FDA rattling its sword as reuse deadlines near

We will enforce these requirements for hospitals’

Firing a shot over the bow, the Food and Drug Administration (FDA) is notifying hospitals that all the talk about reuse of single-use devices is about to translate into action.

In a no-nonsense letter sent to hospital groups and posted on its web site, the FDA reminds that deadlines are coming due for hospitals that want to stay in the reprocessing business. (See Hospital Infection Control, February 2001, pp. 26-29 at www.HIConline.com)

"On several occasions over the past few months, we have notified hospitals about our intention to enforce certain requirements regarding the reprocessing of single-use medical devices (SUDs) for later use on patients," states the letter, dated April 23, 2001.

"We are taking this action because of public health concerns about the cleaning, disinfecting, and sterilizing of previously used SUDs, and the effect reprocessing may have on the functional integrity of the reused device. In brief, we will now require hospitals that reprocess SUDs to meet the same regulatory requirements as the original manufacturer of the product. We will enforce these requirements for hospitals just as we do for medical device manufacturers.

Drop dead dates

"Until now, we have not enforced the regulatory requirements that apply to SUD hospital reprocessors, the FDA states. Our enforcement guidance sets forth certain dates when FDA intends to start actively enforcing these requirements. There are several important dates that SUD hospital reprocessors should be aware of:

• Aug. 14, 2001. Deadline for hospital reprocessors to comply with (a) nonpremarket requirements for class I, II, and III devices, and (b) premarket requirements for the submission of 510(k)s for any class II SUD, unless the classification regulation specifically exempts the device. After that date, we intend to start enforcing the nonpremarket requirements for all reprocessed SUDs that do not comply with these two requirements. Further, if the hospital reprocessor has not obtained an FDA marketing clearance order by Feb. 14, 2002, we will take enforcement action if the reprocessing practice continues.

• Feb. 14, 2002. Deadline for the submission of 510(k)s for any class I SUD, unless the classification regulation specifically exempts the device. After this date, we intend to start enforcing our premarket notification requirements for reprocessed class I SUDs that do not have a premarket notification on file. Further, if the hospital reprocessor has not obtained an FDA marketing clearance order by Aug. 14, 2002, we will take enforcement action if the reprocessing practice continues.

Flexing its muscles

"Underscoring the seriousness of its warning, the FDA listed its enforcement powers, which as summarized below, are considerable:

- Public health alerts and notifications. We have the authority to require a hospital to directly notify health care providers, consumers, and other relevant parties of devices that pose actual or potential risk to the health of the public. In addition, we have the authority to issue our own alerts and notifications on issues that are of a public health concern.

- Warning letter. This is an official FDA document that would inform an individual hospital that we have found serious violations of the Act, and that we may initiate action without further notice if the violations are not promptly corrected. However, we are not legally obligated to send a warning letter prior to initiating action.

- Mandatory recall. We have the authority to require a hospital to recall a reprocessed SUD if it could cause serious, adverse health consequences or death.

- Seizure. We have the authority to seize a medical device that we consider to be adulterated (e.g., one that is determined not to be in compliance with the quality system requirements) or misbranded (e.g., one that is labeled with an incorrect device description, such as size).

- Injunction. We may seek an injunction against a hospital to prevent manufacturing or distributing a device that violates a requirement of the Act.

- Civil money penalties. We may initiate an administrative proceeding to impose civil money penalties of up to $1 million (per proceeding) against persons who violate the Act.

- Prosecution. We have the authority to initiate action to criminally prosecute persons responsible for violations of the Act."