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The American Nurses Association 2011:
__________________________________ José Cárdenas, MD, MPH
Senior Policy Fellow April 6, 2011CleanMed 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 costThe 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 managementResearch on ethical and safety issues associated with utilizing single use devicesDissemination of research on reprocessed SUDs
Thank You!
For more information, contact:
José Cárdenas, MD, MPHSenior Policy FellowCenter for Occupational Environmental [email protected]
