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Copyright © 2008

People, Places, Processes & Products that Influence the Supply Chain

INSIDE THE CURRENT ISSUE

December 2007

Operating Room

Infection Control Update

Participants left uninformed in some halted medical trials

When Congress passed a bill this fall requiring makers of drugs and medical devices to disclose the results of clinical trials for all approved products, advocates of greater study disclosure applauded the move. But a provision that would have mandated disclosures for another group of products never made it into the final version of the bill. It would have covered products tested on patients, but dropped before marketing. "Trial sponsors can still choose to keep information about some trials confidential, creating serious ethical concerns," said Dr. Deborah A. Zarin, the director of ClinicalTrials.gov, a Web site run by the National Library of Medicine. Many experts said the recent Congressional debate underscored a troubling fact: some patients in clinical studies never learn about test results. The problem may be particularly relevant to those implanted with medical devices that stay with them long after a trial is over.

There are no data available for the number of patients who participate in studies of drugs and medical devices that never make it to the marketplace, though it is likely that the number runs into the thousands. A product may not reach the market for a variety of reasons; it may not perform well in trials, for example, or it may be rejected by regulators. Although researchers conducting clinical studies are not required to disclose test results to study participants, they must alert patients taking part in a test to emerging product dangers.

Companies also have to keep promises made to regulators at the time a trial began, like agreements to follow the health of study patients. Such promises are often required to get approval to begin trials in the first place. But researchers and manufacturers do not always fulfill even those minimal requirements. And such failing may be particularly acute in trials of implanted devices, since those products remain inside patients.

Because of loopholes in the recently passed Congressional bill, device makers will still have discretion whether to publicly reveal the results of studies. Under the law, device producers will have to report such "premarketing" studies and their results to the FDA. But that data will remain in a confidential "black box" until a product is approved; if a device is rejected or dropped, a company will not have to disclose those results or even publicly acknowledge that the trials occurred. Device makers lobbied against mandating disclosure for failed products, arguing that releasing such data would be confusing to patients and would give away valuable information to a company’s competitors about devices under development that might succeed in subsequent trials. "Such disclosures could have the unintended consequence of eliminating many small device makers from the marketplace," Stephen J. Ubl, chief executive of the Advanced Medical Technology Association trade group, testified before Congress in June. (New York Times)
 

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The heat is on

Noninvasive patient warming solutions hot on innovation

by Julie E. Williamson

Cincinnati Sub-Zero WarmAir with stand

Perioperative hypothermia has been widely recognized as a contributing factor in the development of surgical site infections, while also contributing to longer length of stay and an increased risk for mortality.

Despite the scads of studies that highlight the potential for hypothermia’s deleterious effects on patient recovery and outcomes, many healthcare organizations still aren’t doing enough to keep their patients normothermic. In fact, it’s been shown that between 30 to 40 percent of all U.S. surgical patients are hypothermic upon admission to post-operative recovery, with approximately 14 million surgical patients becoming hypothermic each year.

Data on file at Arizant Healthcare Inc., Eden Prairie, MN, further underscores that shortcoming. The company reports that an estimated 26 percent of surgical patients deemed to be at risk of hypothermia are actually receiving active patient warming.

What some surgical teams may not realize, however, is that surgery-related hypothermia doesn’t discriminate. In fact, sources told Healthcare Purchasing News that virtually every surgical patient – regardless of age, gender, race, health status, fitness level, or length or type of procedure – is at risk of developing the condition.

"Any patient undergoing anesthesia – general or regional – can become hypothermic if it is not actively prevented," noted David Parks, general manager of global business management, Kimberly-Clark Health Care, Roswell, GA.

Hypothermia is a body’s normal reaction to the induction of anesthesia. When anesthesia is administered, core-to-peripheral redistribution of body heat
occurs, which lowers overall body temperature, and in turn, can impair the immune system.

"Temperature can drop up to 1.6 degrees Celsius in the first hour, so a patient can become hypothermic very quickly," stressed Troy Bergstrom, Arizant’s marketing communications manager.

While anesthesia plays a key role in temperature reduction, it’s by no means the only factor. Also contributing to the disruption of normothermia is the fact that many patients are placed in a flimsy gown atop a very cold table, which draws heat away from the body. Couple that with the often frigid temperature of the hospital – particularly the operating room, which often is set at a brisk 50 to 60 degrees – and it’s little wonder patients find themselves at a disadvantage.

Not-so-hot statistics

Kimberly-Clark Patient Warming System

When assessing the importance of maintaining normothermia, the statistics speak for themselves. Take, for example, the prevalence of surgical site infections, which occur in two to five percent of patients after clean extra-abdominal surgeries (such as thoracic and orthopedic procedures), and in up to 20 percent of patients undergoing intra-abdominal procedures.

SSI prevention takes a multi-pronged approach, with temperature management being widely recognized as one preventive measure. SSIs are associated with 7.3 mean additional postoperative days and cost an additional $3,152 per patient. One 2006 study revealed that the impact of SSIs can be far more devastating, with treatment costs associated with severe organ or space infections costing upward of $30,000 per case.

"Temperature management is actually becoming more vital than ever. In the perioperative environment the issue of surgical site infections and the cost of treating them has become a very large issue," confirmed Brian Stelley, product manager for Gaymar Industries Inc., Orchard Park, NY. "Maintaining a patient’s temperature at a normothermic range is viewed as one of the key ways of reducing surgical site infections."

Parks elaborated, pointing to studies that have shown that patients who successfully reach normothermia during surgery require fewer transfusions, experience less post-operative bleeding, spend less time on mechanical ventilators, require less time in intensive care, and typically go home sooner.

If the SSI-related numbers aren’t chilling enough, there is also the patient satisfaction data to consider. Numerous surveys that asked patients about their surgical experience revealed that discomfort associated with being cold ranked at the top of patients’ list of concerns.

"If you were to read some of the reports, the patients said they expected there would be pain associated with the surgery and they expected it to be a little frightening, but what they didn’t expect or like about the experience was that they were very cold," said Dan Koewler, product manager, Cincinnati Sub-Zero (CSZ), Cincinnati, OH. He stressed that nervousness and intimidation may inhibit patients from verbalizing their discomfort.

Even if they did, that doesn’t necessarily mean they would be actively warmed, however. Although almost anyone who has ever had surgery can attest to the comfort of the ubiquitous warmed cotton blanket, that temporary comfort is where the benefits end.

Gaymar Medi-therm7900

"We still hear people saying that they don’t have to [actively] warm their patients because they use warm cotton blankets. This is a big misconception, though, because warm cotton blankets do nothing to actively or therapeutically raise the patient’s body temperature," Bergstrom said.

There are other barriers to the consistent, appropriate application of patient warming, with misconceptions about the duration of procedures and the lack of need for widespread temperature management being a key factor.

Some facilities do not warm patients for surgical procedures scheduled to last less than an hour or two, assuming that hypothermia only poses a risk in longer procedures. While some longer, more complex procedures can make patients more susceptible, the literature shows that virtually every surgery, regardless of its duration, can result in hypothermia.

A proactive approach

High reported hypothermia prevalence rates and dangers aside, healthcare organizations have a variety of innovative, user-friendly – and above all, safe and effective (when used as directed)– noninvasive active warming solutions that can keep patients both comfortable and normothermic.

Because patient temperature drops quickly in the intraoperative setting, there’s a growing consensus regarding the benefits of warming patients preoperatively.

"If we can start the warming process before a patient heads into surgery that will give their body temperature a boost. It will help balance out the temperature of the core and the periphery so when anesthesia is delivered and vasodilation occurs it won’t cause the patient to become hypothermic, as long as active warming is also being administered during the procedure," said Bergstrom.

Prewarming can be achieved in multiple ways, with many of the latest active solutions offering a heightened degree of flexibility and ease of use. Arizant’s Bair Paws system is a patient warming gown that can be used preoperatively, intraoperatively and postoperatively. In the preop setting, patients can adjust the flow of warm air for enhanced comfort and once that individual enters the OR, their gown is then hooked up to Arizant’s more powerful convective warming unit, the Bair Hugger. The gown can then stay with the patient in post-op to keep them warm and comfortable through recovery.

"We thought it was a little ironic that the one thing that is literally closest to the patient – the gown – had not really changed over the years. Patients were just resigned to wearing that cotton gown and feeling cold and exposed. When our Bair Paws system was first introduced, it was more of a comfort product used in pre- and post-op, but about two years ago we added the capabilities of the OR, which has enhanced its functionality," said Bergstrom. The disposable Bair Paws gown, on average, will cost a facility $13 to $14, with much of those costs being offset by eliminating the need to launder and replace traditional cotton blankets, he said.

Arizant lithotomy underbody blanket

CSZ offers a variety of active warming solutions, including its convective warming Filtered Flo system that moves warm, clean and filtered air through the Filtered Flo Warming Blanket, allowing the air to be evenly distributed to the patient’s tissue. Because of its generous size, the upper body blanket from CSZ can be used in the preop area as a prewarming blanket and then follow the patient into the OR. "If a patient’s temperature is effectively maintained throughout the procedure, they are then sent to the PACU with the correct temperature," said Koewler.

"Obviously, we have to pay attention to what’s best for the patient, but it’s also important for us to realize that there are economic factors that must be considered for the hospital. One of the ways hospitals can be economical and still provide great care for the patient is to have access to [solutions] that allow multiple uses for the same product," he continued.

While convective warming is considered a safe, effective means for warming the patient, the same can be said for conductive solutions; that is, those that work by coming in direct contact with the patient’s skin. The Kimberly-Clark Patient Warming System, for example, integrates a hydrogel interface, which is applied directly to the patient’s skin via an insulated thermal pad.

"Precisely regulated warm water then travels through the thermal pad, delivering warmth to the patient at a controlled rate," explained Parks, noting that heat is conducted directly through the skin, safely maintaining normothermia with only 20 percent of the patient’s skin covered, for maximum surgical access. Various pad sizes allow placement on nearly all body surfaces, making the system ideal for a wide variety of patients and surgical procedures.

New to CSZ’s temperature management lineup is its Gelli-Roll product, which combines patient temperature management and pressure reduction in an easy to use, reusable product. The Gelli-Roll, which may be used before, during and after surgery, consists of a warming blanket that’s encapsulated within Akton gel pads to maintain patient temperature throughout surgery using warmers such as CSZ’s Norm-O-Temp, Blanketrol, or Hemotherm (although Koewler stressed that the Gelli-Roll will also work with other vendors’ solutions that the hospital may already have in place).

"Our warming pad is actually sandwiched between two Akton gel surfaces, which provides the equivalent of an extra half-inch of body fat," Koewler explained. The system is also flexible, meeting the needs of infant to bariatric patients.

Flexibility is also key to CSZ’s microprocessor-controlled Blanketrol III total body Hyper-Hypothermia water therapy system, which allows staff to either warm or cool the patient, depending on their needs.

Gaymar’s Medi-therm Hypo-Hyperthermia conductive warming and cooling system also allows for blanket temperatures of 39 to 107 degrees F (4 to 42 degrees Celsius). The latest model, the 7900, incorporates new features to provide the clinician enhancements that provide even tighter controls for cooling and rewarming. "These features are geared specifically toward the induction of hypothermia and the eventual slow, controlled rewarming process," said Stelley.

Cincinnati Sub-Zero Kool-Kit

Temperature management solutions that can pull double- or triple-duty can not only offset costs, but perhaps also make consistent, appropriate use more likely, stressed Mike Duski, director of marketing for temperature manage-
ment, Cardinal Health’s Infection Prevention Business. "With [temperature management] there’s the recognition of benefits, but there still isn’t always consistent use," he said. "We know that the (typical) end goal is to keep the patient normothermic, and the best way to do that is to start the warming as early as possible." While Cardinal Health isn’t currently offering warming solutions, it’s a segment that the company is eyeing closely because of its infection control implications. "Maintaining patient normothermia falls into the scope of our infection prevention business."

Which solutions, when?

Because there’s rarely a one-size-fits-all solution in healthcare, vendors are offering a wider array of products that can help caregivers manage patient temperature in even the most challenging situations.

Arizant, for example, has recently added two specialty underbody blankets for use with its Bair Hugger solution, allowing caregivers to warm patients in applications that have proved historically challenging. The two latest products include the lithotomy underbody blanket, used for labor and delivery-type procedures and neurological procedures, and the spinal underbody blanket.

The big chill

While literature shows the benefits of maintaining normothermia in surgical patients, data is also mounting on the pluses of therapeutic temperature management (cooling to achieve mild hypothermia) for specific patient populations, including certain stroke, cardiac and traumatic brain injury patients.

  “The use of therapeutic cooling or the intentional reduction of a patient’s temperature is becoming a very hot topic,” confirmed Brian Stelley, senior marketing manager, Gaymar Industries Inc., Orchard Park, NY, adding that guidelines now exist for the induction of therapeutic hypothermia in post cardiac arrest patients.

  Indeed, the American Heart Association has stated that lowering the body temperature of a person who has been resuscitated after suffering cardiac arrest can help prevent inflammation and subsequent brain damage (it’s even been pointed out that grabbing a blanket to warm a cardiac arrest patient can potentially cause more damage). In conjunction with other resuscitation councils around the world, the AHA issued an advisory statement outlining the benefits and appropriate use of therapeutic temperature management in such patients. The advisory stated that lowering the body temperature to between 89.6 F and 93.2 F should be started as soon as possible following successful resuscitation and continued for 12 to 24 hours to help prevent brain damage. Patients are then slowly warmed to a normal body temperature.

   Mild hypothermia induction is also being used during various surgical procedures, including major vascular surgery, with cooling being shown to provide spinal cord protection and overall neuroprotection in these patients.

  “The literature is pointed to many areas where temperature therapy is appropriate and effective,” said Dan Koewler, product manager, Cincinnati Sub-Zero (CSZ), Cincinnati, OH. “When we look at the number of stroke, cardiac and traumatic brain injury patients alone, that represents a large population around the world that can potentially benefit.”

  While no one particular method of cooling is deemed more effective (studies have shown success with external water- or air-based systems as well as invasive catheter systems), Koewler stressed that there’s a growing focus being placed on rewarming – particularly regarding the rate at which temperature should be increased for optimal outcomes.

  “Some of the latest studies suggest that the slower the patient is warmed, the better the outcome. Using the cardiac arrest patient as an example, the guidelines from the American Heart Association state that the rewarming rate should be a maximum of one degree Celcius per hour,” he explained, adding that some of the leading experts in the field now believe that rate should be even slower (perhaps .25 to .5 degrees Celsius per hour) to ensure that all the neurological benefits achieved by the cooling are not erased” Note: Because the literature is so new and so much is still being learned about therapeutic temperature management, the guidelines pertaining to rewarming rates have yet to be modified.

  “We are making such great strides with some of the new things being learned about therapeutic temperature management and rewarming. It’s a very exciting time.”

"When patients are in these awkward positions it can be difficult to use a typical forced air warming blanket," explained Bergstrom. "Our goal was to come up with solutions that could be used in some of the most challenging procedures." In addition to its Bair Paws system and Ranger fluid warming system, Arizant currently offers 24 different styles of blankets. Although the Bair Paws gown system can be a good choice for surgeries involving peripheries, such as knee, elbow or shoulder procedures, Bergstrom explained that its Bair Hugger blankets may be better suited to procedures that require greater flexibility and surgeon access. Small to extra-large blankets are available to meet the needs of more patients.

Parks stressed that more complex surgeries and patient categories will require different temperature management methods than simpler procedures. While, again, most any surgical procedure can lead to hypothermia if active warming isn’t initiated, he explained that patients undergoing surgeries that require a large exposed body area, involve extended intraoperative timeframes, have large incision sites, or require significant fluid exchanges are most susceptible to unintended hypothermia (examples of such surgeries include cardiothoracic, major abdominal, major plastics, trauma, and some orthopedics).

"In addition, patient factors such as thin body habitus and advanced age can impact the rate of heat loss and the impact of redistribution hypothermia," he noted.

As procedures and patient needs evolve, temperature patient management solutions will have to follow suit. Parks said the introduction of high power systems will likely continue. "The ability to warm any patient to a target is now, in fact, doable, and will continue."

If the literature pointing to the benefits of temperature management isn’t enough to light a fire under healthcare organizations, the potential for mandates could be an even bigger eye opener.

With more attention being paid to the link between hypothermia and surgical site infections, and because of the mandatory reporting of SSIs, Parks predicted there may be a move to mandate temperature management for certain cases.

"You’ll see the same thing with glucose control and other things that impact surgical site infections. Facilities will standardize to the best preventable solutions they have and mandate them. Most hospitals adhering to best practices are already doing that."