Reused Medical Devices Pose Health and Safety Risk to Patients; Survey Shows Doctors, Nurses Oppose Practice, Most Consumers Unaware

12/5/2002

From: Laura Trevino of the Center for Patient Advocacy 703-748-0400 ext. 23 or 202-549-2715 (after hours) Email: lauratrevino@patientadvocacy.org

MCLEAN, Va., Dec. 5 -- The Center for Patient Advocacy today released a survey of surgeons, operating room nurses and consumers which reveals that health care professionals have grave concerns about the reuse of single use medical devices and their impact on patient health and safety. These devices, such as surgical blades, catheters and forceps, come in contact with blood and other body fluids and are manufactured to be used only once. The majority of doctors and nurses oppose the use of reprocessed single use medical devices. The survey also shows that most consumers are unaware of the practice of reprocessing.

According to the results of the survey, three out of every four surgeons believe that reprocessed single use only medical devices pose a health and safety risk to patients, including the potential spread of hepatitis and HIV. In addition, the survey found that 74 percent of surgeons felt that single use only medical devices should not be reprocessed and 79 percent of nurses believe that the use of reprocessed single use devices should be discontinued.

"Clearly, this is a safety issue for patients," says Neil Kahanovitz, MD, President and Founder of the Center for Patient Advocacy. "The fact that surgeons and nurses are overwhelmingly concerned that the reuse of single use devices poses a threat to product quality as well as risk of infection and the spread of disease should raise red flags with the public."

In fact, 82 percent of nurses and 71 percent of surgeons surveyed say they would be uncomfortable if a reprocessed single use device were used on themselves or a family member.

"How can we expect patients to feel safe with these reused devices, if surgeons and nurses clearly would not want the devices used on them?" asks Kahanovitz.

Perhaps even more alarming is the fact that 65 percent of consumers are unaware that these surgical devices may have previously been used, often multiple times, in other patients. A recent FDA survey indicates that approximately 25 percent of U.S. hospitals use reprocessed single use only devices.

"It is unacceptable that hospitals and other medical institutions do not routinely inform patients that these devices will be used in their surgery," continues Kahanovitz. "It seems to me that they should have a moral obligation to inform patients about this practice and provide them with an opportunity to accept or reject the use of these devices in their surgery."

By a 2-to-1 ratio, patients surveyed said they would expect to be informed about the practice before surgery. And of those aware of this practice, nearly 70 percent were unaware they had the right to request that such devices not be used in their surgery.

The Center for Patient Advocacy has created a consent form for patients to complete before undergoing surgery to reject the use of reprocessed single use devices in their treatment. The form is available at the Center's website, www.patientadvocacy.org.

Additional findings: -- 69 percent of nurses say that patients should be informed that reprocessed single use devices may be used in their surgery. -- 62 percent of the nurses who work in hospitals that use reprocessed single use only devices have spoken to their administration on the use of reprocessed devices. -- Nearly half of the nurses who work in hospitals that use reprocessed single use only devices have switched reprocessed devices with new medical devices when preparing for surgery. -- 77 percent of consumers are uncomfortable with the idea of reprocessed single use devices being used in their surgery.

"Patients should exercise their right to say no either by using the consent form provided by the Center or adding language to the patient consent form stating that they do not want reprocessed single use medical devices used in their surgery," concludes Kahanovitz.

About the survey: The survey interviewed 401 surgeons of various specialities and 401 surgical nurses between April 22 and May 10, 2002. The consumer survey was conducted via a national adult omnibus and interviewed 1004 consumers age 18 and older between May 1 and May 5, 2002. The margin of error for the doctor and nurse survey is plus 4.89 percent at the 95 percent confidence level. The margin of error for the consumer survey is plus 3.09 percent at the 95 percent confidence level. The survey was conducted by International Communications Research/ICR of Media, Pa. The survey was paid for by Smith & Nephew Inc., Endoscopy Division of Andover, Mass. Further information on the survey is available at www.patientadvocacy.org.

------ The Center for Patient Advocacy is a private, nonprofit grassroots organization founded to represent the interests of patients nationwide and dedicated to ensuring that Americans have timely access to quality health care.