There is an abundance of exciting new technology out there, and what is not new is advancing. CT machines now offer 64 slices with 256-slice prototypes in development, a 9.4 Tesla MRI is in use by researchers, telemetry systems now permit regular consultations among physicians located on different sides of the globe, and robots can be found in the OR performing surgery. It is all very cool and futuristic, but also very expensive. Subsequently, not every hospital (in fact, very few) can easily afford to bring in the latest and greatest, much as the administration, providers, and patients may want it.
When budgets are tight, the difference between want and need becomes important, and biomedical/clinical engineering departments can help differentiate between the two. Once a need is established, biomeds can also help to find the right technology for the hospital. They will consider factors as varied as performance, cost, and clinician personal preference, and they will compare systems and contracts found through a variety of resources.
Detailed reports can identify how a new piece of equipment will fill a need as well as how it can offer cost efficiencies and improved patient care. Analyses of current hospital equipment can also help to set future strategy, permitting equipment replacement or a new acquisition to be well planned rather than a last-minute emergency. This contribution is so valuable that in many facilities, the biomed’s role in capital acquisitions has become a necessity and not just a luxury.
Needs provide the foundation for the search for new equipment. “You have to start with clinical needs first,” says Theodore Cohen, MS, CCE, manager of clinical engineering at UC Davis Health System in Sacramento, Calif. “Typically, a clinician is trying to solve a problem.”
That clinician may approach the administration or capital acquisition team with that problem or, as is more frequently the case according to Cohen, with a proposed vendor solution. “You have to determine if there really is a ‘fit’ between the proposed solution and the ‘real’ problem,” Cohen says. For instance, does radiology really need a 64-slice CT or will the 16-slice device in place meet clinical objectives?
A needs assessment will often provide the starting point for the acquisition of new technology, with smart biomedical/clinical engineering departments planning for those needs ahead of time. “We try to work proactively so we are not replacing equipment at the last minute,” says Izabella A. Gieras, MS, MBA, CCE, CSSBB, director of technology management for Beaumont Services Co LLC, in Royal Oak, Mich.
The clinical equipment management system, or CEMS, can help with this planning. Drawing on equipment history and other information, such as expected life cycles, reports can be produced that prioritize replacement needs. Other reports, analyzing recalls and incidence patterns, can identify problematic equipment. Three-, 5-, and 10-year plans help administrations prepare appropriately.
“We can look at a piece of equipment, such as a defibrillator, and see that it was purchased 6 or 7 years ago and that we need to start preparing the hospital to buy a new one in 3 or 4 years when it has reached its useful life,” Gieras says.
Steve Kehrberg, CBET, vice president of the supply chain clinical engineering group at Catholic Health Initiatives (CHI), Tacoma, Wash, acknowledges that CEMS is an important tool in the technology assessment and acquisition process, but that the information it generates should be balanced against the needs of the hospital overall, which can sometimes change unexpectedly. Technology may become obsolete or the hospital might develop a need for equipment that is more progressive, offers new features, or provides easier operation.
Once a necessity has been established—radiology really does need a 64-slice CT to perform advanced cardiac imaging, for example—there are a number of resources to identify the technology that can fit the bill. Many biomeds cite the ECRI Institute, an international organization with US headquarters in Plymouth Meeting, Pa, as a valuable resource. According to the institute’s Web site, the nonprofit organization is dedicated to applied scientific research with the intent of discerning which medical procedures, devices, drugs, and processes are best and enable improvements in patient care.
Other resources devoted to health care technology cited include Sg2, a health care intelligence company in Chicago; Strata Decision Technology, a health care software consulting company with corporate headquarters in Champaign, Ill; and MD Buyline, a comprehensive health care product database based in Dallas.
Medical magazines, conferences, Web sites, colleagues, and vendors are also valuable sources of information. “RSNA [Radiological Society of North America] is probably the biggest area where we gain most of our information,” Kehrberg says. “We like to bring various people from around the country and assign them tasks to review certain technologies. Then we circle up, share the information, and try to approach an acquisition as a multidisciplinary group rather than just focusing on the one aspect each individual knows, which in my case is the service side.”
Criteria for Purchase
Bringing in individuals from different disciplines to evaluate equipment is a common approach and helps to ensure that all the relevant criteria are considered.
CHI’s capital procurement group analyzes all of its capital procurements. “We have our own database we are developing as a system so that when the hospitals in our groups across the country purchase like devices, they can evaluate them against a set of criteria that makes sense for the individual site,” Kehrberg says.
One important factor is the service line. “For instance, when we purchase a 64-slice CT scanner, rather than just looking at scanners, we ask how we need to develop the service line to optimize the equipment,” Kehrberg says. “For 64-slice CT, we’ll need PACS and credentialed physicians, and a relationship between radiology and cardiology.”
The Beaumont Services Co also takes a committee approach. “We usually assemble a multidisciplinary team involved in the technology,” Gieras says. “We are the project managers representing the technical aspect, but we still need clinical and purchasing to make the right decision.”
The same is true within the UC Davis Health System. “Once a proposal or project is formalized—the larger the project, the more formal it needs to be—a group works with the requester on a variety of aspects, including technical, financial, facility impact, clinical workflow, etc,” Cohen says.
Human factors engineering is not just about encouraging good posture and avoiding repetitive motion injuries, although those are important. It is also about the safe and effective use of equipment. “Many clinical engineering departments are not yet incorporating human factors engineering into their capital procurement process, but it can help to distinguish between different pieces of equipment that are being evaluated for a purchasing decision,” says Izabella A. Gieras, MS, MBA, CCE, CSSBB, director of technology management at Beaumont Services Co LLC, Royal Oak, Mich.
By looking at the user interface of a device, one may be able to ascertain how efficient and safe the operation may be. “Imagine a simple infusion pump device,” Gieras says. “We look at how the buttons are placed and where they are located, what their shape is, and whether they are intuitive and user-friendly for a clinician.”
One of the purposes is to determine if there is the potential for the user to make a mistake during use. “We noticed there are so many issues with the design of equipment,” she says. “About 40% of recalls are a result of design flaws.”
The institution now not only uses human factors engineering to evaluate potential acquisitions, but also offers the service to medical device design manufacturers to help determine whether products in development have potentially fatal design flaws. Suggested changes may be simple and can occur at the user level.
Gieras offers tubing and catheter misconnections as an example. Evaluation of use identified that the male detected on the blood pressure monitor cable has the potential to misconnect with the female luer connector on the IV line. This can result in the infusion of air into the patient’s vascular system, which can cause severe injury or death. The solution: to label the cuffs and change the positioning of the tubing.
“We make sure that from the clinical and technical standpoint, we can use a device without risk,” Gieras says. This helps to protect both patients and caregivers, while aiding the hospital in making smart purchasing decisions.
Most facilities evaluate the same criteria: technical, clinical, regulatory, financial, facility impact, and service. Technical aspects include items such as safety checks, electrical checks, and assurances that the device works from a technical standpoint. “We check the recall databases to make sure the device has not been involved in any recalls,” Gieras says.
Clinical concerns look at the ease of use and whether the equipment actually satisfies the clinician’s needs. Within this category, Beaumont has added human factors engineering considerations, which look at design for both function and ergonomics. “Is there a potential for the user to make a mistake?” Gieras asks.
Regulatory criteria include the necessary approvals and compliance with the proper agencies, such as the FDA. “Is the device approved by the FDA for the intended purpose?” Gieras asks. “The vendor might say you can use it for a specific purpose, but when we look at the 510(k) review, we see the device was actually approved for another use.”
Financial considerations factor in not only the acquisition cost but also the cost of ownership over a short-term period (eg, 5 years) and/or the expected life of the instrument. Projected service costs, consumables, accessories, and setup will all impact the overall expense. Service contracts and training should be negotiated at the time of purchase, and if buying in bulk, volume discounts can be arranged as well. “We will sometimes bundle different types—a defibrillator and physiological monitors and maybe another piece of equipment—to improve buying power and negotiate for a larger discount,” Gieras says. “That same manufacturer might not get just 1 or 2 million dollars but 4 or 5 million dollars as a result.”
Some facilities belong to group purchasing organizations, or GPOs, that can provide excellent pricing opportunities but may restrict options. “It restricts you in the sense that you may not have the entire portfolio of vendors to choose from but a smaller preapproved group,” Kehrberg says. “So for CT, you may have only two vendors to choose from rather than five.”
Facility impact concerns include footprint, environmental needs, and infrastructure. If construction or renovation will be needed, interior designers and architects should be consulted at early stages. If the equipment in question must integrate with other systems, such as utilities or IT, the relevant groups should also be brought in to acquisition discussions. “If you don’t consider these factors early on, there could be a lot of expensive changes that need to be made to the infrastructure later on,” Gieras says. “It’s all important when it comes to plugging in the equipment and having it work when you need it to work.”
Kehrberg notes an advantage of newer equipment is that often the footprint is smaller so space is not the obstacle it once was, but infrastructure issues can still be costly and should be considered. “Some vendors will have different requirements,” he says. “One piece of equipment may require air conditioning to keep a device cool, and another may need an outside chiller, costs that will need to be calculated.”
Another consideration is what to do with the existing technology. In larger systems, such as CHI, a device that is no longer useful in one location may be appropriate for another. “Will a vendor help us to deinstall and/or relocate that device?” Kehrberg asks.
Once the purchasing group has evaluated the criteria and found what it thinks is the perfect piece of equipment, it may have to do some convincing. “We often get a push from administration, who doesn’t want to spend too much money and wants to stick to the budget,” Gieras says. “But we don’t want to go with the equipment that has the lowest bottom line because it may not be the safest or best piece for our hospital.”
Kehrberg agrees that funding is often the biggest challenge. “There is never enough money to go around, so we try to identify the devices that are most important to replace and leverage the system to purchase as much as we can with the limited amount of funds,” he says.
Straight to the Source
There are a number of resources to aid health care facilities with capital procurement decisions. Following are links to some of the sources cited by biomeds.
Technology and consultation services:
- ECRI Institute, Plymouth Meeting, Pa, www.ecri.org
- MD Buyline, Dallas, www.mdbuyline.com
- Sg2, Chicago, www.sg2.com
- Strata Decision Technology, Champaign, Ill, www.strata-decision.com
Conference search engines:
- Congress Resource Center (CRC), www.docguide.com/crc.nsf/web-bySpec
- Health On the Net Foundation (HON), www.hon.ch/cgi-bin/conferences
- medicalconferences.com, Derbyshire, UK, www.medicalconferences.com
- NewsWise, Charlottesville, Va, www.newswise.com/resources/calendars/med/
But even if the administration gives the go-ahead, there may be some push back from clinicians who indicate a strong preference for a particular vendor. “We try to understand if there is truly a clinical difference or a perceived difference,” Kehrberg says. Letting them review the equipment from a clinical standpoint to differentiate between the two can reveal that there is no real difference and achieve their buy-in, even if they maintain a preference.
In some instances, clinicians will push for the most advanced device, seeing it as their “only shot” to obtain new technology, Kehrberg notes. “They’ll push for the Cadillac over the Chevy, so we try to identify the best fit,” he says. “Often, they will agree, but it can be difficult to get there.”
If the need is real but the funds are not available, biomeds will help them to manage until the equipment can be purchased. “You don’t want to get caught in a place where the physician says, ‘I’m going to the hospital down the street,’ so we focus on objective criteria rather than emotional,” Kehrberg says.
Objective criteria are particularly valuable in determining whether the right decision was made, though not all organizations perform this evaluation. “Most places, ours included, do not do a very good job in following up later to see that a purchase was a ‘good’ purchase from the standpoint of a good business decision based on real patient volumes matching estimates/expectations, clinical outcomes, improvements, productivity improvements, etc,” Cohen says.
Yet doing so can help to validate the role biomeds play. In many facilities, the biomedical/clinical engineering department has emerged as a key participant in capital acquisitions. “We’ve transformed from a clinical support group into an operational group,” Kehrberg says. In many institutions, biomedical/clinical engineering’s participation in procurement is not just a want but a need.
Renee Diiulio is a contributing writer for 24×7. For more information, contact .