Patient Safety Tip of the Week
October 5, 2010 More Iatrogenic Burns
Our June 1, 2010 Patient Safety Tip of the Week “Iatrogenic Burns” gave lots of examples of burns occurring as a result of encounters in various parts of the healthcare system. Since then a couple more examples have appeared in the literature or the news. One, in which flash sterilization of an arm positioning device led to a burn, is being litigated. The others are the subject of a recent FDA warning about burns occurring to dental patients as a result of electric dental handpieces overheating.
The first case, related to flash sterilization, is a theme we have seen before. In our June 1, 2010 Patient Safety Tip of the Week “Iatrogenic Burns” one or our recommendations was “In the OR, beware of the burn danger any time a “flashed” piece of equipment is used”. According to the article in Outpatient Surgery, a nurse preparing for a wrist surgery case found that the metal wrist traction tower needed to be sterilized. About an hour before the surgery the device was flash sterilized and brought to the OR to cool. The patient was under general anesthesia when her arm was positioned in the device. After the surgery third-degree burns were noted on the patient’s arm and back (which apparently had also been in contact with the metal tower). Further medical treatment, including skin grafting, was necessary. In a deposition, the surgeon testified that neither he nor the nurse assisting him noted any residual heat from the recently sterilized device.
There are several important lessons in this case. The important point made previously is that even moderate heat applied for a long duration is capable of producing burns and patients may be surprisingly unaware that the burn is occurring even if they are conscious. The potential damage to skin (or other organs) is a function of both temperature and duration. Note that in a previously reported burn related to flashed equipment (Rutala 1999) it was noted that “the nurse was able to hold the instrument in her hand, though it felt warm” but the more prolonged contact with the patient produced a burn. A second consideration is whether flash sterilization produces uniform temperatures thoughout the device being sterilized. In our previous column we noted that microwaved objects are particularly dangerous because heating with microwaves is not uniform. We don’t know if the same issue of non-uniform heating might occur with flash sterilization. And, obviously, one of the most important factors is that the patient was under general anesthesia and could not perceive pain (or was incapable of responding even if she could feel pain).
Given the risk that flash sterilized instruments and devices have for producing burns, there ought to be a protocol for accurate measurement of temperature before such devices are used on patients (or inadvertently set down on the drapes overlying a patient). Even just feeling them to touch is probably not good enough because one would be expected to have on sterile gloves, which might impair one’s ability to perceive excessive heat. We reviewed dozens of articles on flash sterilization and could find no such protocol for assessing whether the flashed device is safe from a burn perspective. They had lots of complex logs looking at all sorts of parameters for the actual strerilization procedure but none for assessing the burn safety aspect. The closest we came was a general statement that hot, wet instruments present a burn risk to both patient and OR staff and that they should be allowed to cool adequately before use. The CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 quotes the previously mentioned Rutala paper (Rutala 1999) “patient burns may be prevented by either air-cooling the instruments or immersion in sterile liquid (eg. saline)” but neither offer any actual parameters for safe use. We’d like to hear from any of you that have put protocols in place for formal temperature measurement of flashed equipment and see how you’ve done this. Otherwise we’d have to look to the device manufacturing industry for guidelines.
Best way to avoid patient burns from “flashed” equipment: plan your cases better so that you have all necessary equipment ready and available well in advance so you have no need to “flash” equipment. We’ll bet that root cause analyses on 90% of these flash-related burns discovered that the piece of equipment in question could or should have been available. Yes, there are emergency circumstances where you may need to flash equipment but the majority of cases are flashing equipment that should have been available.
The second example comes from a just-issued warning from the FDA on patient burns from electric dental handpieces. In fact, this is not a first warning. Rather is a restatement of a prior warning issued in 2007. Re-issuing the warning is the result of the FDA receiving numerous more reports of such injuries. And though most cases involve dental patients, the same sorts of injuries may be seen with rotary surgical handpieces used in orthopedic surgery. The dental devices are electric dental handpieces and electric oral bone-cutting handpieces that are AC –powered hand-held devices. The burns occur because (1) the patient is under local anesthesia (perhaps sometimes even conscious sedation) and cannot feel pain and (2) the dentist cannot feel the heat because there is an insulated handpiece housing around the heated attachment.
The FDA makes the following recommendations:
- Be vigilant about maintaining
electric dental handpieces and electric oral bone cutting handpieces
according to the manufacturer’s instructions.
- Verify with the manufacturer the appropriate routine service interval for your dental practice, based on the actual use of your electric dental handpiece or electric intraoral bone cutting handpieces.
- Train personnel to properly clean and maintain the electric dental handpiece or electric intraoral bone cutting handpiece.
- Develop a method for tracking maintenance and routine service for each dental handpiece or electric intraoral bone cutting handpiece.
- Examine the electric dental handpiece attachments and electric intraoral bone cutting handpiece attachments prior to use. Do not use worn drills or burs.
- Do not use poorly maintained electric dental handpieces or electric intraoral bone cutting handpieces.
- Report overheating to the manufacturer.
The FDA has also requested device manufacturers take the following actions:
- Identify the root causes of the overheating hazard,
- Determine if the handpiece labeling is understood by users and if required maintenance is feasible; and
- Consider risk mitigation steps such as design modification, the addition of an overheating alarm, warning labels, operator training to avoid overheating, or modified use of the handpieces.
While training and labels might help, such are considered “weak” solutions and we think there must be a stronger solution. An overheating alarm would be a step in the right direction but how about just designing the devices with a feedback mechanism that shuts the device off when it overheats? The 2007 warning mentioned that air-driven handpieces typically slow down when problems arise, thus alerting the operator to the problem. But the electric devices actually increase power to the handpiece when problems arise, leading to rapid heat buildup and there is no obvious change that provides feedback to the operator.
Anesthesia, whether local or regional or general, may predispose patients to burns. Even under general anesthesia, where a patient cannot respond, we wonder if there are subtle signs such as changes in heart rate, perhaps mediated reflexly at lower levels, that could alert the surgical team to a potential burn. We must remain ever vigilant for complications such as iatrogenic burns in patients we have rendered incapable of protecting themselves during procedures.
Update: See our Patient Safety Tip of the Week for December 23, 2014 “Iatrogenic
Burns in the News Again”.
References:
Woman Burned by Sterilized Positioning Device Sues Doc, Hospital. OutpatientSurgery.net September 2010
http://www.outpatientsurgery.net/news/2010/09/7
Rutala
WA, Weber DJ, Chappell KJ. Patient injury from flash-sterilized instruments.
Infect. Control Hosp. Epidemiol. 1999; 20: 458
http://www.journals.uchicago.edu/doi/pdf/10.1086/503136
CDC. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
http://www.cdc.gov/hicpac/Disinfection_Sterilization/13_0Sterilization.html
Safety Investigation of Patient Burns Associated with Electric Dental Handpieces and Electric Oral Bone-cutting Handpieces
Date issued: Sept 23, 2010
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm226995.htm
FDA. Safety Alerts for Human Medical Devices. Electric Dental Handpieces and Electric Oral Bone-cutting Handpieces: Safety Investigation of Patient Burns.
[Posted 09/24/2010]
FDA Public Health Notification: Patient Burns from Electric Dental Handpieces
Issued : December 12, 2007
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062018.htm
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