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AORN Guidance Statement: Reuse of Single-Use …

IntroductionToday s economic environment has compelledhealth care organizations to explore methods toreduce health care costs. One prospectiveapproach to controlling rising costs is to reprocesssingle-use medical devices. Reprocessing is rigor-ously regulated by the US Food and Drug Adminis-tration (FDA). AORN, the Association of periOpera-tive Registered Nurses, recognizes the need foreach health care facility to provide safe, cost-effec-tive, quality care to patients and realizes that manyfacilities in today s marketplace are reprocessingand reusing devices labeled for single use. Thesedevices are reprocessed either within the facility orby an external third party contracted to provide thereprocessing service. BackgroundAs surgery evolved and increased in complexity, thenumber of Single-Use devices utilized during surgeryincreased and continues to rise.

Introduction Today’s economic environment has compelled health care organizations to explore methods to reduce health care costs. One prospective

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Transcription of AORN Guidance Statement: Reuse of Single-Use …

1 IntroductionToday s economic environment has compelledhealth care organizations to explore methods toreduce health care costs. One prospectiveapproach to controlling rising costs is to reprocesssingle-use medical devices. Reprocessing is rigor-ously regulated by the US Food and Drug Adminis-tration (FDA). AORN, the Association of periOpera-tive Registered Nurses, recognizes the need foreach health care facility to provide safe, cost-effec-tive, quality care to patients and realizes that manyfacilities in today s marketplace are reprocessingand reusing devices labeled for single use. Thesedevices are reprocessed either within the facility orby an external third party contracted to provide thereprocessing service. BackgroundAs surgery evolved and increased in complexity, thenumber of Single-Use devices utilized during surgeryincreased and continues to rise.

2 In response to thistrend, the practice of reprocessing and reusing Single-Use medical devices began during the led to a wide variety of materials used indevice manufacture and devices became more com-plex, concern for patient safety, informed consent,and ethical practice intensified. In the late 1990s, theFDA determined that increased regulation of repro-cessing was needed to promote safe practice andprotect the public s safety. Although original equip-ment manufacturers have been regulated for manyyears, the FDA determined that they, along withthird-party reprocessors and hospital reprocessors,should be regulated uniformly according to the Food,Drug, and Cosmetic Act. The FDA sought the expert-ise of manufacturers, reprocessors, hospitals, users,and other interested parties in developing a regula-tory document, and in August 2000, it published itsrule governing the reprocessing/reusing of deviceslabeled for Single-Use only.

3 The document is applica-ble to both hospitals and third-party reprocessors. Reprocessing of Single-Use devices (SUDs) is addi-tionally addressed in the Medical Device User Feeand Modernization Act of 2002 (MDUFMA), whichestablishes new statutory requirements for SUDs,including labeling to identify the devices asreprocessed, submission of validation data for manyreprocessed SUDs, and submission of premarketnotification (510[k]) with validation data for someSUDs that previously were exempt from 510(k) sub-mission requirements. Firms and hospitals that arereprocessing are considered by the FDA as manufac-turers and therefore must comply with statutory andregulatory addition, the FDA haspublished an approved list of Single-Use devices thatare acceptable for reprocessing and a list of itemsthat may not be reprocessed.

4 In essence, the regula-tions regard reprocessors in the same way as originalequipment ,4 Guidance StatementReprocessing Single-Use medical devices is chosenby some health care facilities as a cost containmenteffort and to reduce the amount of waste is the role and responsibility of each health carefacility to determine whether and to what extent itwill engage in such practice. As licensed profession-als, perioperative nurses must demonstrate account-ability to the nursing profession, to other membersof the health care team, and to the public , the professional organization of andfor perioperative nurses, believes certain basic tenetsmust underpin any reprocessing program. The fore-most concern is for the patient s safety. Therefore, if a device cannot be cleaned, it cannot bereprocessed and reused; if sterility of a post-processed device cannotbe demonstrated, the device cannot bereprocessed and reused; if the integrity and functionality of areprocessed SUD cannot be demonstratedand documented as safe for patient careand/or equal to the original device specifica-tions, the device cannot be reprocessed andreused; and if anything is opened it needs to be decon-taminated before requirements of the MDUFMA regulation,the FDA has published a list of reprocessed SUDsthat have 510(k) approval/clearance; whose manu-facturers have provided supplemental data onfunctionality, cleaning, and sterility.

5 And whichnow are on the published list of devices that areacceptable for some operational savings may be real-ized by reusing certain devices, any cost-benefitanalysis would necessarily include labor costs;AORN Guidance Statement: Reuse of Single-Use Devices2006 Standards, Recommended Practices, and Guidelines309program costs, including quality system require-ments such as sterility and post-processing devicetesting (see section on quality system require-ments); documentation costs; and the potentialcost of device failure. Using the results of a thor-ough cost-benefit analysis, each provider facilitymust make an informed choice as to whether itwishes to invest the necessary resources to developa safe reprocessing system within the facility. Useof an external reprocessor presents a different, butrelated, set of factors for consideration.

6 When adecision is made in favor of using an externalreprocessing company, it is the user facility sresponsibility to assess the quality of services pro-vided under the contractual userfacility should review the processes used by thecontracted agent and determine whether correctprocedures are being ofwhether an internal reprocessing program is devel-oped or an external reprocessing company isselected, the user facility should be aware that theFDA views any reprocessor as a manufacturer and,as such, subject to federal ,8,9 Federal Regulatory RequirementsIn August 2000, the FDA issued Guidance on thepractice of reprocessing and reusing medicaldevices intended to be used only once. The FDA sgoal in issuing this regulation was to ensure areprocessing and Reuse regulatory program that isbased on good science and protects the publichealth.

7 At the same time, the FDA intended toensure equitable regulatory requirements for allparties engaged in reprocessing. In the guidancedocument,10the FDA indicates that hospitals andthird parties that reprocess SUDs are subject to thesame regulations as the original equipment manu-facturers. The MDUFMA also addressed reprocess-ing of SUDs by amending the federal Food, Drugand Cosmetic Act (the Act) and establishing newstatutory requirements applicable to reprocessedSUDs, including requirements for quality system regulations, medical device reporting, registration and listing, labeling, premarket approval and premarket notification, medical device corrections and removals, and medical device System RegulationAll manufacturers, including hospital and third-partyreprocessors, are subject to the FDA Good Manufac-turing Practices (GMP) requirements.

8 These require-ments are presented in the quality system regulationthat governs the methods, facilities, and controlsused for designing, manufacturing, packaging, label-ing, storing, installing, and servicing system refers to the organizationalstructure, responsibilities, procedures, processes, andresources for implementing quality management. Fordevice manufacturers, including reprocessors, thissystem is required in addition to any quality improve-ment program that may be in place as required byother regulatory bodies. The quality system regula-tion addresses the areas shown in Table Device Reporting (MDR)Under MEDWATCH, the FDA s medical devicereporting program resulting from the Safe MedicalDevices Act of 1990 (Public Law 101-629),12bothmanufacturers and users are required to report deathsor serious injuries to the FDA if it can be reasonablydetermined that a medical device may have causedor contributed to the incident.

9 Manufacturers alsomust report certain device FDA considers reprocessors to be manufacturerswhen they reprocess an SUD,9hospital reprocessorshave dual reporting responsibility. They are subject tomanufacturer s reporting requirements (21 CFR, Part803 Subpart E)14as well as those for the device userfacility (21 CFR, Part 803, Subparts A and C).15,16 Although user facilities must report only deaths orserious injury, manufacturers reporting requirementsare more extensive and require additional supple-mental information. Manufacturers (reprocessors)also must report any event that requires the manufac-turer (reprocessor) to take immediate remedialaction. The Jan 26, 2000, issue of the Federal Registercontains the most recent MDR requirements. Hospi-tals that reprocess SUDs are subject to both userfacility reporting and the more comprehensive manu-facturer reporting and ListingAll persons or entities owning or operating estab-lishments that manufacture, prepare, or processdevices must register with the FDA.

10 The FDA usesReuse of Single-Use Devices2006 Standards, Recommended Practices, and Guidelines310this information to identify and locate establish-ments that it is required to inspect. When register-ing, the following information must be provided: name and address, business names used, business name of owner or operator, and establishment registering for the first time, a specificFDA form is required. An additional registrationform must be submitted annually thereafter. Inaddition to registering with the FDA, each repro-cessing entity must provide a list of the devices itintends to reprocess. A separate listing form mustbe submitted for each device to be are listed by category. The following infor-mation is required: FDA classification name, FDA product code, brand name, and common or usual information about registration andlisting is available in the Code of Federal Regula-tions (21 CFR, Part 807).


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