Patient Advocacy Groups Join To Protect New Jerseyans From Recycled Single-Use Medical Devices

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Contact: Ernest Landante, Jr., Novita Issue Communications, 609-989-1000

NEWARK, N.J., September 20, 2006 — Twenty-two New Jersey patient-advocacy organizations and the HealthCare Institute of New Jersey today announced the formation of PatientGUARD, Patient Groups United Against Reprocessing Dangers, a coalition to raise awareness among physicians and the public about the risks surgical patients face from reprocessed single-use medical devices.

Single-use devices (SUDs) are medical instruments specifically designed,manufactured and approved to be used one time, then thrown away. Despite their intended use and expected disposal, used single-use devices are being picked from the medical waste stream, recycled by third parties and used again on different patients. This practice puts patients at risk for infection and injury.

Federal regulation concerning reprocessed SUDs is lax and does not include a review for safety or functionality. “The Food and Drug Administration hasn’t done enough to either protect or inform the public of the dangers of reprocessed single-use devices,” said Bob Franks, president of the Institute. “Lacking adequate federal oversight, states need to step in to ensure the public’’s safety.”

PatientGUARD looks forward to educating the public about this secretive practice. The coalition is seeking the following:

• Requiring written patient consent prior to using a reprocessed SUD;
• Requiring healthcare facilities to inform physicians that they may be using reprocessed SUDs;
• Providing physicians with the opportunity to reject using reprocessed SUDs;
• Requiring that patient records include an inventory of reprocessed SUDs used in their treatment;
• Establishing registration, tracking, and reporting procedures to monitor the distribution and use of reprocessed SUDs; and
• Establishing liability among reprocessors for reprocessed SUD failures and injury.

"Patients are entitled to decide what risks to take. Withholding the facts about the risks these devices pose, or even that they may be used, erodes the public’s trust,” said Franks. “And it isn’t only the public that’s unaware that these devices are being reused. Physicians are also surprised that this is being done.”

“Medical device regulation in the United States does not provide the same level of assurance of safety and effectiveness for single-use devices and SUDs that are reprocessed for additional use,” Philip J. Phillips, former deputy director for Science and Regulatory Policy in the Food and Drug Administration’s Center for Devices and Radiological Health’s Office of Device Evaluation. “While Federal law has been amended in an attempt to address the public health and safety issues associated with the practice of reprocessing SUDs, the challenges created by the practice have not been completely addressed through the existing regulatory framework. FDA regulation must continue to evolve if the risks associated with reprocessing are to be truly mitigated.”

"Patients should be routinely informed that reprocessed single-use devices will be used in their surgery," said Dr. Neil Kahanovitz of the West Orange-based Center for Orthopaedics, and who is board certified in orthopedic surgery and a member of the American Academy of Orthopedic Surgeons, Scoliosis Research Society, North American Spine Society and Orthopedic Research Society. "There is 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."

“We ask that patients be informed when reprocessed devices are to be used, and given a choice between reprocessed SUDs and devices that are new, unused, and guaranteed to be safe and uncontaminated,” said Kelly Rosso Leight, executive director of the CARES Foundation, Inc. of Union, NJ. “There’s nothing extraordinary about this –– patients are routinely informed about the risks medical treatments may involve. Reprocessed SUDs present additional risks and should be dealt with the same way.”

In previous testimony before a congressional subcommittee, news conference participant Dr. John N. Fielder, professor of philosophy at Villanova University and an ethics consultant, pointed out that patients are normally informed of both significant and small risks associated with a particular medical procedure:

In cases where patients are exposed to a significant risk, ethics requires that they be informed of the benefits of treatment, the risks, and the alternatives. This is true even for common, low-risk procedures. Last October I got a flu shot at the Villanova University Health Center. Vaccines have a small probability of triggering an immune reaction that can cause serious illness or death. Because of this I was asked to read and sign a consent form that informed me of the benefits of the injection, the risks, and alternatives. The form is appended to this document.

Since patients treated with reprocessed single-use devices are also exposed to a significant risk, it is enlightening to construct a consent form for this procedure.Imagine that you are being asked to consent to the use of a reprocessed device in your treatment instead of an otherwise identical new, single-use device.

The form would have to state that the potential harms include the possibility of transmission of TB and hepatitis C, very serious diseases, and possible functional changes or failures. While some studies suggest that the probability of these events occurring is low, we do not really know how likely they are.

Patient GUARD (Patient Groups United Against Reprocessing Dangers) comprises the following organizations: Action CF, Advanced Medical Technology Association Arthritis Foundation - New Jersey Chapter, Autism Family Services of New Jersey, Brain Injury Association of New Jersey, Caregivers of New Jersey, CARES Foundation, Community Health Charities of New Jersey, Creutzfeldt-Jakob Disease Foundation, Diabetes Foundation, Epilepsy Foundation of New Jersey, Family Resource Network, HealthCare Institute of New Jersey, Hyacinth AIDS Foundation, Latino Leadership Alliance of New Jersey, LUPUS Foundation of America - New Jersey Chapter, Multiple Sclerosis Association of America - New Jersey Chapter, New Jersey 2-1-1 Partnership, New Jersey Health Care Quality Institute, New Jersey Association of Mental Health Agencies, New Jersey Pharmacist’’s Association, and Spina Bifida Association Tri-State Region.

# PatientGUARD.org #

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