Total recall striving for prime-time
available, emerging among manual processes
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
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
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
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 —
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.
"It has to be about a culture of safety,"
indicated Eric Sacks, Director, Healthcare Product Alerts,
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
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
"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
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
"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.
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
"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
"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."
Step-by-step recall alert
Industry experts and observers share their tips for an effective
and efficient product recall alert process.
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."
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).
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
roles (who monitors for recalls, who manages recalls for each
specific type of product or department);
2. Some system for
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
"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.
interdepartmental social network to support collaboration and to
minimize duplication of effort.
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
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
– 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
"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?"