Leadership in Standards Development – A Lasting Impact for Better Patient Care

We all use medical practice standards and guidelines, but how are they developed and how do they impact care? In what I consider a career highlight, I was able to find out for myself and engage in this fascinating process.

Practice standards and professional guidelines are important tools intended to help deliver safer patient care. Standards and guidelines improve the quality of practices, reduce unnecessary activities and interventions and help to provide evidence-based treatment with the most benefit to the patient to both advance care and minimize the risk of harm. The standards development process also identifies gaps in evidence and points out clinical research needs.

While many standards and guidelines are voluntary, they are used as the basis for setting healthcare facility policy. Compliance to policy is a requirement by healthcare accrediting organizations and payors.

Standards and guidelines should:

Provide – a distillation of current evidence and opinion on best practice
Be based on – scientific evidence, expert opinion and research (as part of guideline development)
Become – part of the quality system for healthcare facilities
Serve – purpose of achieving better health outcomes by improving practice
Assist – healthcare organizations in solving problems and make decisions

Source: Clover et al. 1995; Grimshaw & Russell 1993

Standards and guidelines have slightly different development processes, but the intents are similar in many aspects. Some standards setting organizations are consensus based where all stakeholders are engaged in the process for a topic or practice area. Clinical Practice Guidelines are typically developed and maintained by a single professional organization within a specific discipline, e.g. infusion therapy, wound care or a practice area, e.g. operating room. Both consensus standards and professional guidelines develop recommendations based on the available peer-reviewed, published evidence and strive to provide recommendations. The method of rating the published evidence may vary between organizations but all strive to identify and cite high quality evidence.

The standards development experience

My first experience with standards development was a baptism by fire when I moved to a new role and was told – ‘you should go to this AAMI meeting’.

At that point, it seemed like just another thing in an already overloaded schedule that required time away from my young family.  It did not take long to realize participation in standards development was an extremely rewarding professional experience with the opportunity to impact real change. Plus, it is interesting and intellectually challenging while providing networking and professional relationship development opportunities like no other with peers and other industry experts.

I’ve since participated as an active member on many committees related to both healthcare and industrial sterilization standards. Most recently, I was named as co-chair for the AAMI Sterilization Standards Committee (SSC) which is the oversite committee for the 31 cleaning, sterilization, disinfection, packaging, microbiology and other related committees.

This co-chair position is responsible for planning and leading the plenary committee meetings with the AAMI Standards Director during the twice-yearly Sterilization Standards Week.  The program of the SSC includes topics such as new technologies and tools, quick updates on key committees, FDA updates, new research, industry trends and critical healthcare issues. As co-chair of the SSC, I will lead the US delegation on behalf of the American National Standards Institute (ANSI) to International Standards Organization (ISO) Technical Committee (TC) 198 – Sterilization of Medical Devices. ISO TC 198 sets global consensus standards for all things related to sterilization of medical devices.  It is a great honor to represent the United States in this important work.

Leadership comes in many forms and, when developing standards, it takes several skill sets. The work involves analyzing evidence, translating that evidence into text and tools that can be interpreted correctly and consistently by the users of the standards, and collaborative team work to resolve team conflicts and differences of opinion while being fair and respectful to all members. Perhaps most importantly, standards leadership provides the opportunity to support and give back your talents and skills to an organization that is so critical to ensure good patient care.

If you’ve ever wondered why a certain standard or guideline exists and want to contribute in a way that makes a meaningful impact, standards development is an area worth considering. It just may be a career highlight for you, as it has been for me.

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