Source: http://aorn.org/guidelines/clinical-resources/clinical-faqs/sterile-technique
Timestamp: 2017-04-29 19:22:00
Document Index: 517485042

Matched Legal Cases: ['§878', '§878', '§878', 'art878', '§803', 'art803', '§1910']

Sterile Technique - Association of periOperative Registered Nurses
Get clinical answers to frequently asked questions about Sterile Technique.
What is strikethrough?
Strikethrough is the passage of liquid that could contain microorganisms through a barrier product, such as a surgical gown or drape, including its seams and points of attachment.1 In the United States, surgical gowns and drapes are considered to be Class II medical devices2,3 and as such, they are subject to regulation by the US Food and Drug Administration (FDA).4 Failure of these devices is subject to medical device reporting requirements according to the Safe Medical Devices Act of 1990 as amended in March 2000.5 Any incidents of strikethrough of surgical gowns or drapes should be reported, investigated, and corrective action taken. These incidents should be reported to the healthcare facility management and to MedWatch: The FDA Safety Information and Adverse Event Reporting Program at http://www.fda.gov/Safety/MedWatch/.6
ANSI/AAMI PB70: Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2012.
Surgical devices, Surgical apparel, 21 §878.4040 (2012). https://www.gpo.gov/fdsys/granule/CFR-2012-title21-vol8/CFR-2012-title21-vol8-sec878-4040. Accessed May 3, 2016.
Surgical devices, Surgical drapes and drape accessories, 21 §878.4370 (2012). https://www.gpo.gov/fdsys/granule/CFR-2012-title21-vol8/CFR-2012-title21-vol8-sec878-4370. Accessed May 3, 2016.
Medical Devices, General and Plastic Surgery Devices, 21 CFR §878 (2014). https://www.gpo.gov/fdsys/granule/CFR-2014-title21-vol8/CFR-2014-title21-vol8-part878. Accessed May 4, 2016.
Medical Device Reporting, 21 CFR §803 (2012). https://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol8/pdf/CFR-2012-title21-vol8-part803.pdf. Accessed May 4, 2016.
MedWatch: the FDA safety information and adverse event reporting program. US Food and Drug Administration. http://www.fda.gov/Safety/MedWatch/. Accessed May 4, 2016.
What should I do if I am exposed to strikethrough of blood or body fluids?
You must wash your hands and skin with soap and water or flush your mucous membranes with water immediately or as soon as possible after coming into direct contact with blood or other potentially infectious materials. You also must replace PPE and clothing as soon as possible after exposure to blood or other potentially infectious materials.
You should report exposures to your health care organization as soon as they occur and infections as soon as the disease process is noted. Early self-reporting of exposures and infections helps prevent transmission to patients and other health care providers.
Guideline for prevention of transmissible infections. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2016:471-503.
Occupational Safety and Health Standards, Toxic and Hazardous Substances: Bloodborne Pathogens, 29 CFR §1910.1030 (2012). Occupational Safety and Health Administration. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051. Accessed May 4, 2016.
Bolyard EA, Tablan OC, Williams WW, Pearson ML, Shapiro CN, Deitchmann SD. Guideline for infection control in healthcare personnel, 1998. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1998;19(6):407–463. Updated May 4, 2016
As a manager, what should I do if personnel report exposure to strikethrough of blood or body fluids?
You must follow your health care organization’s established, written exposure control plan, which should be consistent with federal, state, and local rules and regulations. All exposure incidents (eg, needlesticks, blood exposures) must be reported according to health care organization policy and based on the OSHA bloodborne pathogens standard.
All incidents of occupational exposure to blood or other potentially infectious materials must be documented. Documentation should include:
the route of exposure;
the circumstances associated with the exposure;
the source individual’s serological status, if known;
the employee’s name and social security number;
the employee’s hepatitis B vaccination status and other relevant medical information for both individuals, including vaccination dates and any medical records related to the employee’s ability to receive vaccinations; results of all related examinations, medical tests, and post-exposure evaluation and follow-up procedures;
a licensed health care professional’s written opinion; and
a copy of the information provided to the employee.
Documenting all exposure incidents provides the employer with feedback regarding the circumstances of employee exposures. This information can be used to focus efforts on decreasing or eliminating specific circumstances or routes of exposures.
Bolyard EA, Tablan OC, Williams WW, Pearson ML, Shapiro CN, Deitchmann SD. Guideline for infection control in healthcare personnel, 1998. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1998;19(6):407–463.
How should perioperative team members select surgical gowns?
Perioperative personnel should select gowns, gloves, and drape products for the procedure according to the barrier performance class of the product as stated on the label and according to the anticipated degree of exposure to blood, body fluids, and other potentially infectious materials.1
Surgical gowns and drapes are labeled by the manufacturer as Level 1, 2, 3, or 4 depending upon the barrier properties of the critical zone of the gown or drape (ie, the area where direct contact with blood, body fluids, or other potentially infectious materials is most likely to occur as shown in Figure 1).2 Notably, areas located outside the critical zones (eg, back of gown) may not be protective.2 The manufacturer defines which areas of the gown are critical zones and must label any areas that are not protective.2
Other factors that should be considered by perioperative personnel when selecting surgical gowns, gloves, and drape products for surgical or other invasive procedures include the:
volume of irrigation fluid;
potential for splash, spray, pooling, or soaking;
duration of the procedure;
type of procedure (eg, minimally invasive versus open, superficial incision versus deep body cavity); and
team member’s role.1
Surgical gowns and drape products used during operative and other invasive procedures must provide a barrier and should be resistant to tears, punctures, and abrasions.1 As well, they should be non-abrasive and non-toxic, lint-free, functional, and flexible.1 Surgical gowns, gloves, and drape products should be evaluated for these qualities by the appropriate facility committees and purchasing personnel before purchase.1
Guideline for sterile technique. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2016:65-93.
ANSI/AAMI PB70: Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2012. Updated May 4, 2016
What is the difference in barrier performance between gowns and drapes labeled Level 1, 2, 3, and 4?
Barrier performance and classification of surgical gowns and drapes is established by the American National Standards Institute, Inc. (ANSI) and the Association for the Advancement of Medical Instrumentation (AAMI) in the ANSI/AAMI PB70: 2012, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.1 This standard establishes classifications of barrier performance according to the hierarchy of risks associated with the anticipated exposure to blood, body fluids, or other potentially infectious materials, or other liquid volume involved in the type and duration of procedure or activity being performed.1 These classifications are:
Level 1:	Surgical gowns, isolation gowns, and drapes demonstrating the ability to resist liquid penetration in a water resistance: impact penetration test.
Level 2:	Surgical gowns, isolation gowns, and drapes demonstrating the ability to resist liquid penetration in a water resistance: impact penetration test, and a water resistance: hydrostatic pressure test.
Level 3: Surgical gowns, isolation gowns, and drapes demonstrating the ability to resist liquid penetration in a water resistance: impact penetration test, and a water resistance: hydrostatic pressure test set at a higher value than for Level 2.
Gowns—Surgical gowns and isolation gowns demonstrating the ability to resist liquid and viral penetration using a bacteriophage.
Drapes—Surgical drapes demonstrating the ability to resist liquid penetration using synthetic blood.1
In the United States, surgical gowns and drapes are considered to be Class II medical devices2,3 and as such, they are subject to regulation by the US Food and Drug Administration.4 Notably, in addition to the barrier performance level of the product as stated on the label, perioperative personnel should select gowns, gloves, and drape products for the procedure according to the anticipated degree of exposure to blood, body fluids, and other potentially infectious materials.4 Other factors that should be considered by perioperative personnel when selecting surgical gowns, gloves, and drape products for surgical or other invasive procedures include the:
team member’s role.5
For more specific information regarding test methods, the reader should refer to ANSI/AAMI PB70: 2012, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.1
What is the critical zone of a gown or drape and how is this determined?
The critical zone of a surgical gown is the area where direct contact with blood, body fluids, or other potentially infectious materials (OPIM) is most likely to occur.1 The critical zone of a surgical gown includes the front area of the gown from chest to knees and the sleeves from cuff to above the elbow; however, as shown in Figure 1, the exact dimensions of the critical zone are determined by the manufacturer.1 Critical zones may include the seams of the gown and other points of attachment.1 Because areas outside of the critical zone are also subject to contact with blood, body fluids, or OPIM, the entire front of a gown, including its seams and other components, is required to provide at least the minimum barrier performance (ie, Level 1).1 The back of the gown is expected to remain dry, and for this reason there is no liquid barrier performance requirement for that area.1 The materials used for the back of the gown may be made of lighter weight and more breathable materials.1
The critical zone of a surgical drape is the area where direct contact with blood, body fluids, or OPIM is most likely to occur.1 Because areas outside of the critical zone are also subject to contact with blood, body fluids, and OPIM, and because of the variation in patient size, patient positioning, and draping technique, as well as the potential need to expand the surgical site during the procedure, the entire drape is required to provide the minimum barrier performance (ie. Level 1).1
When should perioperative team members change gloves during an invasive procedure?
Surgical gloves worn during invasive surgical procedures should be changed:
after each patient procedure;
when suspected or actual contamination occurs;
after touching surgical helmet system hoods and visors;
after adjusting optic eyepieces on the operative microscope;
immediately after direct contact with methyl methacrylate;
when gloves begin to swell, expand, and become loose on the hands as a result of the material’s absorption of fluids and fats;
when a visible defect or perforation is noted or when a suspected or actual perforation from a needle, suture, bone, or other object occurs; and every 90 to 150 minutes.
Why should perioperative team members double glove during invasive procedures?
Perioperative team members should double glove (ie, wear two pairs of gloves, one over the other) during invasive procedures to:
In addition, using glove perforation indicator systems (ie, a double gloving system comprising a colored pair of surgical gloves worn beneath a standard pair of surgical gloves) can assist the wearer in identifying glove perforations.
Guideline for sharps safety. In: Guidelines for Perioperative Practice. Denver, CO: AORN, Inc; 2016:417-440.
Are there specific recommendations for gowning and gloving for clean-contaminated procedures (ie, tonsillectomy, cystoscopy)?
Can the same sterile field setup be used for two different areas on the same patient if both are classified as clean procedures (eg, anterior and posterior spine)?
How often should a surgical mask be changed?
What should a scrubbed team member do if they sneeze?
Why does a sterile field opened prior to a procedure need to be monitored continuously?