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Recall Management in Sydney: The Basics

  • Writer: mmw3 degrees
    mmw3 degrees
  • May 13, 2022
  • 5 min read



Following best practices in the recall management process is one crucial area where patient safety can be dramatically enhanced. Product recalls can easily evolve into a disaster without a proper process and the right tools, affecting care delivery, patient safety and putting the hospital under a lot of financial strain.


Food manufacturers, prescription medications and automobiles follow a set procedure for dealing with product recall management. It is critical that hospitals follow suit. Hospitals will be prepared for recalls when they occur by having operational, legal and public relations plans in place, as well as identifying recall teams and their tasks.


Understand Recall Management Process

Thousands of biomedical tools and gadgets, medications, blood products, biologics and medical supplies are used every day in healthcare institutions. Mistakes, tampering, contamination, labelling errors and counterfeiting are all possible problems that might warrant a recall for any product.


The Therapeutic Goods Administration (TGA) is the Australian regulatory authority in charge of ensuring the safety and efficacy of food, pharmaceuticals and cosmetics. According to TGA guidelines, products that are mislabelled, faulty, or potentially hazardous must be recalled if they violate the law. Product recalls are evaluated, classified, monitored and audited by the TGA.


Recalls are usually voluntary and occur when a firm detects a defect in a product and notifies the TGA. In some cases, a manufacturer will recall a product after the TGA has raised concerns. This action could be taken when the government inspects a manufacturing plant or investigates health-related complaints. The TGA may "request" a recall in exceptional circumstances.


Recall management techniques should be implemented consistently, including:


● Forming Recall teams.

● Widely distributing recall notices as soon as possible.

● Tracking all recall communications and activities.


The TGA's responsibility is to manage the company's recall plan, regardless of the reason for the recall. The TGA's assessment of the health hazard aids companies in determining how to communicate the hazards connected with a recalled product.


The TGA considers the depth of the recall, the extent of public warnings required and if the recall will be expanded to wholesale, hospital, pharmacy, retail, patient, or consumer levels when examining a company's proposed recall strategy. A nationwide news release or a letter to the consumer or user group may be used to notify the general public.


However, it should be noted, that the TGA is not engaged in every recall. Many recalls are issued by the manufacturer on their own initiative and are not reported to the TGA. As a result, the TGA's websites do not cover every recall that occurs each year.


Creating a Recall Management Team

Due to the number of products they handle, medical equipment specialists and materials management personnel are often the best informed about recall activities in most hospitals. These experts should share their knowledge with other departments and assist in the formation of a cross-departmental recall management team that includes risk management, patient safety, physicians and the executive community. When the recall has an impact on care delivery or requires patient notification, the team should be enlarged to include clinical, legal and communication departments.


Recall management activity should be reported on a monthly basis to provide insight into areas where process improvements can be made. If these departments are not represented on the recall team, this information should be shared with the recall management team, executive management and other departments such as risk management or the patient safety committee. These reports should, at the very least, include the following information:


● The number of alerts that the department has received.

● The number of alarms that the hospital must respond to.

● The time it takes from when an alert is received until closure steps are completed.

● When appropriate, the number of patients who have been or may be affected.

● The number of products that have been found for return or replacement.


The Tool Chest

Equip your recall management team with a variety of tools to ensure a successful recall. Workflow diagrams, thorough coordination checklists, a recall team employee directory and a policy and procedure manual should all be in your toolbox. Staff roles and duties should be captured in the tools, as well as a staffing and action plan for addressing weekend recalls.


Sharing the News of the Recall Management Activity

Manufacturers and distributors can send recall alerts to hospitals by fax, certified mail, ordinary letters and e-mail. Other times, sales agents or websites inform hospital employees of recalls.


To simplify communication channels, hospitals should write down their recall procedures and policies and distribute them to all vendors and distributors. To aid with product tracking, request that vendors include product, lot and serial numbers on invoices. Also, be sure that your vendor purchase agreements name the person, department, or service in charge of your facility's recall notifications.


Optimising Storage Practices

It's critical to be able to immediately identify products that are affected. Store things so that model, lot and serial numbers are easily available to enable these actions. Ascertain that relevant members of the recall team have the authority to search inventory systems to see if the product was purchased by the hospital. Inventory look-up and product identification will be aided by developing a system-wide consistent nomenclature for inventories. Items that reach the hospital through alternate purchasing methods should be tracked in databases and logbooks. To locate items and amounts, integrate the usage of bar code scanners or automated supply systems.


Product Returns & Replacement

The reply card from the manufacturer is a key part of the recall procedure. The instructions on this card or the linked letter are for employees to ensure correct credit and compensation when applicable. Returning the product to the source, returning the goods to the distributor or manufacturer, or destroying the product is the three most common choices.


Even if you don't have the product in stock, your employees should be taught to fill out the product return reply card and return it. The TGA assesses the recall's success based on card return rates and recalling companies use this data for product reconciliation. As part of the comprehensive recall record, a copy of the reply card should be kept.

Educating and Communicating

The number of recalls appears to be increasing each year, according to historical data. With the number of recalls on the rise, it's a good idea to include your company's recall management strategies in new employee orientation sessions. Conduct annual in-services and proficiency exams to ensure that your employees are comfortable with the tools and those recall activities and documentation are as complete as possible.


The Complete Package

The first step towards effective recall management is to have well-defined recall processes and an active recall management team in Sydney. Combining strategy with tools and proven best practices allows hospitals to manage recalls more efficiently and effectively, while also reducing patient exposure to potentially unsafe items. Organizational efficiency, reduced alert processing time and top-notch patient safety outcomes are all advantages of a well-organized recall programme.

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