From the August 2016 issue of HealthCare Business News magazine
A large number of third-party repair companies at the conference were offering a variety of services. These included a simple mail-in repair on an “as needed” basis, a subscription format with a fixed monthly cost and all-inclusive repair and exchange options, complimentary in-services and brand new OEM equipment sales. When trying to determine whether the cost for service is fair, one AAMI presentation targeted the average replacement value method, which divides the replacement costs by service cost and provides the user with a percentage with which to compare costs.
FDA Initiative on third-party repair: The market for third-party service and refurbishment vendors has grown steadily as providers look to cut costs. However, concerns have arisen throughout the years about just how qualified third-party organizations really are when it comes to servicing and repairing equipment. One study presented at the conference reviewed millions of MAUDE reports throughout the past 10 years and found very little data to support the concerns by original equipment manufacturers. However, the FDA has stated it plans to review the existing data in October 2016 and determine the appropriate course of action, if any, to take.
Flexible scope cleaning:
According to a study presented at the conference by the Osaka University Hospital and Tokyo University Hospital, flexible endoscopes, dental hand pieces and robotic instrumentation (e.g. EndoWrist) are among the most difficult equipment to clean properly. Because of this, the infection rate for these instruments is high.
This prompted the staff of the university hospitals to conduct a study to determine the culprit for the issue. The difficulty of cleaning is a well-known problem and resulted in a voluntary FDA recall of Olympus duodenoscopes in January 2016. Endoscopes’ inner channels are coated with polytetrafluoroethylene (PTFE) known as Teflon.
As the Japanese study trials showed, PTFE is highly hydrophobic and resistant to protein and carbohydrates adhesion. However, it does not prevent lipids from sticking. The design of the biopsy channel and tip elevator, along with inadequate personnel training, variability of cleaning solutions and automation of the cleaning process, contribute to poor disinfection outcomes. The findings of the Japanese trials serve to emphasize the need for proper manual cleaning with brushes by qualified and certified staff. They also suggest that the cleaning process should be taken one step further, from high-level disinfection to sterilization to optimize infection control and cross-contamination.
