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

 

INSIDE THE CURRENT ISSUE

August 2009

Operating Room

Outpatient Connection

FDA: Ongoing safety review of arthroscopic shavers

FDA has become aware of instances in which pieces of tissue have remained within certain arthroscopic shavers, a device used in some orthopedic surgical procedures, even after the cleaning process was believed to have been completed according to the manufacturer’s instructions. Reports submitted to FDA suggested that the tissue retained was not evident to the naked eye. Multiple manufacturers of these devices recently informed their customers of this situation and reiterated the importance of proper cleaning procedures.

The FDA is concerned about this because retained tissue in these devices can compromise the entire sterilization process. They are actively working with the manufacturers of these devices to gather more data about this situation and to understand its potential public health impact. As the FDA obtains more information that better defines the situation and determines whether there are specific risks, information will be provided to facilities, healthcare providers and the public.

The FDA encourages facilities that use any of these types of devices to evaluate the adequacy of their cleaning procedures. Hospitals should consider taking the following steps to minimize any potential risk to patients:

Be sure that all personnel responsible for device cleaning and sterilization at your facility are aware of and comply with all steps in the manufacturer’s instructions for thoroughly cleaning these devices prior to sterilization. Please refer to the specific instructions provided in the labeling or user manual for each brand and/or model of shaver your facility uses.

Consider inspecting the inside of the devices following cleaning to ensure that they have been cleared of any tissue or fluids. There may be multiple ways to accomplish this. As one example, the facility that brought this situation to our attention uses a 3mm video scope to inspect the channels of the shaver handpiece.

If you discover retained tissue in arthroscopic shavers at your facility after following the manufacturer-recommended cleaning procedures, you may file a voluntary report using the online FDA form. These voluntary reports will help gather additional information related to this problem and assess its public health impact.The FDA safety notice is available here: http://www.fda.gov/Medical
Devices/Safety/AlertsandNotices/
ucm170639.htm
 

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Performing under pressure:
Caring for decubitus ulcers

by Susan Cantrell, ELS

ConvaTec’s fecal management system, Flexi-Seal FMS, helps to prevent pressure-ulcer formation and infection

A recent report from the Agency for Healthcare Research and Quality (AHRQ) declared that hospital stays of patients with pressure ulcers are on the rise.1 From 1993 to 2006, there was nearly a whopping 80% increase. Adult stays totaled an astounding $11 billion in hospital costs.1 That’s a lot of money; more importantly, it represents a lot of human suffering.

The AHRQ’s report also stated that "more than 90% of pressure-ulcer—related stays among adults were for the principal treatment of other conditions, such as septicemia, pneumonia, and urinary tract infection," meaning the patient did not have the pressure ulcer before admission to the hospital. That’s very bad news for hospitals these days, since pressure ulcers that were not present upon admission are listed among the "never events" for which the Centers for Medicare and Medicaid Services will no longer reimburse, unless it can be proved that acquiring the condition in the hospital was unavoidable. Pressure ulcers (stages III and IV) have earned a place among never events because they can be prevented, because they carry serious consequences for the patient, and because their development may be a reflection of inadequate or substandard patient care. It’s small wonder that prevention of pressure ulcers is big business.

In addition to CMS changes, Kevin Leach, marketing director, ConvaTec US Wound Therapeutic, Skillman, NJ, cited other concerns related to pressure ulcers: "Regulators and payers are increasingly focused on preventing pressure ulcers due to their costs and impact on patients. Increased regulation, reduced reimbursement, and threat of litigation are among the key reasons why pressure-ulcer prevention and treatment is becoming a priority for healthcare facilities."

WAFFLE Brand Overlay, by EHOB Inc., presents the first line of defense in prevention and treatment of pressure ulcers

Factors in developing pressure ulcers

Pressure ulcers develop when a patient remains in one position for too long. They often start during surgical procedures, where the patient is unconscious and cannot move to relieve pressure points. The tissue pressed between a bony prominence, such as a heel, hip, or tailbone, and an object, such as a mattress or chair, reduces or cuts off circulation. The tissue starts to die. When a sore breaks open the skin, it may become infected.

Certain patients may be more susceptible to developing pressure ulcers, such as the elderly, whose skin may be thin due to aging and whose nutritional status may be below par; the emaciated, who have little tissue to pad between bone and skin; the obese; those who are bedridden; and those who are paralyzed or otherwise do not register pain normally.

A pressure ulcer starts quickly. Lynsey Rosencrans, sales and marketing service manager, EHOB Inc., Indianapolis, IN, explained: "A pressure ulcer starts on the inside and works its way out to the surface of the skin. It may take 3 to 7 days for it to appear, but a pressure ulcer can begin to form in as little as 2 hours." John J. Marks, corporate marketing, Medline Industries Inc., Mundelein, IL, added: "A pressure ulcer often starts as an area of redness and can progress to a blister, an open sore, and eventually a large crater."

Marks noted the importance of assessing the patient’s risk for occurrence of a decubitus ulcer. "No step is more important in preventing pressure ulcers than understanding the patient’s risk. An accurate and thorough risk assessment must be followed by implementation of appropriate nursing care and prevention products. Risk factors for developing a pressure ulcer include reduced blood circulation, mechanical stress, temperature (too hot/too cold), moisture (too wet/too dry), infection, chemical stress, medications, disease, poor nutrition, age (infants and the elderly are most susceptible), and body build (underweight and obese individuals are more likely to develop pressure ulcers). Many of these factors can also be present during surgery. Published evidence shows a 66% postoperative pressure-ulcer occurrence rate."

John Cockwill, MS, BS, CCRP, clinical program manager, Smith & Nephew Wound Management Inc., St. Petersburg, FL, outlined additional contributing factors. "Aggravating factors may be pressure, shear force, or friction. All are byproducts of gravity working on a stationary patient. Pressure causes an inadequate blood supply to the affected tissue, called ischemia, which can cause tissue damage and cell death. Patients are at risk if they are bedridden, use a wheelchair, or are unable to change position on their own. Smokers are also at slightly higher risk."

Smith & Nephew’s RENASYS GO and RENASYS EZ negative-pressure wound-therapy system

An ounce of prevention . . .

What’s the best way to handle a pressure ulcer? Don’t even let it get started. Using best practices to head them off at the pass is the best route, observed Rosencrans, EHOB: "Establishing protocols and increasing staff education helps elevate the nurses’ awareness of skin integrity changes, providing them with the tools to diminish the incidence of pressure ulcers. Other prevention methods primarily rely on action from nurses, ranging from increased mobility to close attention to skin condition. Techniques include proper skin care, turning the body every few hours, helping with nutrition and fluid intake, and frequent documentation of care." Rosencrans noted that clinical protocols for pressure ulcers should address the following factors: cognition; mobilization and ambulation; nutrition and hydration; moisture and incontinence; general medical co-morbidities; existing pressure ulcers (deep-tissue injury); previous pressure ulcers (closed stage III, IV, and unstageable).

Solutions

An entire industry has been built around prevention of pressure ulcers, with a wide variety of solutions available. The logical and vital first step in preventing pressure ulcers is care of the skin, as noted by Marks, Medline Industries Inc.: "Medline offers a complete line of skin care, moisture, and incontinence management products, as well as pressure-redistributing support surfaces. The Remedy Skin Care line includes cleansers, moisturizers, and protectants that nourish the skin, reducing the potential for skin breakdown. Medline’s Ultrasorbs AP underpads and ComfortAire briefs for incontinence wick moisture away from the body while allowing for adequate air circulation. Pressure-redistributing surfaces are available for use on wheelchairs and beds."

STERIS FIT Pads shown mounted on
Amsco 3085 SP Surgical Table

ConvaTec also focuses on skin care, which helps skin to maintain its integrity, which is the first line of defense against infection. Leach cited a study in which their Solutions Algorithm for Pressure Ulcer Prevention and Aloe Vesta skin-care products reduced the incidence of pressure ulcers in a long-term—care setting by 87%.2,3 Use in Maricopa Medical Center reduced the prevalence of hospital-acquired skin breakdown by 90%.3 "A recent AHRQ publication4 cites the Solutions Program as a proven technique to enhance patient outcomes," noted Leach.

Leach also highlighted the role of Flexi-Seal FMS, their fecal-management system, in helping to prevent pressure ulcers and avoid infection of ulcers. He cited a study that demonstrated patients with fecal incontinence are 22 times more likely to have a pressure ulcer.5 "Flexi-Seal FMS has been shown to contain Clostridium difficile within the device and to prevent its transmission into the environment surrounding the device."6

Rosencrans, EHOB, touted the benefits of static air as "the ideal media in which to support soft tissue at risk. This is explained and confirmed by both scientific principles (chemistry, physics, and mechanics) and clinical results. The WAFFLE static-air overlay is a safe, low-profile design that offers a non-gradient perpendicular support to completely contour the soft tissue, thus providing flotation therapy, the optimal environment in which to redistribute the body weight on a surface, dramatically reducing pressure and shear forces on the body."

Kinetic Concepts Inc. (KCI; San Antonio, TX) also offers a wide selection of support systems. Chris McDown, director of US marketing, Therapeutic Support Systems for KCI, said: "KCI has a broad portfolio of therapeutic support systems for reducing pressure, but is seeing heightened hospital interest in the AtmosAir Mattress Replacement System because of its unique, self-adjusting technology (SAT). It uses atmospheric pressure to gently and continuously redistribute a patient’s weight without the need for external power. The durable, breathable material manages moisture, and the bactericidal core material prevents contamination."

McDown recounted experiences of hospitals using AtmosAir that resulted in significant costs savings. "AtmosAir was instrumental in helping two hospitals reduce pressure-ulcer incidence and associated costs. Using KCI’s AtmosAir 9000 mattresses, Owensboro Medical Health System in Kentucky prevented pressure ulcers for 6,300 patients and avoided an estimated $3.3 million in associated treatment costs from 2003 through 2007. They also reduced their annual rental expenses by half. Arizona’s Yavapai Medical Center West reduced therapy rentals by 92%. Their monthly rental expenses plummeted from $14,900 in January 2005 to $1,436 only 6 months later and remained at that level for the following year."

MEGADYNE's Mega Soft, a combination
OR-table pressure-reduction pad
and patient return electrode

KCI offers a complimentary Wound Care Program that focuses on a four-step process: assessment and benchmarking, education, implementation, and ongoing evaluation. "The program is the only curriculum that includes a validated and published prevalence and incidence survey with national data base," said McDown. "KCI hospital partners are consistently reducing the incidence of hospital- acquired pressure ulcers, saving unnecessary patient pain, infection, and cost."

STERIS, Mentor, OH, aims to stop pressure ulcers where they often start, in the operating room. Their Foam Immersion Technology (FIT), used in operating room table pads, combines controlled air; two layers of foam, with conical cutout for critical areas of the body; and a conformable covering membrane. Once the patient’s body weight settles into the pad and the air valve is closed, pressure is redistributed away from bony prominences, essentially immersing the patient in the pad. FIT products have heat-sealed seams and use a proprietary antimicrobial material that is vapor-permeable and biocompatible so as to reduce the risk of infection. FIT products are also available for bariatric patients.

Megadyne Medical Products Inc., Draper, UT, offers Mega Soft, a patient return electrode made of a dry, solid, visco-elastic polymer called Akton. Akton is a registered trademark of Action Products Inc. "This product is used in the operating room as a combination operating-room—table pressure-
reduction pad and an electrosurgical patient return electrode," said Melissa K. Fischer, R.N., MSN, CNOR, clinical specialist, marketing product manager. "Compared to foam," averred Fischer, "this polymer will not cause the build-up of pressure points, will not collapse, will not absorb fluids, and does not support bacterial growth. It also distributes heat and weight evenly across a product surface, making it ideal for use in the prevention and treatment of pressure ulcers. Its ability to significantly reduce shearing also contributes to overall performance. The film casing is extremely pliant yet very durable."

Gaymar Industries Inc., Orchard Park, NY, recently introduced their new Sof•Care Stretcher Overlay. It is designed to help protect patients against starting pressure ulcers during transport and while waiting in emergency departments, operating rooms, post-anesthesia care units, and other stages of care. The Sof•Care Stretcher Overlay redistributes the patient’s weight using three-layer air-channeling technology by immersing the patient in over 300 air cells, which prevents bottoming even when the head of the stretcher is raised.

AtmosAir with SAT 9000 Mattress Replacement System

Sage Products Inc., Cary, IL, offers protection against pressure ulcers of the heel. The Prevalon Pressure-Relieving Heel Protector completely off-loads the heel, providing total and continuous pressure relief by minimizing friction and shear. The accompanying Prevalon Foot and Leg Stabilizer Wedge also helps to prevent lateral foot and leg rotation. Visit http://www.sage products.com/products/heel-protection/delivers-advanced-protection.cfm to see studies showing 66% to 100% reduction in heel pressure ulcers when using Prevalon.

DM Systems, Evanston, IL, offers the Heelift Suspension Boot, Heelift Traction Boot, and Elbowlift Suspension Pad to prevent and treat pressure ulcers. The Heelift incorporates an extra pad to control hip rotation and foot drop. Heelift boots are available in three sizes—petite, standard, and bariatric—and in two interiors, smooth or convoluted.

Sometimes even the most diligent efforts can’t prevent a pressure ulcer. Negative-pressure wound therapy (NPWT) may help. "NPWT helps to close pressure ulcers once they are formed," said Cockwill. "It does not prevent them from developing. By creating an air-tight vacuum over a wound, NPWT removes exudates, dead tissue, and bacteria from the wound; promotes blood flow to the wound bed; and enhances granulation in the wound bed, which improves the likelihood of a graft ‘take.’ NPWT may not close the pressure sore on its own, but is likely to be used in combination with improved care, debridement, infection control, nutritional support, and surgical techniques, such as skin grafts and flaps, to fully close the wound and heal the patient."

Smith & Nephew’s RENASYS NPWT devices and solutions offer "ease-of-use and patient comfort across the full range of wound types," said Cockwill. "Both the RENASYS EZ and RENASYS GO portable NPWT pumps can be used with the RENASYS-F foam and RENASYS-G gauze wound interfaces. This enables clinicians to tailor NPWT to meet their patients’ unique needs and the specific requirements of their wounds."

"Smith & Nephew recently completed a clinical in-market evaluation of its NPWT products on 153 patients with acute and chronic wounds, of which 34 patients (26%) had pressure ulcers. Among the studies’ results was a reduction in the numbers of patients that were clinically infected, from 24 (16%) at baseline to 7 (5%) when treatment was discontinued."

Medline’s Remedy Advanced Wound Care Skin Care System delivers nourishment, sparing compromised skin from further damage

Vendors provide education

Increasingly, healthcare vendors are becoming involved in the educational aspect of their fields, recognizing that not just products but knowledge and experience are vital. Medline is just one example of many companies that make education for their clients a priority.

Marks told Healthcare Purchasing News about Medline’s Pressure Ulcer Prevention Program, which "provides evidence-based education for nurses and nursing assistants on pressure-ulcer—prevention strategies, risk factors, assessment, and documentation. The education is bundled with products backed by evidence-based studies supporting their efficacy. Before the education begins, clinicians take a pre-test to determine their understanding of pressure ulcer prevention. Results are then compared with a post-test taken at the end of the program to measure learning effectiveness. Medline assists facilities in implementing the program and then analyzing the results to determine where additional education can be provided to improve knowledge and understanding. A total of six CE credits and other rewards accompany the program. Additional program components include a Perioperative Pressure Ulcer Prevention educational CD and another CD for physician education."

Educational offerings are nothing new at EHOB either, said Rosencrans. "For more than 20 years EHOB has been offering educational seminars worldwide to clinicians for continuing education credits. EHOB’s educational offerings online is one more way for EHOB’s educational programs to reach wound-care professionals seeking a more in-depth understanding of the physical properties of contouring surfaces, human anatomy, homeostasis, and the pathophysiology of pressure ulcers. We also have numerous clinical studies and white papers located on our website for nurses and consumers to refer to."

Many companies make it convenient for users by providing education online. Smith & Nephew and ConvaTec are among them. "ConvaTec offers comprehensive education on pressure-ulcer prevention," said Leach. "These programs may be delivered online or in person by company representatives or by national thought leaders." Cockwill told HPN a little about Smith & Nephew’s offerings: "Along with their distribution partners, Apria Healthcare and Universal Hospital Services, Smith & Nephew provides education and training to healthcare professionals. It also has comprehensive resources available online at www.globalwoundacademy.com."

References

1. Russo CA, Steiner C, Spector W. Hospitalizations related to pressure ulcers among adults 18 years and older, 2006. AHRQ, Statistical Brief #64, December 2008. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb64.pdf

2. Lyder CH, Shannon R, Empleo-Frazier O, McGehee D, White C. A comprehensive program to prevent pressure ulcers in long-term care: exploring costs and outcomes. Ostomy Wound Manage 2002;48:52-62.

3. Kemmit H. Standardized Algorithms* Make a Difference at Maricopa Integrated Health System (MIHS) (CCE). Paper presented at: 22nd Annual Symposium on Advanced Wound Care and Wound Healing Society; April 26-29, 2009; Dallas, Texas.

4. Lyder CH, Ayello, EA. Chapter 12, Pressure ulcers: a patient safety issue. In: Patient Safety and Quality. An Evidence-Based Handbook for Nurses. Agency for Healthcare Research and Quality. (AHRQ). http://www.ahrq.gov/qual/nurseshdbk/docs/LyderC_PUPSI.pdf

5. Maklebust J, Magnan MA. Risk factors associated with having a pressure ulcer: a secondary data analysis. Adv Wound Care 1994;7(6):25,27-28,31-34.

6. Bowler, P. Clostridium difficile-associated disease (CDAD) infection control and fecal management. Paper presented at: Third Annual World Union of Wound Healing Societies and European Wound Management Association Meeting; June 4-8, 2008.