Enteral Nutrition Practice Recommendations/Bankhead et al 11
Figure 5. Standard Human Breast Milk Label Template (Infant Patient)
InstitutionandDepartmentName–ContactInformation
Patient Name___________________ Room Number _____________
Patient ID
_____________
ENTERAL USE ONLY
Human Breast Milk Contents
Fresh or Frozen (circle)
HBM Fortifier ____cal/oz. and/or __________to make
_________________ (as per prescriber order)
Prepared by: _________________
Date: ________
DeliverySite
Route of Delivery:__________________ Enteral Access Site:_______________
IIVV
_______________________________________________________Administration
Method of Administration: Bolus Continuous
Rate of Administration:______mL/h
Formula Hung By: _______________, NurseDate: ____Time: _____
Expiration Date: ________
Time: _____
IIVV
Time: _____
Figure 6. Human Breast Milk Storage Label
InstitutionandDepartmentName–ContactInformationPatient Name___________________ Patient ID_____________ Room _____________ 6. U.S. Food and Drug Administration. FDA issues health information
advisory on infant formula. September 12, 2008. http://www.fda .gov/bbs/topics/NEWS/2008/NEW01883.html. Accessed October 29, 2008.
7. 21 US Code 106, 107.
Pumped: Date____________Time__________MEDICATIONS TAKEN:IV. WATER AND ENTERAL FORMULA
SAFETY AND STABILITY
Patient care plans that include EN add a degree of complexity to overall management. Two areas of concern in assuring formula safety include microbial contamination and nutrient stability.
Expiration Date:____________________ Time: __________References
1. 21 US Code 360ee(b).
2. Moyer P. “Medical food” available for management of osteoar-thritis. Medscape Medical News. Feb 21, 2006. www.medscape.com/ viewarticle/524011. Accessed April 23, 2007.
3. Brown C. Health claim regulations need not apply to medical
foods. Functional Foods & Nutraceuticals. May 2003. www.ffnmag.com/NH/ASP/strArticleID/337/strsite/FFNSite/articleDisplay.asp. Accessed April 23, 2007.
4. Serafina JM. Food manufacturing practice and quality control for
medical foods. Food Drug Cosmet Law J. 1989;44:523-532.
5. Mueller C, Nestle M. Regulation of medical foods: toward a
rational policy. Nutr Clin Pract. 1995;10:8-15.
A. Water Safety
Water may be required for reconstitution of an EN formula as well as to dilute medications, provide flushes, and maintain patient hydration. The source of water may differ depending on the patient.
1. Types of Water Used in EN:
a. Purified Water – sterile, solute-free, non- pyrogenic water that is free of any chemical or
12 Journal of Parenteral and Enteral Nutrition / Vol. XX, No. X, Month XXXX
Table 1. Components of the Formula Label
Labeling of Enteral Formula
???Patient’s name and room number ???Medical record ID number
???Formula name and strength of formula, if diluted ???Date and time formula prepared* ???Date and time formula hung* ???Administration route
???Rate of administration expressed as mL/hr over 24 hours if continuous administration
???Administration duration and rates are to be expressed on the label if the EN is cycled or intermittent
???Initials of who prepared, hung, and checked the EN against the order
???Appropriate hang time (expiration date and time) ???Dosing weight if appropriate ???“Not For IV Use”
Labeling of Incoming Human Breast Milk
???Infant’s name and room number???Medical record ID number???Dosing weight
???Date and time milk expressed
???Medication or supplements being taken by the mother???Specify whether milk is fresh or frozen
???Contents in syringe/container (expressed breast milk) ???If frozen, date and time milk thawed
???Expiration date (based on whether the milk was fresh or frozen)
???“Not For IV Use”
???Fortified Human Breast Milk also includes: o??Name of fortifier o??Final concentration
o??Date and time formula prepared
o??Initials of who prepared, hung, and checked the HBM against the order
*Date-time formula prepared and date-time formula hung may be different so note both. EN, enteral nutrition; HBM, human breast milk; ID, indentification; IV intravenous.
microbial contaminants; used for preparing or reconstituting commercial products, rinsing equip - ment and utensils; is required to produce sterile water for irrigation and sterile water for injection.1 b. Distilled Water – water that has been vaporized and recondensed but is not necessarily free of dis-solved or suspended matter; therefore should not be used for the preparation or administration of medications.
c. Tap Water – municipal or locally-available pota- ble water that meets the Environmental Protection Agency’s (EPA) National Primary Drinking Water regulations (40 CFR Part 141-143)2 and is con- sistent with World Health Organization (WHO) guidelines for water safety.3 2. Indications for Use of Water
a. Maintaining Hydration/Flushes
Tap water or bottled water may be adequate for hydration of the otherwise healthy, immuno-competent, orally-fed patient. However, the acute or chronically-ill patient requiring invasive enteral feeding with any presumed alteration to their GI barrier function may be at higher risk from expo-sure to non-sterile products including water. Nosocomial infections from contaminated tap water sources have been demonstrated in criti-cally ill patients.4-7 This has also been reported in less acutely ill but immunocompromised patients and is best avoided.8-11 Terminal filtra-tion of tap water may be useful, but retrograde contamination is still an issue.12
b. Diluting Medications
Tap water may not be used in the preparation of dosage forms1 and is also specifically discouraged if being administered via a post-pyloric enteral access device.13 Purified (sterile water for irrigation) or saline should be used as the diluent or flushing vehicle in preference to any other fluid including tap water. Depending on the source, the latter may contain contaminants including not only patho-genic micro-organisms but also pesticides, medica-tion residue, and heavy metals.14,15 The metals and medications may interact with the large surface area of the crushed medication product ingredients and thereby reduce bioavailability. For infants, the recommendation is to flush the enteral access device with sterile water before and after adminis-tration of enteral formula and medication.16 c. Formula Reconstitution
The water supply may be a source of potential contamination if purified water (sterile water for irrigation) is not used in formula reconstitution. Hard water refers to the higher mineral content of the water (especially calcium, magnesium, and possibly iron). Softened water is water that has been treated with ion exchange to remove excess minerals, with the exception of sodium (< 15 mmol/L) and potassium. Chemically softened water is not appropriate for use in the preparation of infant formula.16 All water supplied for feeding preparation must meet federal standards for drinking water and be sterile.16,17 Only chilled, sterile water is recommended for preparing infant formula preparation.16
Enteral Nutrition Practice Recommendations/Bankhead et al 13
Figure 7. Potential Points for Contamination in the Preparation, Storage, Handling, and Adwministration of Enteral Nutrition
Formula,DeliverySite,AdministrationMethod,RateOrderFormulaInaClosedSystemSterileLiquidFormulaSterileNon-SterilePowderFormulaNon-SterileAdditivesHBMPour,reconstitute,mix,placeinanadministrationcontainerPreparationSiteStoreortaketopatientContaminationPointsPatientCareUnitConnectdeliverycontainertoadministrationsetandtopatientBedsideHBM, human breast milk.
B. EN Formula Safety1. Contamination
Background
Contamination of EN formula with micro-organisms can occur at any point throughout the production, preparation, storage, or administration process (see Figure 7). This can pose a significant risk to the patient—particularly if immunocompromised—at either end of the age spectrum or with an alteration of GI barrier function.
EN products in liquid form are considered an ideal growth medium for potentially pathogenic micro-organisms and therefore undergo heat sterilization at the end of production. Commercially-available EN products manu-factured in dry powder form are not required to be sterile and may be contaminated by the end of the production process prior to reaching the market. A study of powdered infant formulas across several European countries revealed Enterobacter spp. contamination in 53% of 141 samples.18 Although these were found in amounts within the accepted maximal limits, once these products are reconstituted with water, especially if at room temperature or in bottle warmers, the organism would be expected to multiply rapidly.19 The meningitis and subsequent death of an infant was directly linked to the presence of Enterobacter sakazakii in a powdered infant formula.17 Of 49 infants screened at that same
Tennessee site, 10 were found to be infected or colonized with Enterobacter sakasakii.17 Dozens of cases of meningitis and necrotizing enterocolitis related to Enterobacter sakazakii in infant formulas and on associated utensils have been published.20 A limited number of powdered products are also available for use in older children and adults.
Preparation/Storage
Contamination of EN formulas (liquid or powder) with subsequent patient colonization or infection is also a concern during preparation in a healthcare setting. EN preparation may include the mixing, reconstitution, or dilution of modular products and formula with water, and/or pouring the formula into an administration container. The sterility of the commercially-available liquid EN products, as well as that of the sterile bags and admini stration sets, is disrupted by any manipulation thereby raising the risk for contamination. Therefore, the environ ment in which EN preparation takes place should be controlled to reduce the risk for contamination. Critical points for contamination are documented to include the dietetic unit/kitchen and the patient care unit.21 For example, some pathogenic organisms may readily attach to and form biofilm on stainless steel surfaces as well as on enteral access devices, further reinforcing the need to prevent contamination in the first place.22 EN formulas prepared in a kitchen or in a patient
14 Journal of Parenteral and Enteral Nutrition / Vol. XX, No. X, Month XXXX
care unit are at much higher risk for contamination than those prepared under aseptic conditions or that undergo sterilization prior to patient administration. As many as 30%-57% of enteral formulas prepared in the hospital and over 80% of those prepared in the home have been found to be contaminated with bacteria.21,23,24 Approximately half of the contami nated EN formulas in the hospital contained bacterial counts that exceed federal limits for foods (104 CFU/mL).21 Some admixtures were contaminated with more than one organism.21 Isolates have included Gram-negative bacilli, Gram-positive organisms, anaerobes, and yeast.25,26 Subsequent growth of a contaminant organism will depend on storage conditions. For EN formulas not used imme-diately after preparation, refrigeration may reduce bacterial growth potential. Bacterial contamination may also reduce nutrient composition available to the patient.27 Patient colonization and infection with organisms that are identical to those isolated from their EN formulas has been clearly documented.28,29 One salmonella outbreak among children and staff was linked to preparation of EN formulas in the hospital’s formula room where cross contamination occurred.30
Reconstitution of any component or initiating a multi-step preparation of an EN formula is best performed by trained personnel in an appropriate environment to reduce contamination.31 The fact that powdered formulas are not commercially sterile requires meticulous adherence to aseptic procedures in the handling and reconstitution process, especially for infants or immunocompromised patients. With the availability of closed EN systems, contamination in the preparation of individualized EN admixtures for adult patients is consi dered a less frequent event compared with the larger numbers of infants and children requiring such a preparation. Preparing infant formula is best done within a clean environment (ie, International Organization for Standardi zation [ISO] Class 5 hood), by personnel trained in aseptic technique, wearing appropriate attire. The prepara tion area should be separate from any storage area to avoid particulate matter contamination. Any instruments or utensils used in EN preparation should either be disposable or undergo heat sterilization prior to use. Hand hygiene and aseptic prac-tices should be in place to prevent EN formula contamina-tion during preparation. Centers for Disease Control and Prevention (CDC) recommendations for handwashing can be found at http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf. These recommendations include hand washing to the elbow with soap and water, and using a Food and Drug Administration (FDA)-approved antimicrobial persistence alcohol hand rub between glove changes, as well as prohi-bition of watches, rings, piercings or artificial nails. Wearing disposable gowns, mask, gloves, and head covers may reduce the spread of airborne pathogens.32 Infants and immunocompromised children are considered among
the most vulnerable patients; many hospitalized immuno-compromised adults are also at risk. Consideration should be given to applying the U.S. Pharmacopoeia (USP) Compounding Category 1 (non-sterile, simple) or Category 2 (non-sterile, complex) moniker (name, label) and word-ing to all EN formula preparation which carry the expecta-tion of adhering to good compounding practices for nonsterile preparations.1 Category 3 is reserved for low-risk but sterile preparations.1 This is based on the corre-sponding probability of contamination and suggests specific preparation and quality assurance practices.1 Such a quality control process may then support hang times for prepared EN formulations of up to 12 hours without compromising the open system.31,33
HBM Preparation, Storage, and AdministrationReduction of bacterial growth during the period between expression of milk and delivery of milk to the infant, because expressed breast milk is not sterile, and to avoid transmission of microbes (eg, hepatitis B or methicillin-resistant Staphylococcus aureus [MRSA]) in milk to infants unrelated to the donor mother is essential to maintain safe HBM. Mothers are given their own collection kits to be attached to hospital-grade electric pumps. The collection kits should be cleaned according to manufacturer’s directions after each use and sterilized daily. Pumps can be used by multiple mothers and sanitized between uses. These pumps should be checked by the hospital biomedical engineering department annually, whenever milk accidentally enters the pump, or when not working properly.16 HBM should be stored in the hospital in containers approved for food storage such as glass or food-grade plastic (polypropylene or polycarbonate) containers.34 Either sterile or aseptic containers may be used to store HBM.34,35 Containers should have a cap to produce an airtight seal in order to avoid leakage or contamination; the use of a nipple on a container is not appropriate for storage.36 Commercially- available containers designed for HBM collection feature universal threading so that they can be used to connect with pump directly in order to minimize touch contamination. Loss of immunologic factors occurs during storage of breast milk; the least losses occur with use of glass or hard plastic containers for storage compared to other containers.
Most hospitals provide a mother with a new storage container each time she expresses her milk. If the mother reuses the storage container, it can be sterilized following the same directions for the collection kits.16 Storage bags intended for HBM storage are sterile and can be used for the infant at home. For the hospitalized infant, storage bags do not provide a closed system, may leak or tear, and are difficult to manage in the preparation of HBM for administration. There may be increased loss of fat and
Enteral Nutrition Practice Recommendations/Bankhead et al 15
f
at-soluble vitamins with the polyethylene bags.37,38 If a mother has already used these bags for the storage of her milk, they should be put into another double-zipped food-storage bag and used only if no other milk container is available.16 While in storage, HBM from each lacatating mother must be segregated from any other mother’s milk by storage in bins or zip-lock bags that are clearly labeled with the correct infant(s) name and medical record number. Dedicated refrigerators and freezers for infant feedings is suggested.16,34 HBM that is appropriately labeled should be stored in an area that has controlled access.
Feeding an infant fresh HBM which has been expressed in the past 48 hours is preferable.39 When fresh HBM is not available, frozen milk can used, starting with the oldest first; colostrum, then transitional, and finally, mature milk. It is important to completely thaw an entire container, because using only the unfrozen part of the milk may result in unequal distribution of milk compo-nents.16 HBM should be thawed and warmed according to policies based on evidence-based protocols such as the American Dietetic Association’s Guidelines for Preparation of Formula and Breast Milk in Health Care Facilities.16
HBM should be prepared with aseptic technique. After performing hand hygiene, the preparer should wear gloves.40 The Occupational Safety and Health Administration (OSHA) has stated that HBM does not constitute occupa-tional exposure based on the lack of evidence that any healthcare worker has acquired a viral infection via breast milk.41 It is recommended that healthcare workers who are frequently exposed to HBM wear gloves.16
Due to sterility concerns about powdered additives, whenever a nutritionally adequate liquid fortifier is available, it is advocated for use as a fortifier of HBM, with this preparation also taking place in a controlled environment.16 Because the volumes are often low when HBM is given as a continuous infusion via an enteral access device, a syringe pump is typically used to deliver the HBM. This also avoids the adherence of fat from the HBM to the enteral pump bag. Mothers often express their milk at home and transport it to the hospital. If the milk is to be used fresh—within 48 hours of expression—the milk can be refrigerated at home and transported chilled (35o-42° F or 2o-6° C). Otherwise the milk should be frozen at home, transported frozen, and stored in the hospital freezer designated for HBM storage.
HBM that is transported to or from the hospital in a frozen state should be tightly packed in a cooler without ice, because water freezes at a temperature higher than HBM and the ice is warmer than the frozen HBM and may thaw the frozen containers. Freezer gel packs are preferred over ice because they have a lower freezing temperature. Any dead space in the cooler should be filled with clean towels, foam chips or newspaper. If the HBM is to be in-transit for an extended length of time,
dry ice can be used in an insulated container. Hospitals often have guidelines and training for personnel involved in the transport of frozen biological material, with instructions regarding special labeling, weight limits for dry ice, use of non air-tight external containers, or the advisability of contacting a shipping company. If < 50% of the volume of frozen milk becomes partially thawed during transport, the milk can be safely refrozen. If the milk is > 50% thawed, the milk should either be used within 24 hours or discarded.
The Human Milk Banking Association of North America recommends dedicated freezers and refrigerators for the storage of HBM.34 HBM in the freezer or refrigerator should be stored in bins for each patient with the name and medical record number clearly marked to avoid misadminis tration. Bins can be reused after washing thoroughly with soap and water. HBM should be arranged in the bins by date so that the oldest milk can be used first.16
The temperature of the refrigerators and freezers must be monitored to ensure that they stay in a safe range, <40°F (<4°C) for refrigerators and -4°F (-20°C) for freezers. Alarms can be linked to the hospital security system to alert personnel to a problem to avoid the unnecessary loss of frozen HBM. The refrigerators should also be plugged into the emergency outlets that provide generator backup in the event of a power failure.16 Due to the concern for the safety and security of HBM, some institutions limit access to the freezers and refrigerators to hospital staff.
Misadministration of HBM occurs when another mother’s milk is administered to an infant. Each hospital should have a policy to address this issue. All breast milk preparation, storage, and administration policies should strive to create an atmosphere where there is a very low likelihood of this occurring, but should have a procedure in place in case a misadministration occurs. An example of a policy is available elsewhere.16
Handling/Administration
Introduction of potentially pathogenic micro-organisms may also occur during handling of feeding systems and during EN administration. In general, it has become clear that hospital-acquired infections associated with contaminated substances occur predominantly in the patient care area, especially when basic hygiene measures are not followed.42 Setting up and manipulating the EN feeding systems in the patient care unit accounts for much of the contamination with potential pathogens.29,43 Contaminated enteral feeding systems can contribute to the etiology of diarrhea in patients receiving EN.44 From a prospective, controlled epidemiologic study, the acquisi-tion of Clostridium difficile (20% vs 8%, P =?.03) and subse-quent organism-associated diarrhea (9% vs 1%, P =?.03) is
ASPEN - EN prac recommendation - JPEN2009 - 图文
