Implant Retrieval and Analysis Services

The Implant Retrieval and Analysis Services operated by CITRA have four important attributes that enable it to provide a world standard service to WA.

Independence

CITRA operates as a fully funded service of the State through the Department of Health WA. The service is not dependant on sponsor or vendor patronage and as such it maintains the right to provide informed scientific advice in relation to the use of medical implant devices in accord with its ascribed responsibilities, without fear or favour. This independence has proven essential in maintaining a prime role as an advocate for WA Health, its clinicians and patients.

Informed advocacy

Routine retrieval and analysis can establish a strong causal relationship between device failure and the underlying factors that contribute to the failure mechanism. These may include factors relating to material, design, manufacturing, surgical utilisation and device selection specific to a given patient. The strength of the causal relationship established by investigation is enhanced by the collective experience of the service and its staff and delivers advice that can be used to direct procurement, to modify clinical practice and to improve implant design and manufacturing. Such advice is timely in that it can be responsive to a small number of incidents directly related to a particular device but based on similar experience with implants with a similar failure profile. This is in contrast to a statistical determination in relation to the occurrence of a failure in a particular device that relies on the prospective collection of a significant sample of documented failures.

Experience

The experiential basis of the service is reflected in the qualifications and specialist involvement of CITRA staff at all levels and the quality of the retrieval archive and database maintained by the service.

The device archive and database of information maintained by CITRA has allowed the state of Western Australia to avoid the implantation of under-performing devices, sparing patients from pain and protracted stays in hospital whilst also saving millions of dollars. Not only does the data help in preventing under-performing devices reaching the patient, it serves as a baseline of relevant clinical information upon which custom implants can be designed.

Documentation, Reporting and Archiving

It is essential that clinical information is accurately recorded, documented and reported to the relevant stakeholders if the information from the device retrieval and analysis program is to be of potential benefit.

Initial evaluation: Retrieved devices referred to CITRA, are all subject to inspection and evaluation upon receipt from Theatres. A clinical summary, photographic record and key data is documented by the laboratory and forms the basis of a report to the referring clinician. All devices are archived or may be set aside for investigation in the case of critical devices (e.g. arthroplasty with a known failure rate) or untoward failure. Archived devices can be accessed to facilitate specific investigation of classes of devices or failure mechanisms, contributing to the strength of the investigation.

Documentation: Data required to identify the device, the patient and surgeon(s) involved, the reason for removal and any observations at the time of removal are entered on the Implant Retrieval Database and the device is allocated a unique number for entry and filing in the archive. A laboratory working file may be created for the storage of any paperwork and preliminary findings related to the analysis and wider investigation of the device, pending completion of the final electronic record.

Documentation is controlled under quality standards included in the Health Technology Management Unit and determined by ISO accreditation.

Reporting:

• Summary findings from the evaluation of the device and subsequent investigations. These are reported to the referring surgeon as the entity directly responsible to the patient.
• Detailed findings of specific analyses and in-depth investigations. Typical investigations relate to atypical (or unique) failures and studies where a number of clinical failures are indicative of a possible design, materials selection or manufacturing defects or where current clinical practice is implicated in the failure. Access to an extensive archive allows prompt assessment of numbers of explanted devices to test whether local implant retrievals reflect national or overseas experience and/or findings in the contemporary literature.
• The findings from detailed investigations are reported to individual clinicians or may be presented to local and national seminars and conferences as a vehicle to more widely inform the profession (e.g. surgical colleges, manufacturers and vendors).
• Inclusion of summary information in the Bioengineering Bulletin distributed to WA hospitals, management and clinical staff.
• Focussed correspondence and communication with the regulator (Therapeutic Goods Administration) in relation to specific device failures or in response to implant device recalls/notifications. This is in addition to routine reporting required under the Act.

Archiving: Devices referred to CITRA laboratories for evaluation and analysis are stored and electronically catalogued for future reference. The archive (currently in excess of 11,000 devices dating back to 1973) provides a valuable resource that is used for research, teaching and the routine analysis of current implant failures.

Importantly, the archive allows immediate reference to numbers of like devices that remain protected within the archive. These devices, while they may not have been recognised as part of a systemic or ongoing problem at the time of removal, in retrospect they make an important contribution to the current investigation. Current studies directed at a particular device can be extended to compare a number of like devices, significantly improving the accuracy, the balance and the depth of contemporary reporting.