By Joseph E. Fishel, CBET, MBA
Do you have purchasing requirements to use as guidelines? Are your guidelines updated with regularity? Have you updated them to reflect the new UL 2900 standards for cybersecurity?
The purchase of a medical device is usually an 8- to 10-year investment. Any changes identified as happening in the near future need to be fed into the procurement process early on. This keeps equipment in compliance with new standards.
So, what do you include in your purchasing requirements? Here are a few thoughts and ideas.
Documentation – What kind of documentation do you want to come with the device? Typically we ask for two copies of the operator’s manual and a service manual. We also request any updates or service bulletins to keep devices current. Some of the documentation that can be required include the following:
Hardware and software – This is where you can define requirements such as password protection, operating system levels, operating systems with an EOS and how it will be dealt with in the future. Hardware and software upgrades in the future and how it will be dealt with. This is an opportunity to ask for what you need. Here are some suggestions:
Acceptance Testing – this is always an interesting subject. When is the device accepted?
Warranty – What is covered and what isn’t and when?
Training – You can negotiate training be free and the level of training.
The vendor shall make available adequate applications training to all shifts of designated department employees. All training shall be at the hospital unless otherwise agreed upon by the hospital. All available training materials including, but not being limited to, videos, CDs, software, manuals, charts, audio tapes, etc. shall be provided to the hospital free of charge for as long as the hospital owns or leases the equipment. Follow-up applications training shall be provided by the vendor during the warranty period at the hospital’s request at the charges agreed to by the hospital and the vendor. In the event that the new software changes the operation of any equipment, supplemental applications training, as needed by the hospital, shall be provided by the vendor at no cost beyond the vendor’s charge for such software.
The vendor shall make available to the hospital a number of training opportunities. The hospital shall use the training only to maintain equipment owned or leased by the hospital, and shall protect all training materials from unauthorized disclosure. The training shall be the same as offered to the vendor’s own service personnel and shall become available before the end of the warranty period. All costs of such training shall be paid by the vendor. The hospital shall pay the trainees’ room, board, and travel expenses. The assignment of training slots shall be as follow:
These are just some suggestions. What do you want to see on yours? Talk with your purchasing/procurement department as well as your legal.
Joseph E. Fishel, CBET, MBA, is the Healthcare Technology Systems Manager with Sutter Health eQuip Services.
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