Reprocessing single-use devices—regulatory roles

AORN Journal,  July, 2002  by Debra Dunn

• E-mail
• Print
• Link

Pacemakers have life expectancies of three to 20 years. In Canada, the cost in 1985 for the generator alone was $1,500 to $1,800, and the refurbishing costs for a pacemaker were approximately $300. If 19% of all used pacemakers were reimplanted, it is estimated that the net savings would have been approximately $4.2 million per year in Canada. The costs would be even greater today, as would the savings. The decision to use a recovered pacemaker on another patient would be based on hospital practice and the clinical judgment of the attending physician. (122)

In Canada, a device that is implanted permanently becomes the property of the patient and is deemed to have been sold. This is because the patient takes the product home with him or her to be used without medical supervision until it malfunctions. This is not true, however, for other SUDs, which when purchased by the hospital are owned by the hospital. Using an SUD or its reprocessed counterpart on a patient does not constitute a sale to the patient. Permission from the patient or a family member (ie, in the event of a patient's death or inability to give consent) must be obtained to remove implanted devices from patients. The reprocessor of the explanted device is considered to be the manufacturer of the device. (123)

A literature review did not find any statements regarding reusing explanted implantables in the United States. The only item that came close to such a description was orthopedic trial fitting devices for implantables. The author of the article referred to ASTM's 1985 "Standard Practice for Care and Handling of Orthopaedic Implants and Instruments," which states that a trial fitting of an implant is not considered equivalent to use. Accordingly, there is a distinction between a trial fitting of an implant, which helps with bone healing, and a prosthetic device, which is designed to replace bone or a joint. The trial fitting of an implant is designed to bear stress temporarily, whereas the prosthetic implant is a permanent substitute for the bone or joint and, therefore, has a lower tolerance for damage during the trial insertion process.

   It was fiscally and environmentally wrong to discard perfectly good screws,
   plates, rods, and other undamaged fracture fixation implants. After a few
   more committee rounds and an extensive literature search, we concluded that
   the key concept is trial implantation of the device. (124)

These items, therefore, feasibly can be used on bone, removed, reprocessed, and used on another patient. In terms of infection, the author reports that there is no difference between the bits of bone and other debris that remains trapped between screw threads of drills and taps of multiuse devices, which are reprocessed routinely, and SUDs. (125)

CONCLUSION

During the past decade, the volume of single-use products has increased dramatically, driving up the cost to perform surgery. Regulators and professional societies have begun to soften their approach from do not reuse to emphasizing the need for written policies and procedures and research on the safety and effectiveness of reused devices. (126) What is needed is a win-win situation that will motivate OEMs, hospitals, and reprocessors to work together, not against each other. (127)