| FAQ - Instruments & Equipment - 2014
I am looking for information on barriers. What thickness is needed for operatory set-up and are they FDA approved?
The 2003 CDC guidelines for infection control in dentistry states the following regarding barrier/surface covers:
Barrier protection of surfaces and equipment can prevent contamination of clinical contact surfaces, but is particularly effective for those that are difficult to clean. Barriers include clear plastic wrap, bags, sheets, tubing, and plastic-backed paper or other materials impervious to moisture (260,288). Because such coverings can become contaminated, they should be removed and discarded between patients, while DHCP are still gloved. After removing the barrier, examine the surface to make sure it did not become soiled inadvertently. The surface needs to be cleaned and disinfected only if contamination is evident. Otherwise, after removing gloves and performing hand hygiene, DHCP should place clean barriers on these surfaces before the next patient (1,2,288).
If barriers are not used, surfaces should be cleaned and disinfected between patients by using an EPA-registered hospital disinfectant with an HIV, HBV claim (i.e., low-level disinfectant) or a tuberculocidal claim (i.e., intermediate-level disinfectant). Intermediate-level disinfectant should be used when the surface is visibly contaminated with blood or OPIM (2,244). Also, general cleaning and disinfection are recommended for clinical contact surfaces, dental unit surfaces, and countertops at the end of daily work activities and are required if surfaces have become contaminated since their last cleaning (13). To facilitate daily cleaning, treatment areas should be kept free of unnecessary equipment and supplies. 1
B. Clinical Contact Surfaces
1. Use surface barriers to protect clinical contact
surfaces, particularly those that are difficult to
clean (e.g., switches on dental chairs) and change
surface barriers between patients (II) (1,2,260,
2. Clean and disinfect clinical contact surfaces that
are not barrier-protected, by using an EPA registered
hospital disinfectant with a low- (i.e.,
HIV and HBV label claims) to intermediate-level
(i.e., tuberculocidal claim) activity after each
patient. Use an intermediate-level disinfectant
if visibly contaminated with blood (IB)
Infection Control and Management of Hazardous Materials for the Dental Team states:
Examples of appropriate materials for surface covers include clear plastic wrap, bags, or tubes, and plastic backed-paper. Some plastics are designed specifically for use as surface covers in the office in that they have the shape of the item to be covered (e.g., air/water syringe handle covers, hose covers, and pen covers). Some sheets of plastic also have a slightly sticky substance on one side to hold them on the surface. Other plastics (e.g., food wraps) have a natural clinging ability on contact with a smooth surface. Some plastic bags are available with drawstrings that hold the bag around an item to be protected. To reduce costs, one can use thin rather than thick plastic sheets or bags, as long as they are not punctured by the surface being covered. Patient bibs are made of plastic-backed paper and also can be used to cover flat operatory surfaces, although thin plastic sheets may be less expensive. 2
It should also be noted that OSHA’s Bloodborne Pathogens Standard states:
Protective coverings, such as plastic wrap, aluminum foil, or imperviously-backed absorbent paper used to cover equipment and environmental surfaces, shall be removed and replaced as soon as feasible when they become overtly contaminated or at the end of the workshift if they may have become contaminated during the shift. 3
And specifically regarding dental radiology, the 2003 CDC guidelines states as follows:
When taking radiographs, the potential to cross-contaminate equipment and environmental surfaces with blood or saliva is high if aseptic technique is not practiced. Gloves should be worn when taking radiographs and handling contaminated film packets. Other PPE (e.g., mask, protective eyewear, and gowns) should be used if spattering of blood or other body fluids is likely (11,13,367). Heat-tolerant versions of intraoral radiograph accessories are available and these semicritical items (e.g., film-holding and positioning devices) should be heat sterilized before patient use.
After exposure of the radiograph and before glove removal, the film should be dried with disposable gauze or a paper towel to remove blood or excess saliva and placed in a container (e.g., disposable cup) for transport to the developing area. Alternatively, if FDA-cleared film barrier pouches are used, the film packets should be carefully removed from the pouch to avoid contamination of the outside film packet and placed in the clean container for transport to the developing area.
Various methods have been recommended for aseptic transport of exposed films to the developing area, and for removing the outer film packet before exposing and developing the film. Other information regarding dental radiography infection control is available (260,367,368). However, care should be taken to avoid contamination of the developing equipment. Protective barriers should be used, or any surfaces that become contaminated should be cleaned and disinfected with an EPA-registered hospital disinfectant of low- (i.e., HIV and HBV claim) to intermediate-level (i.e., tuberculocidal claim) activity. Radiography equipment (e.g., radiograph tube head and control panel) should be protected with surface barriers that are changed after each patient. If barriers are not used, equipment that has come into contact with DHCP’s gloved hands or contaminated film packets should be cleaned and then disinfected after each patient use.
Digital radiography sensors and other high-technology instruments (e.g., intraoral camera, electronic periodontal probe, occlusal analyzers, and lasers) come into contact with mucous membranes and are considered semicritical devices. They should be cleaned and ideally heat-sterilized or high level disinfected between patients. However, these items vary by manufacturer or type of device in their ability to be sterilized or high-level disinfected. Semicritical items that cannot be reprocessed by heat sterilization or high-level disinfection should, at a minimum, be barrier protected by using an FDA cleared barrier to reduce gross contamination during use. Use of a barrier does not always protect from contamination (369– 374). One study determined that a brand of commercially available plastic barriers used to protect dental digital radiography sensors failed at a substantial rate (44%). This rate dropped to 6% when latex finger cots were used in conjunction with the plastic barrier (375). To minimize the potential for device-associated infections, after removing the barrier, the device should be cleaned and disinfected with an patient. Manufacturers should be consulted regarding appropriate barrier and disinfection/sterilization procedures for digital radiography sensors, other high-technology intraoral devices, and computer components. 1
B. Dental Radiology
1. Wear gloves when exposing radiographs and
handling contaminated film packets. Use other
PPE (e.g., protective eyewear, mask, and gown)
as appropriate if spattering of blood or other
body fluids is likely (IA, IC) (11,13).
2. Use heat-tolerant or disposable intraoral devices
whenever possible (e.g., film-holding and positioning
devices). Clean and heat-sterilize heat tolerant
devices between patients. At a
minimum, high-level disinfect semicritical heat sensitive
devices, according to manufacturer’s
instructions (IB) (243).
3. Transport and handle exposed radiographs in an
aseptic manner to prevent contamination of
developing equipment (II).
4. The following apply for digital radiography
a. Use FDA-cleared barriers (IB) (243).
b. Clean and heat-sterilize, or high-level disinfect,
between patients, barrier-protected
semicritical items. If the item cannot tolerate
these procedures then, at a minimum,
protect with an FDA-cleared barrier and
clean and disinfect with an EPA-registered
hospital disinfectant with intermediate-level
(i.e., tuberculocidal claim) activity, between
patients. Consult with the manufacturer for
methods of disinfection and sterilization of
digital radiology sensors and for protection
of associated computer hardware (IB) (243). 1
Infection Control and Management of Hazardous Materials for the Dental Team states regarding the taking of radiographs Use films held within FDA-cleared barrier pouches. And regarding digital radiographic sensors it also states When available, FDA-cleared barriers should always be used as covers. 2
In summary, a variety of products can be used for barrier/surface covers in the dental operatory that need not be FDA approved. However, there are some exceptions (i.e., taking of radiographs and digital radiography sensors) that may specify FDA approved products.
1) Kohn WG, Collins AS, Cleveland JL, Harte JA, Eklund KJ, Malvitz DM, Centers for Disease Control and Prevention (CDC). Guidelines for infection control in dental health-care settings—2003. MMWR Recomm Rep 2003;52(RR-17):1-61. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm Accessed on September 1, 2014.
2) Miller CH. Infection Control and Management of Hazardous Materials for the Dental Team, 5th edition. Elsevier/Mosby Publishers. Pages 153-156 & 189-190.
3) US Department of Labor – Occupational Safety & Health Administration. 1910.1030 - Bloodborne pathogens. https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051 Accessed on September 2, 2014.