You are dispatched to a report of a “man down, unknown medical” outside of a busy supermarket. A minute later the dispatcher notifies you that bystander CPR is in progress. You see this as you pull into the parking lot: there is a small crowd standing around two individuals performing chest compressions and mouth to mouth ventilations on an adult male who appears to be in his 50s.
After grabbing your equipment, you kneel alongside the stricken patient. You apply your defibrillator’s multifunction pads to the patient’s bare chest while your partner is turning on the device.
As you prepare the defibrillator for delivering a possible shock, you suddenly realize that it has not powered up ─ the screen is blank. Quickly, you confirm that the batteries are installed. You look at your partner, who has the same look of panic as you.
Now what?
Emergency medical devices are abundant within the typical EMS unit. Equipment ranges from bag-valve mask (BVM) ventilators and suction machines, to manual monitor-defibrillators and external chest compression devices.
A medical device is defined as "…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease…."[1]
The design, manufacture and distribution of medical devices is regulated by the Federal Drug Administration, using standards promulgated by various organizations such as the International Organization for Standardization and the American Society for Testing and Materials International as a baseline for establishing such regulations.
The FDA generally places medical devices into one of three categories of risk.[2]
1. Class I devices are considered to be low risk to the patient and end user in the case they are used incorrectly.
2. Class II devices are considered to have a greater risk of harm if used incorrectly or if they fail. There is a significantly greater set of regulations controlling the manufacture and distribution of such products. An example of a Class II emergency medical device is a BVM.
3. Class III devices are considered to have the greatest risk to the patient. In addition to adhering to the regulations surrounding a Class II device, manufactures must adhere to so-called “special controls” that further specify design, production and sales of a medical device. Typically, the FDA has to formally approve Class III devices prior to distribution. Defibrillators are an example of Class III medical devices.
There are different ways for all classes of medical devices to enter the market.
If a device existed before the first set of FDA regulations were implemented in 1978, a manufacturer could apply for a 510(K) approval on a new device that essentially performs the same function as the original device. For example, since manual defibrillators were on the market prior to 1976, newer models are generally approved through this process.
High-risk devices that were not available prior to 1976 may undergo a much stricter ─ and more expensive ─ pre-market approval process, or PMA. There are very stringent testing and reporting requirements involved with a PMA.[3][3]
Who maintains medical devices?
While the design and manufacture of medical devices is clearly regulated by federal law, it becomes far less clear once the devices are sold to the end user. Device manufacturers are compelled to issue safety bulletins or recalls in the case of design or manufacturing defects, but most of these actions are voluntary.
However, maintaining the daily readiness of medical devices becomes the responsibility of the end user. Typically, each device comes with a manufacturer’s set of guidelines or standards for maintaining its equipment in good working order.
These standards may be straightforward ─ for example, most disposable medical devices such as BVMs have an expiration date, and should be replaced if not used by that time.
Other standards are more complex, requiring ongoing maintenance and servicing at regular intervals. Failing to adhere to manufacturer’s maintenance standards may expose an agency to significant legal risk in the case of equipment failure during use.
Responsibility for medical device readiness also involves the EMS practitioner. Your agency may require you to check your equipment daily, even per shift.
For example, you might be required to print a test strip from the ECG monitor, check the energy levels in the batteries, and perform a test shock when you first come on shift. Failing to do so, or failing to document this practice, may put you at a personal legal risk.
Tips to keep your devices ready
There are several generally accepted practices throughout the industry that will help ensure your equipment is ready for use.
1. Test equipment
Checking key pieces of equipment such as suction machines, defibrillators, gurneys, and radios for operational readiness on a daily basis is one such practice.
2. Check expiration dates
Inspecting all equipment for expiration dates on a monthly basis will ensure nothing stays on the rig past its recommended due dates. Note however that given ongoing medication shortages within EMS, your agency or region may have policies exempting this practice. Consider donating expired equipment to your local training program so that students can practice with equipment that is used in the field.
3. Read the manual
Read the manufacturer’s recommendations for device use and maintenance. You may be surprised to find all of the information surrounding the medical device you use on a daily basis.
4. Keep batteries charged
While battery technology has improved significantly over the past decade, it is still important to use and recharge the batteries in strict accordance with manufacturer guidelines. Much of our equipment runs on batteries, and carefully maintaining them will prolong their operating life and reliability.
5. Treat equipment well
Finally, be good to your equipment. While most medical devices do not need to be handled with kid gloves, they are not designed to be dropped repeatedly, run over or otherwise abused without incurring damage.
Keep surfaces clean and store devices in accordance with manufacturer guidelines. Make sure they are serviced on a regular basis. If you have any suspicion that a device is not ready for use, take it out of service and tag it for inspection.
EMS providers rely on their medical equipment to deliver high-quality, reliable service to their patients. Maintaining awareness, performing regular service, and checking operational readiness will make sure your equipment is ready to perform when called upon.
References
1. Federal Drug Administration. What is a medical device? Retrieved 9/10/14
2. Federal Drug Administration. What does it mean for FDA to ‘classify’ a medical device? Retrieved 9/10/14
3. Federal Drug Administration. Premarket Approval (PMA). Retrieved 9/10/2014.
