USP 800 versus 797: New Guide for Handling Hazardous Drugs Includes Shoe Covers

USP <800>, the U.S. Pharmacopeial Convention’s new standard for handling hazardous drugs (HDs) in healthcare settings, includes significant safety standards for all healthcare workers, as well as patients and the general public, who have access to facilities where HDs are prepared. This includes pharmacists, pharmacy technicians, physicians, nurses, physician assistants, home health care workers, veterinarians, and veterinary technicians.  Entities that store, transport, prepare, or administer HDs are also affected, including but not limited to pharmacies, hospitals, patient treatment clinics, physicians’ practice facilities, and veterinary clinics.

USP <800> provides facilities with direction on how to set policy and identify what needs to be done for employee safety while compounding and dispensing HDs. These new safety standards expand upon USP <797>, which focused primarily on minimizing the risk of contaminating medicines when compounding sterile IV preparations. USP <800>, on the other hand, is aimed primarily at addressing the entire life cycle of an HD so that all who might come in contact with it are protected.

USP <797> and <800> are related in that each refer to a chapter in the US Pharmacopoeia.  USP <800> is not just limited to chemotherapy but also many drugs that now fall under the National Institute for Occupational Safety and Health (NIOSH) list.  USP <800> has a minor component that currently falls under USP <797> this year but will become fully enforceable in December 2019 and will require full cleanroom and garbing precautions.  USP <797> is under revision; therefore the current version will hold until at least the next year.  This is the year the Joint Commission and Center for Medicare and Medicaid Services (CMS) is requiring compliance with USP <797>.  Since this is the first year that the CMS plans to enforce the IV compounding regulations, most facilities are scrambling to meet compliance.

Health Effects Resulting from Exposure to Hazardous Drugs

Green barrels with toxic substancesGrowing evidence, which has been accumulated over decades by the USP, Hematology/Oncology Pharmacy Association, Oncology Nursing Society, American Society of Clinical Oncology, and the Centers for Disease Control and Prevention indicates that occupational exposure to the more than 200 HDs commonly used in healthcare settings can cause acute and chronic health issues. In addition, over 100 studies have documented evidence of HD contamination in the workplace, including the presence of HDs in workers’ urine. With nearly 8,000,000 healthcare workers exposed to HDs each year, USP <800> aims to prevent associated acute and long-term health effects.

Required Upgrades Under USP <800> Include Shoe Covers

Personal protective equipment (PPE)(gowns; head, hair, and shoe covers; and two pairs of chemotherapy gloves) is required for compounding both sterile and non-sterile HDs, and two pairs of such gloves are required for administering antineoplastic HDs. Facilities also need to develop standard operating procedures regarding appropriate PPE for any workers who otherwise handle HDs.

Both USP <797> and <800> include several references to shoe covers as detailed below.

Compliant Shoe Covers + Automatic Shoe Cover Application and Removal

Shoe Inn’s shoe covers meet USP <797> and <800> guidelines.  If you want to take make Happy-doctors-smallputting shoe covers on faster, easier, safer and cleaner, go with an automatic shoe cover dispenser like the Shoe Inn Stay. You can even take it a step further by implementing an automatic shoe cover remover.  These products help eliminate workplace injuries, prevent contamination, and save precious time (see just how quick and easy in our application and removal videos).

USP <800> became effective on July 1, 2018.

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USP <797> references to shoe covers

Appropriate personnel protective equipment (PPE) shall be worn when compounding in a BSC or CACI and when using CSTD devices. PPE should include gowns, face masks, eye protection, hair covers, shoe covers or dedicated shoes, double gloving with sterile chemo-type gloves, and compliance with manufacturers’ recommendations when using a CACI.

After donning dedicated shoes or shoe covers, head and facial hair covers, and face masks…

When compounding personnel exit the compounding area during a work shift, the exterior gown may be removed and retained in the compounding area if not visibly soiled, to be re-donned during that same work shift only. However, shoe covers, hair and facial hair covers, face masks/eye shields, and gloves shall be replaced with new ones before re-entering the compounding area, and proper hand hygiene shall be performed.

Appendix I: Order of compounding garb and cleansing in ante-area: shoes or shoe covers, head and facial hair covers, face mask, fingernail cleansing, hand and forearm washing and drying; non-shedding gown.

Appendix III: Dons shoe covers or designated clean-area shoes one at a time, placing the covered or designated shoe on clean side of the line of demarcation, as appropriate.

Appendix III: Removes shoe covers or shoes one at a time, ensuring that uncovered foot is placed on the dirty side of the line of demarcation and performs hand hygiene again. (Removes and discards shoe covers every time the compounding area is exited).

USP <800> references to shoe covers

Gowns, head, hair, shoe covers, and two pairs of chemotherapy gloves are required for compounding sterile and non-sterile HDs.

Head and hair covers (including beard and moustache, if applicable), shoe covers, and sleeve covers provide protection from contact with HD residue. When compounding HDs, a second pair of shoe covers must be donned before entering the C-SEC and doffed when exiting the C-SEC. Shoe covers worn in HD handling areas must not be worn to other areas to avoid spreading HD contamination and exposing other healthcare workers.

Hospital Employee Safety: Slips and Falls

Hospitals are one of the most hazardous places to work according to the Occupational Safety and Health Administration (OSHA).  In fact, hospital injuries occurred at almost twice the rate for private industry as a whole in 2011.  In terms of lost-time rates, it is more hazardous to work in a hospital than in manufacturing or construction.

unlucky carefree business man silhouetteHospitals have unique risks (lifting/repositioning patients, needlesticks), slippery surfaces, and a variety of other hazards.  Also, some caregivers feel it is their ethical duty to put their patients’ safety and health before their own.

For 2011, the Bureau of Labor Statistics reported that fully one quarter (25%) of all hospital caregiver injuries was from slips, trips and falls!  Considering the slippery floors in hospitals and the body positioning and movements that caregivers employ in performing their jobs, this statistic is somewhat understandable.  Injuries from slipping can impact employees’ ability to do their jobs, and result in decreased productivity, lost workdays, and expensive worker compensation claims.

As a result, the Centers for Disease Control and Prevention (CDC) has published a guide iStock_000020353612Largefor Slip, Trip, and Fall Prevention for Healthcare Workers.  Though the guide does not address shoe covers, hospital EH&S/safety/risk managers can go the extra mile by implementing the Shoe Inn automatic shoe cover dispensing system with non-slip/high-traction shoe covers.  Shoe Inn can help keep your employees safe by reducing slips and falls associated with putting shoe covers on as well as using superior traction shoe covers.

Cleanrooms

Cleanroom scientists wearing shoe coversCleanrooms (or clean rooms) are used in virtually every industry where small particles can adversely affect the manufacturing process.  Typically located in scientific research or manufacturing settings, a cleanroom is a controlled environment that has a controlled level of contamination (pollutants such as dust, airborne microbes, chemical vapors, and aerosol particles) that is specified by the number of particles per cubic meter (m3) or per cubic foot (ft3) at a specified particle size.  Believe it or not, the ambient air outside in a typical city environment contains about 35,000,000 particles per m3, 0.5 μm and larger in diameter, which corresponds to an ISO 9 cleanroom.  At the other end of the spectrum, an ISO 1 cleanroom allows no particles in that size range and only 12 particles per m3 of 0.3 μm and smaller.

Cleanroom Overview

A cleanroom is any given contained space where provisions are made to reduce particulate contamination and control other environmental parameters such as pressure, temperature, and humidity. The key component is the HEPA (High Efficiency Particulate Air) filter that is used to trap 99.97% of particles that are 0.3 microns and larger in size. All of the air delivered to a cleanroom passes through HEPA filters, and in cases where more stringent cleanliness performance is necessary, ULPA (Ultra Low Particulate Air) filters are employed.

The use of multi-layer adhesive mats for cleanrooms is almost universal.  Matting can vary in size, color, placement, and number based on the characteristics and logistics of each individual cleanroom.

Personnel who work in cleanrooms go through extensive training in contamination control theory, practices and procedures. They enter and exit the cleanroom through air showers, airlocks, and/or gowning rooms, and they must wear special clothing designed to trap contaminants that are naturally generated by our bodies.

Depending on the room classification or function, personnel gowning may be as limited as lab coats and hairnets/beard covers, or as extensive as being fully enveloped in multiple layered bunny suits with self-contained breathing apparatus.  The cleanroom clothing itself must not release fibers or particles to prevent contamination of the environment.

Cleanroom garments include things such as boots, shoes, shoe covers, beard covers, hairnets, bouffant caps, facemasks, coveralls, aprons, frocks/lab coats, gowns, glove and finger cots, hoods, and sleeves. The type of cleanroom garments used reflects the cleanroom classification and product specifications. For example, Class 10,000/ISO 7 cleanrooms may use simple smocks, head covers, and shoe covers.  On the other hand, careful gown wearing procedures with a zipped coverall, boots, gloves and complete respirator enclosure are required for Class 10/ISO 4 cleanrooms.

Cleanroom technicians wearing shoe covers
Cleanroom technicians wearing shoe covers

Air Flow Principles for Cleanrooms

Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. Laminar, or unidirectional, airflow systems direct filtered air downward in a constant stream. Laminar airflow systems are typically employed across 80% to 100% of the ceiling to maintain constant air processing and unidirectional flow. Laminar flow criteria are mandated in ISO 1 through ISO 4 cleanrooms.  Turbulent, or non-unidirectional, air flow uses both laminar air flow hoods and non-specific velocity filters to keep cleanroom air in constant motion, although not all in the same direction. The rough air seeks to trap particles that may be in the air and drive them towards the floor, where they enter filters and leave the controlled environment.

Proper cleanroom design encompasses the entire air distribution system, including provisions for adequate downstream air returns. In horizontal flow applications, this involves the use of air returns at the downstream boundary of the process.  In vertical flow rooms, it requires the use of low wall air returns around the perimeter of the zone.  It should be noted that the use of ceiling mounted air returns is contradictory to proper cleanroom system design.

Cleanroom Classifications

Cleanrooms are classified by how clean the air is according to the number and size of particles permitted per volume of air. Federal Standard 209E is used here in the U.S.  The newer standard is TC 209 from the ISO (International Standards Organization).  Both standards classify a cleanroom by the number of particles found in the laboratory’s air. The cleanroom classification standards 209E and ISO 14644-1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area.

Large numbers like Class 1,000 or Class 100,000 refer to FS 209E, and denote the number of particles of size 0.5 µm or larger permitted per ftof air. The standard also allows interpolation, so it is possible to describe other classes such as Class 2,000.

Small numbers refer to ISO 14644-1 standards, which specify the decimal logarithm of the number of particles 0.1 µm or larger permitted per mof air.  For example, an ISO 4 cleanroom has at most 104 = 10,000 particles per m³.

Both FS 209E and ISO 14644-1 assume log-log relationships between particle size and particle concentration. For that reason, there is no such thing as zero particle concentration.

US FED STD 209E cleanroom standards

Class Maximum particles/ft3 ISO equivalent
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥5 µm
1 35 7.5 3 1 0.007 ISO 3
10 350 75 30 10 0.07 ISO 4
100 3,500 750 300 100 0.7 ISO 5
1,000 35,000 7,500 3,000 1,000 7 ISO 6
10,000 350,000 75,000 30,000 10,000 70 ISO 7
100,000 3.5 x 106 750,000 300,000 100,000 700 ISO 8

ISO 14644-1 cleanroom standards

Class Maximum particles/m3 STD 209E equivalent
≥0.1 µm ≥0.2 µm ≥0.3 µm ≥0.5 µm ≥1 µm ≥5 µm
ISO 1 10 2.37 1.02 0.35 0.083 0.0029
ISO 2 100 23.7 10.2 3.5 0.83 0.029
ISO 3 1,000 237 102 35 8.3 0.29 Class 1
ISO 4 10,000 2,370 1,020 352 83 2.9 Class 10
ISO 5 100,000 23,700 10,200 3,520 832 29 Class 100
ISO 6 1.0 x 106 237,000 102,000 35,200 8,320 293 Class 1,000
ISO 7 1.0 x 107 2.37 x 106 1,020,000 352,000 83,200 2,930 Class 10,000
ISO 8 1.0 x 108 2.37 x 107 1.02 x 107 3,520,000 832,000 29,300 Class 100,000
ISO 9 1.0 x 109 2.37 x 108 1.02 x 108 35,200,000 8,320,000 293,000 Room air

Importance of Using Shoe Covers

Petri dish with bacteriaHave you ever considered what is on the bottom of your shoes?  Besides things you can see, such as grease, oil, gum, mud, leaves, feces, etc., there are the countless things you cannot see, like germs, bacteria, mold, and viruses.  All of these things walk with us everywhere we go, from the house to the car to the parking lot to the building to the lab or production area to the bathroom to the dining area and back again.  How many other places do we go, like gas stations and public parks, picking up things on our shoes all along the way and transporting them where they are unwelcome?

As a result, many industries and settings require the use of shoe covers to maintain sanitary or sterile conditions, prevent contamination, limit the spread of infections, comply with health codes, etc.  A review of the literature turned up several key findings such as the following:

“In this study, the authors subjected six occupied rodent holding rooms in their animal research facility to three conditions: use of disinfectant mats; use of shoe covers; and no disinfectant mats or shoe covers. The authors took bacterial culture samples from the rooms under each condition. There was no significant difference in the mean number of colony forming units (CFUs) cultured when the disinfectant mats or shoe covers were used. However, the mean number of CFUs obtained was significantly lower when either disinfectant mats or shoe covers were used than when neither was used. These results suggest that using disinfectant mats or disposable shoe covers may reduce the bacterial load on rodent holding room floors.”[1]

“We recommend that gloves and footwear worn by employees who handle RF-RTE foods or who work in areas where RF-RTE are processed or exposed be made of impermeable material, in good repair, easily cleanable or disposable (emphasis added), and used only in RF-RTE areas.”[2]

“Health care workers who handle hazardous drugs are at risk of skin rashes, cancer and reproductive disorders. NIOSH recommends that employers provide appropriate personal protective equipment (PPE) to protect workers who handle hazardous drugs in the workplace…Use hair and shoe covers constructed of coated materials to reduce the possibility of particulate or microbial contamination in clean rooms and other sensitive areas.”[3]

Based on the above, it is clear that using disposable shoe covers is a credible and recommended method in a variety of situations and controlled environments.

[1] Allen KP, Csida T, Leming J, Murray K, Thulin J. Efficacy of Footwear Disinfection and Shoe Cover Use in an Animal Research Facility, U.S. National Library of Medicine, http://www.ncbi.nlm.nih.gov/pubmed/20305633

[2] US Food and Drug Administration, Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods, Section XI, Paragraph IV

[3] Personal Protective Equipment for Health Care Workers Who Work with Hazardous Drugs, https://www.cdc.gov/niosh/docs/wp-solutions/2009-106/pdfs/2009-106.pdf