Product Quality and Safety
At Hillrom, the issue of product quality is larger than a program and it is more than a process – it is the promise we make every day to our customers. Quality matters in everything we do, everywhere, all the time.
Keeping this promise means Hillrom takes responsibility for being the company people count on to make things right. That translates to zero tolerance for products and services that do not meet our standards and 100 percent engagement from the employees of Hillrom – from the factory floor to the executive suite.
Hillrom’s products are divided into three business segments:
Patient Support Systems – globally provides our med-surg and specialty bed systems and surfaces, safe patient handling equipment and mobility solutions, as well as our clinical workflow solutions that deliver software and information technologies to improve care and deliver actionable insight to caregivers and patients.
Front Line Care – globally provides patient monitoring and diagnostic technologies, including a diversified portfolio of physical assessment tools that help diagnose, treat and manage a wide variety of illnesses and diseases, as well as a portfolio of vision care and respiratory care devices.
Surgical Solutions – globally provides products that improve surgical safety and efficiency in the operating room including tables, lights, pendants, positioning devices and various other surgical instruments and accessories.
Hillrom does not develop, manufacture or market any drugs, conduct clinical trials or outsource clinical trials to any third party, and we do not conduct any animal testing or outsources animal testing to any third party.
Quality & Safety Program Management
The Senior Vice President of Quality Assurance and Regulatory Affairs is responsible for product quality and safety across all Hillrom operations. The Senior Vice President of Quality Assurance and Regulatory Affairs is a member of the Executive Leadership Team, led by Hillrom's CEO, and has direct reports who have focused responsibility on product safety (Vice President, Medical Affairs) and product quality (Vice President, Quality Operations).
Quality Management System
Hillrom's Executive Leadership Team has established and maintains a Quality Management System that, as appropriate, complies with the requirements of current versions of the ISO 13485 and the EN ISO 13485 standard; the ISO 9001 standard, the U.S. Food and Drug Administration Quality System Regulation (21 CFR 820), the European Union Medical Device Directive (93/42/EEC), Health Canada Medical Devices Regulations (SOR/98-282), Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169), Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), China Good Manufacturing Practices (CFDA 2014 No. 64 Announcement) and Good Supply Practices (CFDA 2014 No. 58 Announcement); and/or other applicable local, state, national and international regulations where applicable (i.e. ISO 17025 - General requirements for the competence of testing and calibration laboratories; ISO 14001 – Environmental Management Systems; OIML non-automatic weighing instruments; applicable cybersecurity standards).
All of Hillrom's design and manufacturing locations maintain active quality management certifications, dependent on the type(s) of medical devices for which the location is responsible. All certifications are externally certified by a notified body, which requires annual audits and/or inspections.
Each Hillrom™ product undergoes appropriate levels of product testing prior to shipment. Through the design and manufacturing process, Hillrom™ products are tested for safety, cybersecurity vulnerabilities, usability and performance, to a level of reliability and confidence based on the risk profile of the product using various product volumes, duration and frequency of testing. The methodology used by Hillrom is based on statistical procedures for the medical device industry written by Dr. Wayne Taylor, a leading expert on acceptance sampling in the pharmaceutical, medical device and diagnostics industries. Procedures to control and verify minor, moderate, and major design changes are established and documented.
Every Hillrom employee is assigned training on an annual basis that covers quality management principles and how they apply to the business, ensuring Hillrom's world class standards in product quality and safety.
Quality Control and Product Recalls
Hillrom has developed a post-market surveillance process that evaluates data from a variety of sources to monitor all product adherence to published marketing, advertising and sales guidelines. This evaluation is performed on an annual basis (or sooner in the case of a safety recall or significant incident) as a part of Hillrom's Clinical Evaluation Reporting process for the collection, analysis and assessment of clinical data to verify the safety, performance and benefits of every Hillrom medical device. Sources of data reviewed and evaluated include the following: clinical literature databases, clinical trial databases, safety registries, adverse event databases, and internal data sources (customer complaints, risk management files, trending, pre-clinical test reports, and post-market clinical follow ups).
In the event that our post-market surveillance process identifies a risk, Hillrom has developed a field action process that determines if a recall action needs to be taken, identifies the steps necessary to investigate and approve such an action, and defines subsequent steps required to identify if the field action is required to be reported to regulatory agencies. The field action process is governed by the Corporate Field Action Committee that is chaired by the Senior Vice President of Quality Assurance and Regulatory Affairs and consists of representatives from Legal, Finance, Marketing and Service.
Supply Chain Quality and Safety
Hillrom medical device, medical device accessory and critical suppliers are expected to acknowledge Hillrom’s quality standards through signing of a Quality Agreement.
Hillrom monitors direct and indirect suppliers for quality performance through routine auditing of approved suppliers and monitoring of delivery performance data. Requests for corrective action are issued to suppliers with product quality issues and tracked by Hillrom until the issue is adequately resolved. If the issue pertains to a sub-tier supplier affecting final product quality, Hillrom requires our first-tier supplier drive actions through resolution at the sub-tier supplier. As needed, Hillrom engages with our suppliers at all tiers to help with problem solving.
Hillrom's Sourcing team has regular business reviews with suppliers, where our quality and safety standards are emphasized, in our endeavor to drive excellence in supplier performance metrics, including on-time delivery and reduction in supplied defective parts per million.
Hillrom is an active member of the Advanced Medical Technology Association (AdvaMed), a trade association that leads the effort to advance medical technology in order to achieve healthier lives and healthier economies around the world. AdvaMed is influential in shaping legislative direction to promote better quality and safety in the supply chain. Recent examples of its activities include providing feedback to the FDA on the Quality, Safety and Effectiveness of Servicing of Medical Devices in Accordance with Section 710 of the Food and Drug Administration Reauthorization Act, Availability of Masked and De-Identified Non-Summary Safety and Efficacy Data, and Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.