From the moment a patient enters a hospital, he is placing not only his trust, but also his life in the hands of health care professionals and the equipment they use. For this reason, hospitals must consider patient safety long before even dreaming of purchasing a medical device. But to properly assess a product’s potential, hospitals must first entrust their own confidence in vendors and organizations like the Food and Drug Administration (FDA), which rigorously tests and approves medical products and devices.

Regardless of safety regulations and testing, defective and dangerous medical products still proliferate in the industry, contributing to approximately 29 million injuries and 22,000 deaths each year, according to the United States Consumer Product Safety Commission.

Furthermore, a recent report by Stericycle ExpertRECALL, a global leader in product recalls, notes a spike in medical device products affected by recalls, with numbers reaching an eight-quarter high in the second quarter of 2012, exceeding 100 million units for the first time since 2010. At least one recall affected more than 140 medical device companies, with one-third of those facing multiple recalls. And Class I recalls for dangerous or defective products that could result in severe health problems or death rose from 4 to 7 percent from the previous quarter.

This is where the purchasing committee (also known as the medical equipment committee, medical technology committee, or the capital budget committee) comes in. Their job is to review, coordinate and judge a hospital’s new equipment purchases – from stents to CT scanners. Of course, no device is guaranteed to be 100 percent safe in every situation. So the pressure is on the purchasing committee to endorse the medical device they ascertain to be the safest, top quality product for their targeted environment.

Evaluating and incorporating safety into the process
When rooting out the potential problems during the medical device purchasing process, health care institutions won’t look twice at equipment that is not FDA-approved. It is also commonplace for hospitals to look into any existing recalls or alerts on the device or technology in question, and to ensure clinical staff are already familiar with the device, or identify if additional educational training is required.

“We put faith in the fact that the FDA does their due diligence when new devices come onto the market,” says Dawn Griffin, Palm Coast, Fla.-based Florida Hospital Flagler’s materials management director. “Studies are normally provided by the vendors in regards to the safety of the devices and the end-users and clinicians look these over.”

To further confirm health care professionals charged with making purchasing decisions are properly trained to evaluate patient safety, health care institutions like Florida Hospital Flagler have biomed technicians and clinical personnel thoroughly review all potential devices and information before they decide to trial a device or even consider it for purchase.

“[Biomed technicians and clinical personnel] have to participate in skills labs provided by our education department on how to use the devices,” says Griffin. “During these skills labs, vendors come in and demonstrate their devices and train the nurses and other clinicians on how to use the device.”

Trialling devices better pinpoints any potential safety issues. Afterward, if patient safety is still a concern, the device is typically eliminated from the clinical trial.

The security of patients’ private health information is also essential when approving certain devices, notes Alfonso Alfonso, director of biomedical engineering at Children’s Medical Center Dallas, Texas. Criteria involves ensuring data encryption is an option; that the device is password protected; checking if the device taps into the organization’s network infrastructure and if it captures, stores and transmits data; and observing if the device is mobile or has a permanent stationary install.

Staff safety is another important consideration
“When it comes down to something like needles, employee safety is also a determinant,” says Donna Drummond, senior VP and chief administrative officer at the Lake Success, N.Y.-based North Shore Long Island Jewish Health System.

Not only do hospitals consider patient and staff safety with new product placements, but they also continue to monitor quality to ensure products currently in use maintain that level of reliability.

“If quality issues arise, we make sure the issue is corrected promptly, or replaced with an acceptable product,” says Ron Collins, VP of The University of Tennessee Medical Center’s (UT Medical Center) supply chain, based in Knoxville, Tenn. “Product improvements are always being made; we strive to make changes quickly for the optimum benefit of our patients.”

Understandably, no medical device is considered too small or insignificant to escape the purchasing committee’s biting wrath. For instance, blood pressure cuffs recently underwent some intense scrutiny at UT Medical Center when an existing vendor developed an eminent quality problem. The vendor, who was called in for a review, was unable to quickly resolve the issue.

“The VAT [value analysis team] reviewed the existing blood pressure cuffs and evaluated them against a competitor,” explains Collins. “After an evaluation was conducted on a variety of units, the competitor’s quality was deemed acceptable for our clinical staff.”

The team was further able to negotiate a better price point for the new cuffs with the assistance of the Medical Center’s affiliate group, Western North Carolina Health Network.

Triggers and processes for purchasing medical equipment
Although a product’s quality and safety tends to be the main game-changer for most committees, the medical device purchasing process as a whole can vary widely from institution to institution.

“Some health care organizations are more technologically advanced than others,” Alfonso says. “This will have
a significant influence on how and what equipment is purchased.”

Even so, the basic format stays the same, according to Griffin. The process predominantly used is called “value analysis,” where groups determine a medical device’s value versus cost. And it always begins with identifying the individual facility’s needs.

“Each institution typically chooses two or three [medical devices] to evaluate, and then they get feedback from the evaluators,” Griffin says.

At Children’s Medical Center Dallas, for example, a request for an evaluation is made, initiating the value analysis process and team review. Once an evaluation is approved, specific criteria and a timeframe are structured to allow for the right involvement and documentation of outcomes.

“If the evaluation determines the product or equipment meets the clinical and operational specifications, a request is made to purchase,” says Brenda Clayton, senior director of supply chain operations and administration at Children’s Medical Center Dallas.

The appropriate VAT proceeds to review this request and a recommendation is made to the supply chain executive committee, comprised of senior and operational leadership.

Typical questions addressed during the reviews include: Will the device meet the clinical/patient care need? Is the device compatible with the existing inventory (for example, user training/experience, spare part inventory,
service contracts)? Is the device compatible with the existing infrastructure (software, hardware)? Is the device capable of wireless communication and electronic medical record integration? Is there an existing device that is at the “end-of-life” and needs to be replaced or upgraded to improve quality of patient care delivery?

“We have worked diligently to create a process that involves a multi-disciplinary team to assist in the review of products and devices,” says Clayton. “We conduct thorough research and evaluations that assist in determining if a product or equipment meets our needs.”

Ongoing challenges and limitations
Despite these efforts and advances, a 2005 study published by the National Center for Biotechnology Information revealed some serious limitations in the selection process at the several sites. There is still a need for a more formal method of incorporating patient safety considerations into the medical device purchasing process, the report concludes.

At the final hurdle of the decision-making process, the committee —usually comprised of physicians, specialists, the chief medical officer, the CFO and an IT director — takes a vote. Sometimes it doesn’t matter how much time and effort was spent during the product evaluation, stepping on toes can be unavoidable, according to Griffin.

“We try to take everyone’s comments into consideration during the decision making process,” Griffin says. “However, in the end, we take what the majority of people say and use that. Unfortunately, you can’t always make everyone happy.”