L-R: Anup Chhetri, BMET II, and George Panyarachun, MS, BME, GNG, manager, conduct high-risk equipment failure mode and effect analysis on a MRI-compatible infant transport incubator.

Most biomeds can relate to the daunting reality of repeatedly fixing the same device over and over. Wouldn’t it be nice to weed out those problematic brands long before they became a headache on the maintenance docket?

As manager of the biomedical engineering department at Childrens Hospital Los Angeles (CHLA) since 2005, George Panyarachun, MS, BME, GNG, has devoted countless hours to minimizing those headaches and taking the guesswork out of risk management. Colleagues may consider him part psychic, but Panyarachun instead relies on failure mode and effect analysis (FMEA), a method developed by the military during World War II but now modified for many industries—including health care.

When deciding on what equipment to purchase, the process involves communication with many different department heads, all of whom have come to trust Panyarachun’s judgment.

“With high-risk equipment, we seek input from medical directors, materials management, clinical staff, nursing, and all the groups that eventually must buy into the process for whatever equipment they are considering for purchase,” Panyarachun says, a recipient of the 2008 Welch Allyn Professional of the Year award from the California Medical Instrumentation Association. “Everybody signs off on the process, and we work together. In the long run, everybody knows the rationale behind the recommendations we make.”

According to John Hull, director of materials management at CHLA, tempering the enthusiasm of clinicians is often a necessary by-product of Panyarachun’s thoughtful approach. When eager physicians decide they want a piece of equipment, Hull and his staff know that hasty action could lead to safety issues for biomeds and countless problems with supply components.

Casting a wary eye on manufacturer claims is part and parcel of CHLA’s approach to risk management. The department accepts nothing on faith, and instead works through the modified failure mode and effects analysis for high-risk equipment (FMEAHRE) checklist before making any decisions.

“Hospitals are very likely to have a knee-jerk reaction that a certain piece of equipment needs to be bought right now because someone wants it,” Hull says. “The more we can slow down that process, while still maintaining the best patient care, the better job that the biomedical engineering department can do to support the institution and the less chance of bad-risk, problem equipment getting in. We do not want to have five different brands in here that we have to repair.”

Detailed Assessments

With any high-risk equipment, Panyarachun prefers high frequency for the preventive maintenance (PM) procedures, and most PMs are customized to fit CHLA’s needs and requirements. “We look at manufacturer recommendations, see what needs to be done, and we add to that,” Panyarachun says, who received his BS in mechanical engineering through the Royal Thai Air Force Academy in Bangkok, Thailand, before coming to the United States for additional training. “We do this from the beginning, and then every 12 months we go back to review the process for high-risk equipment. If in the first year there are no incidents, those frequency requirements can be adjusted accordingly.”

George Panyarachun, MS, BME, GNG, manager of the biomedical engineering department at Childrens Hospital Los Angeles.

Detailed assessment evaluation forms help shape a final score that puts a numerical value on exactly what is high risk. Right now, from a scoring range between 1 and 20, a score of between 15 and 20 is considered high risk. Defibrillators, infusion pumps, cryosurgical units, heart-lung machines, and medical lasers often fall into the high-risk range.

In the particular case of the extracorporeal membrane oxygenator (ECMO), Panyarachun and Hull led an exhaustive review that explored seven specific traits: general requirements, performance specifications, human engineering design, maintenance, recall status, electrical issues, and mechanical issues. Since the ECMO is usually for patients who are already in trouble, the equipment must work correctly.

After Panyarachun narrowed the ECMO heater down to one manufacturer, he worked with users and encouraged them to look for faults and flaws. After a thorough check of the engineering design, he calculated a final score that put the machine squarely in the high-risk category. Despite the score, biomedical equipment technicians, clinical engineers, and officials from materials management thought it was worth the risk.

With the ECMO deemed an acceptable risk, Panyarachun asked users to come up with several likely challenges. “Users have to come up with a list of potential problems, and then we come up with a list of solutions to address them,” Panyarachun says. “If everybody is happy with the list, we can be satisfied that we have everything under control. We then approve that equipment based on the score.”

After purchasing the ECMO, life expectancy for the machine was determined to be about 8 years, and those potential risks will be reevaluated each year. “If no problem occurs at all that we already identified, we will keep that record until the fifth or sixth year of the equipment’s life,” Panyarachun says. “That ECMO heater will have a review chart with all items to evaluate. That is part of the preventive approach to make sure that the failures will not occur if we follow the protocols.”

All equipment ultimately receives an upfront review, and any department head looking to add equipment will receive a 12-page form courtesy of Panyarachun to “define the procedures and responsibilities for the acquisition, maintenance, and control of CHLA equipment.” Since the biomed department also maintains equipment beyond the medical realm, folks who work with research equipment and electrical devices do not escape Panyarachun’s net.

Robert Balian, BMET III (right), and his team, Tony Waree, BMET I (left), and Michael Hoal, BMET I (center), perform risk assessment on a Giraffe infant incubator.

Along with the biomedical engineering department, the materials management department also plays a vital role in the budgeting and contract process, with Hull sitting on committees for infection control and value analysis to get the best possible perspective on budgeting issues. “We don’t always recommend the cheapest product, because it may ultimately cost a lot more to repair it down the road,” Hull says. “The COO listens because over the course of the last 3 to 5 years, biomedical engineering and materials management have built up credibility with finance and administration, and they believe we are going to do the appropriate thing for patients while also being as frugal as possible to keep costs down.”

When it’s time to purchase the equipment, Hull brings Panyarachun in to negotiate the service agreement. “At the time you are buying the equipment you have the most clout over the vendor,” Hull says. “We work together on the recalls and the alerts, perform all the technical reviews, and George completes his analysis. It is a clinical requirement, the same as you would have an engineering requirement to see how equipment is going to fit into the organization.”

Panyarachun and Hull essentially double team the vendor during the decision-making process. Panyarachun looks at the equipment’s technical engineering specifications and determines the impact it will have on the medical center. Meanwhile, Hull examines cost factors and legalities of the agreement.

If they don’t like what they see, they will not hesitate to go back to the COO and make it plain that a certain piece of equipment would be a bad risk. “We look at our incident reports, and we believe in George’s FMEAHRE purchasing policy,” Hull says. “The whole institution knows that if they want to buy a piece of equipment, I will require George to go through his review process before we approve it.”

Judging the Impact

Whether it is replacement or new, Hull contends that a lot of clinicians do not look at the entire risk management picture to determine how equipment will impact staffing, education, training, and total budgeting for related supplies. If it is hard to get the machine serviced, Hull and Panyarachun believe that patient care will be affected.

As a children’s hospital, CHLA faces additional concerns that are unique to pediatric health care. Young patients come in multiple sizes, and pediatric specialties are equally numerous. “We do almost every surgery known,” Hull says. “The intensity level at CHLA is much higher than at a typical community or university hospital.”

In-House, Less Risk

At CHLA, materials management owns a lot of the equipment, a fact that helps biomeds keep track of all repairs. In fact, the quantity of rental equipment is extremely low, yet it is another way for officials to control risk. “We know the service history of our equipment,” says Robert Balian, a biomedical equipment technician II at CHLA. “When it comes to receiving rental equipment from the outside world, biomeds often have to rely on a single document that only indicates the very last inspection on that equipment, and you really do not get an idea of what that equipment has been through.”

Any equipment that comes through the doors at CHLA is subject to a checklist of procedures, and checklists can be customized to accommodate variation. When it comes to IT and interfacing with the biomedical world, IT officials have made significant progress toward establishing chartless medical records (electronic medical records) that rely on medical equipment interface data to populate specific software applications.

“From a biomedical perspective, we have been very involved with the IT group where it makes sense for us to get involved,” Balian says, who has been with CHLA for 1 year after a 20-year stint at UCLA Health Care. “We constantly address various projects from a collaborative viewpoint. When we have meetings, we have all of the applicable representatives, so whichever direction needs to be taken, we get all of the people involved.”

As a relative newcomer to CHLA, Balian is particularly appreciative of Panyarachun’s emphasis on cross training, a philosophy that keeps the operation humming even during shortages. “Technical staff are constantly communicating among themselves to share the technical details that apply to various pieces of equipment,” Balian says. “When we are pressed for time or have conflicting priorities, we can all help each other out by sharing our knowledge. And that makes each individual more effective on a case-by-case basis.”

Everything the department does is performed with an eye toward long-term solutions and a distaste for unexpected problems. Problems certainly occur, but Panyarachun and Hull pride themselves on anticipating virtually all of them. One challenge in implementing any system is employee turnover, and as a teaching hospital CHLA routinely has many new staff members.

Michael Hoal, BMET I (left), performs equipment service cross training with his co-worker Tony Waree, BMET I (right), on a new infant incubator.

“Glitches can occur due to the lack of continuing education that may be available to all of the rotational staff,” Panyarachun says. “Keeping up with the flow of equipment and users that come through here is a difficult challenge.”

While most biomedical services are in house, a staff of 12 can’t do it all. High-end imaging relies on ISOs or OEMs depending on the situation. In 2005, in-house biomeds took back anesthesia services, digital C-Arms, and ultrasound services—and officials are always looking at the feasibility of bringing more services in-house.

Things are unquestionably busy at CHLA, but with little fat to trim, the biomeds have so far avoided layoffs. “When it comes down to the economy, we are already short, so how much can we cut?” Panyarachun says. “We are a level 1 trauma facility, and every time you hear a helicopter landing on the roof, you remember that someone really needs emergency attention. We can’t be cut, and hospital administrators have to look elsewhere. However, the economy has affected us, and we have to think twice before ordering replacement parts and repair parts while always making sure that we do not compromise patient care.”

Read past department profiles in the archives.

Ultimately, the human element is never far from the hearts of all the biomeds at CHLA. With sick children and tearful parents potentially around every corner, the entire biomed department is well aware that staying one step ahead of problems can directly affect patient care. Thanks to the caring environment at CHLA, the job situation is both satisfying and productive.

“As a biomed, we see all kinds of environments and different scenes from happy to sad,” Balian says. “The staff at this hospital is so caring and expresses a loving style. It may not be the happiest of environments at times, but the staff provides so much care and communication with parents. The whole process works the best that it can under difficult circumstances.”

Defining and Mitigating the Risks

Childrens Hospital Los Angeles defines exactly what equipment it considers high risk by using a detailed assessment evaluation form to rate equipment with a numerical value. Equipment with a score of 15 to 20 is deemed high risk. Below is a list of various equipment types and their ratings.



Bath, Paraffin (Physical Therapy)


Centrifuge, Cell-Washing Automated for Immuno-hematology


Defibrillator/Monitor, Battery/Line Powered


Dialysate, Delivery System, Single Patient


Electrosurgical Unit, (ESU)




Generator, Lesion, Radio Frequency


Heart-Lung Bypass Unit


Heat Exchanger, Heart-Lung Bypass


Humidifier, Respiratory Gas


Hyperthermia System, Automatic Control


Hyperthermia System, Manual Control


Incubator, Neonatal


Incubator, Neonatal Transport


Laser, Surgical


Lavage Unit, Surgical


Microscope, Surgical


Mixer, Oxygen (Blender)


Monitor, Blood Gas, Carbon-Dioxide Transcutaneous (Modules)


Monitor, Carbon Dioxide (ETCo2)


Pacemaker, Cardiac, External




Pump, Blood, Extra-Luminal


Pump, Extracorporeal Perfusion (ECMO)


Pump, Infusion (HV)


Pump, Infusion, Syringe


Saw, Electric Bone, Cast


Separator, Therapeutic, Automated, Blood Cell


Stimulator, Ultrasonic (Physical Therapy)


System, Dialysate Delivery Single Patient


Ventilator, Continuous


Warmer, Blood and Plasma


Warmer, Infant, Radiant


Making the Honor Roll

US News & World Report recently named Childrens Hospital Los Angeles (CHLA) as one of only 10 children’s hospitals in America—and the only one on the West Coast—to its “national honor roll” of US childrens’ hospitals. CHLA earned the award by being highly ranked in all 10 pediatric specialties.

  • CHLA has 295 beds (level 1). A planned move to a new tower will soon bring the bed total to 317.
  • Average patient census per day is 250.
  • The biomedical engineering department oversees about 14,000 devices.
  • There are 12 members of the biomedical engineering staff, including biomedical technicians in the I, II, and III categories, and a biomedical assistant.

Greg Thompson is a contributing writer for 24×7. For more information, contact .