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By Patrice Spath, RHIT
Forest Grove, OR
Health care practitioners must know how to operate a wide array of machines. With the growing number of complex medical devices, equipment-related patient incidents are on the rise. Equipment problems are a frequent cause of untoward events. Equipment problems, most of which affect patients’ cardiovascular and respiratory systems, reportedly are the most frequent source of untoward incidents in the intensive care unit.
Equipment can contribute to adverse events either by directly causing the incident or by increasing the likelihood of human errors. Even when equipment malfunction is the direct cause of the accident, malfunctions often can be traced back to human factors. For example, described below is an equipment-related event that occurred in 1998 in the operating room of hospital in the Southwest. While the apparent cause of the incident was faulty equipment, the materials department may have played a role.
"A flash fire broke out during a craniotomy procedure for evacuation of bilateral subdural hematomas. After one hematoma was removed and the neurosurgeon was making an incision to remove the second, a fire broke out on the operating table. The fire destroyed the patient’s oxygen mask and seriously burned his face, ears, neck, and shoulder. It is believed the electrocautery device being used to stop bleeding at the incision sparked the fire." (Doctor: Hospital fire accident. Las Vegas Review-Journal, Aug. 2, 1998.)
Unknown to the neurosurgeon and other people in the operating room at the time of the incident, ECRI, a nonprofit international health services research agency, already had received reports of several incidents of sparking or ignition of electrosurgical electrode cables. In some of the incidents, the cable had ignited and started a fire. ECRI had issued warnings about this problem, suggesting that hospitals should routinely perform pre-use (and cleaning) inspections of reusable cables. Either the hospital involved in the incident had not received the ECRI communications, or the hospital’s materials department had not passed the information along to people in the operating room. The patient undergoing the craniotomy might not have been harmed if the early warning notices from ECRI had prompted further investigation and action.
The causes of medical device accidents fall into four categories:
1. basic device failures (e.g., design/labeling error, manufacturing error, random component failure, and invalid device foundation);
2. external factors (e.g., electrical power supplies; medical gas and vacuum supplies; electromagnetic or radio frequency interference; and environmental controls);
3. system errors (e.g., poor incident/recall reporting systems; failure to impound; lack of competent accident investigation; failure to train and credential; poor pre-purchase evaluation; use of inappropriate devices; and failure to conduct incoming and pre-use inspections);
4. operator errors (e.g., device misassembly; inappropriate reliance on an automated feature; accidental misconnections; improper maintenance, testing, repair, or incoming inspection; incorrect clinical use; incorrect control settings; and incorrect programming). The materials department can help to alleviate some of the problem areas through an effective equipment procurement, maintenance, and monitoring program.
Several steps can be taken to eliminate the error-producing factors in the workplace that may cause undesirable equipment-related events. An important issue is communication. Every hospital should have a formal process for identifying product hazards and communicating effective safety practices to all relevant health care professionals. This means that someone, perhaps in the materials department, should be designated to receive and disseminate information about product recalls and device safety alerts.
Groups such as the Food and Drug Administration, the Institute for Safe Medication Practices, and the ECRI regularly issue equipment hazard reports that are relevant to many different hospital departments. These communications must routinely be distributed to everyone affected by the products in question. (For web-based sources of product recall and device safely alert information, see note at end of article.)
All material and equipment should be inspected briefly for damage in the materials department prior to delivery to patient care units. This inspection involves both the packaging and the equipment/device. Typical steps include the following:
While inspecting the item, ask yourself these questions:
It may be necessary to involve the engineering department in the inspection of electrical items if staff in the materials department are not qualified to evaluate electrical components.
The materials department also can help in identifying high-risk equipment/devices. High-risk products are those that require repeated repair or replacement. The information found in the log of items sent out of the hospital for repair or replacement can be used to evaluate whether the repair rate for a piece of equipment/a device is increasing (a signal that the reliability is decreasing) and determine if repair/replacement rates are higher in a particular unit (a signal of possible misuse or lack of staff knowledge). The materials department staff often are aware of the scope of equipment problems and complaints voiced by physicians and clinical staff. These concerns can be early-warning signs of an impending equipment-related patient incident. If one or more of the situations listed in the table, below, is identified, the materials department should bring the concerns to the attention of the patient safety or other relevant committee.
Table: Early Warning Signs
|How many of these equipment-related early warning signs are present in your environment?|
|•||Only a few people seem to be using the equipment.|
|•||People tend to modify equipment and take shortcuts.|
|•||People refuse to use the materials/equipment.|
|•||People complain that installation of accessories is difficult, confusing, or overly time-consuming.|
|•||Alarms and batteries often fail.|
|•||Incorrect accessories are sometimes installed.|
|•||Parts often become detached.|
|•||People complain that equipment displays are difficult to read or understand.|
|•||People complain that equipment controls are poorly located or labeled.|
|•||People say the alarms are difficult to hear or distinguish.|
|•||People find the alarms very annoying.|
|•||People complain that equipment operation is illogical and confusing.|
|Source: Patrice L. Spath, Brown-Spath Associates, Forest Grove, OR.|
The materials department is responsible for procuring quality materials, supplies, and equipment use at the lowest total delivered cost. However these decisions should not be made in isolation from those who use the products. Every patient care device should be evaluated by user groups to determine if the equipment:
Studies of medical device accidents show that operator error accounts for 50% to 70% of the problems. The goal is to ensure that operators are proficient in critical tasks. Critical tasks are those requiring human performance, which if not accomplished in accordance with product requirements will most likely have adverse effects on equipment reliability or safety.
Before purchasing new patient care supplies, accessories, and equipment, the materials department must make clinical departments aware of any training implications. An operational assessment should be conducted prior to purchase to determine if the new equipment will need to be added to the physician credentialing process or if there is a need for education for physicians, nurse and/or support staff.
Everyone in the hospital can help reduce the number of undesirable patient incidents. Don’t overlook the contribution of nonclinical departments, such as materials management. Although the materials staff are not involved in direct patient care, they can do a lot to minimize the risk of equipment-related adverse events.
[For more information on recalls and device safety alerts, try these on-line resources:
• The complete files of reports received under the FDA’s Medical Devices Reporting Program are available on the web at: www.fda.gov/cdrh/.
• Copies of MedWatch, the FDA’s Medical Products Reporting Program newsletter and related safety notifications are available on the web at: www.fda.gov/medwatch/safety.htm.
• Medication safety alerts related to products involving medication preparation and administration are periodically issued by the Institute for Safe Medical Practices. These are available on the web at: www.ismp.org.
• Medical Device Safety Reports issued by the ECRI are available at: www.mdsr.ecri.org. Nearly 200 documents and case studies are included in this web-based repository of medical device hazard information.
• Occasionally the Joint Commission’s Sentinel Event Alert newsletter contains information about equipment-related accidents. Copies of this newsletter can be found on the Joint Commission’s web site at: www.jcaho.org.]
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4. Kaye R, Crowley J. Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. Washington, DC: Center for Devices and Radiological Health, Food and Drug Administration; 2000. Web site: www.fda.gov/cdrh/humfac/1497.html.
5. Spath P. Patient Safety Improvement Guidebook. Forest Grove, OR: Brown-Spath Associates; 2000.