Extreme care is taken during the production and shipment of medical implants — but what happens after delivery? Setting up protocols to insure that implants are free from contamination or damage prior to surgical insertion is another critical link in the chain. Guess what? There is an ISO standard for this and it’s just been revised. It’s ISO 8828, “Implants for surgery – Guidance on care and handling of orthopaedic implants,” and the new 2nd edition is available from Document Center now.
Yes, this standard has been written for all personnel involved in receiving and handling implants, including surgical staff (surgeons). Nothing is more difficult as a patient than going through a surgery only to have an implant fail due to contamination. So all staff members involved in receiving, storing, transporting, handling, cleaning and sterilizing implants need to be well trained in these recommended procedures.
What does this new revision cover? After the usual scope and definition sections, the document reviews general guidance on such topics as the manufacturer’s instuctions, stock records and rotation, storage, modification and so on. Then there are sections with additional guidance for polymeric implants, ceramic components, and products with rough surfaces or intrinsic porosity. The bibliography provides you with information on 4 additional standards for more detailed data.
This is a technical revision of the ISO 8828 1st Edition from 1988, which is now withdrawn.
You’ll want to get a copy if your staff handles surgical implants. Head off to the Document Center webstore at www.document-center.com and order it in either paper format or for pdf download. You can also opt for multi-user licensed access using our Standards Online service. Just contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com) for more information.
Standards like the ISO 8828 can help you set up procedures and processes to improve outcomes in what-ever line of business you’re in. Rely on Document Center to help you identify and maintain your collection of this type of conformance information. We’re your Standards Experts!
