Mike Capuano: A Medical Equipment Serviceability Standard

At a recent meeting of AAMI’s Equipment Management Committee, I proposed what I call a  “Medical Equipment Serviceability Standard.” The concept is to provide a framework for medical equipment manufactures and vendors to follow when developing and marketing their product. How serviceable is it in the field? Does the company make it possible to service it at all? Do they throw barriers up when it comes to supporting equipment in-house?

Some companies provide excellent support for field service, but others don’t. With every new acquisition the question of technical support is considered, but to what degree? Are we starting from scratch every time?  Has anyone noticed that ECRI evaluations don’t address serviceability concerns even though a large number of their clients are in-house clinical engineering departments?

Are companies responding more often with, “Sorry you can’t fix that; you have to send it in for repair/exchange” or “Sorry, you have to get a contract for that?” Some offer “first-look” or  “shared service” contracts but at a discount that is embarrassing to the clinical engineering department. Do they ask for a PO number when you try to obtain assistance by phone? These may be considered barriers to in-house support.

If these thoughts resonate within you, tell me what you think.

Medical Equipment Serviceability: The level to which a specific medical device can be serviced by individuals or entities other than representatives or direct agents of the original equipment manufacturer.

Sample Criteria:

1.    Service manuals (availability)

2.    Service manuals (effectiveness)

3.    Access codes/passwords/dongles (availability)

4.    Service training (availability)

5.    Service training (effectiveness)

6.    Error codes/log (availability)

7.    Error codes/log (clarity/decipherability)

8.    Test equipment for calibration (availability)

9.    Ability to calibrate in the field

10.  Access to service notes/technical updates

11.  Access to web site for service information

12.  Phone support (availability)

13.  Bundling policies (restrictions on software upgrades and updates)

14.  Contract options (favourability to field service, bundling practices)

15.  Time and material services (availability – ties to service contracts)

16.  Design of equipment (for serviceability in the field)

17.  Granularity of replacement parts (part vs sub-assembly)

18.  Accompanying vendor service personnel (how open are they?)

19.  Charges for any of the above

Mike Capuano  CET, CBET, CCE

Manager, Biomedical Technology Services

Hamilton Health Sciences

8 thoughts on “Mike Capuano: A Medical Equipment Serviceability Standard

  1. The service manuals and OEM tech support hotlines I used in the 80’s and 90’s were vastly more complete, comprehensive and helpful that those same things are today in 2012. Can you imagine I was recently told by an OEM they will not provide a service manual for something as simple as a blood warmer, a light source, an ESU or a video monitor? Can you imagine being told by an OEM tech support person, that they don’t consider a CBET with 30 years of experience capable of, or qualified to, change a pole clamp or repair a light bulb and a power supply in a metal box? Can you imagine?

    This attitude and behavior, in too many cases, is quickly becoming the rule rather than the exception. This is what we are up against. It is my observation (IMHO of course) OEMs are digging in and waging a cold war against their customers right to repair and maintain medical equipment with in house resources. Their reasons and motivations, while easy to surmise, are irrelevant to our position, what is important is what we, AAMI members, Biomeds, CEs and of course healthcare technology management professionals are going to do to defend our right to repair the medical electronic equipment our hospitals purchase and utilize.

  2. A definite need.
    However in the mean time Purchasing has to work closer with Biomed to make sure these pitfalls do not happen. Anything can be negotiated during a requisition for purchase.

  3. It’s a giant slap to the face when a company won’t sell parts to a technician who disassembles and repairs medical devices for a living. I was working on an image capture device, and there was a faulty cable inside. The company said, “can’t sell parts, send it in.” And who is to say they wouldn’t make up all kinds of problems and charge $1,000+ ?!?! I know it was a cable.

  4. I think this is a topic that definitely needs to be looked at closely by AAMI and law makers. As the vice president of a large in-house organization (100+ technicians), I have noticed an alarming trend by equipment manufacturers to make it next to impossible to service their equipment, forcing in-house Healthcare Technology Management (HTM) departments to take out expensive service contracts that we don’t want that increase our cost of maintenance.

    My HTM department has some of the most highly skilled technicians in the country. We spend hundreds of thousands of dollars a year training them, and once trained, they are as capable as the vendor to work on almost any device, including linear accelerators, MRIs, CTs, and ultrsounds. However, the vendors then require you to pay exorbitant amounts for the service key, and as stated by Mike, the delta between a shared service agreement and full service agreement is a joke.

    I was just presented with a proposal after we bought 2 CTS from the same vendor at the same hospital that stated it would cost us $80,000 a year to get 2 service keys to make it feasible for us to service the devices. That doesn’t even include parts, labor or tubes. We had a monitoring vendor just tell us that the telemetry monitors we purchased two years ago are now at end of service life and the software version would no longer be supported. With that, he handed me a quote for $700,000+ to upgrade the system. We paid $150,000 for a large monitor in an OR a couple years ago, and when it started having issues, the vendor we purchased it from said it was manufactured by another vendor, and they had an agreement with them NOT to service the monitor, so we’d have to buy a new one.

    Hospitals seem to spend an awful lot of time worrying about the initial capital cost of the device, but it is the long-term service costs that are contributing to the ever increasing costs of health care. It is also putting qualified in-house HTM organizations at risk. My HTM organizaton has extremely high customer satisfaction scores (96th percentile). We can respond to an issue faster than the vendor and provide the personal touch that our customers value. We also make the manufacturer’s product look better in the eyes of the customer. But I can’t justify to management the need to have BOTH a contract and an in-house technician. The manufacturers know this, and I believe there is a strategy by some of the key manufacturers to put in-house organizations out of business. This will only result in higher costs and poorer service overall.

  5. Mike;

    It is a good start. It’s ironic, particularly since research 45 years ago shows that most equipment manufacturers don’t have a clue as to what’s really needed to maintain their equipment. Based on that alone, you’d think they’d work closely with the hospital staff to identify and do the work that needs to be done, when it really needs to be done.

    • Thank you for the responses. We have some good feedback. More would be great. We need this kind of detail to help construct a standard. Hope to receive more comments.

  6. Mike,
    This is a very good start to a document. At the least, this provides companies looking to purchase equipment with a reference for information to request that would assist them with vendor selection. At some point, having an independent third-party organization provide a ranking against this standard on an ongoing basis would be very helpful.

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