Ban in the USA: Stop reprocessing/repeated washing and touching surgical implants during surgery because it leads to infection
Research has identified that orthopaedic implants undergo repeated bulk-cleaning with dirty instruments from the operating room, leading to microbial and non-microbial residue build up at the small interfaces and possibly on the surfaces. This remains unnoticed by the Sterile Processing Department or other hospital staff, as there is no way to inspect each of the hundreds of implants at microscopic levels individually, and at interfaces not directly visible.
Furthermore, the implants are also being contaminated intraoperatively (during surgery). Sterile implants are directly touched by the scrub technician with soiled gloves for loading onto an insertion device. They are then kept exposed on the working table. A multicentre trial has shown that by the time it is implanted in the patient, it can harbor up to 10e7 bacterial colony forming units. Additionally, one study group used a functional, impermeable sterile guard around the implant to intraoperatively (during surgery) shield the device until insertion into the patient; they reported zero contamination. Thus, [the use of a sterile guard represents] an effective precautionary measure against possible surgical site infection (SSI), or subclinical and chronic sepsis leading to screw loosening and pain.
Recent randomized trial from Mount Sinai Beth Israel hospital in New York, USA, that found a 12.7% infection rate after spine surgery. It is in the patient’s best interest to be exposed to the lowest bacterial dose during surgery; many of these patients are also immunocompromised and have at least one associated high-risk factor that predisposes them to infection, such as old age, obesity, smoking, diabetes mellitus, ischemia secondary to vascular disease, or irradiation. That could represent up to 100,000 patients suffering from surgical site infection in the USA alone. Now multiply that over the entire globe—isn’t this is a serious cause for concern?
For further information visit:
https://spinalnewsinternational.com/pedicle-screw-reuse/
https://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/43040-current-use-of-contaminated-pedicle-screws-required-practice-for-asepsis-in-spine-surgery-2-qs-with-dr-aakash-agarwal.html
https://ryortho.com/2018/10/are-your-sterile-implants-really-sterile/
https://www.healio.com/orthopedics/spine/news/online/%7Bf910003b-acec-4373-90b3-dfd77534113e%7D/implant-infection-after-spinal-fusion-correlated-with-pedicle-screw-loosening-ongoing-pain
https://spinalnewsinternational.com/petition-reprocessed-pedicle-screw-ban/
https://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/43822-fda-petitioned-to-ban-reprocessing-of-orthopedic-implantable-devices.html
https://ryortho.com/breaking/university-of-toledo-professor-petitions-fda-for-reprocessing-ban/
https://orthostreams.com/2018/12/will-the-fda-ban-reusable-orthopedic-implants/
http://utnews.utoledo.edu/index.php/01_11_2019/ut-researcher-calls-on-fda-to-change-rules-to-address-spine-screw-contamination
http://www.bonezonepub.com/2197-orthopedic-infection-prevention-why-one-researcher-is-focused-on-packaging
https://www.infectioncontroltoday.com/operating-room/implanting-pedicle-screws-without-bacteria-how-do-we-keep-track-invisibles
https://www.regulations.gov/document?D=FDA-2018-P-4143-0001
Furthermore, the implants are also being contaminated intraoperatively (during surgery). Sterile implants are directly touched by the scrub technician with soiled gloves for loading onto an insertion device. They are then kept exposed on the working table. A multicentre trial has shown that by the time it is implanted in the patient, it can harbor up to 10e7 bacterial colony forming units. Additionally, one study group used a functional, impermeable sterile guard around the implant to intraoperatively (during surgery) shield the device until insertion into the patient; they reported zero contamination. Thus, [the use of a sterile guard represents] an effective precautionary measure against possible surgical site infection (SSI), or subclinical and chronic sepsis leading to screw loosening and pain.
Recent randomized trial from Mount Sinai Beth Israel hospital in New York, USA, that found a 12.7% infection rate after spine surgery. It is in the patient’s best interest to be exposed to the lowest bacterial dose during surgery; many of these patients are also immunocompromised and have at least one associated high-risk factor that predisposes them to infection, such as old age, obesity, smoking, diabetes mellitus, ischemia secondary to vascular disease, or irradiation. That could represent up to 100,000 patients suffering from surgical site infection in the USA alone. Now multiply that over the entire globe—isn’t this is a serious cause for concern?
For further information visit:
https://spinalnewsinternational.com/pedicle-screw-reuse/
https://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/43040-current-use-of-contaminated-pedicle-screws-required-practice-for-asepsis-in-spine-surgery-2-qs-with-dr-aakash-agarwal.html
https://ryortho.com/2018/10/are-your-sterile-implants-really-sterile/
https://www.healio.com/orthopedics/spine/news/online/%7Bf910003b-acec-4373-90b3-dfd77534113e%7D/implant-infection-after-spinal-fusion-correlated-with-pedicle-screw-loosening-ongoing-pain
https://spinalnewsinternational.com/petition-reprocessed-pedicle-screw-ban/
https://www.beckersspine.com/orthopedic-a-spine-device-a-implant-news/item/43822-fda-petitioned-to-ban-reprocessing-of-orthopedic-implantable-devices.html
https://ryortho.com/breaking/university-of-toledo-professor-petitions-fda-for-reprocessing-ban/
https://orthostreams.com/2018/12/will-the-fda-ban-reusable-orthopedic-implants/
http://utnews.utoledo.edu/index.php/01_11_2019/ut-researcher-calls-on-fda-to-change-rules-to-address-spine-screw-contamination
http://www.bonezonepub.com/2197-orthopedic-infection-prevention-why-one-researcher-is-focused-on-packaging
https://www.infectioncontroltoday.com/operating-room/implanting-pedicle-screws-without-bacteria-how-do-we-keep-track-invisibles
https://www.regulations.gov/document?D=FDA-2018-P-4143-0001
View Comments