Caution: The OR Can Be Hazardous to Your Health

 The patient lies unconscious on the operating room table. Tension mounts as the surgical team focuses to complete a critical step of the procedure. (The terms “surgical” and “operating room” include all invasive procedures and the locations where they are done.) Would this be a good time for the staff to fall asleep because anesthetic gases were not vented properly?

Or for a flash fire to ignite under surgical drapes that have trapped oxygen within their folds? Or for the overhead light to crash onto the surgical field, crushing the patient and staff?

The hazard possibilities in a busy OR department are almost too numerous to count. By its very nature, the stage is set for a wide array of potential disasters to occur daily, but numerous preventive measures are available to the proactive biomedical engineering department staff.

From a panoramic viewpoint, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) considers patient safety a fundamental issue. In its 2004 National Patient Safety Goals, there are two key points that relate specifically to BMET responsibilities and impact the biomedical staff every day: improvements in the safety of infusion pumps and enhanced effectiveness of clinical alarm systems.

In addition to these topics, the prevention of surgical fires is the focus of JCAHO’s attention. It cites data collected by the US Food and Drug Administration and ECRI (formerly Emergency Care Research Institute) that indicate that there are between 50 and 100 surgical fires per year. These fires cause 20 serious injuries and one or two patient deaths during the estimated 50 million inpatient and outpatient surgical procedures performed annually.

Brit Berek, MBA, CCE, associate director, standards interpretation for JCAHO, explains that the OR presents many opportunities for patient safety issues to arise. High density of equipment, numerous devices with alarm systems, highly flammable materials, a “wet” field, exceptionally frequent interactions between staff members, and the critical nature of the work are just some of the site characteristics that make the OR one of the most potentially precarious venues in health care.

To address those risks, JCAHO has developed a sentinel-event policy that provides a reporting mechanism for health care organizations to describe hazardous occurrences. An analysis of the data submitted by several hospitals and other patient care settings provides data for further review.

“If a pattern emerges from analysis of these reports, we look for root causes and get that information back to our organizations,” says Berek. Although an individual event occurs in a specific institution, JCAHO analyzes the aggregate to provide precautionary information to its members.

WEB SITES OF INTEREST

  • ECRI offers several published articles and educational posters concerning surgical fires that are available free of charge. Go to www.mdsr.ecri.org/  and enter the word “fires” into the Search Terms line.
  • For information about reporting sentinel events to the JCAHO, visit: www.rootcauseanalyst.com/se_opt.htm  

Let’s Get Specific
“There are hazards associated with the infrastructure, and then there are those related to equipment,” says Matthew Weinger, MD, director of the San Diego Center for Patient Safety at the Veterans Affairs Medical Center and professor of anesthesiology at the University of California, San Diego. By infrastructure he means systems such as the gas pipeline, electrical wiring, or components that are part of the building itself. Few hospital settings involve a greater equipment-to- patient ratio than the OR.

Bill Dessel, CBET, who serves as a biomedical technician with a specialty in anesthesia and respiratory equipment at Children’s Hospital, Oakland, Calif, explains that the OR must be considered a “wet field” because of all the liquids used and produced. Certainly, coupling a fluid environment with electricity raises the danger level a notch.

“I’ve never been in an OR where they seem to have enough power at the walls, so they’re always trying for more,” says Dessel. That means extension cords between the wall and electrically powered equipment where a splash could spell disaster.

Dessel describes an incident during which a line-isolation-monitor alarm sounded. When he entered the OR, he asked if a liquid spill had occurred. Staff pointed to a corner of the room where a power strip was sitting in a puddle. Mystery solved.

Chris Lavanchy, engineering director of health devices for ECRI, describes another infrastructure-based hazard.

“We hear about, on a fairly regular basis, failure of ceiling-mounted fixtures, the type that support OR lights or monitors,” says Lavanchy. Because they appear to be stable, stationary devices that are moved only to adjust position, it is easy to overlook them during routine inspections. He notes that breakage usually occurs at the base or the hub where it connects to the ceiling because that is where the greatest stress occurs.

Lavanchy suggests that BMETs scrutinize the area closest to the ceiling fixture, looking for fine hairline cracks in the paint that may appear very subtle but can signal an impending catastrophe.

Large machinery in the OR, such as a power OR table or heavy medical imaging equipment, can employ mechanical stops that are designed to shut off the power when a collision with either a patient or other piece of equipment appears imminent. Lavanchy suggests that as part of the inspection process, biomeds should confirm that the stops are working as designed and make necessary adjustments to insure their proper function.

Another infrastructure issue involves appropriate evacuation of anesthesia gases. Dessel explains that the National Institute for Occupational Safety and Health sets standards about the levels of exposure over an 8-hour period to protect the users who work in the OR.

The evacuation line connected to the back of the anesthesia machine that directs used anesthetics to a venting system on the roof of the building, where those gases can be dissipated into the atmosphere and not recalculated into the hospital’s ventilation system, must be designated with its own color code (usually purple).

Children’s Dessel describes an instance in another facility wherein four vacuum lines extended from the ceiling; none were color-coded to indicate their role as the evacuation line for gases. During the procedure, when the OR staff thought they were discontinuing one suction unit, they actually disconnected their scavenging line, exposing the staff to anesthetic.

“Even if in older hospitals they’re tied together, you still need to know which is the evac line,” concludes Dessel.

ECRI’s Table of Typical Coexisting Ingredients That Could Cause an OR Fire1
Oxidizers Ignition Combustible Substances
Oxygen Electrosurgical units Patient (hair, GI tract gases)
Nitrous oxide Electrocautery units (both battery and line  operated) Prepping agents (degreasers [ether, acetone] [Freon is nonflammable.])
Surgical lasers Aerosol adhesives
Fiber-optic light sources Alcohol (also present when spilled from gut suture packets during opening)
Incandescent spark Tinctures (Hibitane [chlorhexidine gluconate], Merthiolate [thimerosal])
Static discharge spark    Linens (drapes [nonwoven, woven, and adherent], gowns, masks, hoods, caps)

Dressing (gauze, sponges, adhesive tape [cloth, plastic])

Ointments (Collodion, Petrolatum [petroleum jelly], tincture of benzoin,  aerosols (e.g., Aeroplast®, paraffin, white wax)

Plastic/rubber products (blood pressure and tourniquet cuffs, gloves, sthtoscope tubing)

Anesthesia components (breathing circuits, masks, airways, endotracheal tubes)

1Excluding flammable anesthetics.

Safety Tasks for OR Devices
The role of the BMET in providing a safe OR environment begins with purchase decisions for equipment that is used there.

Weinger, who researches patient safety at the VA Medical Center in San Diego, stresses the importance of BMETs’ involvement in the evaluation of new additions to the equipment list. He recommends requiring a 2-week trial period prior to purchase. During this time the device can be used in a real environment by multiple representative end users. The BMET should establish a structured evaluation that focuses on “Did it do its job?” rather than “How did you like it?” Developing quantitative data will help to inform the decision-making process.

In addition, Weinger suggests that the team of evaluators request usability-test results from the manufacturer. Because original equipment manufacturers are now required to perform these tests to complete the FDA approval process, they have them on file and should be willing to supply them to customers for their product.

He notes that during the evaluation process, BMETs are the perfect team members to review human-factors engineering concepts. Considering the environment in which it will be used, is the device easy and intuitive to use? Are the alarms so loud and obnoxious that they distract the staff members from their normal tasks? Will the function be disrupted if liquid is spilled on the controls? Is the electrical wiring appropriate to the OR environment? Safe use of all equipment is imperative in the OR and throughout the health care environment.

Finally, Weinger discusses the issue of obsolescence, especially when new safety features have been designed into newer products.

“Particularly with the tight budgets of hospitals these days, there’s a temptation to limit new capital-equipment purchases,” says Weinger. “So the biomedical engineers need to be ever vigilant of both the introduction of new devices and upgrades to older equipment that address specific safety issues.”

JCAHO recommendations
JCAHO recommends that health care organizations help prevent surgical fires in three ways:

1) Inform staff members, including surgeons and anesthesiologists, about the importance of controlling heat sources by following laser and electrosurgical unit safety practices; maintain fuels by allowing sufficient time for patient prep; and establish guidelines for minimizing oxygen concentration under the drapes.

2) Develop, implement, and test procedures to ensure appropriate response by all members of the surgical team to fires in the OR.

3) Report any instances of surgical fires as a means of raising awareness and ultimately preventing the occurrence of fires in the future. Reports can be made to JCAHO, ECRI, the FDA, and state agencies, among other organizations

Preventive Maintenance Holds the Key
Eric Drey, CBET, and Gary Riddell, CBET, both serve as perioperative biomedical technicians at Lehigh Valley Hospital and Health Network in Allentown, Pa. Their routine for keeping their OR safe includes morning rounds to discuss potential problems with staff.

“People tend to be more open with their repair needs if you approach them face to face as opposed to using the email system,” says Drey. Although they have four different methods of communication for staff to contact them, Drey and Riddel have found that personal contact works best. They are seen as integral members of the team, not some distant unknown repairperson.

Drey and Riddell have established a rating system for each piece of equipment depending on its function and how central it is to life support. They use that system to develop a preventive maintenance schedule. For example, a piece of equipment with a therapy function might rate lower on the scale than the monitors that display patient cardiovascular function.

Besides being involved in preventive maintenance, they also evaluate equipment repair needs.

They have determined that some functional equipment is sent for repair if a knowledgeable person does not assess the reported problem. Often the issue could involve user error; a simple, easily accomplished repair; or perhaps an intermittent malfunction. Their daily rounds bring potential problems to their attention more quickly than without that contact.

Drey and Riddel emphasize the importance of training on any new equipment that is purchased and say that Lehigh Valley is committed to ongoing education. Appropriate instruction not only prevents problems from arising, but it also provides a good return on investment because a well-educated workforce can extend the life of a piece of equipment.

“One of my favorite sayings is, ‘Training is expensive but not as expensive as ignorance,’” says Drey.

Other hazards in the OR are reduced with frequent, routine evaluation and preventive maintenance procedures for equipment, according to ECRI’s Lavanchy. Thermal injuries from warming equipment that is not properly calibrated or pressure injuries from a malfunctioning automatic tourniquet that is designed to periodically release its pressure prevent patient well-being. The BMET who checks this equipment frequently will reduce opportunities for injury.

Lavanchy advocates “incoming” inspection for any device that is new to the OR unit. He uses an example of an anesthesia vaporizer that was shipped from one hospital to another overseas.

“There was no incoming inspection because it had been used a few days before it was shipped,” says Lavanchy. The first time it was used in the receiving hospital, the patient died from excessive anesthesia. “When we investigated, we learned that, in shipping, a vibration was introduced [that] caused the calibration screw to rotate, completely throwing the device off.”

In another example, a service representative from the manufacturer came in to make an adjustment and a modification to a balloon pump used in open-heart surgical procedures. The next day, the balloon was threaded to the appropriate spot, the pump was started, and the patient’s aorta ruptured—causing immediate death. The person who had worked on the machine inadvertently reversed the high-pressure line and the low-pressure line.

“A few minutes of attention to verify that the pump worked properly after the adjustment would have saved that patient’s life,” says Lavanchy.

Conclusion
If ever there were a “Help me, Obi Wan Kenobi; you’re my only hope” opportunity for BMETs, maintaining a safe environment in the operating room could be considered a prime candidate. Through careful evaluation of equipment and the infrastructure, routine preventive maintenance activities, and good communication with staff, the biomedical engineering department is critical to the well-being of every patient and all staff who work there.

Cheryl Hall Harris, RN, is a contributing writer for 24×7.