Industry News

F1026 - Standard Specification for General Workmanship and Performance
Measurements of Hemostatic Forceps has had an epsilon edit, available as
F1026-86(2008)e1

F1078 - Standard Terminology for Surgical Scissors-Inserted and
Non-Inserted Blades has had an epsilon edit, available as
F1078-87(2008)e1

F1079 - Standard Specification for Inserted and Noninserted Surgical
Scissors has had an epsilon edit, available as F1079-87(2008)e1

F1223 - Standard Test Method for Determination of Total Knee Replacement
Constraint has been revised to F1223-08

F1408 - Standard Practice for Subcutaneous Screening Test for Implant
Materials has been reapproved, available as F1408-97(2008)

F1613 - Standard Specification for Surgical Tissue/Dressing/Pick-Up
Forceps (Thumb Type) has had an epsilon edit, available as
F1613-95(2008)e1

F1638 - Standard Terminology for Surgical Tissue/Dressing/Pick-Up
Forceps (Thumb-Type) has had an epsilon edit, available as
F1638-95(2008)e1

F1744 - Standard Guide for Care and Handling of Stainless Steel Surgical
Instruments has had an epsilon edit, available as F1744-96(2008)e1

F2003 - Standard Practice for Accelerated Aging of Ultra-High Molecular
Weight Polyethylene after Gamma Irradiation in Air has been reapproved,
available as F2003-02(2008)

F2079 - Standard Test Method for Measuring Intrinsic Elastic Recoil of
Balloon-Expandable Stents has been reapproved, available as
F2079-02(2008)

F2132 - Standard Specification for Puncture Resistance of Materials Used
in Containers for Discarded Medical Needles and Other Sharps has had an
epsilon edit, available as F2132-01(2008)e1

F2183 - Standard Test Method for Small Punch Testing of Ultra-High
Molecular Weight Polyethylene Used in Surgical Implants has been
reapproved, available as F2183-02(2008)

F2214 - Standard Test Method for In Situ Determination of Network
Parameters of Crosslinked Ultra High Molecular Weight Polyethylene
(UHMWPE) has been reapproved, available as F2214-02(2008)

F2259 - Standard Test Method for Determining the Chemical Composition
and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR)
Spectroscopy has been reapproved, available as F2259-03(2008)

F2260 - Standard Test Method for Determining Degree of Deacetylation in
Chitosan Salts by Proton Nuclear Magnetic Resonance (1H NMR)
Spectroscopy has been reapproved, available as F2260-03(2008)

F921 - Standard Terminology Relating to Hemostatic Forceps has had an
epsilon edit, available as F921-85(2008)e1

EN ISO 15883-4:2008 Washer-disinfectors Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes Hospital equipment Cleaning equipment Medical equipment Washing Cleaning Sterilization (hygiene) Sterilizers Performance Conformity Performance testing Disinfectant tests Endoscopic apparatus

EN 60601-1-9:2008 Medical electrical equipment General requirements for basic safety and essential performance. Collateral standard.
Requirements for environmentally conscious design.

ISO 7176-14:2008 Wheelchairs Power and control systems for electrically powered wheelchairs and scooters. Requirements and test methods.

Draft guidance on how the FDA will interpret International Organization for Standardization (ISO) audit reports when determining its inspection priorities for device makers, is imminent.

Bioheart, Inc. provider of intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases, announced it has secured worldwide non-exclusive distribution rights to the Bioheart 3370 Heart Failure Monitor, an interactive and simple-to-use at-home intelligent device designed specifically to improve available healthcare to patients outside hospitals who are suffering from heart failure. The device, manufactured by RTX Healthcare A/S (Denmark), has 510k market clearance from the US Food and Drug Administration for marketing in the U.S. and CE mark approval.

As part of its effort to improve monitoring of imported products, the FDA plans to open two offices in India by 2009.

Abbott announced the start of a post-approval study, with six hospital centers already recruiting and enrolling patients just one week after the U.S. Food and Drug Administration approved the XIENCE VT Everolimus Eluting Coronary Stent System. The study will evaluate the safety and effectiveness of the drug eluting stent in a real-world clinical setting out to five years. Jack Jones, M.D., interventional cardiologist and medical director of the Stormont-Vail Catheterization Lab in Topeka, Kansas, was one of the first physicians to enrol a patient into the study.

Impliant has resumed clinical use of its Tops system, a total posterior arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis. The company had voluntarily suspended all clinical activities in September 2007 following one device-related failure. The company also has FDA approval to restart its Tops IDE clinical study in the US.

Integra LifeSciences Holdings, a provider of surgical implants and medical instruments, has introduced its Tibiaxys plating system, which has received clearance from the FDA, and a CE Mark certification in the European Union. The system for treating ankle arthritis and deformity is manufactured from titanium.