MCP is scheduled for recertification on or before the last working day of January 2026. This MCP will continue to serve as local policy until it is recertified or rescinded.

In the event of contradiction with national policy, the national policy supersedes and controls.

10. SIGNATORY AUTHORITY

Frank P. Pearson, DPT, PA-C CAPT, USN (Ret) U.S. Department of Veterans Affairs Director, Syracuse VA Medical Center Date Approved: January 5, 2021

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

DISTRIBUTION: MCPs are available at: Syracuse Medical Center Document Control SharePoint (DCS).

Attachment D.29 RFP 36C24224R0049 https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://dvagov.sharepoint.com/sites/VHASYR/svdc/

DEPARTMENT OF VETERANS AFFAIRS

VA HEALTHCARE NETWORK

UPSTATE NEW YORK AT SYRACUSE

Medical Center Memorandum December Chief of Staff 00-025

REUSABLE NON-CRITICAL MEDICAL EQUIPMENT (RME) POLICY

I. PURPOSE:

To provide consistent guidelines for the cleaning of non-critical items outside of Sterile, Processing Service (SPS).

II. DEFINITION:

A. Non-Critical reusable medical equipment (RME) are: items that come into contact with intact skin and items that do not come in contact with mucous membrane. Intact skin acts as an effective barrier against microorganisms;

therefore, the sterility of items coming in contact with skin is “not critical”.

B. Level of Disinfection for Non-Critical Items:

1. Cleaning: reduces the bio-burden and removes foreign materials-e.g.: organic residue and inorganic salts.

2. Low level disinfection: destroys vegetative bacteria, some fungi as well as enveloped (lipid) viruses.

Method of disinfection is through liquid (disinfectant) contact or

“wet” time on the surface of the item / equipment.

Examples: Quaternary ammonium chloride (Facility use: 3M #40

RCT

or Quat “PDI Super Sani Cloth” germicidal wipes or Alcohol 70- 90%

A. Intermediate level disinfection: same as number 2 and destroys mycobacteria but not spores. This product is used for non-critical patient care items and/or surface with visible blood.

C. EXAMPLES: of non-critical RME are the following but not limited to:

IV Poles, non-disposable Blood Pressure cuffs, Blood glucose monitors, Pulse Oximeters clips. Vital Sign monitors, Temperature monitors, Reflex hammers, Stethoscopes and or;

Surfaces such as BCMA countertop; keyboards; Med cart drawer:

POC

Crash carts, Isolation carts/caddies, Bedside commodes, EKG leads/ machines, Telemetry leads/boxes, Wheelchairs, Lift equipment; etc.

Medical Center Memorandum December Chief of Staff 00-025 P a g e

D. All Direct Patient Care Staff : Are responsible for wiping down non-critical equipment/items after each patient’s use with approved by Infection Control Committee), as per attached list of equipment.

ATTACHMENT A: Guideline: Cleaning and Disinfection of non-critical RME (routinely updated as new RME is purchased)

E. FMS is responsible for cleaning non critical RME per attached list of equipment, as part of terminal cleaning process and/or scheduled cleaning.

F. Chemicals: SDS will be available for all cleaning and disinfecting chemicals and documentation of appropriate training for use to all staff involved in the cleaning and disinfection process.

III. POLICY:

Non-critical Reusable Medical Equipment (RME) utilized for patient care will have written guidelines for cleaning, care and/ disinfection outside of SPS.

IV. RESPONSIBILITY:

A. Associate Director Patient/Nursing Services (ADPNS) has responsibility for ensuring implementation of the policy.

B. Chief of SPS has technical oversight of all reprocessing of RME and equipment used in reprocessing wherever such reprocessing occurs within the facility.

C. Department Supervisor/Manager or designee is responsible for the routine cleaning and disinfection of equipment/items assigned to their unit/dept.

D. Supervisor, Environmental Services has responsibility for cleaning items as detailed on attached list, on a periodic schedule, and/or as requested (example: stretcher)

NOTE: For grossly soiled equipment/items including blood: these items can be taken to the FMS cleaning area for more thorough cleaning.

E. Total Supply and Support (TSS) has responsibility for distribution of cleaned non-critical RME and stocking consumables (for example- code cart/specialty cart, etc.).

V. PROCEDURE:

A. Don appropriate protective equipment for the task. Wash hands before donning gloves, At least Gloves and may add protective eyewear; gown (depending on the soil and/or disinfectant use) as indicated by Standard Precautions and/or disinfectants’ instruction for use (IFU)

B. Using a semi-wet cloth or wipe, wipe ALL surfaces of equipment, thoroughly with appropriate cleaning/disinfectant.

Chief of Staff 00-025 P a g e

Use 2-step process: first clean of bioburden or blood or other body fluids: 2nd disinfect following disinfectants surface “wet or contact” time to disinfect.

C. Allow cleaning and/or disinfecting solution to remain wet on all surfaces for up to 10 minutes. (See attachment A for specific wet times.)

D. KEY POINT: if equipment is electronic. Follow manufacturer’s instructions for cleaning. Do not over saturate any electronic screen/monitors as this will damage the equipment.

E. Any clarification for manufacturer’s guidelines can be obtained through RME SharePoint.

F. COMPLETENCIES: Competencies will be maintained for all involved in the care, cleaning and/or disinfection of non-critical reusable medical equipment.

1. Competency will include: Knowledge of care, cleaning and disinfection of equipment and knowledge of the general infection control procedure for non-critical equipment.

G. All competency will be signed off by Supervisor/Nurse Manager or designee.

F. Always perform hand hygiene after removing gloves.

VI. REFERENCES:

A. VHA Directive 1116(2) Sterile Processing Services (SPS).

B. APIC Text of Infection Control and Epidemiology: Cleaning, Disinfection and Sterilization: (See APIC Test Online).

https://text.apic.org/the-apic-text-online/a-word-from-the-chair/update-cleaning-disinfection-and-sterilization

C. CDC: Guidelines for Environmental Infection Control in Health Care Facilities: MMWR June 6, 2003:/Vol.52/No. RR-10 https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html

D. Guidelines for Environmental Infection Control in Health-Care Facilities;

Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee, Updated: July 2019.

https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html

VII. RESCISSION:

Medical Center Memorandum 00-025 Procedure for Cleaning Non-Critical Reusable Medical Equipment (RME) Outside of SPS dated January 2017.

VIII. REVIEW DATE:

Attachment D.29 RFP 36C24224R0049 https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html https://text.apic.org/the-apic-text-online/a-word-from-the-chair/update-cleaning-disinfection-and-sterilization https://text.apic.org/the-apic-text-online/a-word-from-the-chair/update-cleaning-disinfection-and-sterilization

Chief of Staff 00-025 P a g e

November 2021

IX. FOLLOW-UP RESPONSIBILITY:

Chief of Staff

Associate Director Patient/Nursing Services

Infection Prevention and Control

Environmental Management Service

(original signed & on file 12/2/2019)

RICHARD W. SALGUEIRO, FACHE

Interim Medical Center Director

ATTACHMENT A