Medical Device Link.

DISPOSABLES

Disposables must be discarded after use, but their importance shouldn't be dismissed quite so quickly. After all, the market for disposable medical products is currently thriving. And, according to a study conducted by the Freedonia Group Inc. (Cleveland), it will continue to gain momentum as a lucrative field in the coming years.

The future bodes well for disposables, according to Freedonia. The study forecasts that U.S. demand for disposable medical supplies will increase 5.6% annually to reach $71 billion in 2009. Of the various product areas that fall in the disposables category, the study predicts that IV, catheterization, and related products will continue to be the most profitable. These products will remain the largest and fastest growing group, amassing a 6.5% annual increase that yields $37 billion in 2009.

Surging prosperity in the field can be attributed to a number of factors, one of which is a concerted effort by hospitals to cut costs when possible. “Disposable devices can be less expensive than reusable devices, and they eliminate the cost of cleaning and validation,” notes Jim Brown, medical business unit manager, Colder Products Co. (St. Paul, MN).

The substitution of disposables for reusable devices in hospitals is not only a means of penny pinching, though. In recent years, various studies have inundated the industry with statistics about the alarming number of hospital-acquired infections (HAIs) contracted by patients. An estimated two million people develop an HAI each year. Moreover, HAIs may be responsible for as many as 100,000 deaths and up to $3.5 billion in additional costs annually, according to a study published in the November/December 2006 issue of the American Journal of Medical Quality . Public reporting of HAI data by states—a relatively new concept pioneered by Pennsylvania in 2005—has reinforced the urgency of the situation.

In response to the criticism that the industry has weathered in the wake of recent reports, it has avowed that precaution is priority number one. As a result, healthcare practitioners have turned to single-use devices in an effort to minimize the spread of HAIs. Many hospitals have begun replacing reusable devices with disposable ones in many procedures. By doing so, healthcare workers reduce the risk of cross contamination. Disposables for such applications as IV, drug delivery, respirator therapy, and surgical and wound-management products stand to gain from this trend, according to Freedonia.

Yet despite their contribution to curtailing HAIs, disposables have actually drawn fire themselves for endangering patients. Controversy has surrounded the subject of reprocessing and reusing single-use devices, owing to the potential health risks presented if not done properly.

“One area that we see in the marketplace is the OEMs desire to limit a single-use device [SUD] to a single use, and prevent reprocessing of these items and then reusing them,” says Brown. “The OEM wants to minimize their liability of a failed device that was designed for a single use, but [was] reprocessed and used multiple times.”

To ensure that SUDs have only been used once, or have been reprocessed correctly, Colder Products has incorporated RFID technology into its connectors and couplings. Suited for use on such equipment as blood-pressure cuffs, blood analyzers, and analytical instruments, the couplings feature a read-write tag, an embedded RFID reader, and an antenna. Equipped with 16 bytes of memory, the technology allows users to program the reader to carry out a task such as recording how many times the coupling was used.

Cardinal Health offers a line of disposable devices, such as the Texium luer, developed to protect healthcare workers from injury and hazardous substances.

Between the reuse of SUDs and cross-contamination, it can seem like patients are constantly in danger. But in hospitals, it's not just the patients who are at risk. Luckily, disposable devices help protect healthcare workers as well. As part of their job, workers deal with toxic drugs and dangerous equipment, such as needles. In light of this, Cardinal Health, Alaris Products (San Diego, CA) offers a range of disposable products aimed at ensuring safety for both patients and clinicians. For example, the company's Texium closed male luer can partner with a SmartSite needle-free valve to enable safe handling of hazardous drugs. With this closed system approach, the firm hopes to curb instances of injury, as well as exposure to dangerous drugs by the workers who prepare and administer them. Safety features of the Texium luer include a no-drip-tip technology, a lock-and-go design to facilitate connection with the needle-free valve, a passive safety system that closes upon disconnection, and an automatic safety lock.

Safety concerns for patients and workers account for a significant portion of disposables sales. However, a shift in surgical practices has had what some view as the most profound effect on the disposables industry.

“A major factor in the growth of disposable medical devices is the shift toward minimally invasive surgery (MIS), which reduces the length of a hospital stay,” says Tilak Shah, founder and president of Polyzen Inc . (Apex, NC), which specializes in balloons and barrier sheet products. “Thus, there is an increased need for one-time use and disposable devices administered by doctors in their offices or in hospital outpatient centers.”

Disposable products for minimally invasive surgery, including Via Biomedical's line of Spectral balloons, are helping to fuel the growth of the disposables market.

Resulting in reduced recovery times, smaller scars, and less physical trauma for patients, MIS is emerging as the preferred method for many operations. Subsequently, there is a growing demand for products necessary for the procedures, many of which are disposable.

Among the disposable devices frequently used in MIS are medical balloons. Serving a range of functions, the balloons are suited for angioplasty procedures, drug delivery, and stent deployment. Via Biomedical (Maple Grove, MN) offers the Spectral line of medical balloons for such applications as occlusion, sizing, fixation, dilatation, and drug and stent delivery. Clear and durable, the products are offered in low- or high-pressure forms and performance characteristics include noncompliant, semicompliant, and compliant. Moreover, the company offers custom construction of the balloons, which can entail surface-mounted active components, laminated constructions, and reinforced structures.

With MIS supplanting more intense and taxing procedures, and SUDs replacing many reusable devices, the disposables industry is primed to reach the $71 billion mark in 2009, as predicted by the Freedonia Group. Armed with such economic clout, the disposables industry may make people realize just how valuable disposables really are.