Biomedical Engineering Reference
In-Depth Information
There are also numerous ISO guidelines relating to the overall systems at the
sponsoring company, including ISO 13485, which describes the quality systems
requirements, and ISO 14971, which describes the application of risk manage-
ment to medical devices. ISO 14937 covers general requirements for steriliza-
tion of a device and ISO 14630 describes general requirements of a non-active
surgical implant. ISO 11134 covers moist heat sterilization (needed to cover
sterilization of containers, tools, and equipment used in manufacturing), ISO
14160 covers terminal liquid sterilization, and ISO 22442-1/-2/-3 cover animal
sourcing practices. ISO 11607 discusses packaging for terminally sterilized
devices; ISO 14155 covers the clinical investigation of the device.
5.10
Conclusions and future trends
The challenges required to develop a new heart valve are considerable, and the
list does not get any shorter as new designs and applications are developed.
Pushing the envelope and developing new technologies will benefit existing
patients with improved therapies and reduced complications and benefit new
patients not currently serviced by existing valve technologies. The trend is
towards reduced use of mechanical valves, because of the significant com-
promises to the patients' quality of life. The development of a mechanical valve
which does not require Coumadin and is more hemocompatible would be a
tremendous advancement which would enable a new mechanical valve to dis-
place bioprosthetic valves. Until that material advancement occurs, bioprosthetic
valves are destined to continue to dominate the market and grow as the tech-
nologies improve, primarily to address the current limitations and shortcomings
of bioprostheses. The successful development of a tissue engineered heart valve
would ensure complete market conversion to bioprosthetic valves, and offer the
greatest therapeutic option for patients.
5.11
Sources of further information and advice
· ASM International. www.asminternational.org. Extensive materials database
available as well as workshops and other resources. Database can be accessed
at http://products.asminternational.org/meddev/index.aspx
· Company websites: Edwards Lifesciences, www.edwards.com. Medtronic, Inc.,
www.medtronic.com. St. Jude Medical, www.sjm.com. Direct Flow Medical,
www.directflowmedical.com. Sadra Medical, www.Sadramedical.com.
· Websites from leading heart valve research institutions and organizations:
American Heart Association: www.americanheart.org; Cleveland Clinic:
www.clevelandclinic.org; Texas Heart Institute: www.texasheartinstitute.org.
Society for Heart Valve Disease: www.shvd.org.
