By Nancy Chobin, RN, AAS, ACSP, CSPM
Q: My hospital is implementing a third-party reprocessing program. I am not in support of this. I cannot believe that a company can take a single-use device and make it safe again. I am all for containing costs but not at the risk of a patient safety. What do you know about this process?
A: Third-party reprocessing is an excellent sustainability project for any healthcare facility. Why? Because we have limited renewable resources, we need to protect the air, water and land we have and our landfills are overloaded with garbage, including medical waste which can seep into groundwater. When the healthcare industry moved to single-use devices (SUD) in the early 1980s no one thought of their impact on the environment. Today, healthcare facilities are dealing with skyrocketing healthcare costs and one way to help with this is a third-party reprocessing program.
In 1999, Congress became involved with reprocessed single-use devices. The idea of reusing a medical device is not a new one. Years ago, everything was reused. Medical devices were made from durable materials like glass, rubber and metal. When we reprocessed them (i.e., probes and surgical instruments) the process involved little more than hand wiping, dipping and soaking in a disinfectant, and/or sterilization.
The healthcare industry demanded new materials which developed into the single-use industry. The practice of reprocessing SUDs expanded when an increasing number of hospitals decided that reuse was a cost-saving measure and when the amount of medical waste generated by disposable devices became noticeable (e.g., cardiac catheters).
Between August 1996 and December 1999, the Food and Drug Administration (FDA)'s Medical Device Reporting (MDR) system documented 245 adverse events associated with the reuse of SUDs: seven deaths, 72 injuries, 147 malfunctions and 19 "other" incidents, as reported by manufacturers. The reports listed 70 different types of products, but the FDA could not discern a pattern of failures with reused SUDs that differ from those observed with their initial use.
This resulted in Congress granting the FDA more than $1million to investigate the reuse issue. Meetings were held throughout the U.S.; however at those meetings, most healthcare facilities denied reuse of SUDs. Furthermore, no one was tracking injuries and deaths due to SUDs. As a result, in August 2000, “Enforcement Priorities for Reuse of Single Use Devices” was published by the FDA. Under this regulation, any hospital or company that reprocesses SUDs must register with the FDA and comply with Good Manufacturing Practices (GMPs).
Many healthcare facilities still look at reuse as a lower standard of care for patients. There are practitioners who are not convinced it is safe and efficacious. The reality is that all institutions must examine cost-savings initiatives that can maintain quality patient outcomes, save the facility money and support sustainability activities. Medical device reprocessing is one solution. Why? Because the usual cost to reprocess a single-use device is approximately 50 percent of the cost of a new device.
The MDR industry has been in existence for more than 20 years. During that time, more than 30 million devices have been reprocessed. As a new industry, the MDR industry is under continual scrutiny of federal, state and local organizations.
You need to understand the science behind the process. What is MDR? It is:
- Identifying specific, durable, single use items that fit well-defined criteria.
- Reprocessing of those items to the substantial equivalent of an original equipment manufacturer (OEM) is the charge of the MDR.
- Unless the device is “re-manufactured” to the specifications of the OEM” the device cannot be re-processed.
- The Heath Care Financing Authority has agreed that a re-processed device can be charged to the patient the same amount as a new device (because it must be substantially the equivalent).
Steps in the MDR process include:
- Inspection: each device must be inspected. This is NOT required or OEMs
On June 26, 2003, the Medical Device User Fee and Modernization Act (MDUFMA) established requirements that hold the reprocessing manufacturer to more stringent requirements than the OEM.
The FDA has stated that that reprocessed medical devices are to be viewed no differently from the OEMs. There is a misunderstanding that manufacturers label some medical devices “single-use” because these devices are unsafe for more than one use. However, the FDA has no labeling requirements regarding number of times a device can be used.
The Joint Commission is not opposed to reprocessed devices, however they do require specific policies and procedures for this practice.
Medical device manufacturers mark each device with a unique identifying number that provides a history of each device including:
- All steps taken throughout the re-processing process
- Collection site (healthcare facility)
- Job control number
- The number of times the item has been re-processed
Based on data collected by the MDR, they know how many times they can safely reprocess a device. If the healthcare facility sends the device for reprocessing and the device has been reprocessed the maximum number of times, it is not reprocessed and the facility is not charged. If, however, the device fails any of the quality checks at any point, the device will not be reprocessed and the facility not charged.
The devices that can be reprocessed are listed by each company. Not all products can be reprocessed. Those that can are collected in FDA approved collection containers. For the program to be successful, it is recommended that the containers be placed in strategic locations to maximize compliance and savings, and that causes minimal interruption to existing workflow processes. Collection is usually made by the company but this can vary with the vendor.
In a congressional hearing in February 2000, it was estimated that 464 out of 3,000,000 reported adverse events could have been attributed to reuse of a SUD (David Feigal, CDRH). Therefore 99.8 percent of reported adverse events may have occurred with OEM devices (new).
On March 21, 2016, Healthcare Purchasing News reported that OEM devices are nearly five times more likely to be defective than reprocessed single-use devices, a study finds.
Original equipment manufacturers (OEM)s' single-use devices may have higher defect rates than comparable reprocessed devices, a study in the Journal of Medical Devices suggests. The independent study led by Banner Health was designed to increase the data available on defect rates of reprocessed SUDs.
OEMs have historically claimed new devices have lower defect rates when compared to reprocessed devices. The FDA considers reprocessed SUDs that meet the FDA's regulatory requirements to be substantially equivalent to new devices. The new study's data supports the FDA's position and suggests that reprocessed SUDs may actually have lower defect rates than new devices.
Study data was collected over a seven-month period in 2013 for two types of bipolar and ultrasound diathermy devices used at Banner Health. A total of 3,112 devices were included in the study -- roughly 55 percent of them were reprocessed devices and roughly 45 percent were new devices. Devices were determined to be defective by a surgical team member when they did not function in a manner consistent with the intended purpose. OEM devices were reported as defective 4.9 times more frequently than reprocessed devices.
The science of re-manufacturing SUDs indicates this practice is safe, effective and cost-effective. The main reason we have difficulty with this change in protocols is “sacred cows” and a lack of understanding of the science behind the process.
I urge you to visit a third party reprocessing facility; in fact, visit several of them. Recognize the savings for your facility. I personally have participated in third-party reprocessing programs for more than 15 years and have found the process to be safe and effective. When we can save costs, improve the environment and not impact on the safe delivery of patient care, it is a win-win for everyone.
Nancy Chobin, RN, AAS, ACSP, CSPM, is a sterile processing consultant and educator.
Reference: Food and Drug Administration, Enforcement Priorities for Reuse of Single Use Devices. August, 2000.