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FDA MEDWATCH ALERTS

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January 12, 2012

Respironics, Inc. Trilogy 100 Ventilators: Class I Recall - Device May Stop Delivering Therapy to Patient

Summary:

FDA notified health care professionals of the Class 1 recall of this product due to a manufacturing issue can stop delivering therapy to the patient. Part of the blower that circulates air and other gases through the ventilator may move out of position and cause the device to alarm.  Failure to respond could result in the potential for harm or death of a ventilator-dependent patient.

January 12, 2012

Bedford Laboratories Vecuronium Bromide And Polymyxin B For Injection USP For Injection: Recall - Glass Particles

Summary:

Bedford Laboratories issued guidance on the nationwide voluntary product recalls originally issued on August 2, 2011. The recalls were initiated after the discovery of a visible glass particle in a limited number of vials within the lots listed.

January 09, 2012

Endo Pharmaceuticals Opiate Products by Novartis Consumer Health: Public Health Advisory - Potential Safety Risk

Summary:

FDA is advising health care professionals and patients of a potential problem with opiate products manufactured and packaged for Endo Pharmaceuticals by Novartis Consumer Health at its Lincoln, Nebraska manufacturing site.

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ASA FEATURED PRODUCT

Self-Education and Evaluation (SEE) Program

SKU: 30701-12CE

... Read more »

Single Copies, Member Price: $300

Standards, Guidelines, Statements and Other Documents

ASA Standards, Guidelines and Statements provide guidance to improve decision-making and promote beneficial outcomes for the practice of anesthesiology. They are not intended as unique or exclusive indicators of appropriate care. The interpretation and application of Standards, Guidelines and Statements takes place within the context of local institutions, organizations and practice conditions. A departure from one or more recommendations may be appropriate if the facts and circumstances demonstrate that the rendered care met the physician's duty to the patient.

Standards provide rules or minimum requirements for clinical practice. They are regarded as generally accepted principles of patient management. Standards may be modified only under unusual circumstances, e.g., extreme emergencies or unavailability of equipment.

Guidelines are systematically developed recommendations that assist the practitioner and patient in making decisions about health care. These recommendations may be adopted, modified, or rejected according to clinical needs and constraints and are not intended to replace local institutional policies. In addition, practice guidelines are not intended as standards or absolute requirements, and their use cannot guarantee any specific outcome. Practice guidelines are subject to revision as warranted by the evolution of medical knowledge, technology, and practice. They provide basic recommendations that are supported by a synthesis and analysis of the current literature, expert opinion, open forum commentary, and clinical feasibility data.

Statements represent the opinions, beliefs, and best medical judgments of the House of Delegates. As such, they are not necessarily subjected to the same level of formal scientific review as ASA Standards or Guidelines. Each ASA member, institution or practice should decide individually whether to implement some, none, or all of the principles in ASA statements based on the sound medical judgment of anesthesiologists participating in that institution or practice.

See also: Practice Parameters


Recommendations and Clinical Management Tools - ASA Committees




These files require Adobe Acrobat Reader®

Ambulatory Anesthesia and Surgery, Guidelines for (2008)

Anesthetic Care During Interventional Pain Procedures for Adults, Statement on (2010)

Anesthesia Care Team, The (2009)

Anesthesia Consultation Program (2008)

ASA Statement Comparing Anesthesiologist Assistant and Nurse Anesthetist Education (2007)

Avoidance of Medication Errors in Neuraxial Anesthesia, Statement on Standard Practice for (2010)

Basic Anesthetic Monitoring, Standards for (Effective July 1, 2011)

Clinical Privileges in Anesthesiology, Guidelines for Delineation of (2008)

Conflict of Interest, Statement on (2008)

Continuing Medical Education in Anesthesiology, Guidelines for Minimally Acceptable (2011)

Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia (2009)

Critical Care and Trauma Medical Services, Statement of Principles (2011)

Critical Care by Anesthesiologists, Guidelines for the Practice of (2009)

Distinguishing Monitored Anesthesia Care From Moderate Sedation/Analgesia (Conscious Sedation) (2009)

Documentation of Anesthesia Care (2008)

Economic Credentialing, Statement on (2008)

End-of-Life Care, Statement on Quality of (2008)

Ethical Guidelines for the Anesthesia Care of Patients with Do-Not-Resuscitate Orders or Other Directives That Limit Treatment (2008)

Ethical Practice of Anesthesiology, Guidelines for the (2011)

Expert Witness Qualifications and Testimony, Guidelines for (2008)

Granting Privileges for Administration of Moderate Sedation to Practitioners Who Are Not Anesthesia Professionals, Statement on (2011)

Granting Privileges for Deep Sedation to Non-Anesthesiologist Sedation Practitioners, Advisory on (2010)

Granting Privileges to Non-Anesthesiologist Practitioners for Personally Administering Deep Sedation or Supervising Deep Sedation by Individuals Who Are Not Anesthesia Professionals, Statement on (2006)

Infection Prevention and Control Instruments for Tracheal Intubation, Statement on Standard Practice for (2010)

Interoperability of Medical Devices, Statement on (2008)

Intravascular Catheterization Procedures, Statement on (2008)

Labeling Pharmaceuticals for Use in Anesthesiology, Statement on (2009)

Liver Transplant Anesthesia, Guidelines for Director of (2009)

Management of Performance Measures by the American Society of Anesthesiologists, Guiding Principles for (2011)

Monitored Anesthesia Care, Position on (2008)

Nonobstetric Surgery During Pregnancy, Statement on (2009)

Nonoperating Room Anesthetizing Locations, Statement on (2008)

Obstetrics, Guidelines for Neuraxial Anesthesia in (2010)

Obstetrics, Optimal Goals for Anesthesia Care in (2010)

Office-Based Anesthesia, Guidelines for (2009)

Organization of an Anesthesia Department, The (2008)

Pain Relief During Labor, Statement on (2010)

Patient Care in Anesthesiology, Guidelines for (2011)

Physican Nonparticipation in Legally Authorized Executions, Statement on (2011)

Postanesthesia Care Standards For (2009)

Practice Parameters, Policy Statement on (2008)

Practice Recommendations for Pediatric Anesthesia, Statement on (2011)

Preanesthesia Care, Basic Standards for (2010)

Qualifications of Anesthesia Providers in the Office-Based Setting, Statement on (2009)

Quality Incentive Programs in Anesthesiology, Principles for (2011)

Regional Anesthesia, Statement on (2007)

Reporting Postoperative Pain Procedures in Conjunction With Anesthesia (2010)

Respiratory Care Practitioner Credentialing, Statement Regarding (2008)

Respiratory Monitoring During Endoscopic Procedures, Statement on (2009)

Respiratory Therapists, (RTs) Statement Of Support For (2008)

Role of Registered Nurses in the Management of Continuous Regional Analgesia, Statement on (2008)

Routine Preoperative Laboratory and Diagnostic Screening, Statement on (2008)

Safe Use of Propofol, Statement on (2009)

Smoking Cessation, Statement on (2008)

Supporting a Member's Right to Practice, Protocol for (2008)

Surgical Care Improvement Project, Statement on (2010)

Transesophageal Echocardiography, Statement on (2009)




Recommendations and Clinical Management Tools - ASA Committees


Anesthesia Machine

Anesthesia Machine Preoperative Checkout Procedures
(Committee on Equipment and Facilities)

Anesthesia Machine Obsolescence
(Committee on Equipment and Facilities)


Blood Management

Plasma Components: An Update From COBM
(Committee on Blood Management)

Additional Plasma Derivatives 2011
(Committee on Blood Management)


Cardiovascular Implantable Electronic Devices (CIED)

The Heart Rhythm Society (HRS) and American Society of Anesthesiologists (ASA) Expert Consensus Statement on the Perioperative Management of CIED Patients
(Committee on Equipment and Facilities)


Critical Care Medicine

Anesthesiology Advanced Circulatory Life Support (ACLS)
(Committee on Critical Care Medicine)


Environmental Sustainability

Greening the Operating Room
(Committee on Equipment and Facilities)


Geriatric Anesthesia

Geriatric Anesthesia Curriculum
(Committee on Geriatric Anesthesia)


Infection Control

Recommendations for Infection Control for the Practice of Anesthesiology (Third Edition)
(Committee on Occupational Health)


Obstetric Anesthesia

Comparative Effectiveness of Interventions to Decrease Cesarean Births
(Committee on Obstetric Anesthesia)

Nitrous Oxide for Labor Analgesia
(Committee on Obstetric Anesthesia )


Trauma and Emergency Preparedness (COTEP)

Trauma and Emergency Preparedness