Process Surveillance and Follow-Up Monitoring to Increase Compliance to Standards in Medical Device Reprocessing

Abstract

Background: Effective medical device reprocessing (MDR) is essential in preventing the spread of microorganisms and maintaining patient safety. Alberta Health Services (AHS) is an Alberta-wide, integrated health system, responsible for delivering health services to >4.3 million people living in the province. In 2010, periodic province-wide MDR reviews were initiated by the provincial health system to verify that the cleaning, disinfection, and sterilization of reusable critical and semicritical medical devices met established standards. To date, there have been 3 review cycles; in cycle 3, a follow-up process for tracking and reporting corrective actions was initiated. Methods: As in previous MDR review cycles, cycle 3 included the use of a standardized suite of tools to measure compliance with standards set by Accreditation Canada, the Canadian Standards Association, and the Government of Alberta. Each cycle involved a review of MDR areas completed by trained reviewers. Interrater reliability among reviewers was maintained through training and debriefings following reviews to ensure agreement. Following reviews, reports were generated for areas, zones, and AHS. As part of the corrective actions and follow-up process, identified deficiencies were categorized into 5 themes. Corrective actions were tracked and periodic reports were generated showing the progress of deficiency resolution. Resolution rates (number of resolved deficiencies divided by total number of of deficiencies) were calculated for each of the identified themes as well as overall for cycle 3. Results: Overall compliance for cycle 3 was 93%. Cycle 3 reviews revealed that more than half of the deficiencies (58%) were identified previously in cycle 2. The resolution rates ranged from 78% to 95% for identified deficiencies for 4 of the 5 themes: documentation, technique, PPE/attire/hand hygiene, and other. The theme related to physical infrastructure showed a considerably lower resolution rate of 49%. The corrective action follow-up process showed increased overall resolution rate from 59% at the start of the follow-up process to 82% at its completion. When this resolution rate was applied to the initial survey compliance rate for cycle 3, overall compliance increased to 99%. Conclusions: Monitoring quality of MDR practices is essential in maintaining and improving patient safety. The standardized provincial review process identified common themes and a coordinated approach to support the resolution of many identified deficiencies. Most of those deficiencies were resolved; however, those deficiencies related to physical infrastructure of the MDR department continue to be seen across review cycles. This review process with follow up of these deficiencies can help bring attention to organization leadership and Funding: authorities during budget cycles.

Funding: None

Disclosures: None