What is ISO 16054 - Implants for surgery about?
ISO 16054 Implants for surgery. ISO 16054 layouts minimum data sets for implants to facilitate recording and international exchange of data for the purposes of implant tracking systems. This data can also be used to support retrieval analysis and implant registry.
ISO 16054 is helpful for the purposes of retrieval analysis and research. It helps in the Automation of both data collection and transmission.
ISO 16054 is applicable to the manufacturers and distributors of medical devices intended for implant via a surgical procedure and to those hospitals and other medical facilities which carry out implant or explant procedures.
ISO 16054 specifies requirements for data items to be recorded by the manufacturers and distributors of implants and by hospitals and other medical facilities at both the time of implant event and at the time of any subsequent explant event.
ISO 16054 is intended to define a minimum data set to be recorded for all implant and explant events as well as provide for the timely retrieval of minimum implant data related to specific subsets of patients who have received specific identified devices or devices within a specified range of lot, batch, or serial codes, for the purpose of patient follow-up.
Note: ISO 16054 is not the intent of this document to provide a means of data recovery that is related to specific medical practitioners, medical facilities, or manufacturers for purposes other than patient follow-up or product recall in the event of unforeseen device malfunction.
Who is ISO 16054 - Implants for surgery for?
ISO 16054 on Minimum data sets for surgical implants is useful for:
- Manufacturers for surgical implants
- Test centres for surgical implants
- Biomedical laboratories
- Regulatory authorities
Why should you use ISO 16054 - Implants for surgery?
The importance and utility of registry, tracking, and retrieval analysis systems in the understanding long-term clinical performance of implants and in patient follow-up in the event of unforeseen implant malfunction are understood.
An impact event is the act of surgical intervention by which an implant is totally introduced into the human body, used to replace an epithelial surface or the surface of the eye, and partially introduced into the human body. Explant event is the act of surgical intervention by which an implant is removed from a patient.
ISO 16054 guidelines helps you with supplier’s data and medical facility data on impact event and explant event for minimum data sets for surgical implants. This helps in maintaining data properly and allows recall for product correction or patient follow-up in the event of unforeseen device malfunction.
What’s changed since the last update?
BS EN ISO 16054:2019 supersedes ISO 16054:2000, which has been withdrawn. BS EN ISO 16054:2019 has some technical changes with respect to ISO 16054:2000. These includes:
- Clarification to definitions with the provision of specific examples of the defined terms
- Updated general requirements for data sets with direction on what constitutes an individual implant
- Inclusion of GTIN and UDI as options for implant identification in data items lists
- Inclusion of expiry date and date of acquisition in supplier data items list
- Defined requirements for data maintenance for medical facilities
- Separated data item lists for medical facilities concerning implant and explant events and identified items specific to each type of event