AAMI News May 2018
Asked & Answered: Patient-Owned Medical Devices
This regular feature showcases questions and answers from professionals participating in AAMI’s online discussion groups, collectively known as AAMI Connect. AAMI does not endorse specific practices or advice. Participants in these forums are sharing their own experiences and insights.
Q: Our policy states that if a patient is bringing in his/her own medical device(s), the Medical Engineering Department will do a visual check and perform an electrical safety inspection, if applicable. We will put a non–hospital-owned (NHO) label on the device and assign an NHO asset number in our computerized maintenance management system. This policy is adhered to during normal working hours. After working hours and on weekends is the issue. My team members are being paged on call during all hours of the night and morning to perform this task. How do you handle NHO medical device inspections after working hours and on weekends?
A: We have gone through the exact same thing in our biomed group, which eats up valuable time both at work and on the weekends. The worst thing was when we spoke with the operating room about the actual use of continuous positive airway pressure (CPAP) postop, they told us the unit was rarely even used.
We talked with respiratory therapy about the weekend and showed them what was needed for the inspections. So, they began handling them on the weekends since they were in house 24/7. If there was a need for an electrical safety test, then maintenance would be called. Again, another group that is in house 24/7. If it is a piece of equipment, such as a suction, personal vent, or something more substantial, biomed is contacted on Monday morning to check the unit. The unit is logged so there is a record in case of an incident.
It has worked pretty well for us, and we have been inspected by The Joint Commission (TJC) with no issues. Be sure your policy is sharp in spelling out what you are doing, and it is within the scope of the National Fire Protection Association (NFPA) regulations if you choose to go this route.
—Joseph Deater, clinical engineer at Munson Medical Center in Traverse City, MI
A: At our hospital, the Clinical Engineering Department is open 24 hours a day, six days a week, 313 days a year. We have someone on call 30 hours a week from Saturday at 10:30 p.m. until Monday at 4:30 a.m., during which time if a personal CPAP order comes in, the on-call technician responds on site within one hour to perform the inspection. We are hoping to go 24/7/365 soon so that someone from clinical engineering is always in house.
—Winston Piohia, BMET II at Cedars Sinai Medical Center in Los Angeles, CA
A: The Centers for Medicare & Medicaid Services, and thus TJC, DNV GL and other accrediting organizations, require all equipment to be inspected before initial patient use, regardless of ownership. So, patient-owned equipment must be inspected. On the other hand, there is no specific requirement for who should perform such an inspection. Therefore, it is possible to delegate such responsibility to clinical staff if they are willing and able to take on this responsibility.
I would recommend having a candid discussion with all involved and establish a clear hospital-wide policy so everyone is aware of his/her responsibility. This policy should consider some restrictions to reduce risks, such as prohibiting the use of (1) high-risk equipment, except in exceptional circumstances, (2) equipment similar to what already exists in the hospital, and (3) equipment that clinical users are not familiar with or that the clinical engineering (CE) team is not able to verify safety and performance. In case of an emergency, patient-owned or -supplied equipment should be allowed to be used by the attending physician but subject to an inspection by CE whenever possible. Besides checking for safety and performance, CE should also evaluate it for maintenance and recall status.
—Binseng Wang, director of quality and regulatory affairs at Greenwood Marketing, LLC, which is based in Buffalo, NY
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