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KSR Publishing, Inc.
Copyright © 2016

         Clinical intelligence for supply chain leadership



September 2013

Products & Services

New Technology

"Intelligent knife" alerts surgeons of cancerous tissue

Scientists from the Imperial College London have developed an "intelligent knife" that can inform surgeons about the tissue they are cutting, alerting them to whether the tissue is cancerous or not by using rapid evaporative ionization mass spectrometry.

In the first study to test the invention in the operating theater, the "iKnife" diagnosed tissue samples from 91 patients with 100 percent accuracy, instantly providing information that normally takes up to half an hour to reveal using laboratory tests.

The findings, by researchers at Imperial College London, are published in the journal Science Translational Medicine.

In cancers involving solid tumors, removal of the cancer in surgery is generally the best hope for treatment. The surgeon normally takes out the tumor with a margin of healthy tissue. However, it is often impossible to tell by sight which tissue is cancerous. One in five breast cancer patients who have surgery require a second operation to fully remove the cancer. In cases of uncertainty, the removed tissue is sent to a lab for examination while the patient remains under general anaesthetic.

The iKnife is based on electrosurgery, a technology invented in the 1920s that is commonly used today. Electrosurgical knives use an electrical current to rapidly heat tissue, cutting through it while minimizing blood loss. In doing so, they vaporize the tissue, creating smoke that is normally sucked away by extraction systems.

The inventor of the iKnife, Dr Zoltan Takats of Imperial College London, realized that this smoke would be a rich source of biological information. To create the iKnife, he connected an electrosurgical knife to a mass spectrometer, an analytical instrument used to identify what chemicals are present in a sample. Different types of cell produce thousands of metabolites in different concentrations, so the profile of chemicals in a biological sample can reveal information about the state of that tissue.

In the new study, the researchers first used the iKnife to analyze tissue samples collected from 302 surgery patients, recording the characteristics of thousands of cancerous and non-cancerous tissues, including brain, lung, breast, stomach, colon and liver tumors to create a reference library. The iKnife works by matching its readings during surgery to the reference library to determine what type of tissue is being cut, giving a result in less than three seconds.

The technology was then transferred to the operating theater to perform real-time analysis during surgery. In all 91 tests, the tissue type identified by the iKnife matched the post-operative diagnosis based on traditional methods.

While the iKnife was being tested, surgeons were unable to see the results of its readings. The researchers hope to carry out a clinical trial to see whether giving surgeons access to the iKnife’s analysis can improve patients’ outcomes.



Total recall striving for prime-time readiness

Automated tools available, emerging among manual processes

by Rick Dana Barlow

On paper the process seems so simple.

The U.S. Food and Drug Administration or a specific product manufacturer issues an alert about one or more products that forces a voluntary or mandatory recall. The designated hospital overseer of such matters — typically someone on a team in Supply Chain — contacts the manufacturer sales representative and the FDA for any additional guidance, then hunts for the affected product(s) throughout the inventory areas for removal. If an implantable is the culprit, then Supply Chain’s recall team works with Surgical Services to identify and notify affected patients.

Call this a calculated surgical strike to protect patient safety and minimize provider liability. Unfortunately, for many healthcare facilities, this surgical strike is nirvana.

Even in an era of high-tech smart phones, tablets and seemingly ubiquitous online access to virtually anything, "snail" mail slots, fax machines, land lines and even pagers have yet to start gathering dust from non-use.

The above scenario hinges on a hospital having a quick-response "recall ops" team to launch into action, mobile and tethered software technology to facilitate rapid communication between regulatory authorities, suppliers and hospital and clinical administrators, and to track and trace product accurately and reliably.

Typically, the average hospital lacks at least one of these components, which slows down reaction time, even with a comprehensive manual plan in place.

Without an accessible national product recall database, standardized product identification tags and acceptable standard processes for notification, identification and extrication of recalled products, hospitals and other healthcare provider facilities must rely on individual plans and procedures with customized software or manual processes.

In this age of automation, electronic capabilities and data standard demands, how well-positioned are healthcare provider organizations in identifying selected products in inventory and circulation and removing them from storage and use?

While effectiveness and efficiency tend to represent two different philosophies, healthcare organizations apparently still need to improve both, sources told Healthcare Purchasing News.

Tapping the arsenal

Short of a national data standard or even a national database of information, hospitals and other healthcare facilities can turn to the 40-year-old Washington-based National Recall Alert Center (NRAC) and its E.-C.L.A.S.S. Alerting, Tracking and Monitoring System. NRAC is a "a closed-loop recall alerting system that not only alerts but also escalates the alerts when the individual or departments being notified have not responded in a time consistent with the class of the alert," said Dr. Mark Cohen, NRAC Founder and Managing Trustee.

This Web-based system doesn’t require any interfacing or integration with a hospital’s Information Technology department like a Materials Management Information System (MMIS), but is plug-and-play without the plug.

"Based on factors including the level of the recall (class I, II or III) the recall is transmitted to the appropriate department(s) in the hospital where the recalled product is most likely to reside," Cohen told HPN. "The alert is timed and a status response is required within a specific time frame back to our computer. If it is not received it then escalates to others. All of this is overseen by a ‘facility primary’who gauges the system-wide recall response status and is able to produce reports and much more."

Progressive healthcare providers, Cohen continued, are looking for a tracking system so that "everyone who ‘touches’ or ‘checks on a defective product’ is registered as having done so." Standards really aren’t an issue, according to Cohen.

"There is a specific protocol of data necessary in order to identify and locate the specific recalls in question," he said. "These include the lot numbers, serial numbers, catalog numbers, whether the recall is active or not, what state or states the recalled products may have been distributed to, the amount of product under recall, the recall number and the reason for the recall and sometimes more. Of course, liability is always a concern but patient safety is paramount in all facilities whether they are acute care or not."

Of course, just like nurses subjected to the cacophony of beeps, sounds and tones from monitoring equipment, those handling the redundancy of product recalls may struggle with "alert fatigue," which is something NRAC keeps in mind.

"Only specific individuals in any department — with a backup person — should be involved in the recall amelioration process," he noted. "Otherwise, recall alerts will be overlooked because others think that still others are involved when they may not be."

Some hospitals may recruit "special recall teams" to oversee the process, but that’s not necessary, according to Cohen, so long as they designate specific individuals within various departments to be responsible for recall remediation. "We ask for a backup person in each department in case the main person in each department is on vacation or out for some other reason," he added. "Nurses are sometimes such individuals — not always."

Any recall alert system with dedicated staffers needs a fail-safe process that prevents missed or overlooked Class I recalls as these can lead to death, according to Cohen. NRAC’s Triple Alert System befits its name because it notifies member facilities of Class I recalls three different ways.

Finally, whatever recall alert technology a hospital chooses must provide hospital- or area-specific alerts that are active at the time of transmission and not be closed, Cohen stressed, so as not to devalue and waste hospital personnel time.

Eric Sacks

"It has to be about a culture of safety," indicated Eric Sacks, Director, Healthcare Product Alerts, ECRI Institute, Plymouth Meeting, PA. "In general, a safety alert management program needs to be designed to ensure that the right people are ‘in the know’ about every alert for every product used in the organization and that resolution of each alert is confirmed and documented. The path to these goals is different for every organization based on purchasing, supply chain and maintenance practices.

Steven Arnold

Steven Arnold, M.D., Chief Medical Director, Access MediQuip LLC, Lake Mary, FL, emphasized the criticality of technology to manage the recall alert products. For example, facilities can learn about recalls many different ways, including FDA notifications, information provided electronically by manufacturers, news articles or by subscribing to a recall information service that delivers recall announcements. A good inventory management system can help facilities locate recalled products, ensure the correct number of products are removed and identify whether there are shipments of the recalled product in transit, he stated.

"When responding to recalls, technology is vital," Arnold noted. "If a surgical device is recalled, a facility needs to have access to a database through which it can identify patients who received the recalled implant or are scheduled to receive it. Even with a good internal database, this can be a challenging process, and when a facility is working to address a recall — especially a Class I or II recall where a patient’s safety and life is at stake — speed is essential to protecting patients. This is why many facilities partner with a company like Access MediQuip that provides recall services. For example, Access MediQuip’s Recall Management Service (RMS) uses its Patient and Device Registry database of facility, device and case-related information to identify patients potentially affected by a recall through a series of reactive and proactive processes. Through this database, RMS is able to recognize patients who have already received a defective device and those currently scheduled to receive one. Access MediQuip then provides its partner health plans and providers with corresponding member/patient and case information."

Steve Edwards

Steve Edwards, Senior Recall Strategist, ExpertRECALL, Indianapolis, emphasized the important role technology plays in recall alert processes, but noted that implementation varies and can be influenced by such factors as the number of floors in the building and the number of satellite offices. In fact, he added, some hospitals still use traditional mail systems such as the United States Postal Service.

One simple reason why hospitals may not be as far along as they should may be a lack of education and not economics, according to Amie Hollis, Recall Coordinator, Vanderbilt University Medical Center, Nashville.

"Most hospitals that don’t have these things in place aren’t actively avoiding a process or system because they can’t afford it," she said. "In my experience, many hospitals don’t know there’s an easier and better way to organize proactively, and they don’t realize the vast, vast number of product recalls that are really out there, or the range of products affected. Just today I saw a recall of a baby activity toy and a portable generator, along with some food items, in addition to items managed by Radiology, Pharmacy and Central Supply."

Designate a point person, Edwards recommended. "The most important thing, regardless of the system used within a hospital, is making sure the content and messaging of the recall gets to the right person at the hospital who knows what to do with the information and can quickly and effectively take the information and make sure the affected item is quarantined," he said.

Tracking the pharma chain

Pharmacy’s recall alert system embraced automation earlier than Supply Chain’s for medical and surgical products.

Michael Lucas

Hospitals currently rely on their medication management systems to alert pharmacies of a recall, according to Michael Lucas, CEO, Frequentz, a Los Altos, CA-based company that provides serialized data warehousing, traceability and information management software. Manufacturers issue these alerts, while the FDA follows with a secondary alert that indicates the severity and recommended actions for the product at issue. After the alerts have passed, hospitals remove the product from their formulary, and scan storage areas for additional inventory, also to be removed.

Unfortunately, as the drug compounding contamination problem in the Northeast demonstrated, the process is far from foolproof. Yet the government and industry are developing solutions, Lucas noted.

"First, the government has responded by crafting regulations and laws to safeguard patients from counterfeit and contaminated drugs," he said. "For example, both the Senate and House of Representatives have been working independently of one another to push forward measures on both compounding and track and trace. On the Senate side, the two measures have been combined into a single bill, the Pharmaceutical Quality, Security and Accountability Act (PQSA Act), while on the House side the measures are proceeding separately. The HELP Committee had previously passed separate iterations of the bill, the Pharmacy Compounding Quality and Accountability Act and the Drug Supply Chain Security Act, on May 22, saying the bills would help give FDA new regulatory authority with which it could use to better inspect compounding facilities and their products and keep track of the pharmaceutical supply chain.

"Second, the drug supply chain provisions resulted in only one modification," he continued. "‘Manufacturers will now be required to provide transaction information, transaction history, and transaction statements in electronic form to their trading partners. This requirement will go into effect four years after the date when serialization requirements [are] due.’

"In response to this, manufacturers will be required to provide a genealogy of the compounds based on events. As a consequence, a chain of custody will be developed via the recording of real-time event data and presented as a form of e-pedigree. IRIS provides the platform to capture, analyze, report on events along the chain, as well as contributing to health and safety by providing a ‘checks and balances’ to the supply chain. Manufacturers and suppliers will need track and trace technology, solutions and service to comply with regulatory requirements."

Standards deviation?

Step-by-step recall alert

Industry experts and observers share their tips for an effective and efficient product recall alert process.

1. Executive sponsorship and a written policy. "Too often, safety alerts management is viewed as the responsibility of clerical, supply chain and technology maintenance staff. These personnel should play a key operational role in the process, but it is critical to also obtain the cooperation of staff with knowledge of specific department inventories. When hospital leadership embraces alerts management as a patient safety priority, the process becomes much more effective and efficient."

2. A comprehensive and independent source for Recalls and Alerts. "In most cases, you should expect your supplier to notify you of recalls and other safety alerts. However, you need independent sources for recalls and alerts for when the vendors’ message does not get through to the right people."

3. Reliable process for identification of affected product. "The ability to search purchasing records, maintenance and physical inventories for product identifiers listed on alerts" is important.

4. Documentation of alert resolution. "[This involves] comprehensive records of who did what and alert resolution for situations such as FDA recall audits, accreditation surveys and lawsuits claiming that a recalled product harmed a patient or staff member."

5. Quality control/improvement measures. "Alerts management impact and efficiency should be monitored through regular reporting to safety committee on alerts that have and currently affecting the organization and which departments are/are not keeping up with resolution of alerts."

– Eric Sacks, Director, Healthcare Product Alerts, ECRI Institute, Plymouth Meeting, PA

1. "Identify an effective means to learn about recalls.

2. Develop a method to validate recall information (when necessary).

3. Appoint individuals to serve as point people for receiving and disseminating recall information and executing the facility’s recall policies and procedures.

4. Have a process in place to properly analyze and respond to recall information. This includes removing and quarantining recalled products; responding according to recall instructions; and identifying and notifying affected patients.

5. Ensure that recalled products on their way to the facility are quarantined upon arrival (and do not make their way to the shelves).

6. Document every step in the recall response process."

– Steven Arnold, M.D., Chief Medical Director, Access MediQuip LLC, Lake Mary, FL

"The hallmarks of an effective and efficient product alert and recall process include:

1. Pre-defined roles (who monitors for recalls, who manages recalls for each specific type of product or department);

2. Some system for timely notification;

3. A way to close the loop to confirm that all areas have processed the recall;

4. Some way to store that information so it can be readily accessed (e.g., in the event of an FDA notification audit);

5. A process or system for an escalated, fast response to product issues: the ones that pose serious, immediate risk to patient safety."

– Amie Hollis, Recall Coordinator, Vanderbilt University Medical Center, Nashville

"In the absence of a process, no technology will work. New, unique software allows for an automated process to work seamlessly.

1. An independent electronic notification service for alerts and recalls.

2. A interdepartmental social network to support collaboration and to minimize duplication of effort.

3. Inventory searching capability.

4. Facilities can no longer afford not to have or perform the above items. The risks to patients and the facility are too high.

The cost of not implementing these technologies comes in two forms.

1. Either safety alerts are not effectively managed exposing the organization to unnecessary risk.

2. Higher effort is required to accomplish effective safety alerts management as result of manual distribution of alerts, duplication of effort due to decentralized information, and additional effort needed to centralize documentation."

– Eric Sacks, Director, Healthcare Product Alerts, ECRI Institute, Plymouth Meeting, PA

Experts are mixed about the need for technology to manage an effective, if not efficient, product recall alert system.

"No facility can afford to be without an organized monitoring system," NRAC’s Cohen insisted. "Whether it is paper-based, computer-based or merely file-based, it is absolutely critical that, regardless of cost, there be a system in place at all times."

But that’s not enough. Neither is a single source of information.

"No facility can rely solely on manufacturers and distributors for their recall information," Cohen continued. "Nor can they solely rely on the FDA’s Enforcement Report since the products listed are often out-of-date and the information is no longer effective or timely."

And despite the prevalence of ‘search bots’ that troll online for desired content nothing like that exists in the healthcare arena, according to Cohen. "Unfortunately, there is no current system or ‘bot’ that will automatically search recall data against hospital’s inventory," he confirmed.

"Though it is not necessary to have a computer tracking system, and certain facilities can get away with not having such a system, it is still important to have some type of compilation service that reports on recalls in a timely and accurate fashion," Cohen added. "Moreover, if such a service were to provide for support, then that service is almost the same as a back office for the hospital."

Access MediQuip’s Arnold countered that hospitals cannot and should not shortchange their prompt responses to recalls due to funding. "The answer is a firm ‘no,’" Arnold said. "Budget concerns or cuts cannot compromise a facility’s ability to respond quickly and properly when a recall is announced. It is a matter of patient safety — and potentially a patient’s life. No amount of savings is worth jeopardizing care and protecting patients. The savings that a facility may achieve through not using or investing in technology and services that help ensure a proper and complete recall process will be lost the moment the facility puts patients’ well-being in danger due to an inadequate and incomplete response to a recall."

The first step in solving this is to speak the same language in the form of global standardization and serialization of data, according to Frequentz’s Lucas.

"The adoption of global standards in the form of a unique identifier number, such as GS1’s GTIN is the essential element to safeguarding patients from counterfeit, substandard and contaminated drugs," he urged. "GTINs also provide a business benefit to hospitals by allowing them to monitor their inventory levels for drugs, devices and plasma/blood. Further, hospitals can leverage GTINs for traceability, authentication and validation of drugs/products used in clinical trials as well as elements used in their discovery centers."

Furthermore, global standards can establish a platform where serialization, traceability and authentication can catch duplicate and unauthorized serial numbers and allow stakeholders to verify supply chain history of each product, Lucas continued, and reduce potential recalls prior to the product entering the hospital. "The healthcare supply chain is complex and fragmented," he added. "No one single segment or stakeholder can resolve the issue of recalls prior to patient safety being harmed. Consequently, we need an integrated process across supply chain for seamless, effective and efficient recalls."

Miles to go

Despite the lack of standards and in spite of the automated electronic systems currently available, experts and observers concede that the recall alert process can be improved.

"Several hospitals are still missing track-and-trace technology, which is implemented in either the drug or product development process," Lucas said. "Hospitals are a critical part of that process, and during a recall, track-and-trace technology allows hospitals to trace the location of the malfunctioning or contaminated components of that product. Track-and-trace technology holds important data that is critical for resource-strapped hospitals in a product recall. The technology arms affected hospitals and facilities with the appropriate data needed to effectively implement a recall. Without it, every hospital, whether it’s affected or not, must devote resources to that recall."

Edwards called for "a unified system for an effective and efficient recall process that is consistent across the board, unlike other industries," he said. "For instance, food recall notices go to the buyers, but in the healthcare industry notification isn’t specified and can go to anyone from the risk manager or the materials manager to the head of pharmacy or the director of surgery."

The industry needs "a reliable, secure, and automated process that avoids human error in identifying inventory that is affected by a recall or alert," Sacks indicated. "ECRI Institute has just released a new service called Automatch that compares alerts on medical supplies to a hospital’s purchase history. It automatically flags alerts regarding products that the hospital has purchased and lists purchase details such as facility, department, and purchase date on the alert in the hospital’s Alerts Tracker system."

Cohen stressed that healthcare facilities use "some recall warning alert service and not rely strictly on either the FDA and/or waiting for manufacturers’ notifications. When it comes to identifying and removing defective products under recall, as well as for the patients’ safety, for the hospitals’ risk management considerations, for liability and accreditation concerns and much more, it is critical that a tracking and reporting, monitoring and closed-loop service be used. However, using more than one such service may be overdoing it and could, in truth, lead to alert fatigue due to redundancies that are both unnecessary and a time waster for hospital personnel."

Hollis instilled some context and reason into the debate.

"There’s no need to recreate the wheel," she insisted. "Each facility is unique, but the effective and efficient processes are basically the same and can be tailored to fit the facility’s needs. Reach out to hospitals that have these processes in place. When we launched our system we had invaluable guidance and recommendations from other hospitals. Regardless of the system you use, it will always need to adapt and change to stay up-to-date. Use each major recall situation as an opportunity to learn. What worked? What didn’t work? What do we wish we had at hand at the time?"

Product alert, recall pain points

What do healthcare industry experts and observers identify as challenges and problems with product alerts and recalls? Read on.

• Redundancy of alerts.

• Too many individuals involved and "tripping" over each other in a non-organized and non-systematic way.

• Missing a recall (if a Class I, in particular) with disastrous potential results.

• Accountability and currency of the particular products being recalled.

• Ability to track with reporting capability.

– Dr. Mark Cohen, Founder and Managing Trustee,
National Recall Alert Center (NRAC), Washington

There are a number of important areas a facility must address for an effective and efficient product alert and recall process. Here are several questions a facility needs to be able to answer with a confident "yes."

• Is there a system in place for the facility to learn about recalls as soon as they are announced (i.e., as soon as possible)?

• Are there policies and procedures in place — and ones that have been tested — to effectively respond to a recall? Do the individuals who receive recall information on behalf of the facility understand the policies and procedures and have the support of leadership to execute the policies and procedures as soon as recall information is received?

• Does the facility have an effective method to identify and inform affected patients of the recall, either individually or communitywide (through the local media)?

• Are staff members informed about how they should respond to questions from patients — past, present and future — about recalled devices?

• If the facility borrows equipment and devices from another facility, is there a process in place for the lending facility to inform the receiving facility of recall information provided by the manufacturer to the lender?

– Steven Arnold, M.D., Chief Medical Director,
Access MediQuip LLC, Lake Mary, FL

Recall processes and product alerts present several challenges. At ExpertRECALL, we suggest focusing on the following:

• Multiple points of communication. The industry lacks a standardized key contact person for all recalls, making multi-modal communication key to implementing an effective and efficient recall. We’ve seen instances where the one key contact is on vacation, returning to initiate the recall a week later. In the past, we’ve also been brought in during the midst of a recall only to learn that a company had only contacted one point person at a hospital. When we suggest increasing the number of people who receive communications, we’ve been able to triple the response rate of the event.

• Clearly defined roles and responsibilities. The best recall plans for hospitals identify a recall team and outline their roles when a recall strikes. For instance, you want to make sure you think through every location where an affected product could be and someone confirms that the affected product has been removed from every floor, every ward and every hospital cart. It sounds obvious, but we’ve been brought in after a recall has closed, only to find a recalled prescription drug still on a cart and potentially headed to a patient. That’s why it’s critical to define roles and responsibilities.

• Management of inventory systems. Making sure your house is in order before the storm can save valuable time when a major recall strikes. If you aren’t sure how much product you have, it will be difficult to make sure the entire amount of affected product is removed from your inventory and that your patients are 100 percent safe.

• Coordinate with satellite offices. The growth of hospitals and satellite offices increases the complexity of the recall and retrieval process. For instance, a hospital branch with 10 — 15 physicians at a smaller office, as well as its own small pharmacy, presents a communication challenge that needs to be accounted for in a recall plan.

• Keeping recall plan up to date. Hospitals have high turnover, a trend that will likely continue as job opportunities remain abundant. With this in mind, a hospital should test its recall plan at least every 12 months, as roles and responsibilities have likely changed. This will keep hospital staff knowledgeable of their defined roles and responsibilities so the team functions smoothly when a major recall strikes.

– Steve Edwards, Senior Recall Strategist, ExpertRECALL, Indianapolis

• Patient Safety comes first. It can be challenging to start building a process for managing recalls, because you quickly learn that there are far, far more of them than you knew. So you’re asking staff to add new roles and responsibilities to their existing workflow. Maintaining the focus on patient safety helps ease that transition.

• Clearly defined roles and responsibilities. From the hospital’s perspective, think of all the steps that would need to happen in order to meet those hallmarks of a good process.

• Where to start. Search your organizational memory for a big product recall, like the mass recall of Heparin a few years ago, and work backwards. How did you find out? Who was notified? Who did what? What worked, and what didn’t?

• Not enough information. As you get deeper into the process, you paradoxically learn a lot about the information you don’t have at hand when you get a recall notice. Is there a date on the letter? Are the recalling company’s contacts clearly indicated? Is there any guidance as to whether there’s a direct threat to patient safety, or what that threat is, or whether you should notify patients? You may want to start working with your suppliers so that they’re familiar with your system and know the information that you need right away.

• Too much information. At its most robust, your recall systems and processes are going to be turning up a lot of recalls that don’t affect you. On average, my facilities find affected product less than 10 percent of the time. Over time, you can implement filters of certain information and work with your suppliers to get more targeted information. The silver lining is that your recall process and system and team have plenty of practice for the day that big recall, which will affect a lot of people, comes through the door.

– Amie Hollis, Recall Coordinator,
Vanderbilt University Medical Center, Nashville

• Missed or late alert notification.

• Failure to find affected product.

• Labor involved in identifying recalled products.

• Duplication of effort.

• Poor compliance by staff responsible for alert review and resolution.

– Eric Sacks, Director, Healthcare Product Alerts,
ECRI Institute, Plymouth Meeting, PA