Health Care Facility Practices Support
Simulated Storage and Shelf Life Determinations
Health Care Facility Compliance Health Care Facilities (HCF) and medical device suppliers to HCF must have data to support expiration dates/stability dates assigned to sterile products produced in and/or supplied to their facilities. This includes, among other things, procedural trays and products wrapped, produced, and stored in the Central Supply. This is a JCAHO (Joint Commission for the Accreditation of Health Care Organizations) and FDA requirements.
HCF
Program
LexaMed
has developed a unique program in this area to
assist both medical device suppliers and the HCF to meet this requirement.
The primary elements of our program include:
Expert Project Staff Competent staff of experienced scientists and regulatory affairs professionals to assist with project design, execution and final report generation. Our staff can also assist with any regulatory submissions to be supported by the generated data. Similarly, our staff has been and is currently involved with many of the AAMI and ISO task teams charged with the production of revised and new industry guidelines and standards in this area.
Certified Laboratory Operation We offer an FDA-registered and ISO certified laboratory operation to perform any associated testing required during program execution, including bioburden quantitation, sterility testing, endotoxin (pyrogen testing), product Ethylene Oxide (EO) residual testing, etc.
EO and Steam Expertise We offer both Ethylene Oxide and steam sterilization capabilities in-house and can duplicate typical hospital sterilization cycles as defined in AAMI standards. We can also coordinate product exposures in the STERRAD system.
Packaging
Solutions We offer a packaging operation and have dedicated
controlled environmental space to conduct these operations. We have
validated heat sealers for production of pouched product and have trained
personnel that are familiar with AAMI specified manual folding procedures
for the assembly of wrapped product.
Simulated Hospital Storage We offer simulated hospital storage in a dedicated large, clean area that is temperature and humidity controlled and environmentally monitored for viable contamination, and designed to simulate storage in the Hospital Central Supply area.
Validation of Reusable Medical Devices
LexaMed can simulate standard HCF ethylene oxide and moist heat sterilization cycles with our in-house sterilizers. This allows LexaMed to assist medical device manufacturers to generate data to support the reprocessing of their reusable products. It is an FDA requirement that medical device manufacturers have data to support any product re-use claims. The LexaMed program is consistent with AAMI guidelines listed below and can also include simulated cleaning and multiple re-processing step verifications/validations.
- AAMI TIR 12: Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
-
AAMI TIR 30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
Please contact us to discuss your specific requirements and determine how our staff can best support you.
