Healthcare Industry News:  reprocessing 

Devices Orthopaedic

 News Release - October 19, 2006

Peer-Review Study Shows Reprocessed Single-Use Only Medical Devices Used in Arthroscopic Surgery May Pose Health and Safety Risk to Patients

Specialized medical devices found to be contaminated and functionally compromised

ANDOVER, Mass., Oct. 19 (HSMN NewsFeed) -- Smith & Nephew's (NYSE: SNN ; LSE: SN ) Endoscopy division announced today that an independent, evidence-based study by a team of surgeons and doctors from the Department of Orthopaedic Surgery from Loma Linda University, Loma Linda, Calif., showed that detectable levels of proteins and nucleic acids were present in reprocessed single-use only arthroscopic shaver blades.

The study, published in Arthroscopy: The Journal of Arthroscopic and Related Surgery, Vol. 22, No. 10 (October), 2006: pp: 1046-1052, also reported that all reprocessed arthroscopic shaver blades examined showed some level of damage or wear -- with two cases demonstrating at least 76%-100% damage.

Arthroscopic shaver blades are specialized medical devices used by surgeons during arthroscopic surgery -- otherwise known as getting "scoped" -- in the knee, shoulder, hip and small joints to remove damaged soft tissue.

In many medical facilities around the U.S., single-use only medical devices already used in surgery, such as Smith & Nephew's arthroscopic shaver blades, are being sent to third-party groups for reprocessing, where they are reportedly cleaned and sterilized, then sent back to the medical facility for use in additional patients' surgeries.

"Millions of Americans undergoing surgery each year may not be aware that the medical devices used in their surgery have been used before, despite the fact that they were developed to be used only once," commented Jerry Goodman, Senior Vice President, Smith & Nephew Endoscopy. "Hospitals and surgery centers who use reprocessed single-use only devices justify this as a way of reducing healthcare costs. From a business perspective, that might make sense. But the practice may also compromise patient safety and diminish patient trust in the healthcare system."

The study concluded that of 27 reprocessed single-use only shaver blades examined, 13, or 48%, had detectable levels of protein and 17, or 63%, had detectable levels of nucleic acid. New arthroscopic shaver blades did not display contaminants. Additionally, 20 of the reprocessed shaver blades had been manufactured with teeth that could be evaluated for visual damage. Of this group, 10 reprocessed shaver blades exhibited 1%-25% damage, 5 exhibited 26%-50% damage, 3 exhibited 51%-76% damage, and 2 shaver blades exhibited 76% to 100% damage. Finally, when reprocessed shaver blades were used to cut meniscal tissue, rougher edges appeared on the soft tissue, as opposed to the smooth edges produced with new shaver blades.

"This is a highly significant evidence-based study which should draw the needed attention to the risks of using reprocessed single-use only arthroscopic shaver blades in surgery," Goodman added. "Patients should be confident that they are receiving the safest care and best clinical outcome possible. This study reinforces our position that hospitals and medical facilities around the world should carefully consider whether using a reprocessed single-use only arthroscopic shaver blade is in the best interest of the patient."

Smith & Nephew Endoscopy provided an unrestricted grant for only the first phase of this first-of-its-kind orthopaedic study. Loma Linda University funded the second phase.

About Smith & Nephew:

Smith & Nephew (NYSE: SNN, LSE: SN) (http://www.smith-nephew.com) is a global medical technology business, specializing in Endoscopy, Orthopaedic Reconstruction, Orthopaedic Trauma and Clinical Therapies, and Advanced Wound Management products. Smith & Nephew ranks as the global leader in arthroscopy and one of the world's leaders in advanced wound management and is one of the fastest growing orthopaedics companies in the world.

Smith & Nephew is dedicated to helping improve people's lives. The company prides itself on the strength of its relationships with its surgeon and professional healthcare customers, with whom its name is synonymous with the highest standards of performance, innovation and trust. The company has more than 8,500 employees and operates in 33 countries around the world and generated sales of over $2.6 billion.

This press release contains certain "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In particular, statements regarding planned growth in our business and in our operating margins discussed under "Outlook" are forward-looking statements as are discussions of our product pipeline. These statements, as well as the phrases "aim", "plan", "intend", "anticipate", "well- placed", "believe", "estimate", "expect", "target", "consider" and similar expressions, are generally intended to identify forward-looking statements. Such forward- looking statements involve known and unknown risks, uncertainties and other important factors (including, but not limited to, the outcome of litigation and regulatory approvals) that could cause the actual results, performance or achievements of Smith & Nephew, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20F, for a discussion of certain of these factors.

All forward-looking statements in this press release are based on information available to Smith & Nephew as of the date hereof. All written or oral forward-looking statements attributable to Smith & Nephew or any person acting on behalf of Smith & Nephew are expressly qualified in their entirety by the foregoing. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement contained herein to reflect any change in Smith & Nephew's expectation with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

Editor's Note:

A few years ago, Smith & Nephew Endoscopy sponsored a landmark study to determine the level of awareness among surgeons, surgical nurses and consumers regarding the use of reprocessed single-use only medical devices such as surgical blades, catheters and forceps.

That study revealed a high level of discomfort among health professionals and a significant lack of awareness on the part of consumers about this issue.

* 65% of consumers were unaware of the practice of reprocessing single-use only medical devices.

* 75% of surgeons said the use of reprocessed single-use medical devices poses a safety risk to patients.

* 71% of surgeons and 82% of nurses said they would be uncomfortable with the use of a reprocessed single-use only device on themselves or a family member.

For more information regarding this study, please contact Joe Metzger at 978-749-1330.


Source: Smith & Nephew

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