By Joy Daughtery Dickinson, Executive Editor
Executive Summary
Silverton (OR) Health reports that six patients were burned when staff members changed diffusers on operating room lights but didn’t know to change filters.
• Always contact bio-engineers for any equipment maintenance.
• Manufacturer’s guidelines should be followed to maintain, clean, and repair technical, electronic, or electrical equipment and apparatus.
• When adverse events happen, involve your legal consultants and liability insurance carrier to advise you about early disclosure.
The incident at Silverton Health in Silverton, OR, started with good intentions. Halogen lights in the operating room (OR) had been cleaned with the wrong solution, and the light covers had been damaged and were affecting the light quality.
In the past, OR staff members had changed light bulbs in the surgical lights instead of calling engineers to do it because the employees thought they could do it in a timely manner without closing the OR. “They thought, we’ve changed light bulbs in past. We can change the plastic covers also,” says Ray Willey director of quality and risk services at Silverton Health.
Some staff members probably didn’t consider lights to be medical equipment that needed to be serviced by bioengineers, Willey says. “They’re used to IV pumps and monitors [being considered medical equipment], but that thinking didn’t carry through to surgical lights,” he says.
A vendor previously had been contacted to replace the diffusers on the light covers. Staff members saw what was done and thought they could handle it forward. However, they didn’t realize that the light covers had two pieces: a diffuser and a filter.
In September 2013, staff members at Silverton Health removed and replaced the diffusers, but not the filters. In June 2014, skin abnormalities began to be found on patients. Some patients had mild burns, but others had severe burns and will have permanent redness on the skin that was exposed to the lights.1 Surgeons were updated.
Some of the patient burns were discovered in the recovery room, and others were found during follow-up visits with surgeons. Eventually six patients, but no staff members, were found to have burns. The surgical services staff looked at common causes of those types of injuries: cleaning solutions used on patients, adhesives on the drapes, and cauterizing devices. By November 2014, when those potential causes had been ruled out, a staff member recalled that the diffusers had been changed, and that action was brought forward as a potential root cause. Once it was determined that surgical lights were the cause of burns, the hospital notified surgeons and shut down the three ORs that had the halogen lighting systems. About 2,100 surgery patients underwent procedures in the ORs during the 14 months before the cause was determined and might have been at risk, Willey said. Since that time, the hospital has replaced the halogen lights with lamps that use LEDs (light-emitting diodes).
Leilani Kicklighter, RN, MBA, ARM, CHSP, CPHRM, LHRM, patient safety and risk management consultant with The Kicklighter Group in Tamarac, FL, says, “This situation happened in a hospital, not an ambulatory surgery center [ASC], but is a potential wake-up call for not only ASCs but also for office-based surgery centers. The issue is the same in any setting, other than the hospital setting is more likely to have an in-house biomedical department with trained biomedical engineers.”
Jane J. McCaffrey, MHSA, CIC, DASHRM, independent consultant in healthcare risk and compliance in Easley, SC, agrees that this issue should get the attention of outpatient surgery managers. “There is liability here in that there was a failure to service the lights in a way they were intended,” McCaffrey says.
Several years ago, another surgery program used a heat lamp that had a bulb burnout. “Staff did what they thought was easy and replaced the bulb with one they found on the unit,” McCaffrey says. It “resulted in the wrong strength and severe burns to a patient.”
Sharing these stories is important “because it is far too easy to become a DIY [do-it-yourself] person to expedite the flow of activity in a clinical situation,” she says.
Lessons learned
Consider these lessons shared by Silverton Health and patient safety experts:
• Use experts to work with your medical equipment.
Involve your biomedical engineering department or contractors in any maintenance on any medical equipment, Willey says. Also, ensure your policies and procedures reflect that involvement, he says. “We had some in place that we thought addressed it, but we did modify and add clarifying language to be clear about engineering roles,” Willey says. They also ensured that proper cleaning solutions are being used.
If you are a surgery center or office-based practice, have a contract/agreement with an individual or company that has knowledge of OR lights and their preventive maintenance, by company and model, and knows how to properly change the bulbs, Kicklighter says. “The cardinal rule in dealing with technical, electronic, or electrical equipment and apparatus is that manufacturer’s guidelines should be followed to maintain, clean, and repair,” she says.
The vendor for medical lights should provide guidance with regard to all maintenance to be performed, McCaffrey says. Care should be taken that this guidance comes from a qualified representative, not just a sales representative, she says.
• Examine your processes for equipment and preventive maintenance.
When lights need servicing, determine if the manufacturer provides a service manual that emphasizes use of filters, and ensure it is available and consulted, McCaffrey says. A copy of all manufacturer service manuals should be kept and maintained as up-to-date with any revisions or service alerts as long as you own or use the equipment, suggests Mark Mayo, CASC, executive director of Golf Surgical Center, Des Plaines, IL.
One gap in the process that Silverton identified concerns the preventive maintenance schedule for new equipment, rental equipment, borrowed equipment that is returned, and equipment returned from service. “Our process wasn’t as tight as it should have been to make sure it was evaluated and to make sure the equipment was put in our preventive maintenance software system,” Willey says. Now, any time equipment enters or re-enters the facility, it is evaluated in terms of what preventive maintenance needs to be performed going forward, he says.
Continually scrutinize your preventive maintenance processes, Willey advises. “Sometimes your employees think, we’re working as best as we can,” but it requires ongoing surveillance to make sure that they do, he says.
Don’t necessarily focus on individuals, says Bethany Walmsley, executive director of the Oregon Patient Safety Commission in Portland. Silverton Health submitted a confidential report on the incidents to the Commission. “It’s more important that the process used to maintain equipment is as reliable as possible,” Walmsley says. “I want to emphasize the importance of having a systems-level view and a process view, rather than focus right away by saying, ‘if we had someone with a much fancier title with a better background, this wouldn’t have happened.’”
• Obtain help when you have adverse outcomes.
When patients are injured, it’s a good idea to engage a healthcare attorney, Kicklighter advises. Also, call in biomedical engineering experts immediately, she says. Many universities have biomedical engineering programs that can be contacted for their expertise, she says. You also can hire certified, trained biomedical technicians from ECRI Institute in Plymouth Meeting, PA. (Web: https://www.ecri.org.)
Also report the incident to the manufacturer, Kicklighter advises. “Do not send the lights back to the manufacturer for evaluation,” she says. “Remember the theory of ‘chain of evidence.’ Get risk management and legal advice before doing so.”
In determining the cause, the industry standard is to perform a root cause analysis, Walmsley says. However, the process doesn’t have to daunting, she adds. “There are ways to do a root cause analysis that are not overly burdensome in terms of time or bandwidth on your staff,” Walmsley says. For example, you can use the five “whys” tool, which takes only five to 10 minutes. (To access the tool, go to http://bit.ly/1DBRnS2.)
Also, a Failure Mode and Effect Analysis (FMEA) can be helpful, Kicklighter says. (For more information on FMEA, go to http://www.patientsafety.va.gov/professionals/onthejob/HFMEA.asp.) Address these questions, she suggests: Were manufacturer’s recommendations followed? Were staff trained and certified to perform the tasks? “Only the answers can tell how to prevent or what should have been done that wasn’t done,” Kicklighter says. Was there omission or commission? “That’s where a good, objective investigation comes into play,” she says.
• Be transparent about your mistakes.
Willey says the hospital leaders discussed the incident with their legal resources and their liability insurance carrier to guide early disclosure. They notified all patients who were at risk for burns. They contacted the local newspaper to notify them of the incident. “We wanted to be completely transparent regarding the situation,” Willey says.
They set up a dedicated phone line for other patients who might be concerned about burns.
Hospital representatives have met individually with patients who have suffered injuries related to this incident to go into more detail and to put them in contact with the insurance carrier for any assistance they might need with medical expenses.
No lawsuits have been filed, Willey says.
“There’s a growing body of research in healthcare that early disclosure in adverse events does reduce litigation, as well as dollar value of claims, but that’s not the reason we did it,” he says. “We did it really because we felt responsibility to our service area.”
The Oregon Patient Safety Commission has praised Silverton Health for its openness about the incident.
“We’re glad to see any organization that is so open about what happened, what they learned, and how it could be applied in another ASC or hospital, so people can pay attention, so people can share the learning,” Walmsley says.
Reference
1. Wozniacka G. Oregon hospital patients burned by lights in operating rooms. Associated Press. Accessed at http://yhoo.it/
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The incident started with good intentions.
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