The American Nurses Association 2011:

__________________________________ José Cárdenas, MD, MPH Senior Policy Fellow April 6, 2011 CleanMed Phoenix, AZ

Safety and Efficacy FDA- Medical Device User Fee and Modernization Act 2002 Review Prioritization Scheme (RPS) – SUD- Category I Non critical (topical contact not penetrate the skin) – SUD-Category II Semi-critical (contact intact mucous membranes) – SUD-Category III Critical (contact sterile tissues)

Safety and Efficacy Which devices are safe to reprocess and reuse? Team decision making regarding safety and cost The healthcare system must be able to: – meet regulation requirements – maintain records for all the reprocessed devices – quality assurance

Safety and Efficacy Joint Commission – Mandate performance standards for Infection control Sterilization Quality improvements activities

Safety and Efficacy Cost should cover training to employees Review/update-guidelines and procedures Certifications market Canada-USA

Occupational Issues Cross –patient infection Pyrogenic reactions Needlestick and sharps instruments Toxicity of reprocessing chemicals Injury

Environmental Issues Disposable equipment creates considerable medical waste Plastic incineration Air pollution Additional cost Public concern

ETHICS Nurses must be aware of the RISKS and LEGAL implications of reusing SUDs Patient populations Insurance AIDS Chronic health conditions

ETHICS Patient safety Administration Legal dept Risk management Staff

ETHICS Cost to patient Reprocessed SUD may be billed at “new” cost High standards /research for safety and ethics * Dunn, D. (2002). Reprocessing Single Use Devices The Ethical Dilemma. AORN Journal, Vol 75, No 5, 994.

ANA 2010 Resolution: Safety & Effectiveness of Reprocessed SUDs in Healthcare Reducing amount and toxicity of healthcare waste by improving end-of-use product management Research on ethical and safety issues associated with utilizing single use devices Dissemination of research on reprocessed SUDs

Thank You! For more information, contact: José Cárdenas, MD, MPH Senior Policy Fellow Center for Occupational Environmental Health