How ambulatory care sites can mitigate the risks of processing reusable medical devices

Reusable medical devices are critical tools in ambulatory care sites, but properly processing those devices can be a challenge for employees due to varying processes and standards for different types of devices and a lack of training among staff. 

Noncompliance with processing standards puts ambulatory care sites at risk of citations from accreditors and increases infection risks for patients. John Whelan, BSN, RN, a clinical educator for Healthmark Industries, discussed the best standards and guidelines for device processing and strategies to mitigate risks during a Sept. 16 webinar hosted by Becker's Healthcare and sponsored by Healthmark. 

Five key takeaways: 

  1. Ambulatory care sites have the highest rate of noncompliance for device processing. The Joint Commission found that "immediate threat to life (ITL) declarations directly related to improperly sterilized or high-level disinfected (HLD) equipment increased significantly between 2013 and 2016, with 74 percent of all ITLs related to improperly sterilized or HLD equipment. Because of the typically decentralized processing and variability in staff training, ambulatory and office-based surgery centers are especially prone to noncompliance, Mr. Whelan said.

  2. Common risks to noncompliance include having multiple sites of care, methods of processing and types of devices. Quality control is harder to manage when there is a lack of standardization across a health system. It's also not uncommon to have providers that aren't properly trained completing the processing. In some facilities, medical assistants, nurses and even physicians may be involved with processing though they lack related formal training. Shortcuts may be taken intentionally or unintentionally to keep up with their workflow, Mr. Whelan said.

  3. Common root causes for health systems' failure to comply with device processing standards include having processes in place but not followed, a lack of clarity or understanding about standards, and having written standards that don't line up with manufacturers' instructions for use. It is critical that local managers and owners make sure the processes that are in place are actually being followed, Mr. Whelan said. Expected cleaning and disinfection practices should always be based on manufacturers' instructions for use (IFU) and national guidelines and standards.

  4. Different health systems have different processing policies because some regulations from national agencies are mandatory and some are recommended. Regulations from the Occupational Safety and Health Administration are mandatory and facilities risk citations or fines for noncompliance. But standards that come from organizations such as the American Society for Gastrointestinal Endoscopy or the Association for the Advancement of Medical Instrumentation are recommendations that aren't legally enforceable. Accreditation survey citations (and related loss of institutional funding) can still be a result of noncompliance to those standards, however. Health systems must decide which standards to uphold and reference them in their written policies, Mr. Whelan said.

  5. Steps to mitigate the risk of noncompliance include assembling a team of key stakeholders, developing gap analyses and conducting regular risk assessments. A team of stakeholders should include a range of professionals including processing specialists, clinical users, infection prevention specialists and administration to get everyone on the same page and resolve conflicts. It's also critical to examine the current state of affairs in your facility and determine what should be happening versus what is happening when it comes to reusable device processing. Prioritize which issues to tackle first, develop follow-up plans and evaluate the program to see your progress. Creating system-wide expectations for processes increases likelihood of compliance with regulatory requirements and increases patient safety, Mr. Whelan said. 

To view the full webinar, click here.

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