HARRY'S CORNER

Sterile Processing continues to change. New devices enter our departments, manufacturers revise their instructions, and industry requirements are updated. We have a responsibility to keep up with those changes because our work has a direct effect on patient care.

A Profession That Never Stands Still

The operating room depends on us to provide instruments that have been cleaned, inspected, assembled, packaged, sterilized, stored, and delivered correctly. Most patients will never see the Sterile Processing department, but the quality of our work follows them into the operating room.

After more than 35 years in this profession, I have seen a great deal of change. Devices are more complex. Instructions for Use, commonly called IFUs, contain more detail. Standards are revised as new information becomes available. Surveyors also look closely at whether a department follows current requirements and its own policies.

Experience is valuable, but experience alone is not enough. A process may feel comfortable because we have used it for years. That does not mean it still meets the current requirement. We have to be willing to check the source and adjust our practice when the information changes.

Understanding the Sources of Direction

One reason this subject can be confusing is that our direction comes from several places. Standards, regulations, accreditation requirements, facility policies, and manufacturer IFUs are related, but they are not the same thing. Staff members should understand where each requirement comes from and who to contact when two sources appear to conflict.

Standards and recommended practices

Organizations such as AAMI and AORN publish standards and recommended practices that guide many areas of our work. These include cleaning, disinfection, packaging, sterilization, storage, environmental conditions, quality systems, and staff competency. A standard may not be a law, but it often helps define accepted practice and may be used when policies, survey expectations, and risk decisions are reviewed.

Manufacturer Instructions for Use

The manufacturer’s IFU gives specific directions for processing a device. It may identify the cleaning chemistry, water quality, brushes, adapters, contact time, rinsing, drying, inspection, packaging, and sterilization cycle that must be used. Staff need access to the current IFU, and the department’s procedures and training should match it.

Regulations and oversight

Federal, state, and local authorities may establish requirements related to medical devices, employee safety, public health, and facility operations. The FDA, CMS, OSHA, and the CDC each have different responsibilities. Accreditation organizations, including The Joint Commission, review whether a facility follows the requirements that apply to it, as well as its own approved policies and procedures.

IMPORTANT POINT  A department policy should be reviewed against the applicable regulations, current standards, accreditation expectations, and the manufacturer’s IFU. One source should not be used while the others are ignored.

Why Outdated Practices Create Real Risk

An outdated process is not always easy to recognize. Instruments may look clean, the sterilizer record may show a completed cycle, and the tray may reach the operating room without a complaint. None of those things, by themselves, prove that every step was performed correctly.

Problems develop when a department uses old cleaning parameters, misses a revised IFU, allows a shortcut to become routine, or continues using a policy that has not been reviewed. The result may be retained soil, damaged instruments, poor sterilant contact, compromised packaging, employee exposure, incomplete documentation, delayed cases, or patient harm.

Whenever I hear, “We have always done it this way,” I know it is time to ask another question: “What current source supports this process?” Asking for the source is not disrespectful to an experienced employee. It is how we make sure that experience is still connected to safe practice.

Staying Current Is a Shared Responsibility

Leaders are responsible for making current information available and for giving staff enough time and training to use it correctly. Technicians are responsible for following approved procedures, completing education, asking questions, and speaking up when something is unclear. Educators and quality staff help connect new information to competency and daily practice. Some changes also require support from Infection Prevention, the operating room, Facilities, Safety, Supply Chain, or other departments.

Certification gives us an important foundation, but learning cannot stop when we earn a credential. A new technician and an experienced leader have the same basic responsibility. Both must be willing to learn, review their practice, and make changes when necessary.

Reliable Ways to Keep Up

It is much easier to stay informed when the department makes it part of normal operations. The following practices can help:

·       Keep current standards, regulations, and manufacturer IFUs available to staff.

·       Assign someone to monitor updates from professional organizations, government agencies, manufacturers, and accreditation organizations.

·       Review policies on a regular schedule and whenever a device, product, process, standard, or requirement changes.

·       Explain changes during staff meetings, shift huddles, education sessions, and written communication.

·       Use a documented competency assessment to confirm that staff can perform the new or revised process.

·       Create a clear way for employees to report conflicting instructions, missing information, or a process that cannot be completed as written.

·       Use audits, quality data, near misses, and survey findings to identify where more education or process improvement is needed.

·       Encourage continuing education and participation in professional associations, conferences, webinars, and peer groups.

From Information to Implementation

Receiving an update is only the first step. Someone has to decide whether it applies to the department and compare it with the current process. The department may need to revise a policy, update a work instruction, involve other departments, educate the staff, assess competency, and monitor the result. If no one is responsible for those steps, important information can sit in an email while the old process continues.

Communication must reach every shift. A department that operates around the clock cannot rely on one morning meeting. Employees need to know what changed, why it changed, when the new process begins, where the approved instructions are located, and who can answer questions. Leaders should follow up by observing the work and reviewing the documentation.

Building a Culture of Continuous Compliance

Compliance should be part of the department’s daily work. It should not begin a few weeks before a survey. Employees should be comfortable asking for the source, reporting a gap, stopping an unsafe process, or requesting clarification. Leaders should take those questions seriously and answer them with current information.

A department with this type of culture is better prepared for a survey, but that is not the main benefit. Consistent practice reduces variation, protects instruments, improves teamwork, and provides more dependable service to the operating room. No one can memorize every standard or regulation. What matters is having a reliable way to find the correct information and put it into practice.

The Professional Standard We Carry

Sterile Processing professionals manage a process that most patients will never see. That makes it even more important for us to do the work correctly, including when no one is standing beside us. Staying current is part of that responsibility.

Standards, regulations, technology, and survey expectations will continue to change. Departments should not wait for an inspection to find a problem. We need to review our practices, listen when employees raise concerns, and make education part of the normal work of the department.

The reason for staying current is simple. Current information helps us make better decisions, maintain a safer process, and protect the patients who depend on our work.

Until next time, stay informed, stay prepared, and keep raising the standard.

Harry

Harry’s Corner