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Localized
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Continuing Education Program
An Online Continuing Education Activity
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Welcome to
Localized Temperature Therapy
(An Online Continuing Education Activity)
CONTINUING EDUCATION INSTRUCTIONS
This educational activity is being offered online and may be completed at any time.
Steps for Successful Course Completion
To earn continuing education credit, the participant must complete the following steps:
1. Read the overview and objectives to ensure consistency with your own learning
needs and objectives. At the end of the activity, you will be assessed on the
attainment of each objective.
2. Review the content of the activity, paying particular attention to those areas that
reflect the objectives.
3. Complete the Test Questions. Missed questions will offer the opportunity to re-read
the question and answer choices. You may also revisit relevant content.
4. For additional information on an issue or topic, consult the references.
5. To receive credit for this activity complete the evaluation and registration form.
6. A certificate of completion will be available for you to print at the conclusion.
Pfiedler Enterprises will maintain a record of your continuing education credits and
provide verification, if necessary, for 7 years. Requests for certificates must be
submitted in writing by the learner.
If you have any questions, please call: 720-748-6144.
CONTACT INFORMATION:
© 2014
All rights reserved
Pfiedler Enterprises, 2101 S. Blackhawk Street, Suite 220, Aurora, Colorado 80014
www.pfiedlerenterprises.com Phone: 720-748-6144 Fax: 720-748-6196
Localized Temperature Therapy
(An Online Continuing Education Activity)
OVERVIEW
Localized temperature therapy, the application of heat or cold, has long been recognized
as an effective therapeutic intervention. The appropriate application of localized
temperature therapy has several clinical benefits including pain relief, improved blood
flow and tissue metabolism, removal of wastes and toxins, and reduction in swelling.
There are several therapeutic modalities available today that either use the body’s
natural thermoregulatory mechanisms to relieve pain, encourage healing, or enhance
the body’s ability to maintain a normal core temperature. Therefore, nurses and other
health-care professionals must remain aware of the use of localized temperature therapy
as an effective treatment modality. The purpose of this continuing education activity is to
provide a review of the clinical considerations related to localized temperature therapy.
An overview of the physiologic process of thermoregulation will be presented, followed
by a discussion of the clinical considerations related to the use of localized heat and cold
therapy. Various types of disposable heat and cold therapy products, with a focus on
hot and cold packs, will be described. The applicable federal regulations and practice
guidelines for the manufacture and use of disposable hot and cold packs will be reviewed.
Finally, selected case studies will provide the participant with the opportunity to synthesize
the information and evaluate workplace scenarios in regard to appropriate use of localized
temperature therapy.
Learner Objectives
Upon completion of this continuing education activity, the participant should be able to:
1. Describe the physiologic process of thermoregulation.
2. Discuss the clinical implications related to the safe use of localized temperature
therapy.
3. Differentiate various types of hot and cold therapy products including their
advantages and disadvantages.
4. Identify regulations and guidelines for the manufacture and use of localized
temperature therapy products.
5. Critique workplace scenarios regarding the appropriate use of localized
temperature therapy.
Intended Audience
This continuing education activity is intended for nurses, nursing assistants, and other
health-care professionals in various practice settings who are interested in learning more
about the appropriate use of localized temperature therapy, including its indications,
applications, and safety considerations.
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CREDIT/CREDIT INFORMATION
State Board Approval for Nurses
Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing,
Provider Number CEP14944, for 2.0 contact hours.
Obtaining full credit for this offering depends upon attendance, regardless of circumstances,
from beginning to end. Licensees must provide their license numbers for record keeping
purposes.
The certificate of course completion issued at the conclusion of this course must be
retained in the participant’s records for at least four (4) years as proof of attendance.
IACET
Pfiedler Enterprises has been accredited as an Authorized Provider by the International
Association for Continuing Education and Training (IACET).
CEU Statements
• As an IACET Authorized Provider, Pfiedler Enterprises offers CEUs for its programs
that qualify under the ANSI/IACET Standard.
• Pfiedler Enterprises is authorized by IACET to offer 0.2 CEUs for this program.
Release and Expiration Date:
This continuing education activity was planned and provided in accordance with
accreditation criteria. This material was originally produced in January 2015 and can
no longer be used after January 2017 without being updated; therefore, this continuing
education activity expires January 2017.
Disclaimer
Pfiedler Enterprises does not endorse or promote any commercial product that may be
discussed in this activity.
SUPPORT
Funds to support this activity have been provided by Cardinal Health.
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AUTHORS/PLANNING COMMITTEE/REVIEWER
Rose Moss, RN, MN, CNOR
Nurse Consultant/Author/Planning Committee
Moss Enterprises
Casa Grande, CO
Judith I. Pfister, RN, BSN, MBA
Program Manager/Planning Committee
Pfiedler Enterprises
Aurora, CO
Julia A. Kneedler, RN, MS, EdD
Program Manager/Reviewer
Pfiedler Enterprises
Aurora, CO
DISCLOSURE OF RELATIONSHIPS WITH COMMERCIAL ENTITIES
FOR THOSE IN A POSITION TO CONTROL CONTENT FOR THIS
ACTIVITY
Pfiedler Enterprises has a policy in place for identifying and resolving conflicts of interest
for individuals who control content for an educational activity. Information listed below
is provided to the learner, so that a determination can be made if identified external
interests or influences pose a potential bias of content, recommendations or conclusions.
The intent is full disclosure of those in a position to control content, with a goal of
objectivity, balance and scientific rigor in the activity.
Disclosure includes relevant financial relationships with commercial interests related
to the subject matter that may be presented in this educational activity. “Relevant
financial relationships” are those in any amount, occurring within the past 12 months
that create a conflict of interest. A “commercial interest” is any entity producing,
marketing, reselling, or distributing health care goods or services consumed by, or used
on, patients.
Activity Authors/Planning Committee/Reviewer:
Rose Moss, RN, MN, CNOR
No conflicts of interest
Judith I. Pfister, RN, BSN, MBA
Co-owner of company that receives grant funds from commercial entities
Julia A. Kneedler, RN, MS, EdD
Co-owner of company that receives grant funds from commercial entities
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contact us at:
Phone: 720-748-6144
Email:
[email protected]
Postal Address: 2101 S. Blackhawk Street, Suite 220
Aurora, Colorado 80014
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http://www.pfiedlerenterprises.com
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Introduction
Localized heat and cold therapy are well-known therapeutic interventions with numerous
clinical applications, including relief of localized pain, stiffness, or aching; reduction in
inflammation and swelling; decrease in muscle spasm and tightness; and control of
bleeding. Heat and cold therapies are based on the same principles, but are on opposite
ends of the spectrum, as they produce opposite effects. Heat increases circulation and
blood flow, while cold decreases blood flow and slows down the body’s metabolism as well
as its oxygen demand.
Today, localized temperature therapy continues to play a role in safe, cost-effective patient
care. Therefore, it is necessary for health-care professionals to have an understanding of
the mechanisms of action and efficacy of therapeutic heat and cold, as well as the various
products available today, in order to recognize which patients would benefit from which
modality. Equally important is understanding who might be prone to adverse effects and
how to promote safe usage practices.
Normal Thermoregulation 1,2,3,
In order to understand and use localized heat and cold therapy most effectively, it is first
necessary to review the process of normal thermoregulation in the human body.
The human body consists of a peripheral shell and a central core. The heat content of
the human body is reflected by its temperature. The mean core temperature is 37° C
(98.6° F) in healthy adults at rest, but small children have larger daily variations. The
core temperature is rather constant in the deeper parts of the body; however, the core
temperature may vary several degrees Celsius between different regions of the body,
depending on the cellular activity. Warm-blooded animals (e.g., homeotherms such as
humans), have a temperature control system and thereby maintain a rather constant core
temperature. Their metabolism can change in order to keep heat production equal to heat
loss.
Thermoregulation, like many physiological control systems, is dependent upon various
levels of positive and negative feedback in order to minimize variations from the normal
status. Temperature is regulated by signals derived from nearly every type of tissue,
including the hypothalamus, spinal cord, deep core tissues, and the surface of the skin.
The processing of thermoregulatory information occurs in three phases: afferent thermal
sensing, central regulation, and efferent response, as described below:
• Afferent thermal sensing. Afferent nerve impulses from anatomically distinct
cold and warmth skin receptors pass to the central nervous system through the
peripheral and sympathetic nerves and return by the efferent pathway to other
parts of the body. Although the skin contains both cold and warmth receptors, there
are 10 times as many cold receptors as warmth receptors.
• Central regulation. The body’s central control mechanism (i.e., its thermostat) is
located in the hypothalamus, which has three functions in temperature regulation:
◦◦ Integration of thermal signals from both peripheral and core structures;
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◦◦ Comparison of mean body temperature with the predetermined threshold, i.e.,
the narrow temperature range across which there is no efferent response; and
◦◦ Coordination of the appropriate efferent response.
How the body determines absolute threshold temperatures is unknown, but the
thresholds vary daily in both sexes by approximately 1° C with the circadian
rhythm and monthly in women by approximately 0.5° C. Exercise, food intake,
infection, hypothyroidism and hyperthyroidism, drugs (including alcohol,
sedatives, and nicotine), as well as cold and warm adaptation alter threshold
temperatures. Central temperature regulation is intact from infancy, but may be
impaired in premies or in the elderly or extremely ill patients.
• Efferent response. Efferent responses to heat and cold include cutaneous
vasodilation or vasoconstriction, piloerection, sweating, and shivering.
If the arterial blood flowing through the thermoregulatory center in the
hypothalamus is above the temperature threshold, the hypothalamus initiates
impulses that cause heat loss through vasodilation and sweating. Vasodilation of
the cutaneous vessels allows greater volumes of blood to reach the skin surface
and thereby dissipates excess heat. Sweating cools the body through evaporative
cooling. Sweating is the only mechanism by which humans can lose heat in an
environment in which the ambient temperature exceeds core body temperature.
A blood temperature that is below the temperature threshold causes the
hypothalamus to relay impulses that result in vasoconstriction, thereby decreasing
blood flow to the periphery and consequently reducing heat loss. In the pilomotor
response, the hairs become more erect to create a layer of still air that reduces
convective heat loss.
Shivering generates heat through an increase in the chemical reactions required
for muscle activity. Vigorous shivering approximately doubles metabolic heat
production; however, this level of intensity cannot be maintained for very long.
The overall efficiency of shivering thermogenesis is somewhat lower than
expected because muscle metabolism increases blood flow to the peripheral
tissues and consequently, heat is lost to the environment.
Nonshivering thermogenesis increases metabolic heat production without
producing mechanical work via brown adipose tissue oxidation. Nonshivering
thermogenesis increases heat production approximately 100% in infants, but only
slightly in adults because the amount of brown adipose tissue in adults is small.
The skin, the largest organ of the human body, is the primary heat exchanger, and
maintains the normal body temperature of 37 °C (98.6° F); however, the normal
temperature of skin is approximately 33 °C (91 °F). The skin temperature is determined
by both the core body temperature as well as the environment (e.g., ambient
temperature, humidity, and air velocity). Thus, the skin temperature is essentially
determined by the needs of the body to exchange heat energy.
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Localized Temperature Therapy
Heat and cold therapies are the two most common types of passive, non-invasive, and nonaddictive treatment modalities still widely used in health care today. The application of heat
and cold is usually a nursing responsibility. While localized temperature therapy can be quite
effective when used properly, it can cause discomfort and even injury when the principles for
their use are not followed properly. The clinician must be knowledgeable of the physiologic
principles for the effective use of heat and cold in order to implement the therapy safely and
maximize its benefits. In addition, the health care worker must be able to teach and supervise
other staff members, patients and their families in the use of therapeutic heat and cold
modalities. This section will provide a review of the clinical considerations and applications of
these modalities, with a focus on localized, disposable heat and cold therapy packs.
Heat Therapy4,5,6,7,8,9,10,11
Overview
Heat treatments are defined as therapeutic applications of superficial or deep-heating
agents to areas of the body. As noted above, some conditions benefit from the application
of heat. Heat causes vasodilation of the blood vessels, which increases blood flow to the
area of application. This in turn, increases the amount of oxygen, nutrients, and white blood
cells delivered to the body tissues. In addition, vasodilation assists in the removal of waste
products from injured tissues, such as debris from phagocytosis.
There are two types of heat treatments: superficial and deep. Superficial heat treatments
are applied to the skin over the involved area. The depth of heat depends on types of tissue
and ranges from 0.19 in (0.5 cm) to 0.39–0.78 in (1–2 cm). Heat depth also depends on the
amount of fat in the area, as fat is an insulator. Several factors determine the extent of the
physiologic response to heat, including the following:
• Level of the tissue temperature (usually 40-45º C [104 - 113º F]);
• Duration of the tissue temperature increase;
• Rate of increase in the tissue temperature; and
• Size of the area being treated.
In contrast to deep heating modalities, localized heating modalities usually do not heat deep
tissues, including muscles, because the subcutaneous layer of fat beneath the skin surface
acts as a thermal insulator as noted above, and therefore inhibits the transfer of heat. In
addition, increased cutaneous blood flow from superficial heating causes a cooling reaction
as it removes the heat that is applied externally. In general, the transfer of heat, regardless
of whether it is used for heating or cooling purposes, is often classified into the following four
types of heat transfer:
• Conduction–Conductive heating is defined as heat transfer from one point to another
without noticeable movement in the conducting medium. Typically, direct contact
takes place between the heat source and the target tissues. Superficial heat is
usually conductive heat (e.g., hot water baths, hot packs, electric heating pads, warm
compresses).
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• Convection–Convective heating is the form of heating that is created by the
movement of the transferring heating medium, usually air or a fluid. Methods
for providing convective superficial heat include a whirlpool, moist air baths,
and hot air baths.
• Conversion–Conversion heating involves the conversion of one energy form
(e.g., light or sound) into another form of energy (e.g., heat). Superficial heat
is produced by heat lamps or radiant lights, with heat being transferred when
the conveying medium (i.e., the light energy) is converted to heat energy at the
skin surface.
• Radiant–Radiant heat loss is the loss of heat to the environment due to the
temperature gradient. Heat radiates away from the body if the skin temperature
is greater than the temperature of the surrounding environment.
Indications
The application of heat is used therapeutically to:
• Relieve localized pain, stiffness, or aching, especially of joints and muscles;
• Decrease muscle spasm and tightness;
• Increase muscle flexibility;
• Increase blood flow to the area, thus aiding wound healing;
• Promote wound drainage;
• Reduce inflammation;
• Increase the body’s temperature; and
• Increase comfort for the patient who states that he/she is chilled.
Contraindications and Adverse Effects from Misuse
Therapeutic heat treatments are contraindicated in patients who have bleeding or
recent hemorrhage, an acute inflammatory process, or localized infection near the
point of application. In cases of infection, heat may cause the area to rupture, resulting
in systemic spread of the infection, which may be life-threatening. The application of
heat over a large area of the body can cause hypotension and therefore should be
used with caution in patients taking certain cardiac and antihypertensive medications.
In addition, heat treatments should not be used over areas of malignancy, decreased
sensation, or vascular disease. Also, localized heat therapy should be used with
caution on patients with heart, lung, or kidney diseases. Deep heat treatments should
not be used on areas above the eye, heart, or on a pregnant patient. Deep heat
treatments over areas with metal surgical implants should be avoided in case of rapid
temperature increase of the metal and the potential for injury.
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Because heat must be fairly intense in order to produce the desired therapeutic effect,
burns may result if the heat is applied improperly or for too long. The temperature
must be hot enough to achieve its purpose, but maintained within a safe temperature
range.
All heat treatments have the potential of tissue damage resulting from excessive
temperatures. Proper insulation and treatment duration should be carefully
administered for each heating modality. Overexposure during a superficial heat
treatment may result in redness, blisters, burns, or reduced blood circulation.
Additionally, heat therapy may produce hot spots and therefore is contraindicated for
patients with metal implants.
Heat therapy should be used with caution in patients with diabetes mellitus, multiple
sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis because it may
cause disease progression, burns, skin ulceration, and increased inflammation. When
using heat therapy, the skin should be protected in heat-sensitive or high-risk patients,
especially over regions with sensory deficits. Caution should be used with products
that generate high intensity heat (greater than 45ºC), such as with hot packs or electric
heating pads; the application time should be restricted for modalities that heat to high
intensity levels.
Considerations for Safe Use
Heat produces pain and tissue damage at tissue temperatures of 113° F (45° C);
therefore, heat therapy with a temperature of greater than 110° F (43° C) should not
be used to warm patients due to the risk of burning the skin. In order to be both safe
and effective, heat therapy should consistently deliver the highest safe temperature
possible without exceeding the tolerance level of the patient’s skin.
Nurses and other health-care professionals must realize that there are metabolic,
vascular, and connective tissue effects secondary to therapeutic heat treatments.
When heat is required for deep structures such as deep into a joint, deep heat is
appropriate. Superficial heating methods are variable and depend on both the area
and goal of the heat treatment.
Nurses and other health-care professionals may also need to provide patients with
instructions on home therapeutic treatments, as there are many heating agents
available commercially. Patients and their families need to be educated on the specific
precautions, heating times per day, duration of heating, proper positioning, and any
specific instructions related to their physical condition/pathology.
Additional clinical considerations regarding the safe use of heat therapy include:
• Heat is applied only when specifically ordered by the primary health-care
provider and done so with caution. The nerves in the skin may become
sensitized and numbed, so the patient may not feel the pain of a burn,
especially if heat has been applied frequently.
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• Specific body parts, such as the eyelids, neck, and inside of the arms, are
particularly sensitive to heat.
• Each patient has his/her own individual sensitivity to heat; therefore, the nurse
should assess the patient for his/her heat sensitivity. In addition, the heat should
be applied slowly and the patient’s reaction assessed. This will help the nurse
determine how much heat the patient can tolerate and for how long.
• Infants, elderly patients, and those with thin, fair skin have a lowered resistance to
heat.
• Patients who are unresponsive, anesthetized, and those with neurological and
psychological disorders or dementia are also at higher risk for injury due to the
application of heat, as these patients are often unable to report when the heat is too
intense.
• Impaired circulation and some metabolic diseases (e.g., peripheral vascular disease,
or diabetes) increase the patient’s susceptibility to burns.
• Patients undergoing chemotherapy or radiation therapy for cancer, as well as those
with any degree of paralysis, are particularly susceptible to burns.
• Always read and follow the manufacturer’s written instructions for the safe use of all
heat therapy treatment modalities.
It is important to note that patient complaints should be taken seriously. Every patient’s
tolerance is different and only he/she can report how the therapy feels. If the patient
complains of pain or discomfort, the therapy should be stopped immediately and the primary
health-care provider consulted.
Localized Heat Therapy Products
Localized heat therapy is available in many forms today, including hot water bottles, warm
moist compresses, electric heating pads, heat lamps, paraffin baths, hydrotherapy, and
commercially manufactured chemical/gel hot packs. Each of these is described in detail
below.
• A hot water bottle is a form of superficial heat treatment. The bottle is typically filled
half way with hot water, covered with a protective toweling, and then placed on the
treatment area where it remains until the water has cooled.
• Warm, moist compresses are also used to apply heat to either a small or large area.
• Electrical heating pads continue to be used primarily as a home treatment, as safety
and convenience issues have limited their use in health-care settings.
• Heat lamps provide heat therapy via an infrared heat lamp. Care must be taken to
avoid burns; they should not be used in patients with a severe heart, liver, or kidney
disorder, peripheral vascular disease, or reduced skin sensation.
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• A paraffin bath involves dipping, immersion, or painting of the affected body part
with melted wax. It is used primarily for small joints, such as those of the hand,
knee, or elbow; it should not be used for open wounds.
• Hydrotherapy involves immersion in agitated warm water in a large industrial
whirlpool. Hydrotherapy enhances wound healing by stimulating blood flow and
facilitating debridement of burns and wounds; it also is used to relax muscles
and relieve pain.
• More recently, several manufacturers have developed disposable, single-use
chemical hot packs for use in the health-care setting. Instant hot packs work
in one of two ways. Hot packs that utilize supersaturated aqueous sodium
thiosulfate within an inner pouch are activated by squeezing the pack to rupture
the inner pouch. When the inner pouch is ruptured, the solution is exposed to
particles within the pack, causing the sodium thiosulfate solution to crystallize
rapidly and release heat for 20-30 minutes. Figure 1 depicts the sodium
thiosulfate type of localized heat product.
Figure 1. Sodium Thiosulfate Hot Pack.
Hot packs that utilize magnesium sulfate contain an inner pouch of water
and granules of the chemical loose within the pack. When the water pouch
is ruptured, the granules begin to dissolve, releasing heat. The rate at which
heat is released is less controlled with this method, as the chemical dissolves
at different rates depending on a variety of factors. Punctured commercial hot
packs should be discarded immediately and the skin washed, as the chemical
agent can burn the skin. Table 1 and 2 compare the efficacy and costs of the two
types of packs.
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Table 1 – Comparison of Sodium Thiosulfate and Magnesium Sulfate Hot Packs
Chemical Name
Hot Pack
Manufacturing
Process
Chemical Cost
Temperature Pattern
Sodium Thiosulfate
More expensive
More difficult
Consistent
temperature near
110° F (43°C)
Magnesium Sulfate
Less expensive
Less difficult
Starts very hot;
temperature
decreases rapidly
Table 2 – Sample Cost Comparison of a Single Heat Therapy Treatment Utilizing
Sodium Thiosulfate and Magnesium Sulfate Hot Packs
Cost Analysis
Sodium Thiosulfate
Magnesium Sulfate
Price per Hot Pack
$ 1.00
$ 0.70
Packs per Treatment
1
2
$ 1.00
$ 1.40
N/A
$ 0.85
$ 1.00
$ 2.25
Subtotal
Disposable Cover
Total
Specialty Applications: Neonatal Heat Therapy
In addition to the general indications noted above for disposable heat packs, there are also
specialty applications for various aspects of neonatal warming. For example, disposable
infant heel warmers can be used to help increase the infant’s blood flow to facilitate a quality
heel stick without repeated attempts. Warming the area also reduces hemolysis and bruising;
moreover, hematocrit and capillary blood gas samples collected from unwarmed heels are
less accurate.4 Figure 2 illustrates the infant heel warmers.
Figure 2. Infant Heel Warmer.
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In some clinical practice settings, infant heel warming is often accomplished without the
use of infant heel warmers by methods such as a glove filled with warm water, wrapping
the site with a towel or diaper that has been moistened with warm water, using fluids
or other products warmed in a microwave oven, or even using one’s hands against the
heel. All of these methods are ineffective and may be problematic in that they provide an
inexact temperature, which may not be warm enough in some instances or may be too
hot and present a burn risk; or they may be a source of cross-contamination. As will be
discussed below, commercially prepared heel warmers are regulated as Class 1 medical
devices by the United States Food and Drug Administration (FDA) with strict temperature
controls, thereby offering a more reliable method of temperature-regulated heel warming.
In addition to infant heel warmers, specialized disposable neonatal warming mattresses
provide an effective method to prevent hypothermia and are used for transportation of
neonatal patients within a facility or between facilities, as they eliminate the need for
electricity or wires and helps absorb vibration during transport. Some mattresses are
also available without metal components, making them safe for use during radiologic
procedures, including magnetic resonance imaging (MRI). Figure 3 shows an example
of an infant warming mattress.
Figure 3. Infant Warming Mattress.
Cold Therapy4, 12, 13, 10
Overview
Cold therapy produces vasoconstriction, which reduces circulation to the affected area,
thereby slowing the body’s metabolism as well as its demand for oxygen. The application
of cold prevents the escape of heat from the body, which also relieves congestion and
often relieves muscle spasm. In general, the therapeutic goals of cold therapy include
controlling hemorrhage, preventing edema, reducing inflammation, and blocking pain
receptors.
Cold therapy is more effective than heat for soft tissue injuries and sprains and is the
preferred treatment within the first 48 hours after the injury. Cold therapy is applied to
prevent additional swelling; however, it will not reduce the edema that is already present.
Cold therapy should be applied as ordered, usually for 15-20 minutes.
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During cold therapy, a drop in skin temperature is almost immediate, followed quickly by
a fall in subcutaneous temperature. Deeper structures are much less efficiently cooled.
The patient initially perceives a sensation of cold, then an ache or burning, and finally
cutaneous anesthesia. The analgesic effects are mediated by cold’s effect on nerves and
nerve endings, by its counterirritant effects and by reduction of metabolic activity. All nerve
fiber types are affected by cold. For example, small myelinated (pain) fibers are affected
first, then large myelinated fibers, then unmyelinated fibers. Nerve conduction velocity
decreases proportionately to decreasing temperature; cold also increases the time of the
nerve’s recovery cycle after excitation and increases the refractory period.
Cooling below 68°F (20°C ) reduces acetylcholine production, which helps relieve muscle
spasms and promotes comfort.
In patients who have less than 1 cm of subcutaneous fat, the temperature at 1 cm muscle
depth drops 3.6-5.4° F (2-3° C ) with 10 minutes of cold application via an ice bag.
However, patients who have more than 2 cm of fat experience little change in muscle
temperature, even at a muscle depth of 1 cm. The greatest reductions in temperature are
achieved with ice water immersion. Rewarming takes a long time due to vasoconstriction;
return to baseline temperature can take over one hour.
Severe reactions to cold are rare; they are related to hypersensitivity reactions and include
the release of histamine (i.e., cold urticaria), generalized symptoms from cold hemolysis
and agglutinins, and a generalized reaction from cryoglobulins.
Indications
The application of cold is used therapeutically to:
• Reduce or stop bleeding;
• Slow bacterial activity in patients with infections;
• Relieve postoperative pain following some types of surgical procedures, tooth
extractions, headaches, or muscle or joint injury;
• Prevent swelling in injured tissues, including fractures and sprains;
• Prevent peristalsis in patients with abdominal inflammation;
• Relieve pain in engorged breasts;
• Control pain and fluid loss in the initial treatment of burns; and
• Diminish muscle contraction and spasm.
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Contraindications
Cold is contraindicated for patients who have developed hypertension during cold
treatment, due to secondary vasoconstriction, or have a cold allergy (e.g., hives,
joint pain) or cryoglobulinemia, or any disease that produces a marked cold pressure
response. Cold should not be applied to areas of reduced skin sensitivity or to tissues
with vascular impairment. Therefore, it is contraindicated in patients who have Raynaud’s
syndrome, rheumatoid arthritis, local limb ischemia, arteriosclerosis, peripheral vascular
disease, or sickle cell anemia, as cold can further impair local blood flow.
Adverse Effects from Misuse
Prolonged exposure to temperatures below freezing will lead to freezing of tissue.
Cold should not be used at temperatures less than 37.4 - 39.2° F (3 - 4° C). Pain from
cooling is generally felt at tissue temperatures at or below 64.4° F (18° C). Some newer
brands of cold packs are designed for direct tissue applications; however, with older
brands, the ice pack should not be applied directly to the skin. Be sure to consult with
the manufacturer’s instructions. Unless direct application is indicated by the instructions
for use for the cold agent, a barrier, such as a towel, should be placed between the cold
agent and the skin’s surface to prevent skin and nerve damage.
As noted, cold therapy can block pain receptors, which is often used to facilitate activity
in an injured limb. However, caution should be exercised with these patients, since the
analgesic effect may allow the patient to exceed his/her desired activity level, and cause
undesirable tissue damage.
Nursing Considerations for Safe Use
Additional clinical considerations regarding the safe use of cold therapy include:
• Patient complaints of numbness in the area of the cold therapy application, along
with the skin appearing blanched or spotty, indicate the need to discontinue the
therapy. The primary health-care provider should be consulted.
• Continued application of cold affects deeper tissues; therefore it is vital that the
patient is monitored closely.
• Cold packs with crystals can become very cold and as a result, can cause the
tissue to freeze very quickly. Therefore, caution should be used when applying
these products.
• Read and follow the manufacturer’s written instructions for the safe use of all cold
therapy treatment modalities.
• Punctured commercial cold packs should be discarded immediately, as the
chemical agent/gel will burn the skin of either the patient or the health-care
professional. In addition any skin that has come in contact with the punctured cold
packs should be washed.
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Localized Cold Therapy Products
Localized cold therapy is available in many forms, including vapocoolant sprays,
refrigerant inflatable bladders, thermal cooling blankets, and disposable ice bags and
cold packs.
• Vapocoolant sprays can drop skin temperatures sharply, e.g., to 45° F (7.2° C)
and should be applied intermittently for 15 to 30 minutes. The temperatures
in muscle 1¼ inches deep and intraarticular knee temperatures can drop
approximately 9° F (5° C). Vapocoolant sprays have generated some concern
because they contain chlorofluorocarbons that can harm the ozone layer.
• Refrigerant inflatable bladders combine cold and compression, which is often
more effective than cryotherapy alone; however, the cryotherapy value of the
bladders is considered minimal.
• Thermal cooling blankets have improved postoperative treatment for some
patients. Patients receiving treatment with cooling blankets have had better
outcomes regarding effusion, ambulation, use of narcotics, range of motion,
quadriceps function, and pain.
• Ice, applied in ice bags, is an effective and inexpensive method of cold therapy.
Disposable ice bags are available in a variety of specialized sizes, shapes, and
design for areas that have been hard to cover with traditional ice bags, such as
the limbs, abdomen, eyes, face, and perineum. Many are available with various
options to keep bags in place, including ties and elastic straps and with an outer
covering to protect the skin and avoid nerve injury and frostbite. Figure 4 shows a
variety of ice bags used for cold therapy.
Figure 4. Ice Bags.
• Disposable, single-use endothermic reaction chemical cold packs are also
available for use in the health-care setting today. Cold packs are available
commercially in many sizes and shapes, often with laminated materials for added
strength and insulation.
18
The chemical ammonium nitrate is most often used in cold packs because it dissolves
in water endothermically, i.e., it absorbs heat when dissolved. In the disposable packs,
deionized water and ammonium nitrate are kept in separate compartments until the pack
is needed. As with a disposable hot pack, the cold pack is also activated by breaking
the seal on the pouch containing the water and then shaking it vigorously; by this action,
the ammonium nitrate dissolves in the water, thereby absorbing heat and starting the
endothermic reaction. The freezing agent stabilizes at approximately 33° F (0.56° C);
the pack stays cold longer than ice with an approximate duration of 30 minutes. Other
chemicals besides ammonium nitrate that can be used in the manufacture of cold
packs include calcium chloride, sodium chloride, and ammonium chloride. However,
ammonium nitrate is the most commonly used chemical in cold packs because it is highly
water soluble and the solution becomes very cold more quickly.
Specialty Applications: Postpartum Care4
One specialty application of cold packs is maternal postpartum care, during the early
postpartum period. Applying ice or a cold pack to the perineum during the first 24 hours
after birth helps prevent perineal edema and the possibility of hematoma formation,
thereby reducing pain and promoting healing and patient comfort. However, the
application of cold after the first 24 hours is no longer therapeutic; after this time, healing
is facilitated if circulation to the area is increased with the use of heat.
Commercial cold packs combined with absorbent perineal pads are now available.
Perineal cold packs typically activate instantly and provide a safe and controlled
temperature for approximately 30 minutes. Available as an all-in-one design, the packs
are cost effective, as they help to reduce nursing time and also eliminate the need for
additional supplies and linens. Premium perineal pads are anatomically shaped, have
an adhesive tape to secure the pad to garments that hold the pack securely against
the perineum, and have a plastic backing to prevent strike-through and subsequent
contamination of linens. Utilizing individually wrapped commercial cold packs instead of
home remedy ice methods allows for a lesser degree of cross-contamination, which is
important, given that the perineum may be compromised from episiotomy or tearing while
giving birth. Avoid self designed ice packs.
Similarities and Differences of Hot and Cold Therapy15
As previously described, modalities for the application of heat and cold can be used
effectively for a variety of clinical conditions. Because many patients can benefit
from the use of both of these modalities, it is helpful to review their similarities and
differences. Their similarities include that they both decrease muscle spasm secondary
to musculoskeletal pathology or nerve root irritation. They also cause analgesia. The
significant differences between the physiologic effects of heat and cold therapy are as
follows:
• Cooled muscle requires a longer time to return to normal temperature. Because
the application of heat increases blood flow, a heated muscle returns to normal
temperature after a few minutes.
19
• The application of heat for the relief of muscle spasm is secondary to muscle
hyperemia, which reduces muscle spasm–induced ischemia/pain and interrupts
this vicious cycle.
• Increased tissue metabolism occurs with an elevation in temperature; conversely,
metabolism is decreased by cold therapy modalities.
• Blood flow increases with heat and decreases with cold.
• The tendency to bleed increases with heat and decreases with cold.
• The formation of edema is facilitated by heat and is decreased by cooling.
• Immediate cooling of burns is beneficial; however, frostbite is treated by rapid
warming.
• Joint stiffness decreases with heating; increases with cooling.
• Due to blood pooling, orthostatic hypotension is produced by the application of
heat to large parts of the body. With the application of cold therapy, hypotension is
decreased secondary to vasoconstriction. Figure 5 illustrates the types of hot and
cold packs.
Figure 5. Instant hot, cold and reusable gel packs.
In order to provide safe, therapeutic care to the patient receiving localized heat and cold
therapy, it is important to adhere to certain basic physiological principles as outlined in
Table 3.
20
Table 3 – Principles for Safe and Effective Application of Heat and Cold Therapy16
Physiological Principles
Implications
1. Nerve receptors for heat and cold
adapt readily if the stimulus is not
extreme.
1. Once receptors adapt, the patient may be unaware
of temperature extremes until tissue damage occurs.
Explain to patient and caution not to increase the heat
or cold.
2. Tolerance of temperature varies with
the individual. Certain areas of the body
are more tolerant to temperature than
others.
2. Apply heat and cold well within safety range of
temperature. Observe skin for sensitivity regardless of
temperature used.
3. Water conducts heat better than air.
3. Moist heat such as a warm, wet dressing must be
applied at a lower temperature than dry heat.
4. The condition of the patient can alter
his tolerance to heat and cold.
4. The very old and very young do not tolerate heat well.
Special care is required for debilitated or unconscious
patients.
Patients with disturbances in circulation are more
sensitive to heat and cold. It may be contraindicated or
temperatures must be less extreme than normally used.
5. Cold immediately constricts blood
vessels.
Prolonged use causes dilation of
vessels.
Heat immediately dilates blood vessels,
but vessels constrict with prolonged
application.
5. Various applications differ in recommended length of
application.
However, 15 to 30 minutes is the usual length of time for
application, but may be up to one hour, followed by at
least one hour before reapplying.
6. The skin is the body’s first line of
defense against infection.
6. Heat or cold applied to open wounds or lesions that
may rupture demands the use of sterile technique.
Special Considerations for Pediatric Patients17,11
It is important to remember that children are not simply “small adults”. For this reason,
there are special considerations for both heat and cold therapy. The local application of
either heat or cold therapy should never be applied to pediatric patients without a specific
order. Once the order is written, the nurse is responsible for applying the treatment,
closely monitoring the effects of the treatment, and documenting those observations.
Documentation parameters for both cold and heat therapy include the type of therapy,
start time, duration of therapy, and the condition of the skin before and after the
application.
With the use of heat therapy, tissue damage can occur, particularly in fair-skinned
children or those who have experienced sensory loss or impaired circulation. Children
should be closely monitored and none should receive heat treatments longer than 20
minutes at a time, unless specifically ordered. Moist heat produces quicker results than
does dry heat and is usually applied in the form of a warm compress or soak. Dry heat
is applied via an electric heating pad, a water-circulating blanket, or an infant-specific
21
instant warming mattress. The use of instant hot packs may be advised; but, be sure to
check with your individual manufacturer. Hot water bottles are not recommended due to
the occurrence of burns associated with improper use. An electric heating pad or watercirculating blanket should be covered with a pillow case, towel, or stockinette. General
clinical guidelines for the use of warming measures in pediatric patients include:
• A child’s temperature should be maintained between 97.7° and 99.5° F (36.537.5° C).
• A preterm infant’s temperature should maintained between 97.3° and 98.9°
F(36.3-36.9° C).
• Hypothermia is considered to be a body temperature below 97.2° F (36.2° C) and
may occur in premature infants and in children with intracranial birth injury, shock,
critical illness, or those under heavy sedation.
• All preterm infants should be maintained under a radiant warmer or in an isolette
until they can maintain their body temperature within a normal range without
adjunct therapy.
• Warming measures should be initiated when a child’s axillary temperature is less
than or equal to 97.2° F (36.2° C).
• A child’s temperature should be closely monitored while warming measures are in
use and until it has returned to within normal parameters.
• Profoundly hypothermic children should be placed on a cardiorespiratory monitor.
• An infant’s head and feet should be covered; the infant’s head represents a large
percentage of the body surface area, therefore heat can be lost rapidly if the head
remains uncovered.
As with heat, intervals of approximately 20 minutes are recommended for both dry cold
(e.g., ice bags and commercial instant-cold preparations) as well as moist cold (e.g., cold
compresses, soaks, or baths). Dry cold applications should be lightly covered to protect
the child’s skin from direct contact. Because cold decreases circulation, prolonged
contact can result in frostbite or gangrene. The child’s skin should be inspected before
and after the application of cold therapy in order to detect redness or irritation. With the
application of either heat or cold therapy in pediatric patients, facility-specific policies and
procedures should always be followed.
Regulations and Guidelines Regarding the Manufacture and Use of Disposable Localized
Temperature Therapy Products
It is also important that health-care professionals maintain awareness of the regulations
regarding manufacture of disposable localized temperature therapy products, the current
economic implications of hospital-acquired burns, and applicable guidelines for their use.
The United States FDA regulates the manufacture of heat and cold therapy products in
its Guidance Document for the Preparation of Premarket Notification [510(k)] Applications
22
for Heating and Cooling Devices.18 The FDA defines a hot or cold disposable pack as a
device intended for medical purposes that consists of a sealed plastic bag incorporating
chemicals that, upon activation, provides hot or cold therapy for body surfaces; they are
classified as Class I medical devices. Except when intended for use on infants, these
devices are exempt from the FDA’s premarket notification procedures.
Safety Concerns and CMS Reimbursement Implications
While the safety of patients has always been the primary concern for all health-care
professionals, it has recently become even more important from a financial standpoint.
Effective October 1, 2008, the Centers for Medicare & Medicaid Services (CMS) has
classified a burn acquired within a facility as a non-reimbursable secondary diagnosis.
CMS routinely identifies hospital-acquired conditions that: 19
• Are high cost or high volume or both;
• Result in the assignment of a case to a diagnosis-related group (DRG) that has a
higher payment when it is present as a secondary diagnosis; and
• Could reasonably have been prevented through the application of
evidence‑based guidelines.
Once a hospital-acquired condition is identified, hospitals no longer receive additional
payment for that condition. In other words, if a condition is not present upon admission,
but is subsequently acquired during the course of the patient’s hospital stay, Medicare
no longer pays the additional costs of the hospitalization; in addition, the patient is not
responsible for the additional costs. The changes to these payment provisions provide
additional incentives for health-care facilities to improve the quality of care delivered to
Medicare patients by focusing efforts on preventing hospital-acquired patient burns.
Recently, the American College of Physicians and the American Pain Society issued
a joint clinical practice guideline for the treatment of low back pain.20 In this guideline,
the application of superficial heat was found to have good clinical evidence and was
determined to have a moderate net benefit; therefore, the panel recommended that
clinicians consider offering the therapy to eligible patients. Specifically, the panel found
that the intervention improves health outcomes and concludes that benefits moderately
outweigh harms, or that benefits are small but there are no significant harms, costs, or
burdens associated with the intervention.
23
Summary
Localized applications of heat and cold are well-known therapeutic interventions that are
indicated for a variety of clinical conditions, including patients suffering sports-related
injuries and arthritic conditions. Because localized temperature therapy continues to play
a role in safe, cost-effective patient care, it is essential that health-care professionals
have an understanding of the human thermoregulatory process, as well as the principles
of heat and cold therapy in order to maximize their benefits. There are several modalities
available to achieve localized temperature therapy. Today, disposable hot and cold packs
are convenient, as well as cost-effective, and can be used for a variety of therapeutic
applications in numerous practice settings. A thorough understanding of the principles
of heat and cold therapy, the associated clinical considerations for safe use, and the
products available today will enable health-care professionals to provide safe, quality
patient care and ultimately promote positive patient outcomes.
24
Case Studies
The following case studies are presented to allow the learner to synthesize and apply the
concepts discussed to workplace scenarios. Read the scenarios carefully, integrating the
data and information to discuss the points to consider.
Case Study 1: Too Hot for Comfort
Deb Bowers, RN is working the day shift and caring for Mrs. JR on the general medical
unit of County General Hospital. Mrs. JR is an 86-year-old female who was admitted
from the emergency department (ED) with a urinary tract infection (UTI) and rule out
stroke. She is currently receiving intravenous (IV) therapy for the UTI while hospitalized
for additional diagnostic tests; she has type II diabetes, hypertension, and moderate
aortic valve stenosis. During the night shift, the IV catheter that was placed in Mrs. JR’s
left forearm in the ED infiltrated; Deb is preparing to restart the IV in time for the next
dose of antibiotics.
In Deb’s initial assessment of Mrs. JR’s arms, she does not see many “good” veins;
Mrs. JR stated that the ED nurse had trouble starting the IV and it “hurt a lot.” Since it
was two hours before the next scheduled antibiotic administration, before proceeding,
Deb obtained two disposable hot packs to apply to Mrs. JR’s forearms. She noticed
that the hot packs on the supply cart were slightly different than the ones she had used
in the past; but after a quick look at the packaging, Deb decided they were essentially
the same as the previous ones. Deb proceeded to activate and apply two warm packs,
one to each of Mrs. JR’s forearms and went on to assess her other patients. After
approximately one hour, Jonathan Richards, CNA informed Deb that he answered Mrs.
JR’s call light at which time she said her arms were hot and starting to hurt.
Upon reassessing Mrs. JR’s forearms, she again states that her arms feel very warm and
have been hurting. When Deb removed the packs, she noted a small, fluid-filled blister
measuring approximately 1 cm by 2 cm on Mrs. JR’s right anterior forearm and another
fluid-filled blister measuring approximately 2 cm x 0.5 cm was noted on her left posterior
forearm.
Points to Consider:
1. What are the important clinical considerations in this scenario?
2. What steps should Deb take next?
3. What should Deb have done differently?
Discussion of Points to Consider:
1. What are the important clinical considerations in this scenario?
- Application of heat therapy in an effort to enhance vasodilation and facilitate
ease of IV insertion.
25
- Mrs. JR’s physical status and medical history: elderly, diabetes; hypertension;
aortic valve stenosis – all of these are indicative of impaired circulation, which
lower her resistance to heat and also increase her susceptibility to burns.
- Mrs. JR’s complaints: Mrs. JR complained that the hot pack was too hot; all
patient complaints should be taken seriously.
2. What steps should Deb take next?
- Clean and cover both sites with a dressing.
- Start the IV in another site.
- Notify the physician for additional orders or change in the plan of care.
What should Deb have done differently?
- Because every patient has his/her own individual sensitivity to heat, Deb
should have assessed Mrs. JR for her heat sensitivity prior to initiating heat
therapy.
- The heat should have been applied slowly and Mrs JR’s reaction assessed in
order to determine how much heat she could tolerate and for how long.
- Deb should have read and followed the manufacturer’s written instructions
for the safe use of this specific hot pack, noting specific instructions for
application, e.g., if it could be applied directly to the skin.
26
Case Study 2: The Chemical Spill
Later that day, Jonathan Richards, CNA is caring for Mr. SB, a 68-year-old male
admitted for pneumonia that fell that morning when ambulating to the bathroom, injuring
his left knee. Mr. SB is a relatively healthy 68-year-old and has no history of arthritis,
arteriosclerosis, or peripheral vascular disease. The physician has ordered a cold therapy
pack to reduce the swelling. Jonathan is busy covering patients for Jane Thomas, CNA,
while she is at lunch. Since Mr. SB has been complaining that he felt the swelling was
getting worse all morning. Jonathan hurriedly grabs the cold pack from the supply cart
and squeezes it forcefully to activate it while on his way to Mr. SB’s room. Jonathan
immediately felt liquid dripping onto his right hand and observed the clear fluid seeping
from a corner of the package. Since there wasn’t a large amount of fluid seeping out,
Jonathan hurriedly continues on his way to Mr. SB’s room and places the cold pack on his
left knee. After 30 minutes, Jane has just returned from lunch and responds to Mr. SB’s
call light. Mr. SB is complaining that his knee feels wet and numb and his skin is burning.
Jane examines Mr. SB’s knee and notes that the skin is blanched. She immediately
removes the cold pack and washes Mr. SB’s skin and then proceeds to find Deb Bowers,
RN to ask her to contact the physician.
Points to Consider:
1. What are the important clinical considerations in this scenario?
2. What should Jonathan have done differently?
3. What should Jane have done differently?
Discussion of Points to Consider:
1. What are the important clinical considerations in this scenario?
- Cold therapy was ordered appropriately to reduce the swelling in Mr. SB’s injured
knee; Mr. SB does not have any of the conditions that would contraindicate cold
therapy (e.g., vascular impairment).
- Jonathan was in a hurry since he was caring for Jane’s patients, in addition to
his own, while she was at lunch and because Mr. SB had been complaining of
pain; he noted that the cold pack was punctured, as he felt the liquid dripping on
his hand, but decided to use it anyway.
2. What should Jonathan have done differently?
- He should have discarded the punctured cold pack instead of applying it to Mr.
SB’s knee, since the chemical agent/gel can burn the skin of either the patient or
the health-care professional. He should have also washed the skin.
- He also should have read and followed the manufacturer’s written instructions
for the safe use of a cold therapy pack, including those for activation and steps
to take in the event of a puncture.
27
- Jonathan should also be more cautious when applying cold packs, since they
can become very cold and as a result, can cause the tissue to freeze very
quickly.
- All staff members should monitor Mr. SB more closely during periods of cold
therapy.
3. What should Jane have done differently?
- Nothing–her actions were appropriate–upon hearing Mr. SB’s complaint
of wetness and numbness in the area, along with noting that his skin was
blanched, she discontinued the cold therapy and asked Deb to consult with the
primary health-care provider.
28
Glossary of Terms
Afferent
Carrying inward to a central organ or section, as
nerves that conduct impulses from the periphery
of the body to the brain or spinal cord.
Brown Adipose Tissue
A type of specialized fat known to convert fat
calories into heat by nonshivering thermogenesis.
Brown adipose tissue is a unique source of heat
energy for the infant because it has greater
thermogenic activity than ordinary fat; its deposits
occur around the kidneys, neck, and upper chest.
Conductive Heating Heat transfer from one point to another without
noticeable movement in the conducting medium;
direct contact takes place between the heat
source and the target tissues.
Convective Heating
The form of heating that is created by the
movement of the transferring heating medium,
usually air or a fluid.
Conversion Heating
The form of heating that involves the conversion
of one energy form (e.g., light or sound) into
another form of energy (e.g., heat).
Core Body Temperature
The temperature of the thermal compartment of
the body containing highly perfused tissues and
major organs.
Cryoglobulin
An abnormal blood protein that has the unusual
property of precipitating from the blood serum
when it is chilled.
Cryotherapy
The use of cold temperature as a form of
treatment for an injury.
Efferent
A nerve conveying impulses from the central
nervous system to the periphery.
Endothermic Reaction A chemical reaction accompanied by the
absorption of heat.
Exothermic Reaction A chemical reaction in which heat is given off, i.e.,
liberated.
Homeotherm
A warm-blooded animal (e.g., homosapiens)
that maintains a relatively constant and warm
body temperature independent of environmental
temperature; also known as endotherm.
29
Nonshivering Thermogenesis
Increased heat production due to enhancement
of normal calorigenic metabolic processes, i.e.,
production of heat in response to cold stress by
other than muscle contractions (shivering), i.e., by
brown adipose tissue.
Neonatal Thermogenesis
Heat gain comes from the metabolism of
the neonate’s stores of brown fat; because
thermogenesis is relatively inefficient in neonates,
it is important to protect them from cold stress.
Normothermia
A core body temperature of 37° C (98.6° F).
Piloerection
Erection of hair, due to action of bundles of
smooth muscle fibers attached to the deep part of
the hair follicles; also known as “goose bumps.”
Pilomotor
Pertaining to the arrector muscles, the contraction
of which produces piloerection.
Raynaud’s Syndrome
A circulatory disorder caused by insufficient
blood supply to the hands and feet, resulting
in cyanosis, numbness, pain, and gangrene, in
extreme cases.
Shivering Thermogenesis
The fastest thermogenic process which the static
body can use; shivering is an involuntary function
with a tremor rate of about 10 per second.
Thermogenesis
The generation or production of heat, especially
by physiological processes.
Thermoregulation Maintenance of the body’s core temperature
within a tolerable range.
Vapocoolant Spray
A topical spray that sharply decreases the
temperature of the skin; often used for pain
control.
Vasoconstriction
Narrowing of the blood vessels resulting from
contracting of the muscular wall of the vessels.
Vasodilation
Widening of the blood vessel lumen resulting from
relaxation of the muscular wall of the vessels.
30
References
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17. U.S. FDA. TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER
H--MEDICAL DEVICES PART 890 -- PHYSICAL MEDICINE DEVICES Subpart F-Physical Medicine Therapeutic Devices Sec. 890.5710 Hot or cold disposable pack.
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