New Regs for Reprocessed Single-Use Devices

A single-use device is approved by the FDA as safe and effective for only one use. The Act defines a reprocessed SUD as an “original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient.” In some instances, hospitals are reprocessing SUDs in-house. In large part, however, a new industry of third-party reprocessors has developed. Symposium, “Regulatory and Liability Considerations.” 6 B.U.J. Sci & Tech 5, 32-33 (Feb. 18, 2000).

Hospitals and medical professionals, under pressure from HMOs, Medicare and insurance companies to cut costs, are opting to re-use disposable devices as a means of cost containment Id.; Hawkins D: “Risky Recycling.” U.S. News & World Report 62-64, 66-67, Sept. 20, 1999. In fact, hospitals and medical centers reportedly can save tens of thousands of dollars each year by using reprocessed SUDs. Svitak LS, Gross PJ: “Drug and Device Litigation in the 21st Century.” 17 Wm Mitchell Law Rev 271, 294 (2000) (citing Kolata G: “'Single-Use' Medical Devices Are Often Used Several Times.” The New York Times Nov. 10, 1999). An added advantage is that recycling SUDs cuts down on medical waste. Hawkins, supra. About 1 million SUDs are reprocessed in the United States annually, and approximately one-third of all hospitals use them. Westphal SP: “Risky Reuse of Medical Equipment Is on Rise.” The Los Angeles Times Aug. 2, 1999.

Doctors do not typically obtain a patient's informed consent before using a reprocessed SUD. Bioethicist John Fielder, Villanova University expert on reuse, calls the practice “medical experimentation without patient benefit, written consent – or even patient knowledge.” Hawkins, supra. Frequently, patients are billed the same amount, regardless of whether they received a new or a second-hand device. Some argue that this practice is unethical. For these reasons, U.S. News & World Report called reprocessed SUDs “medicine's dirty little secret.” Hawkins, supra.

Some doctors and OEMs have expressed concern that cleaning and reusing disposable medical devices endangers patients because SUDs are often difficult to clean and are not designed to withstand the harsh chemicals and high temperatures used in the sterilization process. Id.; Westphal, supra; Karst KR: “Going 90 in a 55 M.P.H. Speed Zone: Reprocessing of Used Single-Use Medical Devices and the Food and Drug Administration's Non-Enforcement of the Food, Drug, and Cosmetic Act.” 56 Food & Drug Law J 57, 68 (2001). Therefore, doctors and OEMs have argued against the use of reprocessed SUDs, citing “serious concerns about functionality and sterility” of such devices. Id. (citing Letter from Josephine Torrente, Hyman, Phelps & McNamara, P.C., on behalf of the Association of Disposable Device Manufacturers, to FDA Dockets Management Branch, at 12-14 (Feb. 1, 2000) (FDA Docket No. 99N-4491)). At least one OEM maintains that, based on independent testing, over 45% of reprocessed SUDs are non-sterile and, sometimes, blood and debris are visible on the devices. Symposium, supra, at 44. In addition, some doctors and OEMs are concerned that reprocessing may weaken the device, thereby increasing the likelihood of device failure. Reprocessors counter that OEMs are concerned about losing sales and suggest that some manufacturers may designate a device as “single-use” to increase a product's sales volume.

In recent years, however, the most hotly contested point regarding reprocessed SUDs was that OEMs and third-party reprocessors were not subject to the same FDA regulations for labeling a disposable device as reusable.

The FDA's Prior Exercise of Discretion

When the FDA approves an SUD, it does so for one use only. If an OEM wants to change the label from single-use to reusable, the FDA considers it a change in the intended use of the product that affects the safety and efficacy of the device. Therefore, the FDA requires OEMs to submit a 510(k) notice or a pre-market application demonstrating that the device is safe and effective for its new use. 21 C.F.R. ' 807.81(a)(3)(ii). The FDA will grant 510(k) clearance if it finds that a new device is “substantially similar” to one already deemed safe and effective. Testing for pre-market approval is much more extensive. The FDA requires the testing to demonstrate that the device actually is safe and effective, which can be a burdensome and expensive process.

For some time, the FDA elected not to require reprocessors to submit 510(k) notices or pre-market applications, even though the reprocessors change the SUD to a reusable device. It did so through the exercise of its “regulatory discretion.” Karst, supra, at 58 (quoting Letter from Larry Spears, Director, Division of Enforcement III, Office of Compliance (OC), CDRH, FDA, to Stephen Terman, Esq., Olsson, Frank & Weeda, P.C. (July 9, 1999) [hereinafter "Spears Letter]). Thus, unlike OEMs, the FDA did not require reprocessors to demonstrate that an SUD was safe and effective for an additional single use.

Commentators argued that the FDA's policies with respect to reprocessors of SUDs were inconsistent with FDCA requirements. See e.g., Karst, supra, at 76. OEMs formed the Association of Disposable Device Manufacturers to lobby the FDA and Congress, asking the FDA to “enforce the law.” Symposium, supra, at 43-44, 47.

In a July 9, 1999 letter to the Association of Medical Device Reprocessors, the FDA declared third-party reprocessing of SUDs to be “unlawful” unless the reprocessor provides documentation that the device is safe for reuse. Specifically, it stated: “Third-party reprocessing of devices labeled for single use is unlawful unless those engaged in this practice comply with all regulatory requirements for manufacturers, including pre-market notification requirements. FDA has exercised and will continue to exercise regulatory discretion for all pre-market notification requirements.” Karst, supra, at 65 & n.12 (quoting Spears Letter). Notably, however, the FDA added a disclaimer regarding its “regulatory discretion.” And FDA officials later admitted that they were not enforcing the policy of requiring reprocessors to meet the same regulatory requirements as OEMs. Hawkins, supra; see Symposium, supra, at 41 (FDA's response has been disappointing”).

Again in February 2000, the FDA said it would begin requiring both hospitals and third parties that reprocess SUDs to meet the same pre-market approval and other FDA requirements traditionally applied to SUDs. It issued a guidance document, which predicted a significant change in the FDA's oversight of SUD reprocessing (US. Dept. of Health & Human Services, Center for Devices & Radiological Health, Enforcement Priorities for Single-Use Devices Processed by Third-Parties and Hospitals. (Feb. 28, 2000)). Congress nevertheless determined that additional controls were necessary and, in October 2002, the Act became law.

New FDA Regulations for Reprocessed SUDs

In the most controversial provisions of the Act, Congress imposed significant reforms on the FDA's regulation of reprocessed medical devices approved or cleared by the FDA for single use only. In response, the FDA has recognized Congress' “intent to have the agency re-examine its policy with respect to reprocessed SUDs” and has stated that it “is committed to fulfilling its responsibilities under” the Act. 68 Fed. Reg. 23139, 23141 (2003). Thus, the FDA has established new regulatory requirements for reprocessed SUDs.

The FDA divided reprocessed SUDs into three groups: 1) Critical: devices intended to contact normally sterile tissue or body spaces during use; 2) Semicritical: devices intended to contact intact mucous membranes and not penetrate normally-sterile areas of the body; and 3) Noncritical: devices intended to make topical contact and not penetrate intact skin. 68 Fed. Reg. 38071, 38072 (2003). The FDA then used a Risk Prioritization Scheme (RPS) to evaluate whether the risk associated with a reprocessed SUD is high, moderate or law. The RPS was based on: 1) the risk of infection, and 2) the risk of inadequate performance following reprocessing. Id. The FDA also considered whether a reprocessed SUD is intended to come into contact with tissue at high risk of being infected with the causative agents of Creutzfeld-Jakob Disease, which generally includes devices intended for use in neurosurgery and ophthalmology. Id.

On April 26, the FDA published two lists required under the Act: 1) a list of critical reprocessed SUDs whose exemption from 510(k) requirements will be terminated, and 2) a list of reprocessed SUDs that are currently subject to 510(k) requirements for which enhanced 510(k) validation data must be submitted. 68 Fed. Reg. 40679, 40679 (2003). Now, reprocessors seeking 510(k) clearance – or seeking to maintain clearance previously obtained – must submit validation data regarding cleaning, sterilization, and functional performance. Also, the validation data must show that the reprocessed device will remain substantially equivalent to its predicate device and demonstrate the maximum number of times the device can be reprocessed safely and effectively. This differs significantly from the previous 510(k) provisions, which only required reprocessors to demonstrate that a non-exempt device was safe and effective for one additional use. The validation data are intended to ensure the “substantial equivalence” of reprocessed SUDs to their “predicate” devices. Id.

In addition, the Act requires reprocessors of Class III devices – the most stringent regulatory category for medical devices – to file Premarket Approval Applications. These are virtually identical in scope to the pre-market approval submission required for the original SUD, and must include validation data demonstrating the maximum number of times the device may be safely reprocessed. Id.

Another significant requirement imposed under ' 302 of the Act is labeling of reprocessed SUDs. Specifically, the Act requires reprocessed SUDs to carry a label stating that it is a “Reprocessed device for single use.” Section 302 also states that the label must “prominently and conspicuously” identify the reprocessor.

The Act requires the FDA to modify its MedWatch forms, which hospitals and medical practitioners use to report patient injuries to the FDA, and it directs the FDA to modify mandatory and voluntary MedWatch forms to facilitate the reporting of incidents involving reprocessed SUDs. Id.; see also 68 Fed. Reg. 22716, 22718 (2003). Now, the name of the reprocessor must be identified on the MedWatch forms. It is hoped that this change will lead to more accurate reporting of patient injuries caused by reprocessing that might have been incorrectly attributed to the original manufacturer.

The Act not only remedies the prior inconsistencies in FDA regulation of OEMs and third-party reprocessors, it implements new controls to ensure that reprocessed SUDs are safe and effective for reuse. The Act's new reporting requirements should enable the FDA to collect more data regarding incidents involving reprocessed SUDs, and the requirement that product labels identify the reprocessor may facilitate efforts to hold reprocessors accountable for injuries resulting from a contaminated or destabilized device. Yet, the Act leaves unresolved the issue of public awareness and patients' informed consent to the use of a reprocessed disposable device. Ultimately, however, the Act's reforms and the FDA's new regulations should achieve a greater balance between the competing goals of cost containment and public safety.

Single-use medical devices (SUDs) are designed and approved by the FDA to be used once and thrown away. The practice of cleaning and reusing disposable medical devices has resulted from hospitals' continuing search for cost-cutting alternatives. The safety and efficacy of reprocessing SUDs has been the subject of significant – and heated – debate.

The primary debate arose in the late 1990s, when the FDA held original equipment manufacturers (OEMs) to stringent regulatory standards but exercised its “regulatory discretion” not to hold third-party reprocessors to the same standards. On Oct. 26, 2002, President Bush signed the Medical Device User Fee and Modernization Act of 2002 (the Act), Pub. L. 107-250, which reforms the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. ' 321, et seq. The Act drastically reforms the FDA's regulation of the practice of reprocessing SUDs. Recent regulations published by the FDA address many of the concerns regarding patient safety – primarily, the risks of infection and device destabilization – that were at the center of the debate surrounding reprocessed SUDs.

The Business of Reprocessing Single-Use Devices

A single-use device is approved by the FDA as safe and effective for only one use. The Act defines a reprocessed SUD as an “original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient.” In some instances, hospitals are reprocessing SUDs in-house. In large part, however, a new industry of third-party reprocessors has developed. Symposium, “Regulatory and Liability Considerations.” 6 B.U.J. Sci & Tech 5, 32-33 (Feb. 18, 2000).

Hospitals and medical professionals, under pressure from HMOs, Medicare and insurance companies to cut costs, are opting to re-use disposable devices as a means of cost containment Id.; Hawkins D: “Risky Recycling.” U.S. News & World Report 62-64, 66-67, Sept. 20, 1999. In fact, hospitals and medical centers reportedly can save tens of thousands of dollars each year by using reprocessed SUDs. Svitak LS, Gross PJ: “Drug and Device Litigation in the 21st Century.” 17 Wm Mitchell Law Rev 271, 294 (2000) (citing Kolata G: “'Single-Use' Medical Devices Are Often Used Several Times.” The New York Times Nov. 10, 1999). An added advantage is that recycling SUDs cuts down on medical waste. Hawkins, supra. About 1 million SUDs are reprocessed in the United States annually, and approximately one-third of all hospitals use them. Westphal SP: “Risky Reuse of Medical Equipment Is on Rise.” The Los Angeles Times Aug. 2, 1999.

Doctors do not typically obtain a patient's informed consent before using a reprocessed SUD. Bioethicist John Fielder, Villanova University expert on reuse, calls the practice “medical experimentation without patient benefit, written consent – or even patient knowledge.” Hawkins, supra. Frequently, patients are billed the same amount, regardless of whether they received a new or a second-hand device. Some argue that this practice is unethical. For these reasons, U.S. News & World Report called reprocessed SUDs “medicine's dirty little secret.” Hawkins, supra.

Some doctors and OEMs have expressed concern that cleaning and reusing disposable medical devices endangers patients because SUDs are often difficult to clean and are not designed to withstand the harsh chemicals and high temperatures used in the sterilization process. Id.; Westphal, supra; Karst KR: “Going 90 in a 55 M.P.H. Speed Zone: Reprocessing of Used Single-Use Medical Devices and the Food and Drug Administration's Non-Enforcement of the Food, Drug, and Cosmetic Act.” 56 Food & Drug Law J 57, 68 (2001). Therefore, doctors and OEMs have argued against the use of reprocessed SUDs, citing “serious concerns about functionality and sterility” of such devices. Id. (citing Letter from Josephine Torrente, Hyman, Phelps & McNamara, P.C., on behalf of the Association of Disposable Device Manufacturers, to FDA Dockets Management Branch, at 12-14 (Feb. 1, 2000) (FDA Docket No. 99N-4491)). At least one OEM maintains that, based on independent testing, over 45% of reprocessed SUDs are non-sterile and, sometimes, blood and debris are visible on the devices. Symposium, supra, at 44. In addition, some doctors and OEMs are concerned that reprocessing may weaken the device, thereby increasing the likelihood of device failure. Reprocessors counter that OEMs are concerned about losing sales and suggest that some manufacturers may designate a device as “single-use” to increase a product's sales volume.

In recent years, however, the most hotly contested point regarding reprocessed SUDs was that OEMs and third-party reprocessors were not subject to the same FDA regulations for labeling a disposable device as reusable.

The FDA's Prior Exercise of Discretion

When the FDA approves an SUD, it does so for one use only. If an OEM wants to change the label from single-use to reusable, the FDA considers it a change in the intended use of the product that affects the safety and efficacy of the device. Therefore, the FDA requires OEMs to submit a 510(k) notice or a pre-market application demonstrating that the device is safe and effective for its new use. 21 C.F.R. ' 807.81(a)(3)(ii). The FDA will grant 510(k) clearance if it finds that a new device is “substantially similar” to one already deemed safe and effective. Testing for pre-market approval is much more extensive. The FDA requires the testing to demonstrate that the device actually is safe and effective, which can be a burdensome and expensive process.

For some time, the FDA elected not to require reprocessors to submit 510(k) notices or pre-market applications, even though the reprocessors change the SUD to a reusable device. It did so through the exercise of its “regulatory discretion.” Karst, supra, at 58 (quoting Letter from Larry Spears, Director, Division of Enforcement III, Office of Compliance (OC), CDRH, FDA, to Stephen Terman, Esq., Olsson, Frank & Weeda, P.C. (July 9, 1999) [hereinafter "Spears Letter]). Thus, unlike OEMs, the FDA did not require reprocessors to demonstrate that an SUD was safe and effective for an additional single use.

Commentators argued that the FDA's policies with respect to reprocessors of SUDs were inconsistent with FDCA requirements. See e.g., Karst, supra, at 76. OEMs formed the Association of Disposable Device Manufacturers to lobby the FDA and Congress, asking the FDA to “enforce the law.” Symposium, supra, at 43-44, 47.

In a July 9, 1999 letter to the Association of Medical Device Reprocessors, the FDA declared third-party reprocessing of SUDs to be “unlawful” unless the reprocessor provides documentation that the device is safe for reuse. Specifically, it stated: “Third-party reprocessing of devices labeled for single use is unlawful unless those engaged in this practice comply with all regulatory requirements for manufacturers, including pre-market notification requirements. FDA has exercised and will continue to exercise regulatory discretion for all pre-market notification requirements.” Karst, supra, at 65 & n.12 (quoting Spears Letter). Notably, however, the FDA added a disclaimer regarding its “regulatory discretion.” And FDA officials later admitted that they were not enforcing the policy of requiring reprocessors to meet the same regulatory requirements as OEMs. Hawkins, supra; see Symposium, supra, at 41 (FDA's response has been disappointing”).

Again in February 2000, the FDA said it would begin requiring both hospitals and third parties that reprocess SUDs to meet the same pre-market approval and other FDA requirements traditionally applied to SUDs. It issued a guidance document, which predicted a significant change in the FDA's oversight of SUD reprocessing (US. Dept. of Health & Human Services, Center for Devices & Radiological Health, Enforcement Priorities for Single-Use Devices Processed by Third-Parties and Hospitals. (Feb. 28, 2000)). Congress nevertheless determined that additional controls were necessary and, in October 2002, the Act became law.

New FDA Regulations for Reprocessed SUDs

In the most controversial provisions of the Act, Congress imposed significant reforms on the FDA's regulation of reprocessed medical devices approved or cleared by the FDA for single use only. In response, the FDA has recognized Congress' “intent to have the agency re-examine its policy with respect to reprocessed SUDs” and has stated that it “is committed to fulfilling its responsibilities under” the Act. 68 Fed. Reg. 23139, 23141 (2003). Thus, the FDA has established new regulatory requirements for reprocessed SUDs.

The FDA divided reprocessed SUDs into three groups: 1) Critical: devices intended to contact normally sterile tissue or body spaces during use; 2) Semicritical: devices intended to contact intact mucous membranes and not penetrate normally-sterile areas of the body; and 3) Noncritical: devices intended to make topical contact and not penetrate intact skin. 68 Fed. Reg. 38071, 38072 (2003). The FDA then used a Risk Prioritization Scheme (RPS) to evaluate whether the risk associated with a reprocessed SUD is high, moderate or law. The RPS was based on: 1) the risk of infection, and 2) the risk of inadequate performance following reprocessing. Id. The FDA also considered whether a reprocessed SUD is intended to come into contact with tissue at high risk of being infected with the causative agents of Creutzfeld-Jakob Disease, which generally includes devices intended for use in neurosurgery and ophthalmology. Id.

On April 26, the FDA published two lists required under the Act: 1) a list of critical reprocessed SUDs whose exemption from 510(k) requirements will be terminated, and 2) a list of reprocessed SUDs that are currently subject to 510(k) requirements for which enhanced 510(k) validation data must be submitted. 68 Fed. Reg. 40679, 40679 (2003). Now, reprocessors seeking 510(k) clearance – or seeking to maintain clearance previously obtained – must submit validation data regarding cleaning, sterilization, and functional performance. Also, the validation data must show that the reprocessed device will remain substantially equivalent to its predicate device and demonstrate the maximum number of times the device can be reprocessed safely and effectively. This differs significantly from the previous 510(k) provisions, which only required reprocessors to demonstrate that a non-exempt device was safe and effective for one additional use. The validation data are intended to ensure the “substantial equivalence” of reprocessed SUDs to their “predicate” devices. Id.

In addition, the Act requires reprocessors of Class III devices – the most stringent regulatory category for medical devices – to file Premarket Approval Applications. These are virtually identical in scope to the pre-market approval submission required for the original SUD, and must include validation data demonstrating the maximum number of times the device may be safely reprocessed. Id.

Another significant requirement imposed under ' 302 of the Act is labeling of reprocessed SUDs. Specifically, the Act requires reprocessed SUDs to carry a label stating that it is a “Reprocessed device for single use.” Section 302 also states that the label must “prominently and conspicuously” identify the reprocessor.

The Act requires the FDA to modify its MedWatch forms, which hospitals and medical practitioners use to report patient injuries to the FDA, and it directs the FDA to modify mandatory and voluntary MedWatch forms to facilitate the reporting of incidents involving reprocessed SUDs. Id.; see also 68 Fed. Reg. 22716, 22718 (2003). Now, the name of the reprocessor must be identified on the MedWatch forms. It is hoped that this change will lead to more accurate reporting of patient injuries caused by reprocessing that might have been incorrectly attributed to the original manufacturer.

The Act not only remedies the prior inconsistencies in FDA regulation of OEMs and third-party reprocessors, it implements new controls to ensure that reprocessed SUDs are safe and effective for reuse. The Act's new reporting requirements should enable the FDA to collect more data regarding incidents involving reprocessed SUDs, and the requirement that product labels identify the reprocessor may facilitate efforts to hold reprocessors accountable for injuries resulting from a contaminated or destabilized device. Yet, the Act leaves unresolved the issue of public awareness and patients' informed consent to the use of a reprocessed disposable device. Ultimately, however, the Act's reforms and the FDA's new regulations should achieve a greater balance between the competing goals of cost containment and public safety.