A physician has a duty to his/her patients to properly select, inspect, maintain and use medical equipment/devices (hereafter referred to as equipment), and supplies within his/her office practice. Thus, it is important to take all necessary safety precautions – whether the equipment is purchased, rented or leased – to increase patient safety and reduce the risk of a claim.
All new equipment should be selected based upon appropriateness for the office and desired use and then inventoried. In addition, all equipment should be maintained and used according to manufacturers’ recommendations, and all inspections, testing, preventative maintenance, and repairs should be documented. Further, all re-usable equipment should be disinfected according to the guidelines for the Food and Drug Administration (FDA), and documentation should exist that verifies efficacy of disinfecting.
Once the equipment has been selected and inventoried, the equipment should be evaluated prior to use for inclusion in an equipment management program using risk-based criteria, including:
• equipment function,
• clinical application,
• preventive maintenance requirements,
• likelihood of equipment failure,
• and environmental/device use area
This information is based upon your office practices, the corrective history of the equipment and the equipment specifications. Based upon the above criteria, the equipment should be assigned a tier level (1, 2, or 3).
Equipment in Tier 1 should be tested on at least a semi-annual basis. An example of equipment within this tier is your life support and/or emergency equipment, such as items on crash carts and/or automated external defibrillators (AED).
Equipment in Tier 2 should be tested on at least an annual basis. An example of equipment within this tier are monitors (i.e. blood pressure, ECG, heart rate, oxygen, stress exercise, etc.).
Equipment in Tier 3 may only need to be visually inspected on an annual basis. Equipment within Tier 3 have little to no risk, such as a patient scale.
Defibrillators/AEDs and Crash Carts
Defibrillators/AEDs and Crash Carts are only effective in assisting during an emergency when all of the equipment is in proper working order. Crash carts should be set up for the type of life threatening event you would expect to occur in your office (e.g., cardiac, anaphylaxis, etc.). Some of the usual items found on crash carts include a defibrillator/AED unit, oxygen and drugs. A defibrillator/AED and/or crash cart should be checked daily to make sure it is ready for use. Here is a quick checklist:
• Check the defibrillator/AED to make sure the battery is charged and it is working properly; refer to the manufacturer’s recommendations for any additional requirements.
• Check to see the oxygen cylinder wrench is placed on the crash cart if not already attached to the cylinder and open the cylinder to make sure it is full and that oxygen is coming from the flow indicator valve.
• A detailed list of all the medications and their expiration dates should be kept in the crash cart binder.
• The drawers to the crash cart must be kept locked at all times to ensure all of the medications, needles, syringes and other equipment are maintained intact.
• Once a defibrillator/AED and/or crash cart is used, all supplies and equipment should be checked and replaced immediately, as necessary, to ensure it is ready for the next emergency. Remember that you may need to download rescue data from the defibrillator/AED after its use.
Vendor Contracts
If you have a contract with a vendor to maintain your equipment, you need to make sure you read the contract thoroughly and consider having your attorney review it as well. Usually the standard form contracts provided by the vendor are in his/her favor. It is important that you evaluate and negotiate service contracts with vendors effectively.
Ensure that everything is written out clearly. All aspects of inspection, testing, preventative maintenance, repairs, engineering changes, parts and materials, and service documentation need to meet manufacturer’s recommendations outlined for the make and model of equipment being serviced. In addition, you need to make sure the contract addresses pricing, response time, service limitations, termination, indemnification, limitation of liability, insurance, and confidentiality.
Staff Involvement
In addition to maintaining the equipment, staff should be trained on how to properly use it. It should be written office policy that if a staff person has not been trained, the individual should not be allowed to use the equipment. Telephone numbers of the equipment vendors should be posted in a prominent location for use by staff in an emergency.
Staff should not only be trained on how to use the equipment within the office, but also on what to do if the equipment malfunctions and/or causes injury to a patient. All equipment malfunctions and/or incidents should be reported to the person in charge at the office practice and investigated. Any malfunctioning equipment involved in a patient incident should be removed from service, secured and not released to anyone, until advised by Princeton Insurance. Any defective equipment should be removed from the patient care area immediately and identified as such so it is not used until repaired. In addition, staff should be trained on any back-up plans established for when a piece of equipment needs to be serviced/repaired.
Documentation
In order to better track the equipment in your office, consider using a binder or notebook to document all pertinent information about each piece of equipment, such as rationale for selecting the equipment, equipment specifications, inspection and maintenance schedule based upon tier level identified as described above, repairs, name of vendor performing preventative maintenance and repairs, if appropriate, and names of users and their training.
See a sample Medical Equipment Tracking Log here.
Resources:
ECRI
Food & Drug Administration (FDA)
Duke Occupational & Environmental Safety Office (www.safety.duke.edu)
AED.COM (www.aed.com)
American Society for Healthcare Engineering (ASHE)