If I were a surveyor or an accredi- tor that visited your facility every two years, I would ask for your product recall binder. An empty binder would indicate to me a system that is not work- ing since, unfortunately, recalls are more numerous than we would hope.

Physician and Patient Notification If a facility learns that it has recalled products on hand, and especially if it learns that patients could have been exposed to these products, the facil- ity and its administrative and clinical leadership should join with the leaders of the facility’s medical staff to deter- mine what information should be com- municated to its patients and attending physicians and how. Clearly, recalls vary in severity from minor labeling issues—with lit- tle or no potential patient impact—to Class 1 serious events. The determi- nation of the steps to take in response should be by consensus of the above leaders on a case-by-case basis. I mentioned earlier that the FDA

categorizes the level of “seriousness” it assigns to all recalls by the degree of probable threat that the recalled drugs and products pose to the health and safety of patients or the general pub- lic. The FDA web site ( Safety/Recalls/ucm165546.htm)


tifies the agency’s current levels of potential harm as follows: Recalls are actions taken by a firm

to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request or by FDA order under statutory authority. ■

■ Subject: Recalls of Drugs, Equipment, and Other Products

Policy: As an important element of our overall commitment to safe medication practices, X Surgery Center will promptly remove and document all drugs and equipment/products that have been recalled by the Food and Drug Administration and/or the manufacturers.

Procedure: 1. All vendors will be informed of our expectation for prompt recall information, including those that supply “sample” or “professional supply.”

2. Vendors will be provided our fax number and/or electronic contact address and to whose attention such information shall be transmitted (e.g., clinical director).

3. On receipt of fax or electronic transmission, facility manager or designee shall examine all stock supplies and withdraw any affected product, ensuring that storage prior to return prevents unintended use.

4. Affected product will be returned to the supplier for replacement, or as oth- erwise instructed.

5. Notation will be made on fax or electronic transmission of all affected prod- ucts returned. Should there be no affected product, this similarly shall be noted on the fax transmission or mailing from the manufacturer or supplier.

6. All fax transmissions or written communications from manufacturers or wholesalers shall be placed on file for a minimum of three (3) years, whether or not affected product was discovered.

7. Facility will pursue, through its material management coordinator, continu- ing awareness of recalled products, using resources such as Safety/Recalls.

ity of serious adverse health conse- quences is remote.

Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probabil-

Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the prod- uct from the market or corrects the violation. For example, a prod- uct removed from the market due to tampering, without evidence of manufacturing or distribution prob- lems, would be a market withdrawal.

Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case[s], these situations also are considered recalls.

In summary, we cannot overstate

the importance of an effective and well understood partnership of product pro- viders with our surgical centers regard- ing products that have failed to ade- quately meet expectations of quality, integrity and regulatory compliance. We have long understood that failure of this process devalues other success- ful medication safety initiatives which a facility may have in place because, when drugs are involved, even the wisest pharmacologic choices, safely administered, fail all concerned if the drug used was unknowingly flawed.

Sheldon Sones is the president of Ambulatory Surgery Center Patient Safety Organization LLC of North Haven, Connecticut, and a pharmacy consultant to ASCs. Write him at Shelsones@ or visit


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