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How to handle a product problem; when a lab product doesn't perform as it should, alert the manufacturer.

In today's competitive marketplace, laboratory suppliers must keep costs low and quality high. Test kits and reagents must perform consistently to insure accurate laboratory data. Thust it is essential that when things do go wrong with lab products, corrective action is swift and effective.

Most diagnostic manufacturers offer excellent, well-researched, and standardized products. Quality assurance testing at the plant is often far more extensive than most in-house QC programs. As conscientious scientists, we also monitor the quality of our laboratory tests on a daily basis. We know when tests are producing proper results on patient specimens, and when they are not. Most medical technologists occasionally encounter a biological reagent that falls short of the package insert's specifications, or a shipment that arrives damaged beyond use. When this occurs, we must act promptly to insure that the problem doesn't jeopardize the accuracy of our data or pose a hazard to the laboratorians handling the materials during testing.

When a product proves unsatisfactory, it is possible to convince even a large corporation to make amends. And if the manufacturer refuses to cooperate, there is a government agency ready to mediate dispute. But it is up to laboratorians to question any product that fails to perform properly. By notifying administrators of the problem and following the steps outlined in this article, you can make a valuable contribution to the integrity of medical technology.

* Identify and verify the problem. Most manufacturers are willing to field complaints and act promptly if a product defect is well substantiated. Packaging problems are readily apparent as soon as the shipment arrives. It is the manufacturer's obligation to protect the item during transport, and most suppliers use reputable and careful carriers. Manufacturers want to know when supplies arrive late or damaged. Some firms send a control shipment to themselves to monitor handling; others periodically check with customers to make sure the order arrived in good condition.

Laboratorians can help this effort by documenting the safe receipt of each shipment. We initial and date the packing slip. Then, if we need to verify a carrier's performance, we simply go to the files and note the shipping time from plant to lab. When a significant problem arises--such as adverse weather causing reagents to spoil or freeze--we tell the supplier right away.

When a product arrives in good condition but fails to perform as promised, don't rush to lodge a complaint. First, check the package insert carefully and make sure you have followed the procedure properly. Even a first-rate technologist can make an occasional error. As many laboratories continually switch products to reduce test costs, we must remember to read instructions closely and never assume that similar procedures are performed exactly alike.

Pointing a finger at a supplier or distributor when the lab is responsible for the product failure is unfair--and potentially costly. The manufacturer launches a frantic investigation to determine what went wrong, the laboratory must replace a perfectly good product, and everyone's normal work flow is disrupted. To avoid this, we repeat a questionable procedure at least once under strictly controlled conditions.

Rigorous repeat testing of commercial media may not be necessary in labs that have considerable experience with a particular product as well as good backup methods. Our media are so reliable that we have dropped routine QC ("Media Quality Control: An Unnecessary Evil," MLO, February 1984). However, we do maintain standardized reference culture strains that can be used to verify positive, negative, and, in some cases, marginally positive results for all of our micriobiology tests.

* Notify the manufacturer. Once a legitimate problem is identified, don't ignore it. We make it a point to speak with the firm's quality assurance technicians. These skilled and experienced professionals can sometimes help troubleshoot the problem. In many cases, they are able to suggest an alternative approach to tide us over until the situation is resolved.

When reporting a problem, be prepared to provide the lot number of the faulty product, the dates it was received and first used in the lab, and the exact nature of the difficulty. This information expedites the manufacturer's investigation at the plant.

Reputable firms will gladly replace a problem product free of charge. Some companies arrange to have the remaining items from the defective lot returned for their own in-house evaluation. Others may instruct you to discard the materials. In any case, we keep defective items on hand until we are certain they will not be needed during the investigation.

Chances are that if your lab is experiencing a particular problem, others are also having trouble with the same item or procedure. We've learned to be skeptical when a manufacturer or distributor claims that we are the only lab reporting a problem.

In one memorable instance, several laboratories--including ours--complained about an antibiotic disk that didn't appear to contain a sufficient amount of the test drug. When the manufacturer dismissed it as a local problem, we made a few phone calls and learned that colleagues across the country were plagued by the same "local" difficulties.

It was clear that the problem would never be corrected if left to the manufacturer. By allowing a defective product to remain in use, this company was jeopardizing the validity of thousands of lab tests and ultimately leading physicians to prescribe a more expensive and broader-spectrum antibiotic than was clinically necessary. After six frustrating months, we decided to bypass the uncooperative manufacturer and take our problem to the United States Pharmacopeia (USP).

* File a formal complaint with the USP. There are many good reasons not to lodge your complaint solely with the manufacturer when a problem or defect is noted in test reagents, packaging, or published protocols. For one thing, the firm may flatly deny that there is a problem.

Even if a manufacturer does acknowledge the reported shortcoming, it may not be in a hurry to respond if this means recalling a heavily promoted product. Some firms may simply have trouble getting organized internally to corret the situation. Since other laboratories may have had trouble with the same product or similar ones from competiros, their combined experiences can often help speed up the corrective process. This certainly was the case when we complained about the defective disks.

The Medical Device and Laboratory Product Reporting Program of the United States Pharmacopeia serves as a support network for laboratories who believe that the produc--and not their technique--is at fault. The USP product reporting program is cosponsored by the American Society for Microbiology, the American Association of Clinical Chemistry, and the College of American Pathologists. It is impossible to overemphasize a laboratorian's responsibility to let this office know whenever any laboratory product fails to perform as expected.

The program's objectives are twofold: to improve product quality and to communicate health hazards to industry and government. The laboratory program, initiated in 1973, is modeled after a successful system used by pharmacists since 1971. The program works simply and efficiently and is designed to evaluate complaints about anything laboratorians consider to be a problem.

Our laboratory used the process successfully to resolve the antibiotic disk dispute. Others have reported confusing or incomplete instructions in package inserts. If a product is improperly packaged, it may leak or become damaged in transit--a significant problem that must be reported to prevent a potential hazard to recipient laboratories and intermediate carriers and handlers. Or perhaps a multipart kit is missing a component or short-filled. The USP receives roughly 3,000 complaints each year and effectively arbitrates just these types of consumer-supplier disagreements.

Ideally, we should all be able to count on a supplier or manufacturer to resolve a problem, and some are quick to help out. Service representatives from one national supply house carry a multipart form that documents both the problem and the company's corrective action (Figure I). The representative helps fill out the form and then provides a copy that can be mailed directly to the distributor. This assures the lab that the complaint is received promptly.

While the laboratory's form is channeling through the company, the representative files his copies with the distributor to expedite an immediate in-house evaluation. When the lab receives a customer credit for the defective item, it also receives the service representative's copy and documentation for its records. Should a manufacturer fail to provide similarly responsible customer service, you may contact the USP directly through their toll-free number: (800) 638-6725. The office will send appropriate forms upon request so that you can lodge an official complaint (Figure II).

When notified of a problem, the USP acknowledges receipt of the complaint and forwards copies to the Food and Drug Administration's Center for Devices and Radiological Health. The FDA then evaluates the report as a potential public health hazard. If the product's continued use could create an extremely dangerous situation--as would a defective pacemaker, for example--the FDA will immediately order the manufacturer to recall all outstanding lots and stop shipment of its existing inventory.

For less urgent situations, the agency usually begins its investigation within 24 to 48 hours. The first step is a computer data search to pinpoint previous problems with the same or similar products, which may uncover a trend and a more widespread threat. The Food and Drug Administration also uses this information to record the history of a device or product.

We filed our complaint by mail and soon heard from the FDA representative assigned to the case. We supplied complete documentation concerning the defective disks--exact copies of the reports sent to the manufacturer several months before.

If data not on file from previous investigations, the FDA has the authority to reproduce the tet results or monitor the manufacturing process with an internal procedural audit. The agency has absolute access to any information needed to complete these studies. Representatives may visit the plant for on-site trials or take samples for testing in the FDA lab.

When test data are readily available from an earlier product evaluation, the process can be completed at minimum cost and inconvenience to customer, manufacturer, and distributor. Since we had alreay done extensive studies documenting the disks' poor performance, the agency was able to follow up promptly.

Once a determination is made, technical staff members at the FDA work diligently to help implement any necessary changes. For example, if labeling, packaging, or shipping is at fault, the investigators will work with the company to formulate an effective course of action.

In our case, we learned that the reagent disks had been batch-processed. The antibiotic was not distributed uniformly, and it was impossible to insure that the full stated potency of the drug was available on every disk. There was a great deal of within-lot variability and even less lot-to-lot consistency. Thus test results with the original product were totally irrelevant. A modification of the manufacturing process and a more rigorous quality assurance protocol at the plant resolved the problem.

Not all manufacturers welcome the investigation and subsequent recommendations, particularly when proposed modifications incur added costs and lost inventory. However, despite occasional corporate resistance, the USP process is becoming widely recognized as a positive influence in medical supply circles. By learning from their competiros, suppliers can work to improve product development and target marketing efforts toward providing a more successful product line.

Indeed, many manufacturers view the USP evaluations as a powerful marketing tool. These forward-thinking firms routinely review USP reports for potential problem areas. They know that customers will continue to do business with companies that provide consistently reliable products and correct deficiencies before they become a lab liability.

The USP relies on field reports from laboratorians. To make technologists more aware of its reporting program, it offers an array of brochures and a newsletter. Wary hospital administrators are reassured that patient confidentiality is never compromised; in fact, no patient names need appear on any report. Complainants themselves can also remain anonymous, by requesting that the USP delete the individual's or institution's name from reports submitted to the FDA. Obviously, the USP must keep the complainant's name on file as a contact for additional information.

The USP should not be considered as merely a "court of last resort." Even when a manufacturer or distributor quickly corrects a problem, you should notify the office and describe both the problem and its outcome. This creates a broad data base that can minimize other laboratorians' headaches if a similar difficulty crops up again.

To inform laboratory consumers about the types of problems reported and corrected, the USP publishes the Monthly Panel Report of the FDA Device Experience Network. The DEN report summarizes all complaints received for the previous month and includes the FDA's final assessment when completed. To be placed on the mailing list for this free publication, write to the United States Pharmacopeia, 12601 Twinbrook Parkway, Rockville, Md. 20852, or call the USP at (800) 638-6725.

* Follow up on complaints. Follow-up is an important final step after a complaint has been initiated through a manufacturer or the USP product reporting program. If replacement products are acceptable, let the FDA know. And if the manufacturer has yet to respond, don't keep your aggravation a secret.

Adopt an attitude of cautious optimism when the next shipment arrives. Some less than scrupulous manufacturers have been known to substitute an acceptable lot of the offending product immediately after a complaint is filed, only to reissue the substandard lot at a later date. Check lot numbers and record QC faithfully. The manufacturer caught pulling a bait-and-switch faces serious trouble with the FDA when the time comes to recertify a product or gain approval for new devices or reagents.

Does the USP reporting program work? Indeed it does. Through the information gathered and shared by laboratorians, many fine products have been developed, and others have been significantly improved to reduce errors in testing and hazards to personnel.

As lab professionals, we share a responsibility to our patients, our institutions, and to manufacturers. This responsibility begins with adequate documentation of safe receipt of the product, followed by appropriate storage. Products must be used as intended and with specified protocols.

Once we meet these criteria, we must left the manufacturer or supplier know when a product falls short of expected performance. The manufacturer's in-house testing cannot anticipate every possible failure in the field. As a consultant, for example, I once visited a doctor's office lab that couldn't seem to maintain an anaerobic environment for their cultures. The technician had followed the instructions on the hydrogen generator pack to the letter--except that she added the 10 ml of water to the anaerobic jar instead of to the pack.

Our vigilance and our willingness to get involved can actually help to make lab products better. The USP and the FDA can be invaluable partners in this process, but only if we allow them to be our allies. Don't ignore product deficiencies, however minor, and don't assume that someone else will take care of the paperwork. Give the manufacturer a chance to correct the deficiency; but if the firm fails to respond within a reasonable length of time, don't hesitate to contact the USP. A product problem that isn't reported cannot be corrected.
COPYRIGHT 1985 Nelson Publishing
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Copyright 1985 Gale, Cengage Learning. All rights reserved.

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Author:Harris, Patricia C.
Publication:Medical Laboratory Observer
Date:Sep 1, 1985
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