The JC standard EC.02.04.01—“The hospital manages medical equipment risks”—states as its first element of performance (EP) that, “The hospital solicits input from individuals who operate and service equipment when it selects and acquires medical equipment.” This is a relatively new requirement in the medical equipment management standards. I am a little surprised that it has not made a bigger splash. Many clinical engineering (CE) departments have long decried the fact that they haven't been more involved with the decisions to select and acquire medical equipment. This EP would seem to be an excellent justification for getting a seat at the table where medical equipment acquisition decisions are made.

Whether you are new to the table or your chair has taken on the imprint of your backside, you need to know how to make the right contributions. Some of this is political. I'm not going to pretend that I know the first thing about your hospital's politics or that I can even teach anyone how to observe, learn, and react to your hospital's politics. What I would like to talk about is making objective, well-reasoned, and fiscally sound recommendations regarding one particular aspect of selecting and acquiring medical equipment – replacement planning.

The most valuable contribution that you can make to replacement planning is good information, and this would typically start with inventory information from the CE database.

It appears that CE departments are very concerned about their opportunities to participate in decisions about new technology. I need to be careful about perceptions because they are invariably tainted by my own experience and opinions. I also need to be careful about what others seem to be saying because they may not speak for the majority. Nonetheless, I don't think there's any doubt that getting hip deep in an evaluation of new technology is one of the most exciting and rewarding aspects of a CE's or biomedical equipment technician's (BMET) job.

On the flip side, what about our involvement in retiring and replacing old equipment? Does that sound exciting and rewarding? If not, it's time to make it so because there's much more opportunity to be involved, and even take a leadership role, than with new technology. It has a greater financial impact because more is spent on replacing existing equipment than on acquiring new technology. It also has the potential for getting involved with new technology. At least some of the time, when old equipment has to be replaced, the replacement will be with some new technology, rather than something almost identical to the old equipment. This is particularly true about the computerization and interconnectivity of new equipment versus old. Also, if you make valuable contributions to decisions for replacing equipment, you are more likely to be asked to help with decisions to acquire new technology. Whether you are already involved in replacement planning or not, here are some recommendations for making contributions to the process.

The most valuable contribution that you can make to replacement planning is good information, and this would typically start with inventory information from the CE database. You should maintain complete and accurate information. EP 2 of the aforementioned standard states, “The hospital maintains either a written inventory of all medical equipment or a written inventory of selected equipment categorized by physical risk associated with use (including all life-support equipment) and equipment incident history. The hospital evaluates new types of equipment before initial use to determine whether they should be included in the inventory.” For purposes of equipment planning, the inventory should include, at a minimum, make, model, acquisition date, cost, and location. Besides inventory information, you should have a maintenance and service history. From this history, you should be able to determine the number and types of problems that equipment has had, and how much it has cost to keep the equipment in good working order.

Your hospital probably has a process for submitting capital equipment requests. This is probably meant primarily for equipment users. When requests are submitted for replacing medical equipment, you should automatically be asked for advice. Even better: Equipment users should come to you before submitting their replacement requests. To promote this idea, you could go to users before they submit their requests. You could offer to provide information about the history of the equipment they want to replace, let them know whether you can support their requests or suggest alternatives to replacement, or, best of all, make replacement suggestions of your own.

A Winning Team

Congratulations to Norton Healthcare for winning AAMI's 2010 Best Practices Award. An article describing the capital equipment replacement program that won the award appeared in the November/December 2010 issue of BI&T. It helped inspire and validate the ideas in this article. It demonstrated that a multidisciplinary team, dedicated solely to replacement planning, can reduce capital and operating costs, and improve patient safety and employee satisfaction. The article emphasized that the clinical engineering (CE) department was indispensable for the success of the program.

The department's database was used to determine the age of equipment, and its repair and downtime history. According to the article, “...the CE data put an objective spin on the replacement needs.” The article also quoted the system VP for materials management as saying, “System wide, this effort raised the profile of CE on decisions. CE became the voice of reason in the process.” In the case of Norton Healthcare, compliance with a JC standard was not the motivation for creating this program. In someone else's case, however, citing a JC standard would lend strength and credence to a proposal for creating a medical equipment replacement planning process.

Getting involved in replacement decisions with equipment is a good way for a clinical engineering department to show leadership.

Getting involved in replacement decisions with equipment is a good way for a clinical engineering department to show leadership.

All requests for new equipment should be accompanied by an explanation or justification. There are quite a few objective justifications possible for replacing equipment. Consider:

  • Age—You should search your database every year for equipment that is older than seven years, and review it for items that should be investigated for possible replacement. The age of equipment alone is not a justification for replacing equipment. (The selection of seven years is based on my observation that most manufacturers will provide parts and service support for at least seven years after the date of last manufacture; some equipment can start to require higher maintenance after somewhere between seven and 10 years; and new technology can make obsolete some types of equipment after seven to 10 years.) If the equipment is working well and still meets clinical needs, then it should not be replaced because of its age. Instead, you should review its service history to see if it is becoming problematic or expensive to maintain. You should also find out from the manufacturer when they are going to stop supporting that model (i.e., no more parts or service). Age is a trigger for considering replacement, but not a justification by itself.

  • Equipment history—You should also search your database for equipment that needs frequent and/or expensive repairs. If you find such equipment, you need to investigate the reasons for these repairs to determine whether there is a way to improve reliability (e.g., overhaul, training), or whether replacing the equipment is called for. It would be worthwhile to discuss reliability issues with the BMETs who service the equipment, as well as the users.

  • Safety—Patient or operator safety is a strong justification for replacing equipment. However, simply saying that a device is unsafe is not a justification. Claiming that equipment is unsafe needs to be backed up with an objective explanation. The best explanation would be a hazard report from the FDA or from ECRI Institute. Another possibility would be an incident investigation and/or risk analysis that you have done in conjunction with your risk management department.

  • Standards and regulations—It is relatively rare, but every once in a while, a standard or regulation will appear that renders a model of medical equipment obsolete. This would typically be associated with a safety issue. An example is the recent FDA requirement that healthcare facilities replace the STERIS System 1 Sterile Processing System by Feb. 2, 2012.

  • End of support—You usually find out that equipment is going out of support via a letter from the manufacturer. Some manufacturers let you know at least a year in advance. Some manufacturers let you know when you place an order for parts, when they tell you that parts are no longer in stock. You tend to like to do business with the former. I'll leave it up to you to decide what you'd like to do with the latter. In any event, when you can no longer guarantee that you can maintain a model of equipment, it is time to replace it. Obviously, lead time helps. Related to the age criterion above, when equipment gets to be seven years old, you should ask the manufacturer how much longer it's going to be supported.

  • Standardization—If your hospital has standardized on a particular make and model of a type of equipment, and you have a handful of oddball models in use, you might want to retire the non-standard equipment in favor of the standard model. There are usually multiple reasons for standardizing on one model of a type of equipment. If all equipment of a certain type (e.g., defibrillators, infusion pumps) is the same model, then training is easier to provide and maintain. Users can borrow equipment or work in different areas and still be familiar with the equipment. BMETs can be more familiar with operation, inspection, maintenance, and repair. Contracts for supplies can be negotiated for a better price. If spares are appropriate, you would only need a single model, and it can be possible to talk a manufacturer into providing a spare(s) if you are committed to only one model. You can also negotiate better prices, better terms, and better support (e.g., a consignment of parts) if you commit to a single model.

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If you plan ahead for replacements, and let senior administration and finance know what your plans are, it should be more likely that you could get commitments for funding. This is particularly true for “fleet replacement.” If you have standardized on a particular vital signs monitor, for example, and find out that end-of-life is one year away, you could propose a multiyear replacement plan. You could replace one-third before parts are no longer available, and save the old units for parts to repair the remainder of the fleet. Then replace the second third the next year, and the final third the year after that. This would spread the cost over a longer period, get more life out of the initial investment, and allow senior management to plan for the budgetary needs. You should also let your vendor know what you intend to do, and lock in the best price while it is still negotiable (e.g., while you are still evaluating what make and model to buy).

CE departments should take advantage of the JC requirement that equipment servicers need to be consulted for equipment selection and acquisition. Don't wait for senior management to come to you. You should point out the JC requirement, and then be prepared with a proposal for regularly submitting short and long range equipment replacement plans.

About the Author

Robert H. Stiefel, MS, CCE, is president of RHS Biomedical Consulting LLC. E-mail: