We built laboratories to address the concerns of the lifecycle of reusable surgical instruments. These devices are designed to last 1-25 years in the field. Most of these evaluations are done on new “off the shelf” components. Governing bodies such as the FDA, TUV and ISO have all taken a stance that the 1st patient is no more important than the 500th.
FDA UCM 253010 Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - The FDA notes that labels on reusable medical devices should either tell users the device's limits of reuse or inform the user how to tell when the device has reached the end of its lifecycle.
Specific section(s) read…
5.L The labeling should either 1) inform the user how many times the device can be reused, based on testing; or 2) provide the user with a mechanism or method to ascertain whether the device has exceeded its use life.
5.L Reuse Life - Reuse life may also be addressed by validating the number of times the product can be reprocessed and reused, and providing this specification in the labeling.
ISO 10993-1 : 2018 Biological Evaluation Of Medical Devices - This standard gives guidelines for the assessment of biological hazards arising from:
— risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;
— breakage of a medical device or medical device component which exposes body tissue to new or novel materials.
Specific sections read…
4.7 The biological safety of a medical device shall be evaluated by the manufacture over the whole life-cycle of a medical device.
4.8 For re-usable medical devices, biological safety shall be evaluated for the maximum number of validated processing cycles by the manufacturer.
This International Standard describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.The requirements for such tests are defined and stated in the product Standard along with the number of cycles for each test procedure. Other, additional, tests may also be required (see the Introduction).
BEAG recommends that a risk management approach is taken when developing a replacement program for Biomedical Devices and that risk factors, including those above, are considered together with the age/lifespan ratio.
IEC 60601 Asks that the manufacturer define the expected service life of the medical device in question.
Our Clinical Reprocessing Cycles, or CRC™, including surgical instrument life cycle testing, can help device producers bring their product to market with more efficiency and with more confidence in the end product.
Utilizing our CRC™ services allows for a technical, non-biased, certified validation in which the end user will be provided with the certificate and corresponding technical documents. Contact Bonesim Laboratories today to learn more.
Do you have new materials that require validation through clinical processing cycles?
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Field Issue Resolution
Etching and ID Selection
Shortened Projects Timelines
Eliminate Intra-Operative Delays
Uncover Tolerance Issues
Solve Life cycle issues
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