If we buy a PET scanner we negotiate for technical training for our staff so that they can get the certification and manuals, things they need for preventative maintenance.

Some companies do prevent that from happening and a big area is clinical lab equipment. They don't tend to train or provide the information we need. We can occasionally get information from other sources, but there are hospitals [that] really struggle with this.


Through the supply chain process we're able to document our requirements and pressure the vendors to provide what we need. If they say they don't train for a device, we're not happy about it, but we shouldn't be servicing a system we're not educated on, although we may fight for preventative maintenance capabilities.

Some places have it more difficult than we do. We are just set up fairly effectively to avoid that happening most of the time. The argument that's out there right now, with biomeds sort of being considered as a third party, is not new in our industry and there are a lot of different viewpoints.

When manufacturers sell you a piece of equipment, they make their capital profit in that equipment and then they make their money on service. I've done enough service contract negotiations to know that their profit margins are pretty significant on the service side, so they have a vested interest in holding on to that. I'm sure some have concerns about the quality of the individuals servicing their equipment and I would say for some third parties that concern may be valid, but it's not a reason to license or put other restrictions on people servicing equipment.

HCB News: Do you feel that new standards or regulations are needed to ensure that biomeds and ISOs are ensuring patient safety at the same level as manufacturers?
AR: We need to know, from the manufacturer’s perspective, what are they looking for that they don't see from an in-house biomed department? What are their concerns? The statistics and the data show that there have been a fractional percentage of medical device failures that have occurred because of poor service and resulted in injury, illness or death to a patient. There is not enough data out there to show that it's a problem.

So, if that's the case, and the information and data is true, what have manufacturers seen that has caused them to have these concerns? Once that’s established, the third parties and ISOs can try to answer to it.

There are some very big, well structured ISOs out there with solid policies and procedures, and a lot of these ISOs are beginning to grow. Many of these companies can provide documentation on training and competencies, so you need to get the right people around the table, which is something I know AAMI is trying to do, and have these discussions to find out where the gap is, and where is the data to back up the concern.

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