Legal and Regulatory Issues

Chapter Outline
Product Liability 339
Manufacturer’s Warranty 339
Medical Equipment Management 340
- Risk Management and Maintenance 340
- Biomedical Engineering Services 340
- Regulation of Medical Devices 341
Classification of Devices 341
Premarket Approval Application 341
- Investigational Device Exemption 341
Good Clinical Practices 342
Premarket Notification [510(k)] 342
Substantial Equivalence 342
Anesthesia and Respiratory Advisory Committee 342
Medical Device Reporting 342
Medical Device Recall 342
Voluntary Standards 343

With the increasing complexity of anesthesia equipment, the practitioner is ever more reliant on biomedical engineering, information technology, and regulatory and risk management activities to ensure the safe operation of equipment used in the delivery of anesthesia. Equipment such as anesthesia machines, which were once relatively simple to maintain and troubleshoot, now far exceed most practitioner’s technological understanding and require extensive in-servicing to operate and special training to service. This chapter will review some of the legal and regulatory issues relevant to medical device safety.

Product Liability

Equipment failure is the primary cause of the minority of critical events during anesthesia; however, a great deal of attention is paid to this concern. Human error is more frequently the most important causative factor of misadventure, medical or otherwise. Focus continues to be placed on equipment malfunction for several reasons. It does appear that it is easier to prevent equipment failure than human error. Practitioners may welcome an opportunity to spread the responsibility for bad outcomes by pointing to the devices on which they depend. Plaintiff’s attorneys may also favor including device manufacturers in lawsuits because of their potential “deep pockets.” Lastly, there is the view that regulatory guidance encourages device manufacturers and users to maintain a focus on patient safety in a competitive and fast-paced environment. Regardless of the reasons, legal and regulatory constraints will continue to be placed on device manufacturers and the healthcare facilities that use their products, even though equipment is not the primary cause of most anesthesia critical events.

Device manufacturers and users share the responsibility for ensuring the safe operation of medical equipment in the care of patients. The users, including practitioners and healthcare facilities, are responsible for routine maintenance, compliance with manufacturer’s product advisories and recalls, and appropriate application of medical equipment as described and defined by the manufacturer. Manufacturers must remain in compliance with FDA requirements, including timely reporting of medical equipment-related patient complications and maintaining manufacturing standards.

Manufacturer’s Warranty

Warranties can be classified as either express or implied. Express warranties are those with which we are all most familiar and are generally a written promise made by the seller to stand behind the product and correct problems should it fail. Such a warranty creates a strict liability for the seller. The Federal Trade Commission (FTC) requires that written product warranties explicitly contain all the elements listed in Table 26-1 . Implied warranties are unstated promises, created by state law, that are based on the common law principle of “fair value for money spent.” Almost all states have adopted some form of the Uniform Commercial Code (UCC), which holds that there are implied warranties that are automatically part of every sales transaction. These warranties cover “merchantability” and “fitness for a particular use.” A manufacturer may expressly disclaim implied warranties. Such disclaimers must be made conspicuous through means such as bold or large type. Manufacturers are not required to provide express warranties in the United States, but healthcare organizations often require express warranties with a specific duration for products to be considered for purchase.

Table 26–1

Elements of an Express Warranty

1.

Who is covered
2.

Length of warranty
3.

Description of what is covered and/or excluded
4.

Steps for customer to follow in the event of a warranty-related problem
5.

Warrantor’s response to malfunctions and failures
6.

Exclusions and limitations
7.

Statement that some states do not allow exclusion and limitations
8.

Statement of consumer legal rights
9.

Any permitted limitations on length of implied warranties

A product’s express warranty, also known as a written warranty, delineates the manufacturer’s explicit responsibilities and guarantees that the covered device meets all relevant specifications such that it will function properly in the defined environment and fulfills its intended purpose. Warranties also state conditions in which the equipment cannot be expected to function properly and various operating conditions that will invalidate the warranty and thereby reduce the manufacturer’s responsibility. Purchasers, users, and patients are all entitled to sue if the terms of the warranty are not met. Manufacturers, distributors, and retailers can all be liable for breach of warranty although the manufacturer is generally most likely to have to pay damages. The other parties become more vulnerable if the manufacturer goes bankrupt.

Express warranties are of two types. Full warranties must meet five criteria specified in FTC regulations, including full money back or replacement, prompt and free repairs, prompt refund if repairs are not fully satisfactory, and customer need only to report the defect and all implied warranties are acknowledged. Limited is the other type of express warranty and must be prominently labeled as such. For example a limited warranty may be good for a limited amount of time or require the customer to ship the product to an approved service center for repair. The distinctions between various forms of warranty vary from state to state and it falls upon the purchaser to read all the products documentation and to understand what is covered (caveat emptor).

Medical Equipment Management

The Joint Commission, formerly known as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), promulgates standards for the inspection, testing, maintenance, and risk management of medical equipment within the healthcare environment. Each accredited healthcare organization must maintain a program for managing medical equipment to fulfill those standards.

Risk Management and Maintenance

The objective of the Medical Equipment Management Program (MEMP) should be to minimize the risk of using medical equipment in patient care by inspection and routine preventive maintenance. The MEMP should also provide for education and in-service training for those who use and maintain the equipment. The Joint Commission’s elements of performance for medical equipment risk management are summarized in Table 26-2 and those for maintaining equipment are summarized in Table 26-3 (see ref. 7, EC.02.04.01 and EC.02.04.03). Note that the Safe Medical Devices Act of 1990 requires healthcare organizations to report all incidents in which medical equipment is thought to be involved in serious injury, illness, or death of a patient (see the Medical Device Reporting section ).

Table 26–2

Joint Commission’s Standards for Hospital Medical Equipment Risk Management

1.

Solicit input from those who operate and service equipment in selection and acquisition.
2.

Maintain written inventory of all medical equipment or at least selected equipment associated with physical risk (life support). Maintain equipment incident history. Evaluate new equipment before use and determine if it should be on the inventory.
3.

Identify and document activities for maintaining, inspecting, and testing for all inventoried medical equipment.
4.

Identify and document frequency for inspecting, testing, and maintaining all inventoried medical equipment based on manufacturer’s recommendations, risk levels, and recent hospital experience.
5.

Monitor and report all incidents in which medical equipment is suspected in or attributed to a death, serious injury, or serious illness as required by the Safe Medical Devices Act of 1990.
6.

Document procedures to follow when medical equipment fails, including emergency clinical interventions and backup equipment.