Common medical device reprocessing deficiencies in physicians' offices

The office assessment is one of the three components of a Physician Practice Enhancement Program (PPEP) peer assessment, and often brings to light important opportunities for improvement in community-based practice related to operating a clinical office. Following are some examples of recurrent issues noticed by clinicians working with PPEP particularly around the topic of medical device reprocessing (MDR):

The clinic does not have manufacturer’s instructions for use (MIFU) for its medical devices. The MIFU dictates specific instructions on how a particular medical device must be reprocessed. Without referring to the MIFU for each medical device, physicians and their staff may be improperly reprocessing equipment, which increases the risk of damage to the device and compromises patient safety. Note: only the MIFU can confirm whether a medical device requires disposal, disinfection, sterilization or other treatment. The MIFU also indicates the appropriate cleaning solution or detergent that can be used.

Dual-purpose areas for both patient care and medical device reprocessing are not used appropriately. Physical space in community-based offices is often limited. Where clinical offices use a common space for patient care and the reprocessing of reusable medical devices, parameters and rules must be in place to ensure each activity is done safely. For example, if the sterilizer is in the exam room used to see patients, reprocessing must only take place when the room is not used for patient care (such as early morning, or after hours).

Biological monitoring is not being performed. When it comes to the sterilization of reusable medical devices and the use of a sterilizer, there are three quality assurance parameters that must be met: biological, chemical and physical monitoring. These parameters are based on the BC Ministry of Heath’s best practice document (see link below). Of the three quality assurance monitoring of a sterilizer, the single most common deficiency seen in practices is the absence of biological monitoring.

Chemical monitoring and physical monitoring are required, but are not sufficient to assure sterilization, as they are not a substitute for biological monitoring. Biological monitoring equipment must include the test strips and the incubator.

Sterilization monitoring parameters are not documented. Documentation of all quality assurance parameters (biological, chemical and physical indicators) must be documented in a log book.

Additional details are available in the BC Ministry of Health’s Best Practice Guidelines For Cleaning, Disinfection and Sterilization of Critical and Semi-critical Medical Devices (2011).