Clinical Issues

Article Outline

• Air Exchanges in the OR
• Corrugated Noncardboard Packaging
• Instrument Corrosion
• Instrument Tracking
• Malignant Hyperthermia
• Medical Gas Handling
• Multipack Needle Counts
• Sterilization Indicators
• Sterilization Monitoring
• Surgical Site Marking Pens
• Types of Fire Extinguishers
• Toxic Anterior Segment Syndrome
• US Food and Drug Administration Product Clearance
• Ultrasonic Washers
• References
• Copyright

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Air Exchanges in the OR 

QUESTION: Our ventilation system malfunctioned recently and completely stopped working over the weekend. No air exchanges occurred in the OR during this time. Subsequently, the ventilation system has been repaired and now is working properly at 15 air exchanges per hour. How long should we wait before resuming surgery in the OR? Is there a specific time frame to wait to ensure that enough air exchanges have occurred before we open sterile supplies and perform surgery?

ANSWER: There is no specific time period recommended regarding the length of time to wait to resume surgery after the ventilation system has been restored. Guidelines developed by the American Institute of Architects suggest that the number of air exchanges may be reduced during periods when the OR is not open and subsequently restored before resuming surgery.¹ These guidelines do not indicate a specific amount of time to wait before using the room.

The “Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care facilities,” developed by the Centers for Disease Control and Prevention (CDC), is a resource that may be used to guide practitioners’ decisions regarding the length of time to wait before using the OR after the ventilation system has been restored. This guideline includes a table that associates the number of air exchanges per hour with the number of minutes required in relation to the removal efficiency of airborne contaminates. According to the CDC, it takes 28 minutes at 15 air exchanges per hour for 99.9% removal efficiency (Table 1).² The number of air exchanges per hour for the individual facility should be known in order to calculate the amount of time necessary to reach the desired effectiveness of airborne contaminate removal. The OR doors should remain closed during this period so the ventilation system can work properly, and the room should not be used until the air in the room has completely changed. Using this CDC table may be useful in making clinically sound decisions for safe patient care.

Table 1. Air Changes Per Hour (ACH) and Time Required for Removal Efficiencies of Airborne Contaminants^1*

1. Jensen PA, Lambert LA, Iademarco MF, Ridzon R; Centers for Disease Control and Prevention. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health-care settings, 2005. MMWR Recomm Rep. 2005;54(17):1-141.

* This table can be used to estimate the time necessary to clear the air of airborne Mycobacterium tuberculosis after the source patient leaves the area or when aerosol-producing procedures are complete.

** Time in minutes to reduce the airborne contamination by 99% or 99.9%

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Corrugated Noncardboard Packaging 

QUESTION: My facility uses very comprehensive and very heavy custom packs for cardiac procedures. The supplier uses an internal corrugated, noncardboard structure to ensure the integrity of the pack. Is it safe to bring corrugated materials into the OR as long as they are not made of cardboard?

ANSWER: Noncardboard, corrugated materials that are used internally for packaging within the custom pack are safe for use in the OR as long as they have not been stored for long periods and are used soon after being brought into the restricted area. Storage devices with web edges or honey-comb structures may collect dust and debris if they are used for long-term storage.

Custom packs that have internal, corrugated structures should be inspected before the initial set up for the procedure. Corrugated structures should be free of debris and should have remained intact through the shipping process. The internal packaging material should be discarded immediately after the procedure. It should not be refilled or kept for the purpose of permanent storage.

When web-edged or corrugated cardboard boxes are used as external shipping containers, the supplies and equipment should be removed from the containers in the unrestricted area before the internal contents are transferred to the surgical suite.⁵ Insects and debris may collect during shipment when there are hollow areas in the external shipping container.

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Instrument Corrosion 

QUESTION: I work in a small sterile processing department of an ambulatory surgery center. Recently, we have noticed that some instruments have brown spots on them after sterilization. These spots come off easily when rubbed. What causes this problem? Is it because the sterilizer settings are off, or could there be a problem with the chemicals being used to process the instruments?

ANSWER: Brown spots left on steam sterilized instruments may be a sign of corrosion. Instrument corrosion is caused by a number of diverse factors including grade of steel and cleaning and sterilization processes. The varying levels of chromium content in the steel determines the instrument's resistance to corrosion.¹ Cleaning products, water quality, exposure times, sterilizer parameters, and the presence of biological salts found in blood and normal saline also contribute to corrosive actions.², ³

Instruments should be processed according to the manufacturer's instructions and with consideration of

Cleaning agents can either protect or cause damage to surgical devices and should be selected according to compatibility with the instrument being cleaned and with the cleaning process used. The wrong chemical selection can cause corrosion during ultrasonic cleaning with washer-disinfectors and washer-sterilizer cycles. The agent should

Sterilizers should receive routine maintenance to ensure operating parameters are maintained and prevent instrument damage or harm to patients. The sterilizer should be inspected and cleaned daily according to the manufacturer's recommendations. The inspection process includes

Daily cleaning of the internal chamber should be completed according to the manufacturer's guidelines for the make and model of the particular sterilizer. Chamber cleaning may occur under the following circumstances:

Older units or units that have not received routine cleaning may experience buildup of scale or heavy residue on the internal chamber walls. Residues that occur during sterilization have been associated with contamination of sterilizer loads, and removal of the residue is necessary.⁵ Heavy scale accumulation that cannot be removed by following the manufacturer's cleaning directions necessitates hiring of a professional with the required expertise to remove heavy scale accumulation.

Sterilizers also should be placed on a preventive maintenance schedule for inspection and replacement of components subject to wear, including drain pipes, valves, steam traps, filters, and door gaskets. Improperly maintained steam lines and generators can result in excessive deposits of contaminates (eg, nickel, zinc, silica, sulfates, copper) contributing to steam impurities and surgical infection.⁶ The relative pH and purity of water-feeds intensifies the buildup of passive films on surgical instruments and leads to corrosion, discoloration, and pitting of instruments. When appropriate cleaning products are selected and water hardness is corrected, surgical instruments will be more resistant to the corrosive nature of hard water.¹

Prevention of instrument damage is a multistep process that necessitates vigilance in maintaining standards for instrument processing. A properly functioning sterilizer, the correct cleaning agents, and feed-water purity are some of the essential components in the sterilization process. For more information on sterilization guidelines, refer to AORN's “Recommended practices for sterilization in the perioperative practice setting”⁷ or the Association for the Advancement of Medical Instrumentation's ST79:2006—Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities.²

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Instrument Tracking 

QUESTION: Our hospital has not developed a method for tracking instruments in the perioperative setting. Is there any benefit to tracking instruments other than knowing that you may have lost one or two instruments? What types of tracking systems are there? How should sterile processing department (SPD) staff members be trained?

ANSWER: Tracking instruments in the perioperative setting is an important function for both the perioperative and sterile processing departments. First and foremost, lost instruments may compromise patient safety. Spending time finding lost instruments decreases productivity because personnel have to waste valuable time looking for the instruments. Finally, replacing lost instruments can be costly.¹

Tracking systems allow perioperative personnel to track instrument use and movements from one location to another. If software systems are used, reports can be produced that can help protect health care facilities against litigation. Legal proceedings have been decided in favor of the plaintiff because there was no documentation to show when a specific surgical instrument used during a surgical procedure had left the OR and when it was last used, cleaned, sterilized, and returned to the OR for use on another patient.²

Another advantage of using an instrument tracking system is the ability to track the extended autoclave cycles required for instruments used during procedures on patients with a known or suspected prion-producing disease. Health care facilities are at risk if documentation cannot be provided to indicate when instruments were used in these procedures. Using these instruments without verification of the extended autoclave cycles required to eradicate prions could result in sentinel events or litigation.³ If a process is not in place to identify which instruments were used on a patient with a known or suspected prion-producing disease, all patients having a similar type of surgery would have to be followed after an index case was identified.

A process can be created to easily identify the patient, date, type of procedure, and the name of the surgeon associated with an instrument. For instance, one instrument tracking system has two-part cards with identification numbers of the instruments in the set. One part of the card is removed from the set when it is opened and is placed in the patient's medical record. A number also should be assigned to each set of instruments via the instrument tracking system.⁴

Several methods are available to track instruments. Sets of instruments can be identified by bar coding and scanned before and after the decontamination process is complete. Another system uses radio frequency identification (RFID) technology to tag instruments with a code containing pertinent information as determined by SPD personnel.² Following are questions that should be asked before an instrument-tracking system is purchased.

Effective manual systems also may be developed if bar coding and RFID are not right for your organization.

According to Nancy Chobin, executive director of the Certification Board for Sterile Processing and Distribution, Inc, (oral communication, January 2007),

having well-trained staff members who are certified in SPD improves patient safety. Completion of competencies, including those pertaining to the tracking system used by the health care facility, verifies and enhances the performance of SPD staff members.

A tracking system requires standardization of instrument names, which is time consuming to develop. When the process of standardizing the instruments is completed, however, staff member time will be used more effectively and efficiently. This also will result in safer patient care.

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Malignant Hyperthermia 

QUESTION: I work in a freestanding ambulatory surgery center (ASC) that recently scheduled a 10-year-old boy for surgery. The patient was healthy and had not had previous surgeries, but the preoperative interview revealed a strong family history of malignant hyperthermia (MH). The patient's maternal aunt had experienced an MH crisis and the patient's mother had tested positive for MH susceptibility. Consequently, the procedure was cancelled, but I wondered if it was appropriate to have scheduled the procedure in our freestanding ASC in the first place. What are the guidelines for treating MH-susceptible patients in outpatient settings? Are there specific preoperative screening measures that should be done differently in an ASC than in a hospital-based setting?

ANSWER: According to the Malignant Hyperthermia Association of the United States (MHAUS), patients who are MH susceptible can be scheduled for surgery in outpatient settings if the anesthesia care provider uses a trigger-free anesthetic technique.1 An example of a trigger-free anesthetic technique is one that includes propofol, opioids, or non-depolarizing muscle relaxants (eg, pancuronium) and does not include halothane or isoflurane as an inhalation agent. Nitrous oxide is safe for use as an inhaled general anesthetic, and local anesthetics (eg, lidocaine, procaine) also are safe.², ³ When MH-susceptible patients undergo uneventful general anesthetics in ASCs, they should be monitored for at least 60 minutes in the phase 1 postanesthesia care unit (PACU) and at least 90 minutes in the phase 2 PACU or step-down unit before being discharged.¹, ⁴, ⁵

Facility preparedness. Every patient should be considered potentially at risk for developing MH no matter where the patient is scheduled to have surgery. Previous uneventful anesthesia does not eliminate the possibility of MH, because patients may undergo multiple episodes of anesthesia before MH is triggered.⁶ Personnel working in any location that administers general anesthetics and/or succinylcholine should be prepared to manage an MH crisis.3 Preparations include stocking a supply of 36 vials of dantrolene sodium and sterile water, having access to ice, and ensuring availability of the pharmacologic agents and equipment listed in Table 1.

Table 1. Malignant Hyperthermia (MH) Cart

Adapted with permission from AORN malignant hyperthermia guideline. In: Standards, Recommended Practices, and Guidelines. Denver, CO: AORN, Inc; 2007:219-228.

1. MHAUS—Malignant Hyperthermia Association of the United States. Medical professional's FAQs—dantrolene. April 2007. http://www.mhaus.org/index.cfm/fuseaction/Content.Display/PagePK/MedicalFAQs.cfm. Accessed August 31, 2007.

2. Lexi-Com. Drug Information Handbook for Perioperative Nursing. Adapted from Anesthesiology and Critical Care Drug Handbook. 6th ed. and Drug Information Handbook for Advanced Practice Nursing. 6th ed. Hudson, OH: Lexi-Comp; 2006:933.

Staff member education. Every facility should include MH training in the orientation plan for new members of the perioperative team and other personnel who will be involved in responding to the crisis. Ongoing periodic reviews also should be scheduled. The MHAUS recommendations suggest that the perioperative team initiate mock MH drills at least twice a year to improve staff member efficiency in treating a patient during an MH crisis.⁷

Dantrolene sodium is difficult to mix, so some institutions reconstitute the outdated medication during staff member education sessions to give hands-on training during the mock drills. Perioperative nurses also may benefit from a review of the electrolyte imbalances and arterial blood gas shifts that occur with respiratory and metabolic acidosis during an MH crisis. Facilities should identify specific tasks assigned to each member of the response team to ensure effective management of an MH crisis. Procedure manuals are available from the MHAUS to assist in assigning specific tasks and to facilitate staff member education.⁷

Signs and symptoms of malignant hyperthermia. Malignant hyperthermia may present with a variety of signs and symptoms during an acute phase or may develop over a course of several hours and present in a subtler fashion. Unexplained tachycardia is often the first sign of an acute MH episode. Jaw muscle rigidity that is severe, sustained, or interferes with intubation should be considered a possible sign of an impending MH crisis.

Guidelines for MH susceptibility. Patients identified as MH susceptible who are undergoing surgery in an ASC and exhibit mild spasms in their jaw or masseter muscle rigidity should not be discharged without further observation. The following guidelines should be used if suspicious symptoms are noted.

Malignant hyperthermia occurs most frequently during administration of anesthesia. Initial symptoms generally are not seen in the PACU, especially after more than two hours have elapsed since the anesthetic agents were discontinued.⁸ When patients present with symptoms of a fever in the PACU, it generally is due to sepsis or iatrogenic heating and is not related to MH. Temperature increases after a patient is discharged generally are not related to MH unless there were signs of MH (eg, myoglobinuria, muscle weakness, muscle rigidity) before discharge.3

Screening for MH. Specific screening measures for MH should not be performed differently in an ASC than in a hospital. Patients and their family members, however, should participate in making the decision about where to have surgery scheduled if the patient has been identified as MH susceptible. It is important for patients and their family members to understand that MH is a genetic disease with an autosomal-dominant pattern. This translates to the following inheritance patterns.

A patient whose history seems suspicious for MH, may wish to have a muscle biopsy test performed before undergoing anticipated surgery, but it is not a requirement because anesthesia care providers have the option of using a nontriggering anesthesia technique. 3 Patients are appropriate candidates for muscle biopsy testing if they have a family history of MH or have experienced unexplained hypercarbia and muscle rigidity related to a general anesthetic.¹¹, ¹², ¹³ In the past, dantrolene sodium was used to pretreat patients who were identified as MH susceptible because it stabilizes the muscle cell membrane and limits intracellular calcium levels. Currently, this is not recommended because patients who have had prophylactic dantrolene sodium regimens have experienced muscle weakness or gastrointestinal upset.¹⁴

When MH susceptibility is identified, perioperative nurses should help the patient and his or her relatives understand the importance of informing the entire surgical team (eg, anesthesia care providers, surgeon, perioperative nurses) about a family history of MH before the patient undergoes any future surgical or invasive procedures requiring general anesthesia. It is critical that patients and their relatives receive counseling and education regarding the pathophysiology and management of MH. If a patient has experienced symptoms suggesting MH during a procedure, the perioperative nurse should suggest that the patient receive and keep a copy of the anesthesia record, laboratory tests, and the PACU/critical care unit notes to show future care providers.

Regardless of whether the surgical procedure is scheduled in an ASC or a hospital setting, nursing care begins when the patient is scheduled for a surgical or other procedure involving general anesthesia. As early as possible in the preoperative phase, the perioperative nurse should ask patients and their family members the following series of questions to help screen for MH susceptibility.³, ⁸, ¹⁴, ¹⁵

Opening a discussion using layman's terms may help the patient and family members talk about situations that relate to MH susceptibility.

If the perioperative nurse believes a patient is susceptible to MH, the nurse should notify the surgeon and anesthesia care provider. Preoperative education and preparation is crucial for the patient who is identified as being susceptible to MH. It is important that the patient and family members understand that answering “yes” to any of the screening questions will not mean they will be denied anesthesia during a surgical procedure but rather that different considerations may be initiated for their anesthesia care. They should participate in decisions about when and where to go for the surgical procedure and understand that counseling is available.

Patients who are identified as susceptible to MH can safely undergo surgery in outpatient settings when anesthesia care providers are prepared to use nontriggering anesthetics and careful monitoring. Perioperative nurses play a key role in preoperative patient assessment and communication when patients are identified as MH susceptible.

Patients who are identified as susceptible to MH can safely undergo surgery in outpatient settings when anesthesia care providers are prepared to use nontriggering anesthetics and careful monitoring. Perioperative nurses play a key role in preoperative patient assessment and communication when patients are identified as MH susceptible.

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Medical Gas Handling 

QUESTION: A paramedic at our hospital instructs staff members to open the oxygen tank valve all the way after the regulator is in place. I have been a nurse for a very long time and was trained to “crack” the tank open one turn after the gauge registers the cylinder pressure to minimize the loss of oxygen when the tank is not in use. Is it necessary to open the cylinder valve completely, and what is the rationale behind this? I would also like to know if it is acceptable to apply a new, disposable regulator washer over an existing washer when changing oxygen tanks. Coworkers who do this say it will prevent leakage. Is this true?

ANSWER: Compressed medical gases, including oxygen, can pose a fire hazard when the cylinder valve is not opened fully. Safe handling guidelines for medical gases include opening the cylinder's post valve fully to prevent excessive heat buildup through the regulator.¹ The 2,200 psi of oxygen in a full cylinder of oxygen is compressed as it passes through a regulator at a rate of 50 psi before it goes through the oxygen cannula. When the cylinder valve is opened, the released oxygen undergoes rapid decompression. As oxygen passes through the regulator, it is recompressed, causing a rapid rise in temperature known as adiabatic compression.², ³ If the cylinder valve is not opened fully, temperatures can escalate more dramatically. In the presence of combustible contaminants (eg, oils, dirt) collecting around the gas outlet, a flash fire may occur from the adiabatic process.

A more common cause of compressed medical gas fires is related to the ignition of entrapped particles (eg, minute shavings) being forcibly blown through the regulator. Sparking occurs when projectile debris pushes through an aluminum regulator, or entrapped aluminum shavings released from the oxygen cylinder make contact with the metals of the oxygen regulator.², ³

Explosive fires also have been associated with damaged disposable crush gaskets or use of multiple reusable sealing washers for medical gas exchanges.⁴, ⁵, ⁶ A joint health advisory issued by the FDA and the National Institute for Occupational Safety and Health (NIOSH) in April 2006 reported that 12 regulator fires occurred as a result of improper use of gasket and washer seals.⁶ Multiuse washers can become damaged from excessive torque used in an effort to seal the cylinder valve to the regulator's surface. With subsequent uses, the damaged reusable washer may become dislodged, causing an oxygen leak at the regulator juncture, which creates an opportunity for combustion.⁵, ⁶ Similar conditions exist when multiple crush gaskets or sealing washers are used together, even if all are intact.⁴ Gaps are created from the irregular fit of the combined devices. The additional force needed to seat the regulator into place can damage the gaskets or washers and the regulator. The forceful leakage of compressed oxygen across the damaged surfaces may produce enough thermal energy to promote combustion of the gasket materials or ignite debris colliding with the regulator.⁵, ⁶

The FDA and NIOSH make the following recommendations for avoiding combustion when handling compressed medical gases.

Compressed medical gases are commonly used in perioperative settings. Safe handling guidelines, therefore, should be reviewed regularly by all staff members responsible for cylinder storage, delivery, setup, and use.

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Multipack Needle Counts 

QUESTION: It is my understanding that suture packages should not be used to verify needle counts. If this is true, am I supposed to open all the multipack suture packages for the initial count and all subsequent counts rather than using the unopened suture packages?

ANSWER: AORN does not recommend using empty suture packages to rectify a discrepancy in a closing needle count, but it is acceptable to count suture needles initially by the number marked on the suture package before the scrub person opens the individual suture packages. Individual multipack suture packages should be opened as close as possible to the time they are to be used. The number of actual needles should be verified at the time they are opened by the scrub person and circulating nurse. Additional multipack needle packages should be counted simultaneously by the scrub person and circulating nurse when they are added to the sterile field during the procedure as close as possible to the time they are to be used.

Opening multipack suture packages for the initial count could increase the risk of injury to the scrub person because of the high number of unconfined sharps remaining on the back table for a long period of time before they are needed. Furthermore, when sharps are unconfined on the sterile field, there is an increased risk for unintentional transfer into the incision, penetration of barriers, or of misplacing sharps (eg, when they are dropped to the floor).¹

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Sterilization Indicators 

QUESTION: We use sterilization tape on the outside of our instrument sets. Why am I not allowed to cut up the tape or use a similar type of indicator on the inside of the trays to show they have been processed? Are there categories of indicators that I need to know about?

ANSWER: Sterilization tape and other types of external indicators only indicate that the item has been through the sterilization process; they are not intended to be used to indicate that sterilization parameters have been met. These indicators are heat-sensitive and usually change from white to black when exposed to the high temperatures used for the sterilization process. They are intended to be used as an easy method to identify which items have been processed; however, this type of indicator may change color when placed in any location where there is an elevated temperature (eg, a window sill in direct sunlight). Based on this information, perioperative personnel should not store this type of indicator in an area that is exposed to sunlight or heat. Sterilization tape is not an appropriate indicator to be used independently as an internal indicator because it only reacts to heat and does not determine whether an item has been exposed to heat for a set amount of time or to other critical parameters of the sterilization process.

The American National Standards Institute (ANSI) and the Association for the AAMI identify five classes of chemical indicators.¹ Each class of indicator responds to different parameters of sterilization (ie, time, temperature, pressure).

One of the major responsibilities of perioperative RNs is to minimize patient risk of surgical wound infections. To fulfill this responsibility, it is important for nurses to pay continuous attention to all aspects of the sterilization process and sterilizer performance. Nurse managers and nurse educators who work in perioperative settings should advocate to include quality control parameters for the sterilization process in employee orientation and staff development programs for all members of the perioperative team.³

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Sterilization Monitoring 

QUESTION: I am new to perioperative nursing and I am confused about the terminology for sterilization process monitoring. I have heard several terms, but I am not sure how to differentiate each one quickly. Can you provide a quick way to reference the following types of monitoring devices: mechanical indicators, Bowie-Dick tests, process challenge devices, chemical indicators, biological indicators, “rapid-read” indicators, “enzyme-only” indicators, and integrators? Where can I read about sterilization process monitoring in more detail?

ANSWER: Perioperative nurses are responsible for verifying that supplies and instruments used during surgery are sterile. To do this, nurses need to understand the purpose and design of sterilization equipment and products used to measure performance in their facility. Following is a brief summary of several monitoring devices (eg, mechanical, chemical, biological, “rapid-read,” enzyme-only, and integrator indicators; dynamic air-removal tests; process challenge devices) identified by the Association for the Advancement of Medical Instrumentation (AAMI) to verify the performance of the equipment being used for the sterilization process.¹

AORN recommends including a sterilization process indicator in each package to be sterilized and with all items being flash sterilized. A separate process indicator should be used on the exterior of a package when the process indicator is not visible from the outside of the package. The purpose of external sterilization process indicators is to differentiate between processed and unprocessed items. Internal process monitors do not establish whether an item is sterile but show that the sterilant was able to penetrate the package, exposing the package contents to conditions of sterilization.² For more information, refer to AORN's “Recommended practices for sterilization in the perioperative practice setting”² and the ANSI/AAMI ST79, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities.¹

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Surgical Site Marking Pens 

QUESTION: Currently at our facility, the marking pen used to mark the surgical site is being used on more than one patient. What type of pen should be used? Is there a possibility of cross-contamination with infection when using marking pens on more than one patient?

ANSWER: Marking pens used to mark surgical sites should be permanent ink markers that have enough permanency to remain visible even when skin preparation solutions are applied.¹ The manufacturer of marking pens should be asked if the marking pen contains an antiseptic solvent. If the marking pen does not contain an antiseptic solvent, it should be a single-use item and should be used on only one patient.

A laboratory experiment was conducted in vitro to test two commercial skin markers for transmission of methicillin-resistant Staphylococcus aureus (MRSA). The pens were contaminated with a higher rate of MRSA inoculation than normally is found in a clinical setting. The MRSA did not survive on pen #1 for more than 15 minutes, but it survived for up to three weeks on pen #2. The researchers believe that growth of MRSA was inhibited in pen #1 because the pen contained isopropyl alcohol and ethanol as a solvent; pen #2 contained water as a solvent and had no antiseptic to inhibit growth of MRSA.²

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Types of Fire Extinguishers 

QUESTION: Recently, we read several articles about fire safety, and now we are confused about the type of fire extinguishers that should be maintained in the OR. With so many different kinds and differing opinions, it is difficult to know what to do. Does AORN have a recommendation on the type of fire extinguishers to use in the OR? Where can we find more information about fire safety and fire extinguishers?

ANSWER: The National Fire Protection Association (NFPA) sets standards for classification, ratings, and performance of portable fire extinguishers.¹ Local authorities, however, have jurisdiction over specific requirements for portable fire extinguishers in health care facilities. The NFPA standards provide guidance to authorities for establishing local ordinances and regulations.¹ The agency that governs fire control and prevention regulations for each state is either the fire marshal or the state department of health. In addition, there may be local or regional regulations. Your facility's designated safety office should contact the local fire district for specific regulations in your area.²

To gain a better understanding of the specifications for fire extinguishers, refer to the NFPA codes and standards for fire prevention and safety. The NFPA establishes codes and standards for every building, process, service, design, and installation in the United States, including health care facilities. The NFPA standards for health care facilities recommend that portable fire extinguishers suitable for the particular hazard be readily available and located in an area easily accessible to personnel.³ The NFPA recommends that fire extinguishers are intended to be the first line of defense in managing a fire in addition to automatic sprinkler systems and other fixed protection systems.¹ The ECRI, a designated evidence-based practice center and nonprofit health services research agency, recommends that perioperative clinicians attempt to douse or smother the fire before using an approved fire extinguisher in surgical or procedural settings.⁴ The NFPA 10: Standards for Portable Fire Extinguishers is intended to provide guidance on the selection, purchasing, installation, design, and maintenance of fire extinguishers.¹

The selection of fire extinguishers is determined by several factors that include, but are not limited to, the nature of potential fires, type of facility, occupancy, and hazard to be protected. Fire extinguishers are rated according to the type of fire they are designed to extinguish. The NFPA classifies fires as

Some portable fire extinguishers are appropriate only for one class of fire, but others may be appropriate for two or three classes. No fire extinguisher is suitable for all types of fires. The label on the fire extinguisher should indicate the type of fire it is designed to extinguish. The NFPA recommends marking extinguishers with the appropriate letter to designate the type of fire classification. For example, the letter A in a triangle should be plainly marked on a fire extinguisher that can be used for ordinary combustibles.¹

Fire dangers in the OR generally are classes A, B, and C. Extinguishers intended for use in an OR, therefore, should be rated accordingly.¹ When possible, fire extinguishers rated for all three classes of fires (ie, A, B, C) may be the best suited for the OR. Considering the unique nature of the OR, dry chemical extinguishers may not be appropriate. When discharged, dry chemical extinguishers spread powder throughout the room and could possibly compromise asepsis.

Selection of the appropriate fire extinguisher can get confusing and overwhelming with the large variety of choices on the market. Each facility should consult with the local fire district for the specific types of fire extinguishers to acquire based on the type of potential fire danger present.

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Toxic Anterior Segment Syndrome 

QUESTION: I work at an eye surgery center and our surgeons are concerned about preventing toxic anterior segment syndrome (TASS). They have asked us to review how we process cataract instruments. What is TASS and how does the cleaning and sterilization of eye instruments affect the risk of TASS?

ANSWER: A recent outbreak in the United States has brought TASS to the attention of many ophthalmic surgeons and perioperative RNs working in ophthalmic surgery centers. Toxic anterior segment syndrome is a postoperative, acute, inflammatory reaction caused by a noninfectious toxic substance that is introduced into the anterior segment of the eye during ophthalmic surgery, usually cataract surgery. The toxic substance causes serious and potentially irreversible damage to intraocular tissue.¹ A rapid onset of symptoms typically occurs within 24 hours after surgery, although there are some reports of delayed onset.¹ The inflammatory response

Patients report blurred vision, some eye pain, and eye redness. The inflammation may be severe, with the formation of corneal edema and pus in the anterior chamber. Toxic anterior segment syndrome can cause permanent iris damage, leaving a dilated and irregular pupil that constricts and dilates poorly. Patients frequently have decreased intraocular pressure early on, but cellular damage eventually may lead to ocular hypertension or glaucoma. Corneal epithelium is the most sensitive tissue in the anterior segment of the eye; therefore, the cornea usually is most severely affected by TASS.¹

There are several known causes of TASS, including

Although there are no conclusive epidemiological data to suggest any single cause or product is responsible for TASS, cleaning and sterilization of ophthalmic instruments used for cataract surgery appears to be an important factor, though not the only consideration, in the prevention of TASS. Any substance used in cleaning and sterilizing ophthalmic instruments may cause TASS. Failure to clean or adequately rinse detergents from instrument surfaces and small lumens of cannulated items has been implicated in TASS.⁴

Ultrasonic and phacoemulsification hand pieces that have been improperly flushed and rinsed can introduce enzymatic detergents and endotoxins into the eye. Enzymes or other active ingredients in detergents are not inactivated at sterilization temperatures lower than 140° C (284° F); therefore, usual steam sterilization temperatures of 121° C to 135° C (250° F to 275° F) will not inactivate detergent enzymes.⁴

Reusable cannulas, tubing, and irrigation/aspiration tips can be another source of contamination. Lumens of small- gauge cannulas are difficult to clean and rinse and can retain toxic detergents easily. When sticky viscoelastic solutions are present, the chance that toxic substances may be retained inside the lumen of cannulas increases. Properly flushing the lumens with large amounts of sterile water can be tedious and time consuming, but it is a critical step in preventing TASS. Although it can be tempting to shorten the required cleaning time for instruments, this temptation should be resisted.

Ultrasonic water baths are used to clean instruments between procedures. Ultrasonic machines can be a source of endotoxin residue if they have not been emptied and cleaned properly, because the residue can be left on the instruments and introduced into the anterior chamber of the eye. Ultrasonic machines should be emptied and cleaned at least daily to remove any endotoxin residue. The ultrasonic machine manufacturer's directions for detergent selection and proper use, care, and maintenance should be followed carefully.⁵

Preventing TASS should be a priority for every perioperative RN involved in the care of ophthalmic surgical patients. Conscientious adherence to recommended practices for using, cleaning, disinfecting, and sterilizing ophthalmic equipment and instruments will help to minimize the risk of TASS. Ophthalmic instrument decontamination and sterilization measures to prevent TASS should include, but not be limited to, the following steps.

If an outbreak of TASS occurs in a health care facility, a thorough analysis of all medications and fluids used during surgery and in the cleaning, disinfection, and sterilization process should be performed. Appropriate corrective measures should be taken.

An investigation into the epidemiology of TASS, funded by a grant from the American Society of Cataract & Refractive Surgery, is underway at the Intermountain Ocular Research Center in Salt Lake City. Suspected cases of TASS should be reported to the Centers for Disease Control and Prevention Division of Health Care Quality Promotion at (800) 893-0485 or to Nick Mamalis, MD, University of Utah Intermountain Ocular Research Center, at nick.mamalis@hsc.utah.edu or (801) 581-6586.⁷

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US Food and Drug Administration Product Clearance 

QUESTION: In the last year, we have begun requiring US Food and Drug Administration (FDA) clearance letters on all new products and devices when they are brought into our facility for evaluation. Some items have a 510(k), some have a premarket approval (PMA), and some items or instruments have nothing. What needs to be cleared by the FDA, and what is the difference between the types of clearances for medical devices used on patients?

ANSWER: The FDA is the federal regulatory agency responsible for assuring the safety of medical devices, and it serves as an important information resource in the evaluation of a product's safety and efficacy. The FDA clearance is an important piece of information that should be considered as a part of a collaborative process for prepurchase evaluation of medical devices and products.¹ Perioperative RNs participating in the selection and purchase of medical products and devices should be familiar with terms used in the FDA's market-approval process.

The FDA determines a medical device's classification based on the level of regulatory control that is necessary to assure the safety and effectiveness of the device. A device's classification determines the process (ie, premarket notification [510(k)] versus PMA) that the manufacturer must complete to obtain FDA clearance and approval for marketing. Examples of items that do not require either a 501(k) or PMA include exempt class II devices, such as a urodynamics measurement system, jet lavage, or wheeled stretcher.²

The manufacturer is required to develop data and information necessary to submit a marketing application and obtain FDA clearance to market. For some 510(k) submissions and most PMA applications, clinical performance data must be submitted to obtain clearance to market. In these cases, a trial must be conducted in accordance with the FDA's Investigational Device Exemption (IDE) regulation in addition to submission of the application for marketing clearance.³

Premarket submission. A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective and is substantially equivalent (ie, comparable) to a legally marketed device that has previously been cleared for marketing. Examples of items that require a 510(k) include anesthesia breathing circuits and surgical sponges. The manufacturer must compare the device to one or more similar devices currently on the US market and submit descriptive data and, when necessary, performance data to establish that its device is substantially equivalent to a predicate device.

A device is substantially equivalent if, in comparison to a predicate device, it has

A claim of substantial equivalence does not mean that the new and predicate devices are identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. A 510(k) is required when

Premarket approval. A PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of class III medical devices. Class III devices are those that support or sustain human life; are of substantial importance in preventing impairment of human health; or present a potential, unreasonable risk of illness or injury. Examples of items that require a PMA include new equipment technologies (eg, optical lasers, percutaneous transcatheter technology); new packaging configurations for medications; and changes to existing devices. The FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices because of the level of risk associated with class III devices. These devices, therefore, require a PMA application to obtain market clearance. Some class III preamendment devices also may require a class III 510(k). For purposes of 510(k) decision-making, the term “preamendment device” refers to devices legally marketed in the United States before May 28, 1976, and those

The PMA is the most stringent type of device-marketing application required by FDA. The manufacturer must receive FDA approval of its PMA application before marketing the device. The PMA is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended uses. An approved PMA is, in effect, a private license granting the applicant or owner permission to market the device.⁴

As new medical devices and products are introduced, perioperative RNs play an integral role in evaluating and selecting products that are safe and effective. Familiarity with the FDA market-approval process will help in making wise purchasing decisions.

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Ultrasonic Washers 

QUESTION: The sterile processing department where I work just installed a new ultrasonic washer. The new unit requires a “degassing” cycle that is to be run before instruments are cleaned. The previous unit did not have this cycle. What is a degassing cycle? Is it necessary to ensure proper cleaning? How does an ultrasonic washer clean instruments?

ANSWER: When an ultrasonic unit is filled with water, naturally occurring dissolved gases (eg, hydrogen, oxygen, carbon dioxide) are found in the water stream. Degassing is the process used to remove these inherent gases to permit a uniform ultrasonic wave frequency through the fluid. Frequently, this is accomplished by placing an empty wire mesh basket into the water bath and running a cycle. The mesh basket intercepts the ultrasonic wave and prevents damage to the washer unit. Newer ultrasonic washers may have a separate operation for degassing to serve as a visual reminder to complete the step. Older models that do not have a designated degassing function require an initial cycle as described above to complete the degassing process.

Ultrasonic washers work on the principle of high-frequency sound emission passing through a fluid medium, causing the rapid formation and violent collapse of millions of microscopic bubbles. The bubbles are formed during the low-pressure phase of the ultrasonic cycle and implode with onset of the high-pressure phase, resulting in a vacuum.¹, ² This process is called cavitation. Cavitation is more effective when gases are removed from the fluid medium, allowing the high-frequency waveforms to impact the instrument surface evenly. When used in combination with cleaning solutions (eg, enzymatic cleaners) and temperatures no greater than 140° F (60° C) to avert hemocoagulation, cavitation has proven effective in the removal of organic and inorganic submicron particles, viruses, bacteria, and fungi from instrument surfaces, crevices, cavities, and joints.², ³, ⁴

Before instruments are placed in the ultrasonic washer, gross bioburden should be removed and the items should be placed in a wire mesh basket.⁵ The water-detergent solution should be clean without signs of soilage. Water quality plays an important role in ultrasonic cleaning, and poor water quality can impede the effectiveness of the ultrasonic washer. Poor water quality from previous cleaning cycles or from the source point, in combination with improper ultrasonic washer rinse parameters, can cause residual detergent and rinse water particles to adhere to instrument surfaces.³, ⁵ Staining and marking of instruments also has been noted from slow drying cycles at high temperatures.³ Recontamination of instruments by impurities in ultrasonic water has been associated with toxic anterior segment syndrome⁶ and instrument damage leading to bioburden accumulation and breakage. Sterilization in an autoclave does not deactivate residual cleaning agents, so instruments with lumens should receive an additional flush of tap, distilled, or deionized water.⁶ For more information on how your ultrasonic washer works, consult the manufacturer's manual or request an inservice program from your vendor's representative.

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