OR buying new reusable instruments or equipment? Have SPD weigh in first.

It’s an all-too-common conundrum: Sterile Processing (SP) professionals discover too late in the acquisition cycle that new surgical instruments or equipment have been purchased – without those in the Operating Room (OR) or other user departments first ensuring SP technicians have the knowledge, training, instructions for use (IFU) (and, sometimes, even the required processing equipment) to ensure it can be cleaned and sterilized safely and effectively.

Numerous factors can contribute to this glaring oversight (one that, by the way, can jeopardize patient safety and place the healthcare organization at significant liability risk). For starters, it’s not uncommon for physicians/surgeons to demand certain devices or equipment based on their experience with them at previous facilities, and for their current facility to then cater to their wishes without first considering all implications of the purchase.

Lack of SP visibility and presence within the facility can also play a key role. In some cases, SP professionals aren’t actively involved in multidisciplinary committees, so they may be either simply unaware of product evaluation or purchasing discussions, or don’t want to rock the proverbial boat by interjecting their opinions, objections or concerns. What’s more, not all facilities have effective, enduring partnerships between SP, the OR and Infection Prevention (IP), an unfortunate reality that can perpetuate an “us and them” perception that erodes effective, proactive communication across all sides of business.

Over the years, the International Association of Healthcare Central Service Materiel Management (IAHCSMM) has heard numerous examples of near-disastrous consequences stemming from new purchases being made without first consulting with those in the SP department (SPD). Some shared how new reusable devices or equipment made their way into the department for initial processing, only to discover the SPD lacked the required equipment to clean, high-level disinfect or sterilize the item according to the manufacturer’s IFU. One SP professional shared how a surgeon became infuriated when told the SPD didn’t have the proper equipment to process the new device safely and properly. The surgeon sternly suggested the SPD process it with the equipment they had (a request that was promptly and prudently denied by the SP manager who reiterated the need to follow IFU, standards and best practices to the letter).

Stakeholders must step up

SP professionals who don’t currently participate in detailed discussions on new product selection, evaluation and, ultimately, purchase need to take steps now to ensure they have a regular seat at the table (if any efforts to participate are met with resistance, it can be helpful to seek support from IP).

 Every instrument or piece of equipment that would require reprocessing by SP professionals must be carefully assessed prior to purchase and acquisition to ensure the technicians have the resources (e.g., supplies, equipment, training, IFU, etc.) to manage the new item(s) safely and consistently. ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, recommends healthcare organizations establish a multidisciplinary product evaluation committee that has representation from those who will be affected by the new product.¹ For a product that would undergo steam sterilization, for example, the committee could consist of someone from the SPD, the OR, IP, Risk Management, Materials Management, Staff Development, and potentially others.

During the evaluation process, it is recommended to ensure all stakeholders have access to critical data that includes clearance documentation from the US Food and Drug Administration; the manufacturer’s literature and written IFU for the product being evaluated; expert opinions and relevant research published in peer-reviewed journals; and reports from peers who are currently using the product or have trialed it.¹

The following factors should also be considered before a facility procures a new product¹:

• How the new product will contribute to patient care and safety;
• Legal concerns or safety implications that could arise from the product’s use;
• Product’s expected return on investment;
• Education/training needed to ensure all staff members can safely and effectively use the product;
• Product’s ease of use and compatibility with the facility’s existing equipment and products;
• Product’s environmental impact;
• Availability of ongoing vendor support (e.g., for training or maintenance); and
• The new product’s impact on inventory standardization.

Conclusion

New product and equipment purchases are ongoing and necessary to keep healthcare organizations competitive and current with the latest medical/surgical procedures and industry trends that impact the delivery of patient care. It is essential, however, that new product evaluations and purchasing decisions never occur in a vacuum but rather with multidisciplinary involvement that includes representation from all disciplines that would be impacted by the purchasing decision. Only then can facilities help ensure that the purchasing decision is one that meets the broader needs and priorities of the organization and the patients it serves.

References

1.  ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Section 15, New product evaluation.