The reprocessing of single-use devices (SUDs) received much ink and argumentative moments in 2006. The practice also received new points of governance in 2006 from the U.S. Food and Drug Administration (FDA). Regulated by FDA since 2000, reprocessing allows SUDs to be cleaned, checked for functional integrity, and sterilized according to all of the requirements currently applicable to original equipment manufacturers (OEMs). However, the debate on the safety and efficacy of this practice has bounced back and forth as much as any child’s rubber ball over the last several years.
Much of this argument encircles the use of third-party reprocessors to reprocess SUDs. According to FDA, since 2000, on average, FDA has conducted inspections of reprocessor firms once every two years — a rate it claims is “considerably higher” than the average one inspection in four years for OEMs.¹ Of the seven firms currently known to be reprocessing, all have been inspected within the last two years. FDA says it continues to evaluate newly registered firms to confirm whether they are performing SUD reprocessing and updates its inspectional plan as required.
Don Selvey, vice president of regulatory affairs for Ascent Healthcare Solutions, Inc., — one of those aforementioned seven firms — says it is most prudent to contract with a commercial firm regulated by the FDA. “They are going to have the responsibility, they are going to have the liability, they are going to have the validated processes and methods. Then, all of the responsibility is shifted to that commercial firm,” he points out.
Adding to the accompanying liability of reprocessing SUDs, FDA recently ordered that all reprocessors — be it a healthcare facility or a third-party reprocessor — must prominently and conspicuously add its name to the reprocessed device. It needs to be a generally recognized abbreviation of the name, or a unique and generally recognized symbol identifying such manufacturer. ² The only exception to this requirement is when the original device, or an attachment to it, does not prominently and conspicuously identify the name of the OEM. Under this circumstance, the reprocessor may use a detachable label on the packaging to identify the manufacturer of the reprocessed device. The requirement that a reprocessed SUD, or an attachment to the SUD, must bear the reprocessor’s mark became effective on August 1, 2006.
Post-market monitoring of device-related adverse events (AEs) and product problems is accomplished through the FDA Medical Device Reporting (MDR) system. FDA also receives voluntary reports, generally from healthcare professionals, through its MedWatch reporting system. Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the MedWatch reporting form 3500A was revised to include a data entry field to ask if the device associated with the reported event was a reprocessed SUD. This question was added to the form to enhance the Agency’s ability to quickly identify and investigate reports of problems associated with reprocessed SUDs, according to Daniel Schultz, MD, director of FDA’s Center for Devices and Radiological Health (CDRH) in a presentation before the Committee on Government Reform on September 26, 2006.
Schultz notes that as of September 2006, FDA had received nearly 200 pre-market notification 510(k) submissions for reprocessed SUDs. These submissions cover from one, to as many as several hundred, device models, he explains. Of the almost 200 submissions, approximately 67 percent have been cleared by FDA.¹
In conjunction with Schultz’s presentation to the Committee on Government Reform, on Sept.25, 2006, FDA published two new rules: the direct final rule for Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; and a proposed rule for Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data; Companion to Direct Final Rule (proposed rule). These amendments will help ensure that reprocessors submit the data, including cleaning, sterilization, and functional performance data, needed to demonstrate that their device is substantially equivalent to the predicate device.
Schultz adds that the FDA continues to review and assess the practice of reprocessing SUDs, including doing the following:
- CDRH established an active internal work group to ensure that review scientists remain current with the evolving scientific literature and new consensus standards that are relevant to the reprocessing of SUDs.
- CDRH has convened a second work group, called the “Post-market Issue Action Team,” to develop a long-term strategy for monitoring, evaluating, and communicating information about reused SUDs.
- CDRH continues to submit reprocessor inspection requests to the Office of Regulatory Affairs to schedule inspections of reprocessor facilities to assess conformance with the quality system regulation.
- CDRH periodically updates its reuse Web page so that healthcare facilities and providers will have current information on legally marketed, reprocessed SUDs. Recently, easy-to-read tables listing FDA requirements for specific reprocessed SUD types were added to the Web site. (www.fda.gov/cdrh/reuse/index.html).
- CDRH regularly updates guidance to industry and FDA reviewers on validation data requirements for reprocessed SUDS.
- CDRH regularly updates the list of reprocessed SUDs subject to the additional pre-market requirements imposed by MDUFMA.
- CDRH is conducting research to develop/ establish “acceptable” SUD cleaning criteria.
- CDRH is collaborating with two local healthcare facilities to help monitor changes in the design of some SUDs and identify new SUDs being reprocessed.
“I believe FDA currently has many tools to ensure the safety, effectiveness, and manufacturing quality of reprocessed, single-use devices,” adds Schultz in his report to the Committee.
But some disagree. A group formed in September 2006 called PatientGUARD — Patient Groups United Against Reprocessing Dangers — is fighting to do away with reprocessing SUDs. The group’s loudest plea is its push for hospitals to obtain consent from patients before a reprocessed device is used in the patient’s treatment. The group says that despite the intended single use and expected disposal of these items, the “devices are being picked from the medical waste stream” and are putting patients at risk for infection, injury or worse.
PatientGUARD also says government oversight lacks adequacy and says states need to step in for further oversight. “The FDA hasn’t done enough to either protect or inform the public of the dangers of reprocessed single-use devices,” says Bob Franks, president of the HealthCare Institute of New Jersey, in a press release. The HealthCare Institute of New Jersey is a trade association that represents several medical devices companies, and is the founding parent of Patient- GUARD.
A critical reprocessed SUD is intended to contact normally sterile tissue or body spaces during use.
A semicritical reprocessed SUD is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.
A noncritical reprocessed SUD is intended to make topical contact and not penetrate intact skin.
The group also says it seeks the following:
- Written patient consent prior to using a reprocessed SUD
- Require healthcare facilities to inform physicians that they may be using reprocessed SUDs
- Provide physicians with the opportunity to reject using reprocessed SUDs
- Require that patient records include an inventory of reprocessed SUDs used in their treatment
- Establish registration, tracking, and reporting procedures to monitor the distribution and use of reprocessed SUDs
- Establish liability among reprocessors for reprocessed SUD failures and injury
“Patients are entitled to decide what risks to take. Withholding the facts about the risks these devices pose, or even that they may be used, erodes the public’s trust,” Franks adds.
Nancy Chobin, RN, AAS, CSPDT, CSPDS, CSIT, CSPDM, SPD educator for the Saint Barnabas Health Care System, and executive director of CDSPD, Inc., says this push for informed consent is nothing more than a ploy to soak up more hospital funds for the OEMs. “There is nothing wrong with reprocessing with a third party reprocessor,” she asserts. Chobin, who has been a long time advocate of streamlining best practices for the central sterile and sterile processing departments around the country and educating professionals on these best practices, adds that she truly believes the process to be safe, or she would never allow it in the Saint Barnabas system.
Selvey says Ascent currently has 74 FDA approved 510(k)s, “and this number will continue to rise,” he adds. (For a full list of SUDs known to be reprocessed or considered for reprocessing, visit: www.fda.gov/cdrh/reuse/fr-attachment1.html.) Moreover, according to collected 2006 press releases from Ascent, the company has reprocessed more than 40 million SUDs for over 1,700 healthcare facilities nationwide — many of which frequent the annual top U.S. hospitals lists. In the coming year, Ascent expects to help its customers save in excess of $92 million in supply expenses. This is due in part to the fact that some reprocessed devices cost a healthcare facility 50 percent of the cost of the new device. Ascent also expects to eliminate over 7,000 tons from the nation’s landfills annually. In fact, in May 2006, Ascent received the Hospitals for a Healthy Environment (H2E) Champions for Change Award for its leadership in improving the environmental performance of the healthcare sector. The Champions for Change Award recognizes Ascent’s contribution to helping the healthcare industry address environmental issues through the reduction of medical waste.
ECRI, a nonprofit health services research agency, in its latest coverage of this topic, offers the following pointers for hospitals looking to employ a third-party reprocessor:³ 1. Establish a multidisciplinary committee to evaluate each prospective vendor and its products 2. Confirm that the company is registered with FDA, and verify that the company has FDA 510(k) clearance or a pre-market approval from FDA to reprocess the devices under consideration 3. Make decisions on informed consent based on local and state laws (taking into account that several states have pending legislation that, if enacted, will require that informed consent be obtained) and on the input of the facility’s patient safety, legal, and risk management departments.
ECRI declares that the recent “largely negative, and largely incorrect media attention” on the subject of reprocessing SUDs is one of the biggest challenges in instituting a reprocessing program and overcoming the poor understanding staff members may have of the subject. ECRI writes in its device safety newsletter in October 2006 that it “neither encourages nor condemns” the reuse of SUDs, adding, “We have seen no independent evidence that the practice of reprocessing SUDs, as regulated by FDA, affects patient care or safety.”
On July 31, 2006, the Associated Press (AP) published an article titled, “Recycling Single-Use Devices Raises Concerns,” in which AP stated that FDA had received 13 reports of patient deaths and 421 reports of other events associated with reprocessed SUDs.4 One hundred thirty of these cases involved serious patient harm, according to the report.
The article referenced a July 2006 FDA study in which a search of the agency’s Manufacturer and User Facility Device Experience (MAUDE) database for reports of incidents involving reprocessed SUDs between December 2005 and July 2006 produced 434 reports. However, AP had to revise its story on August 11, 2006, when FDA pointed out that contrary to its initial report, no patient deaths were involved in the use of reprocessed SUDs and that only 65 of the reports actually involved or were suspected to involve reprocessed SUDs.
In Schultz’s presentation in September he notes, “According to FDA, on Jan. 24, 2006, I and others briefed this Committee about SUD reprocessing. At that time, we provided background information including the current regulatory framework and AE data. Specifically, we searched our MAUDE database for reports from October 22, 2003, to December 13, 2005, that were coded as adverse events associated with reprocessed SUDs. The search produced 176 reports of death, serious injury, and/or device malfunction; however, analysis of these reports did not disclose a clear causative link between a reprocessed SUD and subsequent patient injury or death.”¹ In July 2006, FDA updated its search to include all reports entered into the MDR, MAUDE, and MedWatch databases between December 2005 and July 2006. FDA had received a total of 434 reports — this includes MedWatch forms on which the reprocessed SUD field was checked “yes.”
“Our analysis of these reports determined that many of the devices were not reprocessed SUDs. Rather, they were implanted devices or devices that were designed to be reusable,” Schultz points out.
The final analysis of the reports found that the types of adverse events reported to be associated with the use of SUDs were the same types of events that also are being reported for new, non-reprocessed devices. Therefore, it was unclear whether the device, the medical condition of the patient, the medical procedure, or other confounding factors caused or contributed to the adverse event.
“It is as safe and effective as a new device if they meet our requirements,” Larry D. Spears, deputy director for regulatory affairs at FDA, solidified for the AP.
ECRI, in its newsletter report, further points out that education on the issues is key. New Jersey recognized this and set out last October to educate its players. “The FACTS about Third Party Reprocessing,” a seminar co-sponsored by the New Jersey Healthcare Central Service Association (NJHCSA), the Northern New Jersey Association for Professionals in Infection Control and Epidemiology, Inc. (APIC) chapter, and the Mid Atlantic Central Service Association (MACSA) of the International Association for Healthcare Central Service Materiel Management (IAHCSMM), was held October 4, 2006 to present the facts about third-party reprocessing “so facilities can make informed decisions based upon facts and science.” Featured speakers at the event included FDA’s Larry Spears, Ascent’s Don Selvey, and Dan Vukelich, director of the Association of Medical Device Reprocessors.
Anthony Monaco of the New Jersey State Department of Health addressed the New Jersey State standards for reprocessing SUDs, and Nancy Chobin and Terri Matthews, RN, CSPDM, CNOR, both of the Saint Barnabas Health Care System, addressed the financial impact reprocessing SUDs has on a healthcare facility.
“We spent a tremendous amount of time covering FDA oversight and how they control and restrict these reprocessed goods, also the moral, legal and ethical were all addressed,” says Etta Bushong, ACSP, CRCST, CSPDT, materials manager for Bon Secours Healthcare System of New Jersey, the Region 2 director for the American Society for Healthcare Central Service Professionals (ASHCSP), who was so motivated by the event that she now has set out to educate other professionals on the topic.
Other recent regulation concerning the reprocessing of SUDs includes that of the FDA amending certain classification regulations for reprocessed SUDs whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to pre-market notification for which validation data, as specified under MDUFMA, are necessary in a 510(k).5 The rule will be effective February 7. Any changes to the current verbiage of the rule hinges on any comments that may have been received by the December 11, 2006 deadline. If no significant adverse comments were received, a document confirming the effective date of the final rule will be published in the Federal Register by January 11.
1. United States Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Statement of Daniel Schultz, MD, director of CDRH, before the Committee on Government Reform. September 26, 2006. Accessed online at: www.fda.gov/cdrh/reuse/testimony-092606.html.
2. FDA. Guidance for Industry and FDA Staff - Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices. May 1, 2006.
3. ECRI. Health Devices Alert newsletter. Vol. 30, No. 42. October 20, 2006.
4. Associated Press. Recycling single-use devices raises concerns. Aug 11, 2006. Available online at: www.msnbc.msn.com/id/14118527.
5. FDA. Medical Devices; Reprocessed Single-Use Devices; Requirement for Submission of Validation Data. Federal Register. Volume 71, Number
REPROCESSING: Q & A with Don Selvey, vice president of regulatory affairs and quality assurance with Ascent Healthcare Solutions, Inc. SUD REPROCESSING UPDATEQ: How can your reprocessing services help increase supply and reduce costs?
A: “Reprocessed single-use devices (SUDs) offer a tremendous advantage. In addition to the cost savings benefit, reprocessing these devices is a form of recycling that pays dividends to a hospital in waste and community benefit.
“Reprocessed devices are available in several models. One is a classic out-sourcing model, in which the hospital sends devices to a reprocessor and receives the same devices back after they have been cleaned, tested, repackaged, and sterilized; or, a distribution model in which reprocessed devices are shipped from the reprocessor’s inventory to replenish or maintain the facility’s inventory at par.”Q: What standard protocol should your clients adhere to on their end? For example, should the item be sent wrapped, what instrument documentation is needed, etc.?
A: “The simplest method of device collection is also the best – use the specially designed collection system which requires no decontamination of the device. This greatly reduces the risk of healthcare worker exposure. A critical step in the development of reprocessing steps is determining how a device will be collected, decontaminated, and then cleaned. The ‘worst-case’ scenario for the reprocessor is if no decontamination is done at the hospital or ASC, and the device is allowed to dry (under extreme environmental conditions) in the container. Consequently, when the process is developed, this scenario is assumed to exist. That is, all the cleaning operations are predicated on this worst-case situation. Since decontamination is not required, why endure the cost and risk to personnel? Merely place it in the container and let the reprocessor take care of it. No inventory or documentation is required; the reprocessor does that, too.”
Q: How many times can you reprocess an item? When is it time to “call it quits” with an item and purchase a new one?
A: “Each reprocessable device has a finite life cycle; devices cannot withstand unlimited reprocessing cycles. In fact, reprocessors must validate every aspect of the reprocessing operation with this limitation in consideration. Consequently, some devices can be reprocessed once, some three times, some six times – all dependent on the process that has been developed and determined to be consistently effective. Regardless of the number of allowable cycles, each device must also meet the minimum performance specifications. Even if a device is allowed to be reprocessed three times, if it fails the performance test, it will be rejected – and not returned to the hospital.”
Q: What are the more common or most economical items to reprocess?
A: “Although reprocessing is acknowledged to be extremely limited, there is a broad array of devices suitable for this program. Many of the durable orthopedic devices are reprocessable: burs, bits, blades, arthroscopy shavers, and external fixators. Likewise, several devices used in minimally invasive surgery can be reprocessed, such as trocars, scissors, dissectors, and ultrasonic/electrocautery scalpels.
“Obviously, not all SUDs are candidates for reprocessing, but the variety may be surprising.”