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October 13, 2022
Publish Date: October 12, 2022   |  Tags:   Instrument Reprocessing and Care


OEMs Raise the Bar for Safety and Effectiveness Standards

Optimizing Efficiencies at a Busy GI Center

The Value of OEM Service for Endoscopes for the OR Team - Sponsored Content

Quality of Medical Device Servicers Questioned

FDA Issues Guidance on 'Remanufacturing' vs. 'Servicing' of Medical Devices


OEMs Raise the Bar for Safety and Effectiveness Standards

Regulated by the FDA, device manufacturers and their authorized servicers are on the leading edge of making their products safer.

St Cloud St. Cloud Surgery Center
HOW SAFE? Medical device manufacturers and their authorized servicers must follow rigorous FDA regulations, while unregulated third-party servicers do not.

The Advanced Medical Technology Association (AdvaMed) says original equipment manufacturers (OEMs) meet the highest standards for servicing medical devices, which is vital for this often complex equipment to function safely and effectively. The same, AdvaMed claims, can't be said about what it calls unregulated third-party service providers.

AdvaMed, a medical device trade association, notes that OEMs and their authorized servicers must comply with rigorous FDA regulations that third-party servicers are not legally bound to follow. "OEMs… must follow comprehensive FDA quality system requirements to ensure their devices are properly serviced and maintained and continue to meet safety and effectiveness standards set by the agency," says AdvaMed. "However, tens of thousands of unregulated third-party servicers do not follow the same FDA requirements, putting patients and device users at risk."

Here are five areas in which OEMs and their authorized servicers must comply that aren't legally required of third-party servicers.

Quality system regulation (QSR). This ensures that all servicing operations are carefully controlled and executed. QSRs are documented and approved policies and procedures that cover all aspects of a company's operations, including purchasing of replacement parts and components; staff training; equipment and facility maintenance; supplier evaluations; recordkeeping and document retention; and corrective action taken.

Registration. OEMs must provide the FDA with the locations of their facilities so the agency can inspect them.

Device reporting. Deaths, serious injuries or malfunctions involving a medical device must be reported to the FDA so the agency and the manufacturers know about serious and potentially serious safety problems.

Voluntary recalls. Recalls can lead to quick and efficient resolution of problems with devices. A recall can result in anything from a relatively simple labeling change to a full removal of a product from the market. There are comprehensive procedures attached to recalls designed to protect patients from injury, deception or defective products.

Corrections and removals. Companies must report anything found in the field to address health risks posed by their devices.

While there are many third-party servicers who operate conscientiously and responsibly, FDA-monitored OEMs and their authorized dealers remain the ultimate, final-word authority on their own products and the latest changes and corrections to them.

Optimizing Efficiencies at a Busy GI Center

Standardized equipment and strict adherence to manufacturer reprocessing instructions keep high-volume lines moving profitably.

GI Northwell Health
QUICK TURNAROUND To keep endoscopy lines moving both smoothly and safely, reprocessing professionals should follow scope manufacturer instructions to the letter.

Running a high-volume GI center is no easy feat as it requires a team commitment to improving efficiencies and productivity informed by data-driven actions. Standardization is a big component of this effort.

Klaus Mergener, MD, PhD, MBA, MASGE, immediate past president of the American Society for Gastrointestinal Endoscopy and an affiliate professor of medicine at the University of Washington in Seattle, says equipment standardization is critical for high-volume endoscopy centers. "Don't mix and match endoscopes from different vendors," he says. "When you standardize equipment, you can operate with less inventory and less staff training."

Dr. Mergener says the number of scopes a center needs to optimize efficiency depends on its reprocessing throughput and workflow. He suggests analyzing historical case volume data for insights into how many scopes to maintain. "Assume one patient will be undergoing a procedure while an endoscope is being reprocessed and another scope is readied for the next case," he says. "Then extrapolate the total number of endoscopes you need based on how many rooms you run in parallel and how many cases are performed in a day."

Having enough scopes on hand is one thing; making sure they are safe to use on patients is another. Staff must be properly trained on how to reprocess endoscopes based on written instructions for manual cleaning and high-level disinfection received from the scope manufacturers. This is another case where standardizing your scope fleet as much as possible can pay efficiency and productivity dividends.

"Regular maintenance of automatic endoscope reprocessors and investing in updates of the equipment are important ways to ensure staff have access to the most up-to-date models and care for scopes efficiently and correctly," says Dr. Mergener.

The Value of OEM Service for Endoscopes for the OR Team
Sponsored Content

Timely, high-quality service is more than worth the investment.


The OR outpatient teams that take excellent care of patients every day have patient safety and superior care top of mind. Their responsibilities include taking care of the equipment and tools used to perform surgery of all types – and that role is taken just as seriously as the surgery itself. At times, costing strategies that seem cheaper at the outset often result in substandard outcomes and greater long-term costs. Any savings experienced up front are negated by a poorly-performing product, reduced surgeon satisfaction and a higher risk to patient safety — all of which may have a significant financial impact.

One study of a leading hospital shows how cost-cutting measures can take a cut out of quality. Endoscope service costs were measured using KARL STORZ as the service provider for a 3-year period, and then using an Independent Service Organization (ISO) for 3 years. In the case study, a hospital used KARL STORZ PROTECTION1® Services for three consecutive years. The costs for both repairs/exchanges and new capital purchases during that 3-year period were measured. In an attempt to save money, the hospital switched to using an ISO once the 3-year period with KARL STORZ Service had ended. Costs during the next three years with an ISO as the service provider were measured.

The results showed a long-term benefit of retaining the PROTECTION1® Services. Over the 3-year period with KARL STORZ as the service provider, the hospital spent an average of $100,031 for both new capital purchases and repair expenditures. After switching to an ISO for repair services for the following three years, the average expenditure per year went up by 23%, which included additional capital outlay for unplanned new equipment.

In fact, the increase in costs from using an ISO for endoscope service eroded any upfront savings that the hospital had experienced. When it comes to endoscope repair, cost shouldn't be the only factor that healthcare facilities consider. With higher quality of service, the initial equipment investment will be retained, reducing the need to repurchase capital equipment in the near future. This lowers long-term costs and the total cost of ownership.

The less expensive solution is not always the best choice as this real-world example demonstrates. Significant problems including increased frequency of repairs, slower turnaround time, inconsistent repair results, and operating room delays can cause risks to clinical performance. For endoscope care, the higher the quality of service and repair, the lower the total cost of ownership.

Additionally, surgeons and OR staff needed to be able to rely on high quality, consistent service and prompt turnaround times. The value of timely, high-quality service is more than worth the investment. Hospitals and outpatient facilities require equipment that is well maintained and ready to deliver optimal surgical performance and patient safety at all times. The resulting surgeon confidence and satisfaction helps them attract and retain the best surgeons. The quality and dependability of endoscopic equipment is essential to the facility's recruiting efforts, as well as their overall reputation and patient safety.

Note: For more information go to Endoscopic & Instrument Exchange Service Program - Karl Storz (karlstorznetwork1.com)

Quality of Medical Device Servicers Questioned

Advocacy group calls for greater FDA oversight of independent repair firms.

Third-party companies that service complex medical devices should be held to the same standards as repair services provided by the original device manufacturers, according to a whitepaper issued by the Medical Imaging & Technology Alliance (MITA). Although the FDA holds device manufacturers accountable, MITA Executive Director Patrick Hope says no public or private entity provides the same oversight of third-party servicing businesses.

The MITA whitepaper says the FDA enforces strict pre- and post-market requirements for manufacturers, which must register devices, report associated adverse events and maintain a quality management system. It also points out that accreditation organizations provide accountability for services provided by healthcare organizations.

However, says MITA, third-party companies are not held accountable by any such mechanisms. "Beyond voluntary standards, third-party servicing businesses operate within a regulatory gray area that raises significant concerns for patient safety and device performance," a MITA press release stated.

Mr. Hope says third-party servicing businesses should be held to certain minimum requirements, including the adoption of a Quality Management System and making themselves known to the FDA through registration and the reporting of notable malfunctions, deaths and serious injuries.

"If there is any takeaway from this document, it is that patients assume and deserve safe servicing," he says. "They should have confidence that the devices from which they are receiving care always perform safely and effectively, no matter who has been servicing the device."

FDA Issues Guidance on 'Remanufacturing' vs. 'Servicing' of Medical Devices

Goal is to enhance patient safety through appropriate regulation and oversight.

In June 2021, the FDA issued its first-ever draft guidance on the remanufacturing of medical devices, partly for the purposes of clarifying whether activities performed on medical devices are considered "servicing" or "remanufacturing."

In a blog post, law firm Snell &, Wilmer, LLP, says the FDA's goal is to help provide consistency and a better understanding of the applicable statutory and regulatory requirements involved, while also providing recommendations for information that should be included in labeling. The clarification of "remanufacturing" versus "servicing" is meant to address whether activities performed by original equipment manufacturers (OEMs) and third parties on devices intended for reuse and maintenance are considered "remanufacturing," writes the firm.

The FDA now defines remanufacturing as "the processing, conditioning, renovating, repackaging, restoring or any other act done to a finished device that significantly changes the finished device's performance or safety specifications, or intended use." Conversely, the FDA says, servicing involves repair and/or preventive or routine maintenance of one or more parts in a finished device after distribution, for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use.

Entities that perform remanufacturing activities are subject to the regulatory requirements set forth in the Federal Food, Drug, and Cosmetic (FD&C) Act, even if the entity self-identifies as a servicer, says Snell & Wilmer.

In the draft guidance, the FDA writes, "Regardless of an entity's self-identified designation as a 'servicer' or 'remanufacturer,' the FDA focuses on the specific activities an entity performs on a particular device. The FDA enforces requirements under the FD&C Act and its implementing regulations on entities engaged in remanufacturing, including but not limited to registration and listing, adverse event reporting, the Quality System (QS) regulation, and marketing submissions."

"Many medical devices are reusable and need preventative maintenance and repair during their useful life; therefore, proper servicing is critical to their continued safe and effective use," says William Maisel, MD, director of the Office of Product Evaluation and Quality in FDA's Center for Devices and Radiological Health. "It is important for industry personnel, such as OEMs, servicers and remanufacturers, to have a clear understanding of activities that are considered remanufacturing so that they can apply appropriate statutory and regulatory requirements which exist to keep the American public safe."