An MD&DI January 1997 Feature Article

GMPs

The remanufacturing of medical devices is a growing phenomenon within the health-care industry. The types of devices that are currently refurbished range from machines such as neonatal monitors and anesthesia vaporizers to devices used in surgery, such as forceps, endoscopes, and cytoscopes. Many firms are also restoring used disposable devices, such as catheters and surgical cutting instruments and accessories. Regardless of the product type, medical device remanufacturing carries an indisputable benefit--reduced health-care costs. With that benefit, however, comes an increased risk that the original device's safety and effectiveness may be compromised. Such risk has led many to wonder whether medical devices can, in fact, be restored to their original safety and effectiveness, and to ask about who is ultimately responsible for ensuring the safety of such devices.

FDA fully recognizes the existence of the potential risks related to device remanufacturing. On October 7, 1996, the agency published its quality system regulation--a revision of its good manufacturing practices (GMP) regulation--which specifically includes a definition of remanufacturer.¹ As for servicers and refurbishers, the agency has set up a special task force that will separately address regulations for those types of firms.

FDA's concern regarding device remanufacturing is also evidenced by the fact that, by November of last year, the agency had issued at least three warning letters to remanufacturers of medical devices. Among the significant violations cited in these letters were the failure to document conformance to original device specifications, failure to validate reprocessing procedures, and failure to file a 510(k) notification.

The risk of reduced safety and effectiveness extends to the original device manufacturer who, aside from losing sales to its remanufacturing competitors, faces possible damage to its business reputation and the increased likelihood that it will be called to defend a product liability suit. What, if anything, the original manufacturer chooses to do in such situations will vary depending on the circumstances. If the impact on its business is not significant, the best alternative may be to do nothing. However, if substantial sales are being lost and the original manufacturer's reputation is being damaged, some action may be necessary. Options available to companies finding themselves in such situations are discussed in the latter portion of this article.

THE QUALITY SYSTEM REGULATION

The new quality system regulation, which becomes effective June 1, 1997, specifically includes remanufacturers in the category of manufacturer. A person or firm that "processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications or intended use" qualifies as a remanufacturer under section 820.3(w). The preamble to the final regulation explains that by specifying that such individuals are subject to the regulation, FDA is simply codifying "longstanding policy."

The longstanding policy was expressed in part in a compliance policy guide (CPG) published by FDA in 1987--and later revised in March 1995--for reconditioners and rebuilders of medical devices.² Section 300.200 (formerly section 7124.28) states that a company acquiring ownership of a device and restoring or refurbishing it for purposes of resale or commercial distribution must comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. The section also specifies that remanufacturers must register and comply with the requirements for labeling, premarket notification, GMPs, and medical device reporting.

With respect to labeling requirements, section 300.200(C) requires, among other things, that a remanufacturer "clearly and conspicuously" disclose on the label its name and address, the original manufacturer's name and address, and the fact that the device was reconditioned or rebuilt. As for premarket notification, FDA supplemented its guidance in the specific instance of refurbished disposables in a draft document entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device." The agency advises that the labeling change that occurs in the reuse of single-use-only devices "impacts intended use and would usually require submission of a 510(k)."³ Although not binding, an FDA discussion document dated September 1995, which was used to draft the final revisions to the quality system regulation, indicates FDA's policy that the remanufacturing of disposables changes the intended use. It explains that companies that receive used, single-use devices from a health-care provider, resterilize them, and return them to the provider have changed the intended use from single use to multiple use, and are consequently considered remanufacturers.⁴

FDA previously expressed its concern for the safety of remanufactured disposables in CPG 300.500 (formerly section 7124.16), in which the agency states that "the reuse of disposable devices represents a practice which could affect both the safety and effectiveness of the device." The CPG states that institutions and practitioners reusing disposable medical devices should be able to demonstrate that the device can be adequately cleaned and sterilized, that the physical characteristics or quality of the device are not adversely affected, and that the device remains safe and effective for its intended use. And once a disposable device is used, FDA advises that the responsibility for safety and effectiveness shifts to the refurbisher and second-time user. The CPG states: "Since disposable devices are not intended by the manufacturer . . . for reuse, any institution or practitioner who resterilizes and/or reuses a disposable medical device must bear full responsibility for its safety and effectiveness."

In the new quality system regulation, FDA goes one step further than its previous written policy by defining a remanufacturer as anyone who changes a device's performance or safety specifications. Although the terms performance and safety specifications are not defined in the regulation, use of the terms is consistent with the policy evidenced in the three warning letters FDA issued last year in which it warned remanufacturers of their failure to establish procedures for returning a device to original specifications. Use of those terms also indicates the agency's position that a 510(k) would be required for a specification change that could affect safety or performance. Following publication of the new regulation, Kim Trautman, FDA's quality system expert, stated that, with respect to disposables, the agency will exercise "regulatory discretion" by not requiring 510(k) submissions immediately and will wait until a special task force makes a recommendation.

The preamble to the quality system regulation indicates that FDA recognizes the special issues posed by servicers and refurbishers who return devices to the original specifications outside the control of the original manufacturer. However, because of "sharply divided views" on how to deal with this group, FDA has elected to address them in a separate rule following evaluation by a special FDA task force.⁵ Many of the firms in this group were previously excluded from CPG 300.200, which specifically stated that it applies to persons or firms that "acquire ownership" of a device and does not apply to those who simply service a device and return it to its owner. In practice, however, some remanufacturers were using special leasing agreements so that they never "acquired ownership" of a device, and therefore the CPG did not apply to them.^4,6 Effective June 1, 1997, however, a servicer or refurbisher who significantly changes the performance, safety specifications, or intended use of a device--regardless of whether it acquires title to the device--will fall within the definition of remanufacturer in the quality system regulation. Servicers and refurbishers who do not fall within the new definition, on the other hand, are currently in a state of limbo--at least until FDA publishes a final regulation addressing their regulatory status.

WARNING LETTERS

FDA has recently stepped up its efforts--manifested in the warning letters issued in January, April, and August 1996--to monitor the growing remanufacturing industry. Of particular importance in these letters was FDA's observation that the remanufacturers had failed to document that the refurbished devices met the original manufacturers' specifications. This requirement could be disastrous for remanufacturers that do not consult with original manufacturers. One of the warning letters suggests that a remanufacturer may need to submit a 510(k) premarket notification or premarket approval (PMA) application.

Orlando Warning Letter. On January 11, 1996, FDA's Orlando office issued a detailed and comprehensive warning letter following a GMP inspection of a firm that refurbishes electrophysiology catheters. Six of the eight noted violations specifically involved issues arising from the company's unique position as a remanufacturer.

First, the warning letter noted the firm's failure to meet the requirements of section 820.100 of FDA's GMP regulation, which states the need for written manufacturing specifications and processing procedures that "assure that the device conforms to its original design or any approved changes in that design."⁷ The letter gave two examples of this violation: inadequate validation of the cleaning, repackaging, and resterilization processes for the disposable devices; and failure to validate a heat sealing operation in the repackaging of the devices.

The company's failure to comply with section 820.116(a) of the GMP regulation requiring written procedures for the reprocessing of a critical device or component was also noted.⁸ Such procedures must be designed to ensure that the reprocessed device or component meets the original or subsequently modified and approved specifications and to prevent adulteration because of material, structural, or molecular change in the device or component. The warning letter cited the company for failing to establish such procedures and for failing to document the maximum number of reprocessing operations for the device.

Also mentioned was the firm's failure to comply with section 820.160, which requires written procedures for finished device inspection to ensure that device specifications are met.⁹ Specifically, the letter noted inadequate procedures for measuring the degree of fatigue suffered by some components and for ensuring that repeated use of the devices would be safe and effective.

The warning letter also noted the company's failure to comply with section 820.56(b), which requires documented procedures designed to prevent contamination of equipment by cleaning and sanitizing substances.¹⁰ Also cited was the firm's failure to comply with section 820.184, which requires maintaining a device history record that includes, among other things, manufacturing dates and any control numbers used.¹¹ According to the letter, the company also failed to maintain in its device history record the information it received with the devices.

Finally, the January warning letter noted the firm's failure to comply with section 801.1 because the device's label did not contain the name of the original device manufacturer in addition to the refurbisher's name and address and a statement explaining the company's relationship to the device (for example, "refurbished by," "reconditioned by," or "rebuilt by").

New Orleans Warning Letter. Another warning letter was issued on April 18, 1996, by FDA's New Orleans office to a company that was refurbishing oxygen concentrators. Although not as comprehensive as the January letter, it indicates the agency's position that the modifications made in refurbishing a device render it a "new device" requiring 510(k) notification. The April warning letter specifically cited the company's failure to provide "a notice or other information . . . as required by section 510(k)."

The April letter cited three violations arising from the company's position as a device remanufacturer. These violations were the failure to document that the refurbished device conformed to the original manufacturer's specifications, failure to establish criteria for the acceptance or inspection of components used to refurbish the device, and failure to conform to FDA regulations requiring a refurbisher to identify its connection with the device on its label.¹² The Form FDA-483 that preceded the warning letter also noted these deviations.

The April letter also noted several general manufacturing violations, including the failure to list the device in its registration with FDA, as required by section 510(j) of the FD&C Act; failure to establish written documentation of testing checks/parameters to be performed; failure to establish written procedures for handling reports of failures and other complaints; and failure to establish written procedures or to document the calibration and maintenance of testing equipment.

Denver Warning Letter. On August 30, 1996, FDA's Denver office issued a warning letter to a firm in Utah that was reprocessing laparoscopic needles, among other devices. This letter echoed the two previous warnings. First, the firm was cited for its failure to establish control measures to ensure that the device met approved specifications as required under section 820.100. Second, the letter warned of the failure to establish procedures to ensure that the reprocessed device met original or approved specifications as required under section 820.115.

PROTECTION FOR ORIGINAL MANUFACTURERS

Several options are available to a device manufacturer wishing to reduce both possible damage to its business reputation and the risk that it will be held responsible for failure or contamination of its remanufactured device. These options include running a promotional campaign, contacting the remanufacturer directly, filing a trade complaint letter with FDA, or, as a more aggressive approach, filing a civil action alleging unfair competition and violations of federal trademark law. Of course, each situation varies, and a manufacturer may decide to pursue none, one, or a combination of the following approaches.

Promotional Campaign. One option for the original manufacturer is to launch a promotional campaign directed at health-care providers and risk managers. Such a campaign would inform them that the refurbished devices could be inferior, resulting in decreased safety and effectiveness and an increased risk that they--the reusers--could be held liable in the event of device failure. Of course, care needs to be taken in any such campaign to ensure that all statements made by the original manufacturer are truthful and are not misleading.

Direct Contact. Another approach is to contact the remanufacturer directly and request that it cease its remanufacturing operations or, at the very least, state on its label that the original manufacturer bears no responsibility for the safety and effectiveness of the device. If the remanufacturer's response is less than satisfactory, the original device manufacturer may wish to consider filing a trade complaint letter with FDA.

Trade Complaint Letter. A trade complaint letter can be filed in the name of the original device manufacturer, anonymously, or through a law firm. An effective complaint letter should point out the possibility of violations such as those enumerated in the previously mentioned warning letters. It should also emphasize the remanufacturer's likely failure to meet the original specifications as well as the possible change in intended use that would require the submission of a premarket notification or PMA application.

Depending on the region and whether the remanufacturing of devices continues to be a high priority of FDA, a trade complaint letter may have limited or slow success, especially if it involves a servicer or refurbisher that is currently excluded from the quality system regulation or a remanufacturer of a disposable device (over which FDA is currently exercising regulatory discretion). Nevertheless, a trade complaint letter serves as a vehicle for the original device manufacturer to communicate to the agency that it is aware that its devices are being remanufactured and that it assumes no responsibility for their reuse.

Civil Action. As a more aggressive approach, the original manufacturer can notify the remanufacturer of its intent to file a civil action for trademark infringement and unfair competition under the federal Lanham Trademark Act. Section 32 of the act provides for a cause of action against a competitor who uses "a reproduction, counterfeit, copy, or colorable imitation of a registered trademark."¹³ In addition, section 43(a) provides for action against a competitor who causes confusion as to the origin of its goods or misrepresents their nature, characteristics, or qualities.¹⁴ Remedies under the Lanham Trademark Act include injunctive relief and, although more difficult to obtain, monetary damages.

The first major case to address unfair competition and trademark infringement in the context of remanufacturing was the 1947 Supreme Court case, Champion Spark Plug Co. v. Sanders. The Supreme Court found that the remanufacture and sale of a product (spark plugs) under the original manufacturer's trademark is permissible under the Lanham Trademark Act if the remanufacturer has clearly stated on the label that the product is repaired or used.¹⁵

Based on more-recent federal cases, however, a court could determine that even with such disclosure, the Lanham Trademark Act gives a medical device manufacturer the right to control the manufacturing process and quality of its trademark. As one federal court found in 1994, "A product is not genuine unless it is manufactured and distributed under quality controls established by the manufacturer."¹⁶ Another court explained that "the Lanham Trademark Act affords the trademark holder the right to control the quality of the goods manufactured and sold under its trademark."¹⁷ Consequently, a device manufacturer could bring an action against a firm that is refurbishing its devices, arguing that the latter is violating its right to control the quality of its trademark.

Similarly, if the original device manufacturer can establish the lesser quality of the refurbished device, that evidence will support a claim under this theory. It has been held that failure to maintain the quality control standards established by the trademark owner constitutes evidence of a trademark violation.¹⁸ Proof of lesser quality is not required, however, as one court stated that "the actual quality of the goods is irrelevant; it is the control of quality that a trademark holder is entitled to maintain."¹⁹ In yet another case, a court found that a company is entitled to "shape the contours of its reputation," and therefore "there can be a Lanham Act violation even if the plaintiff's and defendant's goods are of equal quality."²⁰

Cases involving the remanufacture of disposables can be distinguished from the 1947 ruling in Champion Spark Plug because the reuse of single-use-only devices presents very different issues. In the Champion case, the products stayed with their labels, which disclosed that they were repaired or used, until they reached the consumer. By contrast, even if disposable surgical devices are marked "restored by" or "reconditioned by," as FDA requires, they are usually separated from their packages before the surgeon uses them. Once the packaging and inserts are separated from the sterilized product, a refurbished device is difficult, if not impossible, to distinguish from an original, unused device. Unless the physician knows where the hospital buys such devices, he or she will have no way of knowing that a device has been refurbished. This could be held to cause confusion as to the true source, nature, characteristics, or quality of the restored device.

Another difference between the situation presented by refurbished disposables and the Champion Spark Plug case could be that the remanufacturer in that case did not claim that its spark plugs were comparable to the original. Some remanufacturers may represent that their restored disposables are as safe and effective as the original devices. A court could find that such statements are not true, especially if presented with FDA regulations and warning letters demonstrating the agency's concern for the safety and effectiveness of restored devices, evidence that reuse of a single-use-only device reduces its effectiveness, or evidence that the remanufacturer's sterilization procedures do not remove all contamination or that they change the molecular structure of the device in such a way as to pose safety concerns.

WHETHER TO LITIGATE

Litigation always involves risk, time, and expense. A company considering this option may determine that the injury caused by the remanufacturing of its device does not outweigh those factors. Nevertheless, litigation does offer at least one significant advantage over filing a trade complaint letter with FDA: a relatively speedy result. A federal court will probably afford relief more quickly than FDA could. With the growing number of remanufacturers entering the market, the agency cannot get to each of them to determine whether there are GMP or other violations, and if it does, it probably cannot do so as quickly as a federal court could rule on a motion for a preliminary injunction.

Two years ago, in a Lanham Trademark Act case concerning remanufactured medical devices, Judge Zita Weinshienk (sitting on the U.S. District Court for the District of Colorado) granted a motion for a preliminary injunction within two months following the filing of the complaint and motion. That case involved the particularly egregious conduct of a remanufacturer that was obtaining used surgical clip appliers, removing the trademark of the original manufacturer, and replacing it with its own. Under trademark law, this process is known as reverse passing off, meaning that the original trademark is removed without authorization before reselling the product as one's own. (Traditional passing off or palming off is the selling of a product of one's own creation under the name or mark of another. A typical example is a company creating and selling inferior copies of an original, such as fake name-brand watches, luggage, and clothing.) While every remanufacturer today may not be guilty of reverse passing off, the Colorado case and the judge's comments indicate that some courts will recognize the need to step in quickly where FDA cannot.

Judge Weinshienk did not believe that FDA's failure to take action indicated that the agency approved of reverse passing off. Rather, the court found that FDA's failure to act was a function of its understaffing and noted the need for courts to assume the duty of preventing customer confusion and eliminating risk to patients who were unknowingly receiving inferior products. Judge Weinshienk ultimately granted the manufacturer's requested relief--an order that the remanufacturer cease distribution of the altered device until it could establish that it had taken sufficient measures to eliminate customer confusion.

CONCLUSION

The answer to the question of who will ensure the quality control of remanufacturers ultimately involves two entities: FDA and the original device manufacturer. For FDA, the tools for ensuring the safety of such devices include warning letters, other enforcement mechanisms, and implementation of new regulations. For original manufacturers, letters, complaints to the agency, and possibly Lanham Trademark Act claims can be effective. The ultimate goal for all players is ensuring that the risks associated with the growth of the remanufacturing industry are kept to a minimum and the benefits are fully maximized.

REFERENCES

1."Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation," Federal Register, 61 FR:52601.

2.Compliance Policy Guide, sect 300.200 and 300.500, Rockville, MD, FDA, Office of Enforcement, Div. of Compliance Policy, September 1987 and March 1995.

3."Deciding When to Submit a 510(k) for a Change to an Existing Device," draft 2, Rockville, MD, FDA, Center for Diseases and Radiological Health, August 1, 1995.

4."Trial Balloon: FDA Discussion Document," September 1995 (for discussion at the International Association of Medical Equipment Remarketers meeting September 29­30, 1995).

5.61 FR:52601, 52610.

6.Hooten WF, "FDA's New GMP Working Draft: Industry's Last Chance for Comment," Med Dev Diag Indust, 17(9):72­79, 1995.

7.Code of Federal Regulations, 21 CFR 820.100.

8.21 CFR 820.116(a).

9.21 CFR 820.160.

10.21 CFR 820.56(b).

11.21 CFR 820.184.

12.21 CFR 801.1(c).

13.15 USC 1114(1).

14.15 USC 1125.

15.Champion Spark Plug Co. v. Sanders, 331 U.S. 125, 130 (1947).

16.Caterpillar, Inc. v. Nationwide Equipment, 877 F. Supp. 611, 615 (M.D. Fla. 1994) (citing Shell Oil Co. v. Commercial Petroleum, Inc., 928 F.2d 104 [4th Cir. 1991]).

17.Shell Oil Co. v. Commercial Petroleum, Inc., 928 F.2d 104 (4th Cir. 1991) (quotation omitted) (citing El Greco Leather Products Co. v. Shoe World, 806 F.2d 392, 395 [2d Cir. 1986], cert. denied, 485 U.S. 817 [1987]).

18.Anthony Distributions, Inc. v. Miller Brewing Co., 904 F. Supp. 1363, 1367 (M.D. Fla. 1995).

19.Shell Oil Co. v. Commercial Petroleum, Inc., 928 F.2d 104 (4th Cir. 1991).

20.Caterpillar, Inc. v. Nationwide Equipment, 877 F. Supp. 611, 615-16 (M.D. Fla. 1994) (citing Truck Equipment Serv. Co. v. Freuhauf Corp., 536 F.2d 1210, 1216 [8th Cir.], cert. denied, 429 U.S. 861 [1976]).

Edward M. Basile is a partner and Susan S. Quarngesser is an associate in the Washington, DC, office of King & Spalding.

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