Down time for medical devices costs can alter the bottom line of any medical business. Therefore, determining the expected life of a medical device is an important, yet complicated issue. Each type of medical device is different and, unless it is clearly labeled, it is necessary to research the device and its performance history prior to purchase. Once purchased, it is important to maintain and record a strict inspection, maintenance, and right repair schedule. Adverse effects can occur after the expiration date of a maintained and inspected medical device which can raise challenges both in usability and liability. It is essential to determine the life expectancy of medical equipment to identify how long the product should be in service and approximately when a product may no longer be safely used in a sustainable and responsible way. Below we will explore what will determine the lifespan of various medical equipment.
Medical Devices
To determine the life expectancy of a medical device one must first identify the type of device it is. Medical devices occur in three categories:
Sterile
- Needles
- Syringes
- Implantable pacemakers
- Surgical sponges
- Facemasks
- Drug Tests
- Suction catheters
Non-Sterile Short Life
- Bed Rails
- Wheelchairs
- Walkers
Non-Sterile
- Enema Kits
- Elastic Bandages
- Manual Stethoscopes
- Bedpans
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Shelf Life of Sterile Medical Devices
Sterile, packaged medical devices are usually date labeled, or have a pull date, and may have a shelf life as defined by the 1991 FDA Guidance document on shelf life. Generally, the life span of these devices is over once the package has been opened and the device has been used one time. However, this document is not clear if shelf life is determined before it is first used.
Non-Sterile Short Life Devices
Expected shelf life or short life statements for a non-sterile medical device such as a bed rail, wheelchair, or walker, may be noted by the manufacturer in the device manual. The timeline could be short which may be due to the manufacturer’s knowledge of durability issues in terms of usage. Although the manufacturer’s recommendations are stated, optimal use of the device can be obtained with regularly scheduled sterilizer maintenance or other types of medical equipment maintenance.
Non-Sterile Devices
The life expectancy of non-sterile devices, not Short Life devices, may be defined as a period of time that manufacturer’s cover any repairs. Manufacturers determine that a medical device is at the end of life when it stops issuing:
- Security updates
- Technical support
The FDA defines the life of a medical device as the period of time that the device is expected to remain operational after it is placed into use. It’s expected to remain operational with regular maintenance, repairs, or upgrades, for an estimated period of time. The life expectancy of a medical device is determined by the following:
- Manufacturer’s expected life span
- Contracted support during the manufacturer’s life span
- Operational use
- Extended support and/or security options
- Inspection and maintenance schedule
Of the above, the most important is the inspection and maintenance schedule which, if strictly adhered to and documented, can likely provide maximum device life expectancy.
We are at ERD, LLC. Medical Equipment Services recommend regularly scheduled and documented inspections and maintenance for maximum life expectancy of all your medical devices.
