Emerging issues in technology
IntroductionThe quality of prehospital care is increasingly measured by clinical outcome, rather than mere response time standard compliance. EMS is increasingly integrated into the healthcare system at large. Prehospital clinical information and actions are parts of systems that determine patient destinations to and within healthcare facilities. For example, telemetry of 12-lead EKGs received at hospitals allows patients to bypass emergency departments and go directly to cardiac catheterization labs. Point-of-care testing is used to obtain vital data that permits more sophisticated on-site interventions. It may provide diagnostic information to physicians. The success of these interventions relies on the clinical expertise of prehospital personnel, the appropriate selection, use and maintenance of medical devices, and the proper integration into the healthcare system. The decision to implement medical technology is driven by medical control and regulatory bodies. However, we as healthcare professionals carry the burden of dealing with exposures created by the use of technology.
When the use of technology becomes part of a protocol, there is a duty for us to use it as indicated. Since any device can malfunction, the use of technology creates an exposure hazard, that is, there is a probability of a patient experiencing an adverse event. EMS personnel have an “extended workforce interface”. The variety of environments in which we work creates the potential for a large number of exposure hazards. A large number of exposures may occur before there is an adverse event which actually hurts a patient. An iceberg is usually used to describe the increasing severity of events. Exposures make up the largest portion of the iceberg. The underwater part you can’t see. That is followed by close calls, minor adverse events, serious adverse events, and sentinel events. A sentinel event is “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes the loss of limb or function.” An example of a sentinel event in this context is defibrillator failure which created a lost chance of survival. How can we address exposures? Both clinical and administrative personnel must be involved in identifying exposures. Concrete, verifiable exposure data must be collected. Methods for mitigating, and when possible, eliminating hazards must be developed and promulgated. The following sections will offer considerations pertinent to reducing exposures.
Once a decision is made to implement a particular type of medical device, stop and think about how it will specifically be used. As you review devices, determine from the specifications that the device has FDA approval for the desired functions. Look at the maintenance and storage requirements. What daily and periodic inspections are required? What must be done to insure an adequate interface between the device and the power source? Are temperature, humidity, exposure to light and other environmental considerations compatible with our workplace? If the device is sensitive to vibration, has it been tested and documented to work in an ambulance? Will software updates be necessary? How often? Is the device protected from hacking? Is the transmission of information HIPAA compliant? How will we document compliance with these issues? In addition to the device specifications, read the entire product manual.
Write down questions regarding ease of operation, troubleshooting, and specific maintenance/repair requirements. Determine the useful life of the product. Ask the vendor about any manufacturer or FDA recalls for the specific product, product accessories or power sources. Once your questions are formulated, put them in writing and require a written response, dated and signed. When hospitals acquire medical devices, they are tested by internal clinical engineers before used on patients. Warranties should guarantee that all equipment has been tested for compliance to FDA and all other applicable standards and are guaranteed to meet said standards upon receipt. Since both clinical and administrative people must be involved in identifying exposures, it follows that they should be involved in medical device selection.
Establishment and maintenance of operator proficiency
The see one, do one, teach one days are gone. Before a medical device is introduced into a system, a training program should be formally developed with guidance from the vendor, medical director and internal educators. Specific objectives for cognitive and psychomotor skills must be developed. A testing mechanism must affirm that these objectives are met. Periodic review and re-affirmation of proficiency should be planned, but the plan may be altered to address specific issues as experience with the device reveals exposures, as new information from the manufacturer changes operational requirements/device modifications or as medical direction provides additional requirements. It should be noted that the operational, maintenance and trouble-shooting considerations are separate and of equal importance to clinical applications. There is ample evidence in the literature that user error and maintenance issues due to inadequate inspections are major causes of medical device failures. One study documented that in a 15 year period, 1,000 cardiac arrest deaths occurred as a result of AED failure. A robust incident reporting policy provides a source of “bedside” information about the real-life operation of a device. It may detect errors that lead to exposures before they become adverse events. The information derived may be used to uncover the need for device modification, changes in accessories or power sources (chargers, batteries), other un-anticipated technical issues, and the need for re-training and additional affirmation of proficiency.
Sources of medical device errors/medical device failures
While we use a vast array of devices, from monitor defibrillators to point-of-care testing with reagents to telemetry to video aids for direct laryngoscopy, there are some commonalities to errors and medical device failures. They include operator errors, reagent issues, environmental factors, software and hardware problems, and system failures. We will not cover every device, but use items that have generic application.
Examples with battery powered defibrillators include: inadequate knowledge of proper device operation, spillage onto unit, incorrect placement of charging apparatus, dirty paddles, unrecognized loose paddle cable connector, inconsistent operational checks by clinical users, poor or delayed reporting of operational issues, and poor preventive maintenance. For blood testing devices: sample contamination, improper amount of blood specimen, inappropriate source (capillary, venous, arterial), incorrect insertion of strip, inaccurate timing, defective strips or reagents, improper maintenance, cleaning, or calibration, incorrect storage of data, and use of strips not compatible with device.
Considerations for reagents include: expired strips or reagents, damaged or contaminated strips, failure of strips and quality control measures, incorrect dimensions of strip, interference with chemical reactions on the strip, and inadequate container/storage which fail to prevent deterioration or desiccation.
These errors may be the result of device effects or human factors. Device effects may be the result of temperature, humidity, altitude, electromagnetic radiation, visible light and sunlight. The position in which a device or accessory is stored may affect its performance. Human factors that inhibit the ability of people to process information include: lighting, glare off meter or other LED surface, visual and auditory distractions, stressful conditions and limited manual dexterity.
Software and hardware
Although some software and hardware problems may be due to manufacturing defects or internal damage not readily detectable by the operator, the aforementioned inconsistent daily operational checks may be the culprit. When this occurs the “blame” for a failure is misdirected. A system defect is not identified and creates the potential for further exposures.
Errors related to systems are physical trauma, vibrations, incorrect calibration/adjustment, calibration failure, interference, use of the device beyond its useful life, and failure to capture outdated accessories. There must be mechanisms in place to recognize and immediately act upon medical device recalls or advisories. Policies and procedures must specify how the information will be received, acted upon, communicated to all pertinent individuals and how the receipt of and response to the recall/advisory information will be documented.
Note that the physical condition of the patient may affect the operation of devices. Point-of-care blood testing may be affected by dehydration, hypoxia, hyperglycemic-hyperosmolar states, hypotension, shock, ketoacidosis, and substances in the body such as those from maltose containing intravenous solutions. Pulse oximetry may be affected by conditions which alter the oxyhemoglobin dissociation curve. Body habitus may create the need to alter the gain on EKGs.
- www.jointcommission.org/sentinel_event Accessed June 18,2018
- www.fda.gov/MedicalDevices Accessed June 11,2018
- www.sca-aware.org Accessed June 21, 2018
- www.fda.gov/safety/medwatch Accessed June7, 2018
- “User Error an Defibrillator Discharge Failures” Health Devices, Dec 1986:15(12): 340-2
- “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use. Guidance for Industry and Federal Drug Administration Staff” Us Department of Health and Human Services, October 11,2016
- “LIFEPAK 1000 Defibrillators by Physio-Control: Voluntary Field Action[Immediately Remove and Reinstall Battery” FDA MedWatch, January 14, 2017
- Krause t, et alia, Taking the Lead in Patient Safety, Wiley, Hoboken, New Jersey 2009