STERILE PROCESSING
Melinda Benedict, Director, Infection Prevention and Control, Olympus Corporation of the Americas
“We have a moral obligation to leave the world a better place than we found it. We are blessed in this country with resources. We should do all we can to preserve them. To do this we must under- stand the costbenefit of our activities. We have an obligation to investigate the total cost of resources used for both reusable and disposable instruments. believe that currently, this favors the use of reusable flexible endoscopes. With an estimated million .. annual endoscopic pro- cedures performed, imagine resources required to build the endoscopes and the mountains of waste that will be created if all were disposable. ooking at the root
causes of the need for disposable flexible endoscopes we find two primary drivers. First, failure to properly clean and process reusable endoscopes; second, in the case of ECP endoscopes engineering design and lastly, industries need to create new markets to sell more products. With the exception of those endoscopes with design flaws (some ECP endoscopes), flexible endoscopes can be effectively reprocessed and rendered safe for use if the reprocess- ing staff is competent and follows the F. s T includes new requirements for cleanliness testing and drying both will help improve outcomes. ike any other production system, if the staff is not properly trained, super- vised and managed there will be failures in the process. n addition, T calls for detailed event tracking. This is the area
that most often see failure to comply. Many facilities do not track and man- age events as they should to improve the system. ften, staff are lax in report- ing events, events are not reported with enough details and no one reviews the history to recognize trends. Events tell you where system failure is occurring. Event tracking and monitoring should be the most important task that PD and Endoscopy managers have. Endoscopes that have design flaws that hamper effec- tive cleaning or sterilization should be and are being corrected. astly, there is an incentive for manufactures to create repeat sales. Disposable products do this often at the expense of the environment.
Gregg Agoston, Vice President, Business Development, SPD Transformation Services, SpecialtyCare
‘Right to Repair’ remains steeped in ‘caveat emptor, let the buyer beware’
S
everal industries outside of healthcare but linked to health- care are grappling with a regulatory solution to a long-time lingering challenge through “right-to-repair” laws that are igniting a flurry of lawsuits. Essentially, these laws are designed to prevent original equip-
ment manufacturers (OEMs) from refusing to license or sell their components and parts to independent service organizations (ISOs) so that the OEMs retain the maintenance and repair busi- ness of their products. ome argue that these measures suppress competition from third-party companies. Providers see s as a less expensive alternative to the OEMs, but the OEMs counter with quality concerns among third-party repair companies that may affect the durability and performance of a device. To protect themselves, OEMs may void product warranties when customers opt for third-party s to control costs. Two industry experts offered their observations and takes on this controversial issue with reasonings designed to satisfy a single mission, if not reach some kind of middle ground. “On this issue, Olympus agrees with industry group AdvaMed,
which has developed a website outlining its position. The position is presented in high-level form as follows The manufacturing and repair of highly complex medical technologies and devices is rigorously regulated by FDA, the global gold standard for medical device safety and efficacy and for good reason patient safety is number one. Editor’s Note: You can access AdvaMed’s “The ‘Right to Repair’ is Wrong for Patients” here:
https://www.advamed. org/industry-updates/policy-issues/right-to-repair-wrong-for-patients/
Melinda Benedict, Director, Infection Prevention and Control, Olympus Corporation of the Americas
This is a very big topic that needs to be focused to help make sense of the situation. fter having represented three maor Es service offerings (e.g., . uller, arl torz and tryker) and an ndependent ervice rganization ( a k a Third-Party
Repair) over the past 25 years, looking at the products by clas- sification can be helpful. First, lets limit the discussion to surgical instruments. This removes medical equipment such as beds, pumps, monitors etc. For surgical instruments, they can be classified as general and complex. eneral instruments consist primarily of hand-held stainless-steel instruments, such as graspers, needle drivers, speculums, etc. These are most frequently serviced by s either with or without authorization of the E. For these instruments most of the work involves polishing, sharpening and replacing small components such as springs, screws and carbide inserts. ISOs have been repairing and refurbishing general instruments for many years and have access to parts. For general instruments, part acquisition is not an issue as there are many sources avail- able with most of the parts being made in ermany. “For complex surgical instruments such as endoscopes, cam- eras, power tools and video equipment, parts for most of the maor manufacturers are available either from parts suppliers, reverse engineering and in some cases from the E. any ISOs have reverse-engineered components and make their own parts or they outsource the parts to other third parties. Parts typically are not a significant issue for devices that have been on the market for a few years. Parts for new technology are often an issue as the ISO has not had time or perhaps the technical skills necessary to reverse-engineer (copy) the component. Parts sup- pliers generally wait for demand before they invest in sourcing or reverse engineering components. The Es claim that they want and need to control the components to avoid unauthorized repair activities to their products.
Legal reality, responsibility The repair of medical instruments and devices is not regulated by the FD. The manufacture of medical instruments is heavily regulated. However, when an E repairs its products, this is
36 November 2022 • HEALTHCARE PURCHASING NEWS •
hpnonline.com
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