"Two roads diverged in a wood, and I, I took the one less traveled by, and that had made all the difference"

21 Sep

When To Follow, When To Lead

Should, can, may, must… Healthcare is an industry that is highly regulated. And there are regulatory requirements that should be met for manufacturers and users, for the benefit of the patient. There are various products and processes available in sterile processing for the same intended purpose, whether it’s for decontamination, sterilization, or for surgical and patient care procedures. Some processes are mandatory, and others require critical thinking and even an educated guess to understand whether an action is mandatory or left to the users’ discretion. Healthcare professionals must follow HIPPA Guidelines, Safety Precautions, Universal Precautions, OSHA Guidelines, Hospital policies and procedures, and maintain patient confidentiality. Then, it’s expected that they follow AAMI and AORN standards and guidelines. Where things get messy is when faced with conflicting messages.

IFUs and guidance documents are not the law

Different manufacturers IFUs may not be aligned and even conflict. Nonetheless, FDA and The Joint Commission have suggestions for mediating conflicting information. The Joint Commission does not say that users must use only the products or services a specific manufacturer recommends or identifies in their IFU. Rather, The Joint Commission states that it takes an investigation, comparing features and benefits, and asking qualifying questions to make an informed decision. Most medical devices require validation and an FDA 510k. Others, products like instrument chemistries, especially disinfectants, need approval from EPA to be introduced into the market. Some companies, like Case Medical, voluntarily work with regulatory agencies, like EPA Safer Choice, to ensure that their products, i.e. cleaners and instrument chemistries, are safe, effective, and sustainable. Thus, asking each manufacturer to supply their validations, certifications, or technical information can contribute to a sound decision.

TIRs are not normative and appendices may only suggest what a process might include

I attended the AAMI conference last week virtually and heard a range of opinions that contribute to best practices and some that were concerning from some industry experts. What I’ve found over the years is that in the end of a three to five year process a standard usually reaches consensus from users and industry members, but at times guidance is included when there may be other options. I learned this week something I feel is important to share. AAMI TIRs provide suggestions for users to consider and appendices are examples of what some processes might include. One that concerns me is when only one process or pathway is provided by industry experts when there can be a better way.

The path you take can make a difference

Life has many choices and every decision made has consequences. Sometimes we cannot go back and change our choices once they are made. This can also be described as the process of being at a crossroads and making a decision that once taken makes all the difference and ends well. William Frost’s poem, “The Road Not Taken” is about the choices and opportunities in life. The poem highlights the sensation of regret that accompanies all the roads that a person doesn't take. It also means acting independently, freeing oneself from the conformity of others. In healthcare, the decision made should be in the best interest of the patient and this is where sound thoughtful decision making comes into play as it can make all the difference.

Case Medical is a US EPA Safer Choice Partner of the Year, Best in Class Midsize Employer for NJIT, Enterprising Women in Commerce 2023 for CIANJ and Sustainable Manufacturing 2022, and finalist in Life Science Leader in Manufacturing, and currently a finalist for NJ Innovator of the Year.

Visit us anytime at www.casemed.com to learn more about our products and services. We are here to help.

Kindest Regards,

Marcia Frieze and the Case Medical team

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