Handling Reports of Product Use in Incidents Causing Injury or Death

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI September 1998 Column

Being aware of common pitfalls in device investigations and preparing for such investigations can go a long way toward getting through adverse incidents with minimal complications.

The medical device reporting (MDR) regulation (CFR 21) requires that when a medical device company becomes aware of or is notified of a device-related incident involving death or serious injury, it must report that incident to FDA within specific time limits and following specified formats. Companies that distribute products in Europe should report incidents through the Vigilance Program and to the competent authorities of the country where the product is registered. Since the user may be geographically removed from the manufacturer, there is an added level of involvement in handling reported product problems in foreign locations.

ADVANCE PLANNING

A manufacturer never plans for its products to cause injuries or death, but sometimes such things happen anyway. The manufacturer should prepare for this possibility by forming a trained crisis management committee. The committee members need to learn how to handle the media, the public, the customer, the hospital staff, and plaintiff attorneys. The crisis committee should study model cases to learn how to handle these types of situations, which can rapidly escalate out of control without the proper actions. It is absolutely vital for the chief executive officer to participate in the crisis committee and for communication between committee members to be highly developed. Hiring the services of a communication consultant is an invaluable insurance measure for a manufacturer.

A manufacturer should have quality system procedures in place to handle returned product that has been involved in incidents involving injury or death. Employees who will come into contact with returned product should be trained on how to handle and store the product and protect the manufacturer.

Templates should be created that include descriptions of the actions to be taken when a manufacturer is notified of an MDR-reportable event, and the templates should also specify which persons are responsible for what actions. FDA often has to take action, such as issuing safety bulletins, before all the facts are known, because media attention forces it to address public health issues immediately. The possibility of such an event should be addressed in the templates.

RECEIVING A REPORT

It is imperative for the manufacturer to investigate the facts of a reported incident as soon as possible, including the inspection of the product alleged to have been responsible. In many cases, the device did not the cause the problem experienced by the user. One such real-life example occurred when a hospital reported that a nurse was shocked, knocked onto the floor, and hurt. The manufacturer sent an expert investigator to examine the then-stored device, which he did in the presence of a hospital official. Each step of the investigation was photographed. The investigation and photographs revealed that the hospital had added a power connector to the device prior to its operation. A hospital repairman had incorrectly assembled the power connector so that one side of the balanced power line and the neutral wire were interchanged. The operating nurse was severely shocked when she opened the electrified grounding wire clamp on the device, which acted as a power switch. The photographs clearly showed that the medical device manufacturer did not cause or contribute to the incident.

A medical device company also must retrieve the product that allegedly caused the incident. Retrieving the device is the most important action in the entire investigation, yet many companies delay undertaking this critical step.

COMMON RESPONSES TO REPORT

Medical device companies commonly make assumptions about the reports they receive, which can mask the true nature of the incident and prevent them from obtaining accurate information about the product. Some common mistakes made upon receipt of a report include:

RETRIEVING THE PRODUCT

If a company prepares for the possibility that it might receive a report that its product was involved in a reportable incident, the common mistakes listed above can be corrected. The first action to be taken after awareness of an incident is obtaining access to the product; such access is crucial to the appropriate resolution of the alleged problem. The best solution is to have the product returned to the manufacturer. The second-best solution is for the manufacturer to have unhindered access to the product at the customer's site. Time is important because the worst solution, from a manufacturer's point of view, is to have the customer remove the product to a third-party site before the manufacturer has an opportunity to examine it.

Disposable versus Reusable Product. How a manufacturer handles delivery of or travel to the product involved depends on the type of product in question. There are two types of product—disposable and reusable. The reusable category incorporates products of all sizes and includes instruments that are cleaned or sterilized between each use as well as capital equipment such as monitors and diagnostic, treatment, and life-support instruments.

Returning disposable product should be fairly easy as long as it is not lost, damaged, or disposed of before the report is made. In some cases, the product packaging has already been disposed of, and the manufacturing lot number cannot be obtained, but the investigation should proceed using physical investigation. Not having the lot number makes identifying the extent of the problem difficult, but it will not prevent investigation of the problem's cause.

If disposable product is involved in a reported incident and the customer still has the product, then the manufacturer can immediately instruct the customer on how to handle and package it for return shipment. If the product is not packaged properly, the handling and shipment could change the product's condition from that in effect at the time of the incident. Such changes would hinder any investigation and could result in a lack of conclusions. Thus, it would be more prudent for the company to send field representatives to the site to retrieve the product.

If the product is a reusable piece of capital equipment, the decision to return it to the company will depend on how large it is. Again, the manufacturer may elect to send a representative to the customer to package and retrieve the product in person, which may entail creating a crate to house the product to prevent damage during shipment. If the customer is at all reluctant to package the product, the manufacturer should immediately send someone to the site to retrieve it. Otherwise, the investigation may instead need to be conducted at the customer's site.

Establishing Trust. Manufacturers should make an agreement with the customer that all reports, investigations, and facts that the customer obtains about the incident shall be shared with the company and vice versa. Such an agreement helps create an atmosphere of trust between the parties and can speed up the resolution of the problem. Finger pointing should not take place in these circumstances. The agreement should stipulate that no testing or investigation of the unit will be performed without a representative present from all parties. In some situations, the manufacturer may choose to invite FDA to the device investigation if the problem is severe, potentially widespread, or highly publicized. If there is a pending or existing lawsuit prior to an investigation, the company should follow the advice of its liability attorney but still control the decisions made.

HANDLING THE PRODUCT

The return of a product for investigation should not be treated the same as other product returns but with a higher level of concern and attention. The incident in question had serious consequences; it was not an everyday complaint. This is not the time to be trying to save costs. The costs incurred should be viewed as insurance to protect the company.

The product should be addressed to the attention of a single person in the company who will be responsible for the product investigation. The product should be shipped using a carrier who can track it during shipment. The label should include the serial or lot number of the product, if applicable, and the return goods authorization (RGA) number or whatever number a company uses to authorize return of products.

Products to be investigated should not go through the normal channels at receiving. They must be handled carefully to maintain their condition and should be kept separate from other products. They should not be opened by a receiving area operator, and they should not be stored in receiving quarantine or any other standard quarantine area. A special area should be designated for products to be investigated. Preferably, this area should be at a stable temperature and humidity to prevent inadvertent changes to the product while it is being stored and before it is investigated.

The product should not be handled by anyone other than the person assigned to perform the investigation. Handling should be done in the presence of a witness, and all activities should be videotaped, photographed, and documented. It is imperative that no comments, opinions, or remarks be made during the video taping or in the documentation and that everyone's facial expressions remain neutral during taping and photographing.

In some cases, the product will have been used on a patient and may be contaminated with bodily fluids. In these cases, the product must be carefully handled during packaging to prevent contaminating the person handling it and the person receiving it. Many manufacturers require the customer to sterilize the product to ensure that the biological contamination is eliminated before the product is returned to the company.

However, sterilizing a product that has allegedly been involved in a serious injury or death potentially destroys the evidence needed to determine the cause of the product's failure or to prove that the product was not responsible. Potentially contaminated product should be carefully packaged by the customer in a sealed container and stored and opened only in a biological containment room. The term room here is relative and could refer to a small closet-size area dedicated for this purpose. There may be other uses for this area, such as inspection of product after testing in simulated-use conditions for design verification and validation.

Common mistakes made by manufacturers in the retrieval and handling of product include the following:

INVESTIGATING THE PRODUCT

If the device has been successfully retrieved or carefully retained at the company until the manufacturer's representatives have arrived, it would then be a shame to compromise the investigation during the product inspection. However, this happens all too often. Some common pitfalls include the following:

In-House Investigations. After the product has been returned to the manufacturer, only the person who is assigned to lead the investigation should handle it. The following recommendations should be followed when applicable. This list includes several points that are not requirements but represent the best practices. The product should be handled with nonshedding, nonleaching gloves and should be stored in a designated area. A second or even a third party should witness the investigation process, which should also be videotaped. If the product is moved to the investigation area from the storage area, both the storage and investigation areas should be photographed, as well as all sides of the unopened package, including the shipping label, as it had been received.

The layers of packaging should be removed one at a time and each layer photographed. The product should be photographed from all angles. Detailed documentation of all observations and findings should be recorded. Investigators should report facts and not include any opinions or comments. Explain in a written record as well as orally for the videotape any observations that cannot be photographed clearly without changing the condition of the product. Every step of the investigation should be photographed and recorded, as well as the condition of the product. A summary report should be written to record the findings of the investigation.

On-Site Investigations. If the product cannot be returned from the customer (e.g., because of size constraints), the manufacturer should send a minimum of two people—an investigator and a witness—to the customer site. The customer will also want to witness the proceedings. If a patient lawsuit has been filed, the plaintiff's attorney may send a representative to witness the investigation.

It is important to get to the customer site as quickly as possible—within hours, not days—after the company becomes aware of the problem. If the hospital risk manager has already been notified, the manufacturer's reps should meet with him or her. If the risk manager has not been notified, the reps should deal with the customer or user directly. The people who go to the customer site should be experienced in these types of situations and highly familiar with the product, its design, and its servicing. Taking an attorney along on this visit can escalate a potentially simple situation into a complicated issue.

In addition to the steps mentioned earlier on how to conduct an investigation, keep the following items in mind when conducting the investigation at a customer site. The manufacturer and the customer should agree prior to the investigation that everyone present will get copies of all documents and photographs from the company and a copy of the videotape from the investigator. Copies of the patient files and the treatment data, including comments from physicians and nurses, should be obtained. If power cords or accessories were used with the product, they should be photographed as well, including the plug end and any strain relief. If other products were being used at the time of the incident, photographs are also needed of the condition of these items, along with a list of the products' manufacturers and their descriptions, including interviews about how the product or products were used in conjunction with the product being investigated. Note any chemicals used on or in the vicinity of the products.

With a witness present, the investigator should interview as many people as possible concerning the incident, videotaping the interviews if possible. If the customer allows the product to be returned to the manufacturer at this point, photographs of it should be taken as it is being packaged. The carton opening should be taped, signed, dated, and photographed as proof of seal.

The information generated during the initial investigation may only lead to reports and not conclusions. This is acceptable. Further evaluation and investigation can be conducted later.

In some regions, the sheriff or the police may become involved following a death. In these jurisdictions, it is standard procedure to consider the medical device a murder weapon until information becomes available. This can be a positive situation, because these agencies usually rely heavily on the device manufacturer as having the most knowledge about the operation and performance of the device. This is in the manufacturer's favor, and it should thus treat these agencies with respect.

If the product is shipped back to the manufacturer following an on-site investigation, the item should remain sealed and be stored in a special storage area, not in the standard quarantine area.

If attorneys are involved there are many activities to be performed, such as determining the jurisdiction of the case, calculating the damages involved, and finding a local attorney for the jurisdiction.

AFTER THE INVESTIGATION

After an investigation is completed, the results should be analyzed to determine whether the product was involved in the incident and whether it was the root cause of the problem. Reports should include the conclusions and discussions of the cause and the corrective action. Updates should be sent to FDA per the MDR regulation and to all the parties involved as agreed.

The customer should receive a replacement device or an offer to repair and return the original unit, whichever the customer prefers. However, if the failure mode was unique, the involved unit should be stored in an area with the proper environment to prevent its deterioration over time. The manufacturer should keep the unit until the statute of limitations expires for the type of problem or for the life of the company, as applicable. If the failure mode was not unique, the product should be stored for at least one year or for another time frame based on the advice of counsel. The bottom line: Never lose control of the problem unit.

CONCLUSION

Manufacturers do not plan for their products to fail or to cause harm to patients. But if an incident should occur that results in the serious injury or death of a patient, the problem must be investigated immediately to prevent it from occurring again. Federal regulations require that a manufacturer report the event to FDA. However, the customer, the patient, his or her family, and the manufacturer all need to know what happened, which makes the investigation of the problem critical.

While time is of the essence, no one benefits from rushing through the investigation and leaving out critical steps or doing a sloppy job. To avoid such problems, medical device manufacturers should have a trained crisis management committee in place long before a complaint is received. Likewise, standard operating procedures should be developed and implemented to define what actions are to be taken and by whom.

Anita Thibeault is president, Anita Thibeault & Associates (Rogers, AR), and an editorial advisory board member for MD&DI.

Illustration by Lael Henderson

Copyright ©1998 Medical Device & Diagnostic Industry